History
# Registration date Revision Id
2 2018-07-27, 1397/05/05 73860
1 2017-11-08, 1396/08/17 24668
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  • Protocol summary

    Target: Investigation the effect of preoperation oral and infusion riched carbohydrate diet on postoperative nausea, vomiting and quality of recovery in laparascopic cholecystectomy surgery. In a randomized clinical trial, single blind (only patient), non-diabetic candidate patients administered to Rasoul Akram Hospital in 1396 for laparascopic cholecystectomy surgery considered in the study. After informed consent, patients are divided into 3 groups randomly by a non-independent researcher according to the computer number generator. Any group assign to receive a specific diet; Group 1: Infusion of 250 ml dextrose 10%, 2 hours before operation Group 2: 200 ml oral carbohydrate solution (25 gr dextrose), 2 hours before operation Group 3: control group with normal diet and no perception glucose and sugar. Last given meal to all groups is at 8 hours before operation and use of non-carbohydarte oral liquids are prevented 4 hours before surgery. All patients are preperdfor surgery in a same condition. Blood glucose of 3 groups is determined 2 hours before surgery right before study fluid infusion. During all stages of surgery, any patients of any groups will not receive any IV carbohydrate infusion. Anesthetic techniques are equal for every groups. The laparascopic surgery is the choice method for all patients. After surgery Acetaminophen 15 mg/kg, TID is infused for all patients and Plasil ampulla 10 mg altimately TID considered in case of nausea if needed. Any consumption of antiemetic or antianalgesic drugs must be recorded in type, dose and number of using. Blood sugar is evaluated immediately after surgery in recovery room and also in first day after operation at 8:00 AM. It is asked the patient to inform their desire to eat to be recorded. The severity of the pain is achived by Visual Analogue Scale (VAS) in 1, 6 and 24 hours after operation. The score of nausea and vomiting is also checked in 1, 6 and 24 hours after operation by using VAS in the first 24 hours after surgery. Quality Of Recovery questionnire (Includes 5 aspects: Patient support, Comfort, Emotions, Physical independance and Pain) will be given to the patients and according to the taken scores and data of every 3 groups, It wil be analized and compared . The camparison of effect of preoperation carbohydrate therapy on nausea and vomiting and quality of recovery after surgery according to the questionnire and measured indicators will be done.
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    هدف: بررسی اثر رژیم پرکربوهیدارت خوراکی و تزریقی قبل از عمل بر تهوع، استفراغ و کیفیت ریکاوری بعد از عمل در جراحی کوله سیستکتومی لاپاراسکوپیک. در یک مطالعه ی کارآزمایی بالینی تصادفی یک سوکور، بیماران غیردیابتی کاندید عمل جراحی کوله سیستکتومی لاپاراسکوپیک پذیرفته شده در بیمارستان رسول اکرم در سال 96 در مطالعه در نظر گرفته شدند. پس از اخذ رضایت نامه آگاهانه بیماران بطور تصادفی براساس جدول تصادفی (computer number generator) توسط یک محقق غیر وابسته به سه گروه تقسیم می شوند، مقرر شده است تا هر گروه رژیم خاصی را دریافت کند; گروه 1: تزریق 250 میلی لیتر محلول دکستروز 10% 2 ساعت قبل از عمل گروه 2: 200 میلی لیتر محلول کربوهیدرات خوراکی (25 گرم دکستروز)، 2 ساعت قبل از عمل گروه 3: گروه کنترل با رژیم معمولی و بدون دریافت گلوکز و قند آخرین وعده غذایی داده شده به هر سه گروه، 8 ساعت قبل ازعمل جراحی است و از مصرف مایعات خوراکی بدون کربوهیدرات 4 ساعت قبل از عمل جلوگیری می شود. همه ی بیماران با شرایط یکسان برای جراحی آماده می شوند. قند خون هر 3 گروه 2 ساعت قبل از عمل، دقیقا قبل از تزریق محلول مطالعه، اندازه گیری می شود. هیچ کدام از بیماران در هر سه گروه در طول تمام مراحل جراحی هیچ گونه کربوهیدرات تزریقی داخل وریدی دریافت نخواهند کرد. تکنیک های بیهوشی برای همه ی بیماران یکسان خواهد بود. جراحی لاپاراسکوپی برای همه ی بیماران روش انتخابی می باشد. بعد از عمل استامینوفن تزریقی با دوز 15 میلی گرم به ازای هر کیلوگرم، 3 بار در روز برای همه ی بیماران تزریق می شود و آمپول پلازیل 10 میلی گرم حداکثر سه بار در روز در صورت نیاز در مورد تهوع در نظر گرفته شده است. هرگونه مصرف داروی ضد تهوع یا ضد درد باید از نظر نوع، دوز و تعداد دفعات استفاده ثبت شود. قند خون فورا بعد از جراحی در اتاق ریکاوری و همچنین ساعت 8 صبح اولین روز بعد از جراحی ارزیابی می شود. از بیمار خواسته می شود تمایل خود را به غذا بعد از عمل جراحی اعلام نماید تا ثبت شود. شدت درد بر اساس Visual Analogue Scale) VAS) یک ساعت و 6 ساعت و 24 ساعت بعد از عمل بدست آورده می شود. میزان تهوع و استفراغ نیز به کمک VAS یک ساعت، 6 و 24 ساعت بعد از عمل چک می شود. در 24 ساعت اول بعد از عمل پرسنامه Quality Of Recovery (که شامل پنج جنبه patient support, comfort, emotions, physical independence, and pain می باشد ) در اختیار بیماران قرار داده خواهد شد و براساس امتیازهای بدست آمده و داده های هر 3 گروه، آنالیز و مقایسه خواهد شد. مقایسه ی تاثیر کربوهیدرات تراپی قبل از عمل بر تهوع و استفراغ و کیفیت ریکاوری پس از عمل بر اساس پرسشنامه و شاخص های اندازه گیری شده، انجام خواهد پذیرفت.
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    Investigation the effect of preoperation oral and infusion riched carbohydrate diet on postoperative nausea, vomiting and quality of recovery in laparascopic cholecystectomy surgery
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    بررسی اثر رژیم پرکربوهیدارت خوراکی و تزریقی قبل از عمل بر تهوع، استفراغ و کیفیت ریکاوری بعد از عمل در جراحی کوله سیستکتومی لاپاراسکوپیک
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    clinical single blind trial with control groupe divided into 3 parallel groups by an independent researcher according to the computer number generator.
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    کارآزمایی یک سویه کور و دارای گروه کنترل در 3 گروه موازی تقسیم شده براساس جدول تصادفی (computer number generator) توسط یک محقق مستقل
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    Selection of laparascopic cholecystectomy cases is performed in general surgery department of Rasoul Akram Hospital.In this single blind study,Participants remain unaware of a particular intervention group after obtaining informed consent and general introduction of study groups.Method;*Perception of Last meal 8h and prevention of use of non-carbohydarte oral liquids 4h before surgery.*The same condition of laparascopic surgery.*Check of BS 2h before surgery.*Perception of Acetaminophen 15 mg/kg,TID and Plasil ampulla 10 mg altimately TID if needed.*Check of BS in recovery room,also in first day after operation at 8:00 AM.*Recording the patient desire to eat,pain severity,N/V score by VAS in 1,6 and 24h after operation.*Completion the QOR questionnire at first 24h after surgery.
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    انتخاب نمونه های کوله سیستکتومی لاپاراسکوپی در بخش جراحی عمومی بیمارستان رسول اکرم(ص) انجام میگیرد. روش اجرا: دریافت اخرین وعده غذایی 8 ساعت و جلوگیری از مصرف مایعات خوراکی فاقد کربوهیدرات 4 ساعت قبل از عمل. شرایط یکسان جراحی لاپاراسکوپی چک قند خون 2 ساعت قبل از عمل، دقیقا قبل از تزریق محلول مطالعه بعد از عمل استامینوفن تزریقی با دوز 15 میلی گرم بر کیلوگرم، 3 بار در روز و آمپول پلازیل 10 میلی گرم حداکثر سه بار در روز در صورت نیاز چک قند خون در اتاق ریکاوری،همچنین ساعت 8 صبح اولین روز بعد از جراحی ثبت تمایل بیمار به غذا، شدت درد,میزان تهوع و استفراغ بر اساس VAS یک ساعت و 6 ساعت و 24 ساعت بعد از عمل تکمیل پرسنامه Quality Of Recovery در 24 ساعت اول بعد از عمل
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    Inclusion criteria: Elective laparascopic cholecystectomy for cholelithiasis; Informed consent of patient, Exclusion criteria: Acute cholecystitis and Urgent surgery; Patients with open cholecystectomy surgery; Diabetes mellitus; Hepatic and Renal failure; Chronic inflammatory bowel disease; Acute recent infectoion; Patient under corticosteroid therapy or Anabolic and Catabolic drugs; Stomach empeting disorders; Gastroesophageal reflux disease
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    معیار ورود: کوله سیستکتومی لاپاراسکوپیک انتخابی برای سنگ صفرا؛ رضایت آگاهانه ی بیمار معیار خروج: کوله سیستیت حاد و عمل اورژانس؛ بیماران مشمول عمل جراحی باز کوله سیستکتومی؛ دیابت شیرین؛ نارسایی کبدی و کلیوی؛ بیماری مزمن التهابی روده؛ عفونت حاد اخیر؛ ییماران تحت درمان با کورتیکواسترویید یا داروهای آنابولیک و کاتابولیک؛ اختلالات تخلیه معده؛ ریفلاکس گاستروازوفاژیال
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    Group 1: Infusion of 250 ml dextrose 10% Group 2: 200 ml oral carbohydrate solution(25 gr dextrose) Group 3: control group with normal diet and no perception glucose
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    گروه 1: تزریق 250 میلی لیتر محلول دکستروز 10% 2 ساعت گروه 2: 200 میلی لیتر محلول کربوهیدرات خوراکی (25 گرم دکستروز) گروه 3: گروه کنترل با رژیم معمولی و بدون دریافت گلوکز
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    nausea and vomiting and quality of recovery after surgery
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    تهوع، استفراغ و کیفیت ریکاوری بعد از عمل
  • General information

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    Not used
    Used
    Treatment
    Supportive
    N/A
    3
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    2017-10-23, 1396/08/01
    2018-01-21, 1396/11/01
    2018-03-20, 1396/12/29
    2018-09-23, 1397/07/01
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    2018-02-04, 1396/11/15
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    2018-10-12, 1397/07/20
    Investigation the effect of preoperation oral and infusion riched carbohydrate diet on postoperative nausea, vomiting and quality of recovery in laparascopic removal of gallbladder surgery
    Investigation the Effect of Preoperation Oral and Infusion Riched Carbohydrate Diet on Postoperative Nausea, Vomiting and Quality of Recovery in Laparoscopic Surgery of Gallbladder Removal
    Investigation the effect of preoperation oral and infusion riched carbohydrate diet on postoperative nausea ,vomiting and quality of recovery in laparascopic cholecystectomy surgery
    Investigation the Effect of preoperation oral and Infusion Riched Carbohydrate Diet on Postoperative Nausea, Vomiting and Quality of Recovery in Laparascopic Cholecystectomy Surgery
    Elective Laparascopic cholecystectomy for Cholelithiasis
    Informed consent of patient
    کوله سیستکتومی لاپاراسکوپیک انتخابی برای سنگ صفرا
    رضایت آگاهانه ی بیمار
    Acute cholecystitis and Urgent surgery
    Patients with open cholecystectomy surgery
    Diabetes mellitus
    Hepatic and Renal failure
    Chronic inflammatory bowel disease
    Acute recent infectoion
    Patient under corticosteroid therapy or Anabolic and Catabolic drugs
    Stomach empeting disorders
    Gastroesophageal reflux disease
    کوله سیستیت حاد و عمل اورژانس
    بیماران مشمول عمل جراحی کوله سیستکتومی به روش باز
    دیابت شیرین
    نارسایی کبدی و کلیوی
    بیماری مزمن التهابی روده
    عفونت حاد اخیر
    بیماران تحت درمان با کورتیکواسترویید یا داروهای آنابولیک و کاتابولیک
    ختلالات تخلیه معده
    ریفلاکس گاستروازوفاژیال
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    Participants remain unaware of a particular intervention group after obtaining informed consent and general introduction of study groups.
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    پس از کسب رضایت آگاهانه ی شرکت در مطالعه و معرفی کلی گروه های مطالعه، از قرارگیری در یک گروه خاص مداخله بی اطلاع می مانند.
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    The researcher who evaluates the results of intervention in patients after intervention is unaware of intervention type.
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    محققی که پس از مداخله, ارزیابی نتایج مربوط به مداخله در بیماران را برعهده دارد، از نوع مداخله بی اطلاع است.
  • Health conditions studied

    #1
    K81
    Cholecystitis
  • Secondary outcomes

    #1
    زمانی که بیمار اعلام تمایل برای خوردن غذا دارد
    زمانی که بیمار اعلام تمایل برای خوردن غذا را اعلام می کند
    #2
    مدت زمان بیهوشی
    مدت زمان بیهوشی
  • Intervention groups

    #1
    group 3: control group with normal diet and no perception of glucose and sugar.
    group 3: control group with normal diet and no perception of glucose
    گروه 3: گروه کنترل با رژیم معمولی و بدون دریافت گلوکز و قند
    گروه 3: گروه کنترل با رژیم معمولی و بدون دریافت گلوکز
  • Recruitment centers

    #1
    Name of recruitment center - English: Rasoul Akram Hospital
    Name of recruitment center - Persian: بیمارستان رسول اکرم
    Full name of responsible person - English: Parisa Hosseinpour
    Full name of responsible person - Persian: پریسا حسین پور
    Street address - English: Rasool Akram Hospital, Niayesh street, Satarkhan street
    Street address - Persian: خیابان ستارخان ، خیابان نیایش ، بیمارستان رسول اکرم 
    City - English: Tehran
    City - Persian: تهران
    Province:
    Country: Iran (Islamic Republic of)
    Postal code:
    Phone:
    Fax:
    Email:
    Web page address:
    Name of recruitment center - English: Rasoul Akram Hospital
    Name of recruitment center - Persian: بیمارستان رسول اکرم
    Full name of responsible person - English: Parisa Hosseinpour
    Full name of responsible person - Persian: پریسا حسین پور
    Street address - English: Rasool Akram Hospital, Niayesh street, Satarkhan street
    Street address - Persian: خیابان ستارخان ، خیابان نیایش ، بیمارستان رسول اکرم 
    City - English: Tehran
    City - Persian: تهران
    Province: Tehran
    Country: Iran (Islamic Republic of)
    Postal code: 1111111111
    Phone:
    Fax:
    Email: DR.PERSIA1990@GMAIL.COM
    Web page address:
    #2
    Name of recruitment center - English: Rasoul akram hospital
    Name of recruitment center - Persian: بیمارستان رسول اکرم
    Full name of responsible person - English: parisahosseinpour
    Full name of responsible person - Persian: پریسا حسین پور
    Street address - English: sattarkhan street, niayesh street
    Street address - Persian: خیابان ستارخان، خیابان نیایش
    City - English: tehran
    City - Persian: تهران
    Province: Tehran
    Country: Iran (Islamic Republic of)
    Postal code: 1111111111
    Phone: +98 21 6666 6666
    Fax:
    Email: dr.persia1990@gmail.com
    Web page address:
  • Sponsors / Funding sources

    #1
    contact.organization_id:
    Name of organization / entity - English: vice chanceller of research, Iran University of Medical Sciences
    Name of organization / entity - Persian: معاونت پژوهشی دانشگاه علوم پزشکی ایران
    Full name of responsible person - English: vice chanceller of research, Iran University of Medical Sciences
    Full name of responsible person - Persian: معاونت پژوهشی دانشگاه علوم پزشکی ایران
    Street address - English: Near Milad tower, Hemmat highway
    Street address - Persian: بزرگراه همت ، جنب برج میلاد
    City - English: Tehtan
    City - Persian: تهران
    Province:
    Country: Iran (Islamic Republic of)
    Postal code:
    Phone:
    Fax:
    Email:
    Web page address:

    Name of organization / entity - English:
    Name of organization / entity - Persian:
    Full name of responsible person - English: Parisa Hosseinpour
    Full name of responsible person - Persian: پریسا حسین پور
    Street address - English: Near Milad tower, Hemmat highway
    Street address - Persian: بزرگراه همت ، جنب برج میلاد
    City - English: Tehtan
    City - Persian: تهران
    Province: Tehran
    Country: Iran (Islamic Republic of)
    Postal code: 1111111111
    Phone: +98 21 8670 3359
    Fax:
    Email: php_111@yahoo.com
    Web page address:
    empty
    Public
    empty
    Domestic
    empty
    Academic
    vice chanceller of research, Iran University of Medical Sciences
    Vice Chancellor Of Research, Iran University of Medical Science
    #2
    contact.organization_id:
    Name of organization / entity - English: Vice Chancellor Of Research, Iran University of Medical Science
    Name of organization / entity - Persian: معاونت پژوهشی دانشگاه علوم پزشکی ایران
    Full name of responsible person - English: dr kazem malakouti
    Full name of responsible person - Persian: دکتر کاظم ملکوتی
    Street address - English: Near Milad tower, Hemmat highway
    Street address - Persian: fبزرگراه همت، جنب برج میلاد
    City - English: tehran
    City - Persian: تهران
    Province: Tehran
    Country: Iran (Islamic Republic of)
    Postal code: ۱۴۴۹۶۱۴۵۳۵
    Phone: +98 21 86701
    Fax:
    Email: PR@iums.ac.ir
    Web page address:
    empty
    Yes
    empty
    100
    empty
    Public
    empty
    Domestic
    empty
    Academic
    empty
    Vice Chancellor Of Research, Iran University of Medical Science
    empty
    معاونت پژوهشی دانشگاه علوم پزشکی ایران
  • Person responsible for general inquiries

    contact.organization_id:
    Name of organization / entity - English: Rasoul Akram hospital
    Name of organization / entity - Persian: بیمارستان رسول اکرم
    Full name of responsible person - English: Parisa Hosseinpour
    Full name of responsible person - Persian: پریسا حسین پور
    Position - English: Stager
    Position - Persian: استاجر
    Latest degree:
    Area of specialty/work: 0
    Area of specialty/work title - English:
    Area of specialty/work title - Persian:
    Street address - English: Rasool Akram Hospital, Niayesh Street, Satarkhan Street
    Street address - Persian: خیابان ستارخان،خیابان نیایش،بیمارستان رسول اکرم
    City - English: Tehran
    City - Persian: تهران
    Province:
    Province - English:
    Province - Persian:
    contact.provinces_available: 1
    Country: Iran (Islamic Republic of)
    Postal code:
    Phone: +98 930 257 7379
    Mobile: +98 930 257 7379
    Fax:
    Email: php_111@yahoo.com
    Web page address:

    Name of organization / entity - English:
    Name of organization / entity - Persian:
    Full name of responsible person - English: Parisa Hosseinpour
    Full name of responsible person - Persian: پریسا حسین پور
    Position - English: Intern
    Position - Persian: اینترن
    Latest degree: med_doctor
    Area of specialty/work: 88
    Area of specialty/work title - English:
    Area of specialty/work title - Persian:
    Street address - English: Rasool Akram Hospital, Niayesh Street, Satarkhan Street
    Street address - Persian: خیابان ستارخان،خیابان نیایش،بیمارستان رسول اکرم
    City - English: Tehran
    City - Persian: تهران
    Province: Tehran
    Province - English:
    Province - Persian:
    contact.provinces_available: 1
    Country: Iran (Islamic Republic of)
    Postal code: 1111111111
    Phone: +98 21 8670 3359
    Mobile: +98 21 8670 3359
    Fax:
    Email: Dr.parisahosseinpor@gmail.com
    Web page address:
  • Person responsible for scientific inquiries

    contact.organization_id:
    Name of organization / entity - English: Rasoul Akram Hospital
    Name of organization / entity - Persian: بیمارستان رسول اکرم
    Full name of responsible person - English: Parisa Hosseinpour
    Full name of responsible person - Persian: پریسا حسین پور
    Position - English: Stager
    Position - Persian: استاجر
    Latest degree:
    Area of specialty/work: 0
    Area of specialty/work title - English:
    Area of specialty/work title - Persian:
    Street address - English: Rasool Akram Hospital, Niayesh Street, Satarkhan Street
    Street address - Persian: خیابان ستارخان،خیابان نیایش،بیمارستان رسول اکرم
    City - English: Tehran
    City - Persian: تهران
    Province:
    Province - English:
    Province - Persian:
    contact.provinces_available: 1
    Country: Iran (Islamic Republic of)
    Postal code:
    Phone: +98 930 257 7379
    Mobile: 00
    Fax:
    Email: php_111@yahoo.com
    Web page address:

    Name of organization / entity - English:
    Name of organization / entity - Persian:
    Full name of responsible person - English: Parisa Hosseinpour
    Full name of responsible person - Persian: پریسا حسین پور
    Position - English: intern
    Position - Persian: اینترن
    Latest degree: med_doctor
    Area of specialty/work: 30
    Area of specialty/work title - English:
    Area of specialty/work title - Persian:
    Street address - English: Rasool Akram Hospital, Niayesh Street, Satarkhan Street
    Street address - Persian: خیابان ستارخان،خیابان نیایش،بیمارستان رسول اکرم
    City - English: Tehran
    City - Persian: تهران
    Province: Tehran
    Province - English:
    Province - Persian:
    contact.provinces_available: 1
    Country: Iran (Islamic Republic of)
    Postal code: 1111111111
    Phone: +98 21 8670 3359
    Mobile: +98 21 8670 3359
    Fax:
    Email: Dr.parisahosseinpour@gahoo.com
    Web page address:
  • Person responsible for updating data

    contact.organization_id:
    Name of organization / entity - English: Rasoul Akram Hospital
    Name of organization / entity - Persian: بیمارستان رسول اکرم
    Full name of responsible person - English: Parisa Hosseinpor
    Full name of responsible person - Persian: پریسا حسین پور
    Position - English: Stager
    Position - Persian: استاجر
    Latest degree:
    Area of specialty/work: 0
    Area of specialty/work title - English:
    Area of specialty/work title - Persian:
    Street address - English: Rasool Akram Hospital, Niayesh Street, Satarkhan Street
    Street address - Persian: خیابان ستارخان ،خیابان نیایش، بیمارستان رسول اکرم
    City - English: Tehran
    City - Persian: تهران
    Province:
    Province - English:
    Province - Persian:
    contact.provinces_available: 1
    Country: Iran (Islamic Republic of)
    Postal code:
    Phone: +98 930 257 7379
    Mobile: 00
    Fax:
    Email:
    Web page address:

    Name of organization / entity - English:
    Name of organization / entity - Persian:
    Full name of responsible person - English: Parisa Hosseinpor
    Full name of responsible person - Persian: پریسا حسین پور
    Position - English: intern
    Position - Persian: اینترن
    Latest degree: med_doctor
    Area of specialty/work: 30
    Area of specialty/work title - English:
    Area of specialty/work title - Persian:
    Street address - English: Rasool Akram Hospital, Niayesh Street, Satarkhan Street
    Street address - Persian: خیابان ستارخان ،خیابان نیایش، بیمارستان رسول اکرم
    City - English: Tehran
    City - Persian: تهران
    Province: Tehran
    Province - English:
    Province - Persian:
    contact.provinces_available: 1
    Country: Iran (Islamic Republic of)
    Postal code: 1111111111
    Phone: +98 21 8670 3359
    Mobile: +98 930 257 7379
    Fax:
    Email: Dr.parissahosseinpour@gmail.com
    Web page address:
  • Sharing plan

    undecided
    undecided
    undecided
    undecided
    undecided
    undecided
    undecided
    empty
    there is no more information
    empty
    اطلاعات بیشتری وجود ندارد

Protocol summary

Study aim
Investigation the effect of preoperation oral and infusion riched carbohydrate diet on postoperative nausea, vomiting and quality of recovery in laparascopic cholecystectomy surgery
Design
clinical single blind trial with control groupe divided into 3 parallel groups by an independent researcher according to the computer number generator.
Settings and conduct
Selection of laparascopic cholecystectomy cases is performed in general surgery department of Rasoul Akram Hospital.In this single blind study,Participants remain unaware of a particular intervention group after obtaining informed consent and general introduction of study groups.Method;*Perception of Last meal 8h and prevention of use of non-carbohydarte oral liquids 4h before surgery.*The same condition of laparascopic surgery.*Check of BS 2h before surgery.*Perception of Acetaminophen 15 mg/kg,TID and Plasil ampulla 10 mg altimately TID if needed.*Check of BS in recovery room,also in first day after operation at 8:00 AM.*Recording the patient desire to eat,pain severity,N/V score by VAS in 1,6 and 24h after operation.*Completion the QOR questionnire at first 24h after surgery.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Elective laparascopic cholecystectomy for cholelithiasis; Informed consent of patient, Exclusion criteria: Acute cholecystitis and Urgent surgery; Patients with open cholecystectomy surgery; Diabetes mellitus; Hepatic and Renal failure; Chronic inflammatory bowel disease; Acute recent infectoion; Patient under corticosteroid therapy or Anabolic and Catabolic drugs; Stomach empeting disorders; Gastroesophageal reflux disease
Intervention groups
Group 1: Infusion of 250 ml dextrose 10% Group 2: 200 ml oral carbohydrate solution(25 gr dextrose) Group 3: control group with normal diet and no perception glucose
Main outcome variables
nausea and vomiting and quality of recovery after surgery

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT2017090231324N3
Registration date: 2017-11-08, 1396/08/17
Registration timing: prospective

Last update: 2019-01-05, 1397/10/15
Update count: 1
Registration date
2017-11-08, 1396/08/17
Registrant information
Name
Seyed Hamzeh Mousavie
Name of organization / entity
Iran University Of Medical Science
Country
Iran (Islamic Republic of)
Phone
+98 912 296 7445
Email address
mousavie.sh@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chanceller of Research, IRAN University of Medical Sciences
Expected recruitment start date
2018-01-21, 1396/11/01
Expected recruitment end date
2018-09-23, 1397/07/01
Actual recruitment start date
2018-02-04, 1396/11/15
Actual recruitment end date
2018-10-12, 1397/07/20
Trial completion date
2018-10-12, 1397/07/20
Scientific title
Investigation the Effect of preoperation oral and Infusion Riched Carbohydrate Diet on Postoperative Nausea, Vomiting and Quality of Recovery in Laparascopic Cholecystectomy Surgery
Public title
Investigation the Effect of Preoperation Oral and Infusion Riched Carbohydrate Diet on Postoperative Nausea, Vomiting and Quality of Recovery in Laparoscopic Surgery of Gallbladder Removal
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Elective Laparascopic cholecystectomy for Cholelithiasis Informed consent of patient
Exclusion criteria:
Acute cholecystitis and Urgent surgery Patients with open cholecystectomy surgery Diabetes mellitus Hepatic and Renal failure Chronic inflammatory bowel disease Acute recent infectoion Patient under corticosteroid therapy or Anabolic and Catabolic drugs Stomach empeting disorders Gastroesophageal reflux disease
Age
From 18 years old
Gender
Both
Phase
3
Groups that have been masked
  • Outcome assessor
Sample size
Target sample size: 78
Actual sample size reached: 78
Randomization (investigator's opinion)
Randomized
Randomization description
Participants remain unaware of a particular intervention group after obtaining informed consent and general introduction of study groups.
Blinding (investigator's opinion)
Single blinded
Blinding description
The researcher who evaluates the results of intervention in patients after intervention is unaware of intervention type.
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Iran University of Medical Sciences
Street address
Near Milad tower, Hemmat Highway
City
Tehran
Province
Tehran
Postal code
1111111111
Approval date
2017-08-12, 1396/05/21
Ethics committee reference number
IR.IUMS.FMD.REC1395.9021216158

Health conditions studied

1

Description of health condition studied
Cholecystitis
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
nausea and vomiting score
Timepoint
1, 6 and 24 houre after surgery
Method of measurement
Visual Analogue Scale

