The effect of oral betahistine reduce post operative nausea and vomiting (ponv) in cholecystectomy laparoscopic surgery with general anesthesia
Design
The study was performed as a clinical trial, with a control group, with parallel groups, two-way blind, approved (by blocking method with random allocation software), two-way blind, phase 3 on 120 patients.
Settings and conduct
The study population is patients who are candidates for elective laparoscopic cholecystectomy referred to Imam Khomeini Medical Center in Sari. After obtaining informed consent, the interventions were performed on 120 patients 3 hours before surgery (by the project nurse). The severity of nausea and vomiting, the amount of ondansetron and opioids used and other possible drug side effects including dry mouth, headache, itching and skin rash were evaluated and recorded after recovery in consciousness and then in surgery and 24 hours after surgery.
Participants/Inclusion and exclusion criteria
Inclusion criteria: The patient's desire to participate in the study; No history of betahistine allergy; No history of gastrointestinal disease and cardiovascular disease and respiratory problems.
Exclusion criteria: Patients with uncontrolled diabetes; History of nausea and vomiting and taking anti-nausea and vomiting drugs in 24 hours before surgery; Middle ear disease; Pregnancy; High blood pressure.
Intervention groups
Betahistine 16 mg tablets (manufactured by Octovorco) orally, 3 hours before surgery.
Control group: An oral placebo (Starch composition and similar in size and shape to betahistine tablets) 3 hours before surgery.
Main outcome variables
Nausea and vomiting
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20201225049829N1
Registration date:2021-01-10, 1399/10/21
Registration timing:retrospective
Last update:2021-01-10, 1399/10/21
Update count:0
Registration date
2021-01-10, 1399/10/21
Registrant information
Name
Masoume Enayati
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 11 3304 4000
Email address
masoumeenayati@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-10-22, 1398/07/30
Expected recruitment end date
2020-03-18, 1398/12/28
Actual recruitment start date
2019-10-22, 1398/07/30
Actual recruitment end date
2020-03-18, 1398/12/28
Trial completion date
2020-10-21, 1399/07/30
Scientific title
Effect of oral betahistin in reducing of nausea and vomiting after laparoscopic cholecystectomy with general anesthesia
Public title
Effect of oral betahistin in reducing of nausea and vomiting after surgery
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
The patient's desire to participate in the study and gain informed consent
Candidate for elective laparoscopic cholecystectomy
Age between 15 to 60 years
No history of betahistine allergy
No history of gastrointestinal disease and cardiovascular disease and respiratory problems
Exclusion criteria:
Patients with uncontrolled diabetes
Underlying gastrointestinal disease
History of nausea and vomiting and taking anti-nausea and vomiting drugs in 24 hours before surgery
Middle ear disease
Pregnancy
Patients with BMI> 35
High blood pressure, cardiovascular disease, diarrhea with respiratory problems
If the laparoscopic surgery becomes an open cholecystectomy
Age
From 15 years old to 60 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Investigator
Data analyser
Sample size
Target sample size:
120
Actual sample size reached:
120
Randomization (investigator's opinion)
Randomized
Randomization description
The sampling method is two-stage. In the first stage, with the available sampling method, 120 patients are assigned to the intervention and control groups using the blocking method. The random allocation process is done by block allocation method with random allocation software.
Blinding (investigator's opinion)
Double blinded
Blinding description
This study is a double-blind and statistical expert, project physicians and patients are unaware of the placement of patients in treatment groups and the data collection form is completed by the project nurse who is unaware of the study groups.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Mazandaran University of Medical Sciences
Street address
Valiasr Blv., Sari
City
Sari
Province
Mazandaran
Postal code
4815733971
Approval date
2018-12-18, 1397/09/27
Ethics committee reference number
IR.MAZUMS.IMAMHOSPITAL.REC.1397.058
Health conditions studied
1
Description of health condition studied
Postoperative nausea and vomiting
ICD-10 code
R11
ICD-10 code description
Nausea and vomiting
Primary outcomes
1
Description
Severe nausea
Timepoint
At times 1, 3, 6, 12, 24, 48 after surgery
Method of measurement
NRS (numerical rating scale)
2
Description
Vomiting
Timepoint
At times 1, 3, 6, 12, 24, 48 after surgery
Method of measurement
NRS (numerical rating scale)
Secondary outcomes
1
Description
The amount of ondansetron and narcotics consumed
Timepoint
At times 1, 3, 6, 12, 24 and 48 hours after surgery
Method of measurement
Questionnaire
2
Description
Dry mouth
Timepoint
At times 1, 3, 6, 12, 24 and 48 hours after surgery
Method of measurement
Questionnaire
3
Description
Headache
Timepoint
At times 1, 3, 6, 12, 24 and 48 hours after surgery
Method of measurement
Questionnaire
4
Description
Itching
Timepoint
At times 1, 3, 6, 12, 24 and 48 hours after surgery
Method of measurement
Questionnaire
Intervention groups
1
Description
Intervention group: Betahistine 16 mg tablets (manufactured by Octovorco) orally, 3 hours before surgery.
Category
Treatment - Drugs
2
Description
Control group: An oral placebo (made by Sari School of Pharmacy, with starch composition and similar in size and shape to betahistine tablets) 3 hours before surgery
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Khomeini Hospital
Full name of responsible person
Masoume Enayati
Street address
Razi street, Sari
City
Sari
Province
Mazandaran
Postal code
4815733971
Phone
+98 11 3304 4000
Email
masoumeenayati@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Dr Majid Saeedi
Street address
Valiasr Blv., Sari
City
Sari
Province
Mazandaran
Postal code
4815733971
Phone
+98 11 3304 4000
Email
masoumeenayati@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mazandaran 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
Mazandaran University of Medical Sciences
Full name of responsible person
Masoume Enayati
Position
Resident
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Mazandaran university of medical sciences, Valiasr Blv.
City
Sari
Province
Mazandaran
Postal code
4815733971
Phone
+98 11 3304 4000
Fax
Email
masoumeenayati@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Masoume Enayati
Position
Resident
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Mazandaran university of medical sciences, Valiasr Blv.
City
Sari
Province
Mazandaran
Postal code
4815733971
Phone
+98 11 3304 4000
Fax
Email
masoumeenayati@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Masoume Enayati
Position
Resident
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Mazandaran university of medical sciences, Valiasr Blv.
City
Sari
Province
Mazandaran
Postal code
4815733971
Phone
+98 11 3304 4000
Fax
Email
masoumeenayati@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
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