The aim of this study was to evaluate the effect of betahistine in preventing nausea and vomiting after surgery of laparoscopic cholecystectomy.
Design
70 patients randomly entered into one of two parallel groups of study or control. Study will be double blinded.
Settings and conduct
This study will be performed in Urmia Imam Khomeini Hospital .90 minutes before surgery, the intervention group will receive 8 mg of oral betahistine and placebo will be given to the control group. The anesthetic method and the drugs used for anesthesia will be the same for both groups.Up to 2 hours after the operation, every 30 minutes, ask the patients about nausea and vomiting, and they will be recorded in the questionnaire. Patients and reviewers will not be aware of the type of medication and placebo.
Participants/Inclusion and exclusion criteria
patients aged 20-60 years undergoing laparoscopic cholecystectomy.Exclusion criteria include: asthma, pheochromocytoma, gastroesophageal reflux, severe obesity, BMI 35, pregnancy, breast feeding, kidney failure, history of drug addiction and alcoholism, diabetes and gastrointestinal obstruction.
Intervention groups
90 minutes before surgery, the intervention group will receive 8 mg of oral beta-thiostin and placebo will be given to the control group.
Main outcome variables
Post-operative nausea and vomiting
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20170408033280N2
Registration date:2019-01-02, 1397/10/12
Registration timing:prospective
Last update:2019-01-02, 1397/10/12
Update count:0
Registration date
2019-01-02, 1397/10/12
Registrant information
Name
Ebrahim Hassani
Name of organization / entity
Urmia University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 44 3346 8967
Email address
ehassani@umsu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-01-21, 1397/11/01
Expected recruitment end date
2019-05-21, 1398/02/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of betahistine on post-operative nausea and vomiting in pateints undergoing laparascopic cholecystectomy
Public title
The effect of betahistine on post-operative nausea and vomiting in patients undergoing laparascopic cholecystectomy
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
patients undergoing laparascopic cholecystectomy from 20 to 60 years
Exclusion criteria:
َAsthma
Pheochromocytoma
Gastroesophageal reflux
severe obesity
difficult airway
pregnancy
lactation
liver and kidney diseases
history of drug addiction and alcoholism
neuromuscular diseases
Psychiatric disorders
diabetes mellitus
gastrointestinal obstruction
Alcoholism
Age
From 20 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Sample size
Target sample size:
70
Randomization (investigator's opinion)
Randomized
Randomization description
Patients will be randomly assigned to one of the two groups on the basis of last digit of the file number.
Blinding (investigator's opinion)
Double blinded
Blinding description
Medication and placebo will be administered in the same volume to patients in both groups by a collaborator, and the patient, investigator and evaluator will not be aware of it.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Urmia University of Medical Sciences
Street address
Urmia University of Medical Sciences
City
Urmia- Resalat Boulevard-,
Province
West Azarbaijan
Postal code
5714783744
Approval date
2018-10-03, 1397/07/11
Ethics committee reference number
IR.UMSU.REC.1397.247
Health conditions studied
1
Description of health condition studied
Post -Operative Nausea and Vomiting
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Postoperative nausea and vomiting
Timepoint
Every 30 minutes\vsakhli
Method of measurement
ًQuestionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group:Administration of 8 mg oral Beta-histein 90 minutes before surgery
Category
Prevention
2
Description
Control group: Oral administration of the placebo 90 minutes before surgery
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Khomeini Hospital
Full name of responsible person
Ebrahim Hassani
Street address
Ershad Avenu Imam Khmeini Hospital Anesthesiology Department
City
Urmia
Province
West Azarbaijan
Postal code
8135157157
Phone
+98 44 3346 8967
Fax
+98 44 3346 8967
Email
ehassani87@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Oroumia University of Medical Sciences
Full name of responsible person
Professor Iraj Mohebbi
Street address
Resalat Blv. Urmia University of Medical Sciences
City
Urmia
Province
West Azarbaijan
Postal code
5714783734
Phone
+98 44 3223 1930
Fax
+98 44 3223 0642
Email
research@umsu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Oroumia 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
Oroumia University of Medical Sciences
Full name of responsible person
Ebrahim Hassani
Position
Head of Department
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Ershad Ave
City
Urmia
Province
West Azarbaijan
Postal code
8135157157
Phone
+98 44 3346 8967
Fax
+98 44 3346 8967
Email
ehassani87@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Oroumia University of Medical Sciences
Full name of responsible person
Ebrahim Hassani
Position
Head of Department
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Ershad Ave
City
Urmia
Province
West Azarbaijan
Postal code
8135157157
Phone
+98 44 3346 8967
Fax
+98 44 3346 8967
Email
ehassani87@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Oroumia University of Medical Sciences
Full name of responsible person
Ebrahim Hassani
Position
Head of Department
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Ershad Ave
City
Urmia
Province
West Azarbaijan
Postal code
8135157157
Phone
+98 44 3346 8967
Fax
+98 44 3346 8967
Email
ehassani87@gmail.com
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
Not applicable
Informed Consent Form
No - There is not 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