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Camparison of the effect of ondansetron and placebo versus ondansetron and aprepitant on post-operation nausea and vomitiing of cholecystectomy surgery

Protocol summary

Study aim
The aim of this study is to determine the effect of ondansetron and placebo versus ondansetron and aprepitant on nausea and vomiting after cholecystectomy surgery. If the combination of aprepitant and ondansetron has a greater effect on nausea and vomiting, this method can be used as an auxiliary treatment in the treatment of postoperative nausea and vomiting.
Design
A clinical trial with a control group, with parallel groups, double-blind, randomized by block randomization method, phase 2 on 60 patients.
Settings and conduct
Patients undergoing cholecystectomy at Shahid Modares Hospital in Tehran between 2020 to 2021. This study is conducted in a double-blind manner. A nurse not involved in the study codes the drugs, the person who prescribes the drug, and those who collect information from the patients after the procedure are blinded. Nausea and vomiting of patients are evaluated 6 and 24 hours after the end of the operation.
Participants/Inclusion and exclusion criteria
Inclusion criteria: All patients between the ages of 18 and 50 years old with a 1 or 2 score on the ASA health scale, are candidates for cholecystectomy surgery. Exclusion criteria: patients with a 3, 4, or 5 score on the ASA health scale; Patients undergoing cholecystectomy with another anesthesia method; patients suffering from any systemic disease, People addicted to alcohol, drugs, and smoking; Acute cholecystitis.
Intervention groups
Control group: At the same time as the operation, 4 mg of ondansetron is administered intravenously and a placebo capsule is administered one hour before the operation. Intervention group: Aperpitant capsule of 80 mg one hour before the operation, and at the same time as the operation, ondansetron 4 mg is administered intravenously.
Main outcome variables
Nausea and vomiting after the operation

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20221110056459N1
Registration date: 2023-09-21, 1402/06/30
Registration timing: registered_while_recruiting

Last update: 2023-09-21, 1402/06/30
Update count: 0
Registration date
2023-09-21, 1402/06/30
Registrant information
Name
Maryam Abbasi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2207 4087
Email address
maryamabbasi@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-03-21, 1402/01/01
Expected recruitment end date
2024-04-19, 1403/01/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Camparison of the effect of ondansetron and placebo versus ondansetron and aprepitant on post-operation nausea and vomitiing of cholecystectomy surgery
Public title
effect of aprepitant on post-operation nausea vomiting of cholecystectomy surgery
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
patients with ASA health scale of 1 or 2 patients who are candidated for cholecystectomy surgery
Exclusion criteria:
patients with ASA health scale of 3, 4 or 5 patients with other anesthesia methods patients with any systemic diseases such as diabetes, asthma, cardiovascular diseases, gastroesophageal reflux, severe obesity, BMI > 30, hepatorenal diseases, neuromuscular diseases, psychiatric illnesses, alcoholic patients, drug abusers, smokers pregnant or lactating patients patients presented with acute cholecystitis
Age
From 18 years old to 50 years old
Gender
Both
Phase
3
Groups that have been masked
  • Participant
  • Care provider
  • Investigator
  • Outcome assessor
Sample size
Target sample size: 60
Randomization (investigator's opinion)
Randomized
Randomization description
The randomization method assigns Patients to one of the intervention and control groups. The randomization method is based on random blocks of four. In this way, each study group is assigned code A or B, and different blocks of four were made by https://www.sealedenvelope.com/ website. Then patients were assigned to different blocks based on the order of entering the trial.
Blinding (investigator's opinion)
Double blinded
Blinding description
Medications are coded by a nurse who is not participating in the study. The person who prescribes the medicine also does the prescription without knowing the type of medicine. In the recovery and inpatient ward, colleagues collect information without knowing the type of drug received and the groups.
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Shahid Beheshti University of Medical Sciences
Street address
department of general surgery, Shahid Modarres hospital, Saadat Abad intersection, Yadegar Imam Highway
City
Tehran
Province
Tehran
Postal code
1998734383
Approval date
2022-05-24, 1401/03/03
Ethics committee reference number
IR.SBMU.MSP.REC.1401.116

Health conditions studied

1

Description of health condition studied
Nausea
ICD-10 code
R11.0
ICD-10 code description
Nausea

2

Description of health condition studied
vomiting
ICD-10 code
R11.1
ICD-10 code description
Vomiting

Primary outcomes

1

Description
The degree of nausea
Timepoint
6 and 24 hour post-operation
Method of measurement
VAS criteria

2

Description
vomiting
Timepoint
6 and 24 hour post-operation
Method of measurement
if vomiting happen or not

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: Aperpitant capsule 80 mg is prescribed one hour before the operation, and at the same time as the anti-nausea drug ondansetron 4 mg is administered intravenously.
Category
Treatment - Drugs

2

Description
Control group: At the same time as the operation, the anti-nausea drug ondansetron 4 mg is administered intravenously and a placebo capsule is administered one hour before the operation.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Shahid Modarres hospital
Full name of responsible person
Seyed Hassan Fatemi
Street address
General surgery department, Shahid Modarres Hospital, Saadat Abad Intersection, Yadegar Imam Highway
City
Tehran
Province
Tehran
Postal code
1998734383
Phone
+98 21 2207 4087
Email
modarres@sbmu.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Dr. Afshin Zarghi
Street address
Fifth Floor, Building No. 2, Shahid Arabi Street, Yemen Street, Shahid Chamran Highway
City
Tehran
Province
Tehran
Postal code
1985717443
Phone
+98 21 2243 9780
Email
info@sbmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Beheshti 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
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Nasser Malekpour Alamdari
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
General Surgery
Street address
General surgery department, Shahid Modarres Hospital, Saadat Abad Intersection, Yadegar Imam Highway
City
Tehran
Province
Tehran
Postal code
1998734383
Phone
+98 21 2207 4087
Email
nassermalekpour@sbmu.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Nasser Malekpour Alamdari
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
General Surgery
Street address
General surgery department, Shahid Modarres Hospital, Saadat Abad Intersection, Yadegar Imam Highway
City
Tehran
Province
Tehran
Postal code
1998734383
Phone
+98 21 2207 4087
Email
nassermalekpour@sbmu.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Maryam Abbasi
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
General Surgery
Street address
General surgery department, