Comparison of ondansetron and amisulpride effectiveness on post operative nausea and vomting (PONV) reduction in elective abdominal surgeries with general anesthesia.
Design
In this randomized double-blind clinical trial, 116 patients who meet the inclusion criteria will be randomized using randomized numbers table in two groups and the intervention and bias in patient selection will be minimized by the researcher.
Settings and conduct
The subjects will be selected from patients undergoing elective surgeries with general anesthesia in Azad University hospitals during 2020 and 2021. Then, the patients will be divided into two groups which are matched in terms of age, gender and type of surgery. In the first group, at half an hour before the ondansetron surgery, 4 mg and in the other group at the same time, amisulpride is injected intravenously.
Participants/Inclusion and exclusion criteria
Indication for general anesthesia
Being in ASA 1,2 anesthesia class
Patient satisfaction to participate in the study
Possibility of follow-up within 24 hours of abdominal surgery
18.5<BMI<30
Advanced underlying disease
Patient dissatisfaction to participate in the study
Catching Motion sickness
Excessive bleeding during surgery
Severe postoperative complications
Intervention groups
The patients were divided into two groups that will be matched in terms of age, gender, type of surgery and type and method of general anesthesia. The first group will be injected intravenously with 4 mg of ondansetron within half an hour before the end of surgery and the other group will be injected 5 mg amisulpride intravenously. All patients will be evaluated for postoperative nausea and vomiting within 24 hours.
Main outcome variables
Ondansetron
Amisulpride
Gender
Age
BMI
Post operative nausea and vomiting
Stress
Opioid
General information
Reason for update
Acronym
PONV
IRCT registration information
IRCT registration number:IRCT20210926052599N1
Registration date:2021-10-19, 1400/07/27
Registration timing:prospective
Last update:2021-10-19, 1400/07/27
Update count:0
Registration date
2021-10-19, 1400/07/27
Registrant information
Name
Alireza Momennia
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 13 4262 4156
Email address
rudsar93@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-10-23, 1400/08/01
Expected recruitment end date
2021-12-22, 1400/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The comparison of the effect of ondansetron and amisulpride on post operative nausea and vomiting (PONV) in general abdominal surgeries
Public title
The comparison of the effect of ondansetron and amisulpride on post operative nausea and vomiting (PONV) in general abdominal surgeries
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Indication for general anesthesia
Being in American Society of Anesthesiologists (ASA) 1,2 anesthesia class
Patient satisfaction to participate in the study
Possibility of follow-up within 24 hours after abdominal surgery
18.5< Body mass index (BMI) <30
Exclusion criteria:
Advanced underlying disease
Patient dissatisfaction to participate in the study
Catching Motion sickness
Excessive bleeding during surgery
Severe postoperative complications
Age
No age limit
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Data and Safety Monitoring Board
Sample size
Target sample size:
116
Randomization (investigator's opinion)
Randomized
Randomization description
Using random numbers table
Blinding (investigator's opinion)
Double blinded
Blinding description
After confirmation of this study by the university's research committee, patients who are candidates for elective abdominal surgery with general anesthesia are introduced to the researcher by the professor of anesthesia. On the night before surgery, in order to meet the inclusion criteria and brief description of the study for the patient to be informed of the patient and get written consent of attachment number two on the patient's bedside will be present.
It is also explained to the individual that their absence in this study does not cause any problems in the routine process of their treatment and is completely optional. It is also explained to them that according to appendix 1 questionnaire, 24 hours after surgery, they will be revisited to fill out the questionnaire.
Patients who meet the inclusion criteria based on the criteria will be randomized using random numbers table in two groups and control will be minimized by this method of involvement and bias in patient selection by the researcher. Patients themselves do not have the right to choose to be in the case or control group.
In order to blind the study on the day of surgery, the operating room personnel are unaware of the type of injectable drug and at the time of injection, syringes of the same shape and color will be provided to the anesthetic technician who does not know the content of the syringes. Finally, after collecting data and analyzing the data, the results are compared between the two groups.
Placebo
Not used
Assignment
Factorial
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Islamic Azad University of Tehran Medical Sciences
Street address
Islamic Azad university of Tehran medicine science, Zargandeh street, Shariati street
City
Tehran
Province
Tehran
Postal code
1949635881
Approval date
2021-02-24, 1399/12/06
Ethics committee reference number
IR.IAU.TMU.REC.1399.553
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
Efficacy of medication on postoperative nausea and vomiting
Timepoint
24 hours after surgery
Method of measurement
Questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: The first group will be injected intravenously at 5 mg of Amisulpride within half an hour before the surgery.
Category
Treatment - Drugs
2
Description
Control group: The second group will be injected intravenously with 4 mg of ondansetron within half an hour before the surgery.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Buali hospital
Full name of responsible person
Dr Hosein Yahyavi
Street address
Buali hospital, Damavand street
City
Tehran
Province
Tehran
Postal code
1949635881
Phone
+98 21 2200 6666
Email
rudsar93@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Islamic Azad University
Full name of responsible person
Dr Amirmahyar Khoshsirat
Street address
Islamic Azad university of Tehran medicine sciences, Shariati street
City
Tehran
Province
Tehran
Postal code
1949635881
Phone
+98 21 2200 6666
Email
rudsar93@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Islamic Azad University
Proportion provided by this source
1
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
Alireaz Momennia
Position
intern
Latest degree
Medical doctor
Other areas of specialty/work
General Practitioner
Street address
No 11, behind of Shahid Ghasemi sport complex, Enghelab street
City
Rudsar
Province
Guilan
Postal code
4481833777
Phone
+98 13 4262 4156
Email
rudsar93@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Alireza Momennia
Position
Intern
Latest degree
Medical doctor
Other areas of specialty/work
General Practitioner
Street address
No11, behind of Shahid Ghasemi sport complex, Enghelab street
City
Rudsar
Province
Guilan
Postal code
4481833777
Phone
+98 13 4262 4156
Fax
Email
rudsar93@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Alireza Momennia
Position
Intern
Latest degree
Medical doctor
Other areas of specialty/work
General Practitioner
Street address
No11, behind of Shahid Ghasemi sport complex, Enghelab street
City
Rudsar
Province
Guilan
Postal code
4481833777
Phone
+98 13 4262 4156
Fax
Email
rudsar93@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
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available