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Comparison of intrathecal administration of bupivacaine and fentanyl with bupivacaine and dexmedetomedine on postoperative analgesia in cesarean section

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History
# Registration date Revision Id
2 2020-03-31, 1399/01/12 127504
1 2020-02-15, 1398/11/26 121921
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  • Protocol summary

    This study was done at Shariati Hospital of Hormozgan University of Medical Sciences. Spinal anesthesia were done in the sitting position through the aseptic technique using 25 G Quincke spinal needle at the L4-5 interspace. After observing free flow of CSF, the patients were randomly allocated into two groups (n= 55) as follows: I.Group B-D received 10 mg hyperbaric Bupivacaine 0.5% + 5μg Dexmedetomidine [total volume of 2.5cc] II.Group B-F received 10 mg hyperbaric Bupivacaine 0.5% + 25 μg Fentanyl (ROTEXMEDICA 0.5 mg/10ml 22946TRITTAU. Germany) [total volume of 2.5cc] Then, the patients lied in the supine position. Hemodynamic parameters including systolic blood pressure, diastolic blood pressure, mean arterial pressure, heart rate and spo2 were recorded in 0 minutes (immediately after injection), 5-10-15-30-60 minutes and in recovery.
    This study will be done at Hormozgan University of Medical Sciences. Spinal anesthesia were done in the sitting position through the aseptic technique using 25 G Quincke spinal needle at the L4-5 interspace. After observing free flow of CSF, the patients will randomly allocated into two groups (n= 55) as follows: I.Group B-D received 10 mg hyperbaric Bupivacaine 0.5% + 5μg Dexmedetomidine [total volume of 2.5cc] II.Group B-F received 10 mg hyperbaric Bupivacaine 0.5% + 25 μg Fentanyl [total volume of 2.5cc] Hemodynamic parameters will be recorded in 0 minutes (immediately after injection), 5-10-15-30-60 minutes and in recovery.
    این مطالعه در بیمارستان شریعتی دانشگاه علوم پزشکی هرمزگان انجام گرفت. بی حسی اسپاینال در پوزیشن نشسته و با روش آسپتیک توسط متخصص بیهوشی با نیدل Quinke شماره 25واز فضای نخاعی L4-L5 تحت بی حسی اسپاینال قرار گرفتند و پس از رویت جریان آزاد CSF بیماران به صورت تصادفی به 2 گروه (55 نفری) به ترتیب زیر تقسیم شدند: 1.گروه بوپی واکائین- دکسمدتومیدین: دریافت کننده 10میلی گرم بوپی واکائین هایپرباریک 0.5%+5ماکروگرم (حجم کلی 2.5 سی سی) 2.گروه بوپی واکائین- فنتانیل: دریافت کننده 10 میلی گرم بوپی واکائین هایپرباریک+25 ماکروگرم فنتانیل (حجم کلی 2.5 سی سی) سپس همه بیماران در حالت خوابیده به پشت قرار گرفتند. پارامترهای همودینامیکی بیماران شامل فشار خون سیستولی، دیاستولی، فشار متوسط شریانی، ضربان قلب و درصد اشباع اکسیژن خون توسط پالس اکسیمتری علاوه بر مقادیر اولیه در دقایق صفر ( بلافاصله پس از تزریق) ، 5-10-15-30-60 دقیقه و در ریکاوری ثبت گردید.
    این مطالعه در دانشگاه علوم پزشکی هرمزگان انجام خواهد گرفت. بی حسی اسپاینال در پوزیشن نشسته و با روش آسپتیک توسط متخصص بیهوشی با نیدل Quinke شماره 25واز فضای نخاعی L4-L5 تحت بی حسی اسپاینال قرار گرفتند و پس از رویت جریان آزاد CSF بیماران به صورت تصادفی به 2 گروه (55 نفری) به ترتیب زیر تقسیم خواهند شدند: 1.گروه بوپی واکائین- دکسمدتومیدین: دریافت کننده 10میلی گرم بوپی واکائین هایپرباریک 0.5%+5ماکروگرم (حجم کلی 2.5 سی سی) 2.گروه بوپی واکائین- فنتانیل: دریافت کننده 10 میلی گرم بوپی واکائین هایپرباریک+25 ماکروگرم فنتانیل (حجم کلی 2.5 سی سی) پارامترهای همودینامیکی علاوه بر مقادیر اولیه در دقایق صفر ( بلافاصله پس از تزریق) ، 5-10-15-30-60 دقیقه و در ریکاوری ثبت خواهدگردید.

  • General information

    110
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    2016-02-20, 1394/12/01
    2020-02-20, 1398/12/01
    2016-09-20, 1395/06/30
    2020-04-20, 1399/02/01
    2016-03-15, 1394/12/25
    empty
    2016-10-19, 1395/07/28
    empty
    2016-12-21, 1395/10/01
    empty
    empty
    Problem writing
    empty
    ایراد نگارشی

  • Recruitment centers

    #1
    Name of recruitment center - English: Shariati hospital of Hormozgan University of Medical Sciences
    Name of recruitment center - Persian: بیمارستان شریعتی دانشگاه علوم پزشکی هرمزگان
    Full name of responsible person - English: Hashem Jarineshin
    Full name of responsible person - Persian: هاشم جری نشین
    Street address - English: Jomhuri Blvd, Shahid Mohammadi Hospital
    Street address - Persian: بلوار جمهوری، بیمارستان شهید محمدی
    City - English: Bandar abbas
    City - Persian: بندرعباس
    Province: Hormozgan
    Country: Iran (Islamic Republic of)
    Postal code: 9791991551
    Phone: +98 76 3334 5009
    Fax:
    Email: hjarineshin@yahoo.com
    Web page address:
    Name of recruitment center - English: Shariati Hospital Of Hormozgan University of Medical Sciences
    Name of recruitment center - Persian: بیمارستان شریعتی دانشگاه علوم پزشکی هرمزگان
    Full name of responsible person - English: Hashem Jarineshin
    Full name of responsible person - Persian: هاشم جری نشین
    Street address - English: Jomhuri Blvd, Shahid Mohammadi Hospital
    Street address - Persian: بلوار جمهوری، بیمارستان شهید محمدی
    City - English: Bandar Abbas
    City - Persian: بندرعباس
    Province: Hormozgan
    Country: Iran (Islamic Republic of)
    Postal code: 9791991551
    Phone: +98 76 3334 5009
    Fax:
    Email: Hjarineshin@yahoo.com
    Web page address:

  • Sponsors / Funding sources

    #1

    Name of organization / entity - English:
    Name of organization / entity - Persian:
    Full name of responsible person - English: Hashem Jrineshin
    Full name of responsible person - Persian: هاشم جری نشین
    Street address - English: Jomhuri Blvd, Shahid Mohammadi Hospital
    Street address - Persian: بلوار جمهوری، بیمارستان شهید محمدی
    City - English: Bandar abbas
    City - Persian: بندرعباس
    Province: Hormozgan
    Country: Iran (Islamic Republic of)
    Postal code: 9791991551
    Phone: +98 76 3334 5009
    Fax:
    Email: hjarineshin@yahoo.com
    Web page address:

    Name of organization / entity - English:
    Name of organization / entity - Persian:
    Full name of responsible person - English: Hashem Jarineshin
    Full name of responsible person - Persian: هاشم جری نشین
    Street address - English: Jomhuri Blvd, Shahid Mohammadi Hospital
    Street address - Persian: بلوار جمهوری، بیمارستان شهید محمدی
    City - English: Bandar Abbas
    City - Persian: بندرعباس
    Province: Hormozgan
    Country: Iran (Islamic Republic of)
    Postal code: 9791991551
    Phone: +98 76 3334 5009
    Fax:
    Email: Hjarineshin@yahoo.com
    Web page address:

Protocol summary

Study aim
Reduce pain and better recovery after cesarean section
Design
A clinical trial of 55 patients with two treatments parallel groups of 55 patients(Fentanyl and Dexmedetomidine,added to intrathecal Bupivacaine), double-blind, Randomised with Random allocation software
Settings and conduct
This study will be done at Hormozgan University of Medical Sciences. Spinal anesthesia were done in the sitting position through the aseptic technique using 25 G Quincke spinal needle at the L4-5 interspace. After observing free flow of CSF, the patients will randomly allocated into two groups (n= 55) as follows: I.Group B-D received 10 mg hyperbaric Bupivacaine 0.5% + 5μg Dexmedetomidine [total volume of 2.5cc] II.Group B-F received 10 mg hyperbaric Bupivacaine 0.5% + 25 μg Fentanyl [total volume of 2.5cc] Hemodynamic parameters will be recorded in 0 minutes (immediately after injection), 5-10-15-30-60 minutes and in recovery.
Participants/Inclusion and exclusion criteria
110 pregnant women Inclusion criteria: Gestational age ≥ 37 weeks and candidate for cesarean section by spinal anesthesia, and physical classes 1,2(ASA I, II) Exclusion criteria: Emergency patients, patients with regional block bans, patients with heart valve disease, patients with a history of drug allergy, addictive or alcoholic patients, patients with placenta previa
Intervention groups
The first group received 10mg bupivacaine + 5μg dexmedetomidine The second group received 10mg bupivacaine + 25μg fentanyl
Main outcome variables
Systolic blood pressure Diastolic blood pressure Mean arterial pressure Arterial Oxygen Saturation Percentage nausea and vomiting Shivering Apgar score Postoperative pain Duration of analgesia

General information

Reason for update
Problem writing
Acronym
IRCT registration information
IRCT registration number: IRCT20110313006044N2
Registration date: 2020-02-15, 1398/11/26
Registration timing: prospective

Last update: 2020-03-31, 1399/01/12
Update count: 1
Registration date
2020-02-15, 1398/11/26
Registrant information
Name
Hashem Jarineshin
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 76 3334 5009
Email address
hjarineshin@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-02-20, 1398/12/01
Expected recruitment end date
2020-04-20, 1399/02/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of intrathecal administration of bupivacaine and fentanyl with bupivacaine and dexmedetomedine on postoperative analgesia in cesarean section
Public title
To investigate the effect of dexmedetomidine and fentanyl on spinal analgesia
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Candidate for elective cesarean section and gestational age ≥ 37 weeks
Exclusion criteria:
Emergency patients Patients with a ban on regional block Patients with heart valve disease Patients with a history of allergy to the drugs used Addictive or alcoholic patients Patients with placenta parvia Patients who require medication during surgery because of incomplete blockage
Age
From 16 years old to 41 years old
Gender
Female
Phase
3
Groups that have been masked
  • Participant
  • Outcome assessor
  • Data analyser
Sample size
Target sample size: 110
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization was performed based on Random allocation software and based on that even numbers were considered for dexmedetomidine and odd numbers were considered for fentanyl accordingly.The numbers were put in closed envelopes and opened by a person other than the procedure handler, and according to which the drugs were prepared for injection they were given to the procedure physician while the doctor did not know the details of the syringes.
Blinding (investigator's opinion)
Double blinded
Blinding description
In order to eliminate bias from patient's awareness or anesthesia assistant and person who evaluate the results and its possible impact on the outcome of the study, the study will be conducted in a double-blind condition. After receiving written informed consent from patients, spinal anesthesia was done by given the same drugs and same volume to the anesthesiologist, then relevant information was recorded in the questionnaire by the anesthesiologist who was not aware of the injection of the drugs. It is obvious that the patient and the anesthesiologist were not aware of the type of drug being administered.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Commitee Of Hormozgan University Of Medical Sciences
Street address
Jomhuri Blvd, Shahid Mohammadi Hospital
City
Bandar Abbas
Province
Hormozgan
Postal code
9791991551
Approval date
2016-03-14, 1394/12/24
Ethics committee reference number
IR.HUMS.REC.1394.185

Health conditions studied

1

Description of health condition studied
Cesarean section
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Pain rate and duration of analgesia
Timepoint
Measurement of pain and duration of analgesia in recovery and during 6-3 hours after surgery
Method of measurement
Patients' severity of pain is based on the Visual Analogues Scale, with the left side indicating no pain and the right side showing the number "10" indicating the most severe pain. Score style 1-3 indicates mild pain, 4-7 moderate pain, severe pain 8-10), duration of analgesia from time to block until patient requests for analgesics

Secondary outcomes

1

Description
Timepoint
Method of measurement

Intervention groups

1

Description
Intervention group 1: 10mg bupivacaine 0.5% + 5mg dexmedetomedine(PrecedexTM 200mcg/2ml Hospira, Inc,lake Forest, IL60045USA)
Category
Treatment - Drugs

2

Description
Intervention group 2: 10mg bupivacaine 0.5% + 25mg fentanyl(ROTEXMEDICA 0.5 mg/10ml 22946TRITTAU. Germany)
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Shariati Hospital Of Hormozgan University of Medical Sciences
Full name of responsible person
Hashem Jarineshin
Street address
Jomhuri Blvd, Shahid Mohammadi Hospital
City
Bandar Abbas
Province
Hormozgan
Postal code
9791991551
Phone
+98 76 3334 5009
Email
Hjarineshin@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Bandare-abbas University of Medical Sciences
Full name of responsible person
Hashem Jarineshin
Street address
Jomhuri Blvd, Shahid Mohammadi Hospital
City
Bandar Abbas
Province
Hormozgan
Postal code
9791991551
Phone
+98 76 3334 5009
Email
Hjarineshin@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Bandare-abbas University of Medical Sciences
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
Bandare-abbas University of Medical Sciences
Full name of responsible person
Hashem Jarineshin
Position
Associate Professor
Latest degree
Subspecialist
Other areas of specialty/work
Anesthesiology
Street address
Jomhuri Blvd, Shahid Mohammadi Hospital
City
Bandar Abbas
Province
Hormozgan
Postal code
9791991551
Phone
+98 76 3334 5009
Email
Hjarineshin@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Bandare-abbas University of Medical Sciences
Full name of responsible person
Hashem Jarineshin
Position
Associate Professor
Latest degree
Subspecialist
Other areas of specialty/work
Anesthesiology
Street address
Jomhuri Blvd, Shahid Mohammadi Hospital
City
Bandar Abbas
Province
Hormozgan
Postal code
9791991551
Phone
+98 76 3334 5009
Email
Hjarineshin@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Bandare-abbas University of Medical Sciences
Full name of responsible person
Hashem Jarineshin
Position
Associate Professor
Latest degree
Subspecialist
Other areas of specialty/work
Anesthesiology
Street address
Jomhuri Blvd, Shahid Mohammadi Hospital
City
Bandar Abbas
Province
Hormozgan
Postal code
9791991551
Phone
+98 76 3334 5009
Email
Hjarineshin@yahoo.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
All data can be shared
When the data will become available and for how long
Starting the post-access period of the paper was accepted
To whom data/document is available
All researchers
Under which criteria data/document could be used
All researchers
From where data/document is obtainable
Correspondence Dr Hashim Jarineshin contact by email hjarineshin@yahoo.com
What processes are involved for a request to access data/document
Details are available within a week at most
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