Protocol summary
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Study aim
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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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Design
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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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Settings and conduct
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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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Participants/Inclusion and exclusion criteria
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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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Intervention groups
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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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Main outcome variables
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nausea and vomiting and quality of recovery after surgery
General information
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Reason for update
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Acronym
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IRCT registration information
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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
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Registration date
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2017-11-08, 1396/08/17
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Vice Chanceller of Research, IRAN University of Medical Sciences
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Expected recruitment start date
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2018-01-21, 1396/11/01
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Expected recruitment end date
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2018-09-23, 1397/07/01
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Actual recruitment start date
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2018-02-04, 1396/11/15
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Actual recruitment end date
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2018-10-12, 1397/07/20
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Trial completion date
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2018-10-12, 1397/07/20
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Scientific title
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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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Public title
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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
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Purpose
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Supportive
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Inclusion/Exclusion criteria
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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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Age
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From 18 years old
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Gender
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Both
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Phase
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3
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Groups that have been masked
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Sample size
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Target sample size:
78
Actual sample size reached:
78
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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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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Blinding (investigator's opinion)
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Single blinded
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Blinding description
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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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Placebo
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Used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2017-08-12, 1396/05/21
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Ethics committee reference number
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IR.IUMS.FMD.REC1395.9021216158
Health conditions studied
1
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Description of health condition studied
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Cholecystitis
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ICD-10 code
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ICD-10 code description
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Primary outcomes
1
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Description
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nausea and vomiting score
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Timepoint
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1, 6 and 24 houre after surgery
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Method of measurement
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Visual Analogue Scale
2
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Description
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quality of recovery Score
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Timepoint
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1, 6 and 24 houre after surgery
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Method of measurement
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Quality Of Recovery Questionnaire
Secondary outcomes
1
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Description
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duration of hospitalization
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Timepoint
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duration of hospitalization after surgery
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Method of measurement
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patient hospitalization file
2
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Description
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blood sugar
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Timepoint
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2 houre before surgery, immediately after surgery and first day after operation at 8:00
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Method of measurement
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laboratory kit
3
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Description
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duration of recovery
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Timepoint
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duration of pateint recovery time
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Method of measurement
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interview and inspection
4
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Description
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pain score after surgery
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Timepoint
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severity of pain at 1, 6 and 24 hour after surgery
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Method of measurement
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Visual Analogue Scale
5
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Description
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strat of starving
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Timepoint
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the time of patient desire to eat
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Method of measurement
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interview
6
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Description
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duration of anesthesia
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Timepoint
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duration of patient anesthesia after surgery
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Method of measurement
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nursery records and inspection
7
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Description
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Surgery Complications
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Timepoint
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Any complication after surgery such as: Bleeding, Ulcer infection, Ileus, Pnomonia ...
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Method of measurement
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Patient File
8
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Description
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the amount of analgesic drug administered
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Timepoint
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after surgery
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Method of measurement
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patient file
9
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Description
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the amount of anti nausea drug administered
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Timepoint
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after surgery
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Method of measurement
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patent file
10
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Description
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past medical history(diseae history)
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Timepoint
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any disease during surgery
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Method of measurement
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interview
Intervention groups
1
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Description
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group1: 250 ml dextrose 10% infusion 2 hours before surgery
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Category
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Treatment - Other
2
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Description
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group2: 200 ml oral carbohydrate solusion (includes 25 gram of dextrose 10%), 2 horse before surgery
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Category
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Treatment - Other
3
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Description
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group 3: control group with normal diet and no perception of glucose
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Category
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Treatment - Other
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Vice Chancellor Of Research, Iran University of Medical Science
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
2
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Vice Chancellor Of Research, Iran University of Medical Science
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Undecided - It is not yet known if there will be a plan to make this available
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Study Protocol
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Undecided - It is not yet known if there will be a plan to make this available
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Statistical Analysis Plan
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Undecided - It is not yet known if there will be a plan to make this available
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Informed Consent Form
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Undecided - It is not yet known if there will be a plan to make this available
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Clinical Study Report
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Undecided - It is not yet known if there will be a plan to make this available
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Analytic Code
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Undecided - It is not yet known if there will be a plan to make this available
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Data Dictionary
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Undecided - It is not yet known if there will be a plan to make this available