2

Description
quality of recovery Score
Timepoint
1, 6 and 24 houre after surgery
Method of measurement
Quality Of Recovery Questionnaire

Secondary outcomes

1

Description
duration of hospitalization
Timepoint
duration of hospitalization after surgery
Method of measurement
patient hospitalization file

2

Description
blood sugar
Timepoint
2 houre before surgery, immediately after surgery and first day after operation at 8:00
Method of measurement
laboratory kit

3

Description
duration of recovery
Timepoint
duration of pateint recovery time
Method of measurement
interview and inspection

4

Description
pain score after surgery
Timepoint
severity of pain at 1, 6 and 24 hour after surgery
Method of measurement
Visual Analogue Scale

5

Description
strat of starving
Timepoint
the time of patient desire to eat
Method of measurement
interview

6

Description
duration of anesthesia
Timepoint
duration of patient anesthesia after surgery
Method of measurement
nursery records and inspection

7

Description
Surgery Complications
Timepoint
Any complication after surgery such as: Bleeding, Ulcer infection, Ileus, Pnomonia ...
Method of measurement
Patient File

8

Description
the amount of analgesic drug administered
Timepoint
after surgery
Method of measurement
patient file

9

Description
the amount of anti nausea drug administered
Timepoint
after surgery
Method of measurement
patent file

10

Description
past medical history(diseae history)
Timepoint
any disease during surgery
Method of measurement
interview

Intervention groups

1

Description
group1: 250 ml dextrose 10% infusion 2 hours before surgery
Category
Treatment - Other

2

Description
group2: 200 ml oral carbohydrate solusion (includes 25 gram of dextrose 10%), 2 horse before surgery
Category
Treatment - Other

3

Description
group 3: control group with normal diet and no perception of glucose
Category
Treatment - Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Rasoul Akram Hospital
Full name of responsible person
Parisa Hosseinpour
Street address
Rasool Akram Hospital, Niayesh street, Satarkhan street
City
Tehran
Province
Tehran
Postal code
1111111111
Phone
Email
DR.PERSIA1990@GMAIL.COM

2

Recruitment center
Name of recruitment center
Rasoul akram hospital
Full name of responsible person
parisahosseinpour
Street address
sattarkhan street, niayesh street
City
tehran
Province
Tehran
Postal code
1111111111
Phone
+98 21 6666 6666
Email
dr.persia1990@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Parisa Hosseinpour
Street address
Near Milad tower, Hemmat highway
City
Tehtan
Province
Tehran
Postal code
1111111111
Phone
+98 21 8670 3359
Email
php_111@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor Of Research, Iran University of Medical Science
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

2

Sponsor
Name of organization / entity
Vice Chancellor Of Research, Iran University of Medical Science
Full name of responsible person
dr kazem malakouti
Street address
Near Milad tower, Hemmat highway
City
tehran
Province
Tehran
Postal code
۱۴۴۹۶۱۴۵۳۵
Phone
+98 21 86701
Email
PR@iums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor Of Research, Iran University of Medical Science
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Parisa Hosseinpour
Position
Intern
Latest degree
Medical doctor
Other areas of specialty/work
Others
Street address
Rasool Akram Hospital, Niayesh Street, Satarkhan Street
City
Tehran
Province
Tehran
Postal code
1111111111
Phone
+98 21 8670 3359
Fax
Email
Dr.parisahosseinpor@gmail.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Parisa Hosseinpour
Position
intern
Latest degree
Medical doctor
Other areas of specialty/work
General Practitioner
Street address
Rasool Akram Hospital, Niayesh Street, Satarkhan Street
City
Tehran
Province
Tehran
Postal code
1111111111
Phone
+98 21 8670 3359
Fax
Email
Dr.parisahosseinpour@gahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Parisa Hosseinpor
Position
intern
Latest degree
Medical doctor
Other areas of specialty/work
General Practitioner
Street address
Rasool Akram Hospital, Niayesh Street, Satarkhan Street
City
Tehran
Province
Tehran
Postal code
1111111111
Phone
+98 21 8670 3359
Fax
Email
Dr.parissahosseinpour@gmail.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
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