The effect of betahistine on nausea and vomiting after Laparoscopic Cholecystectomy
Design
Clinical trial with control group, randomized with SPSS software, single blind, phase 3 on 80 patients.
Settings and conduct
In the study of a single blind clinical trial in Azerbaijan Azerbaijan Hospital in Urmia ̨ patients will be randomly divided into two groups of 40 using computer crash software, all participants are blind.
Participants/Inclusion and exclusion criteria
Inclusion criteria: all patients between the ages of 20 and 70 undergoing Laparoscopic Cholecystectomy.
Exclusion criteria: people with BMI above 35, drug allergy, receiving anti-inflammatory drug 24 hours before surgery.
Intervention groups
In one group of patients, Betahistine will be given and in another group, a Placebo will be given 3 hours before the operation.
Main outcome variables
Severity of nausea and vomiting,Frequency of vomiting
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200902048594N1
Registration date:2020-09-22, 1399/07/01
Registration timing:registered_while_recruiting
Last update:2020-09-22, 1399/07/01
Update count:0
Registration date
2020-09-22, 1399/07/01
Registrant information
Name
ََAida Madani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 44 3224 9432
Email address
pinarmadani94@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-09-05, 1399/06/15
Expected recruitment end date
2021-03-15, 1399/12/25
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of Betahistine on nausea and vomiting after Laparoscopic Cholecystectomy
Public title
The effect of Betahistine on nausea and vomiting after surgery
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
All patients undergoing Laparoscopic Cholecystectomy
Exclusion criteria:
BMI more than 35
Allergy to drugs
Receive anti-inflammatory medication 24 hours before surgery
Age
From 20 years old to 70 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Randomized
Randomization description
Patients are divided into two groups A and B using SPSS software and simple randomization. Group A patients receive placebo and group B patients receive betahistine.
Blinding (investigator's opinion)
Single blinded
Blinding description
Patients are fully aware of the intervention and have sufficient satisfaction, but are unaware of grouping (A, B). After collecting all the data, the information will be analyzed.
As stated in the intervention groups, the placebo was an empty drug that looked similar to betahistine
Placebo
Used
Assignment
Other
Other design features
Individuals are randomly divided into two groups, the first group receiving Betahistine and the second group receiving Placebo.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
ethics committee of Islamic Azad University - Shahrood Branch
Street address
Central building, Islamic Azad University, next to the gas station, Daneshgah Blvd, Shahrood, Semnan
City
Shahrood
Province
Semnan
Postal code
3614871151
Approval date
2019-07-04, 1398/04/13
Ethics committee reference number
IR.IAU.SHAHROOD.REC.1398.008
Health conditions studied
1
Description of health condition studied
postoperative nausea and vomiting
ICD-10 code
R11.2
ICD-10 code description
Nausea with vomiting, unspecified
Primary outcomes
1
Description
Score of nausea and vomiting after Laparoscopic Cholecystectomy
Timepoint
Patients will receive medication 3 hours before cholecystectomy.
Method of measurement
Questionnaire
Secondary outcomes
1
Description
Patient satisfaction with nausea and vomiting control
Timepoint
The first 30 minutes and 30 minutes to 24 hours after the operation will be asked.
Method of measurement
Questionnaire
Intervention groups
1
Description
Intervention group:Betahistine at a dose of 16 mg from Ecterco factory, which is given to patients 3 hours before laparoscopic cholecystectomy.
Category
Rehabilitation
2
Description
Control group: placebo which is prepared as an empty medicine with a betahistine-like appearance prepared in Urmia School of Pharmacy which will be given 3 hours before the operation.
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Azarbaijan hospital
Full name of responsible person
Dr. Jalal Pourghasem
Street address
Daneshkade ave
City
Urmia
Province
West Azarbaijan
Postal code
5715933766
Phone
+98 44 3224 9432
Email
pinarmadani@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Islamic Azad University
Full name of responsible person
Dr.Fatemeh amirkhalili
Street address
Khatam ol Anbia hospital, shahrood town
City
Shahrood
Province
Semnan
Postal code
3619943189
Phone
+98 23 3239 0360
Email
pinarmadani@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Islamic Azad University Shahrood Branch
Proportion provided by this source
100
Public or private sector
Private
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
Islamic Azad University
Full name of responsible person
Dr.Fateme Amirkhalili
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
General Surgery
Street address
22 Bahman St. - 12th Alley - Fateh Doctors Building - First Floor - Unit 3
City
Shahrood
Province
Semnan
Postal code
3615658985
Phone
+98 23 3223 1067
Email
dr.amirkhalili@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Dr.Fateme Amirkhalili
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
General Surgery
Street address
22 Bahman St. - 12th Alley - Fateh Doctors Building - First Floor - Unit 3
City
Shahrood
Province
Semnan
Postal code
3615658985
Phone
+98 23 3223 1067
Email
dr.amirkhalili@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Dr.Fateme Amirkhalili
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
General Surgery
Street address
22 Bahman St. - 12th Alley - Fateh Doctors Building - First Floor - Unit 3
City
Shahrood
Province
Semnan
Postal code
3615658985
Phone
+98 23 3223 1067
Email
dr.amirkhalili@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD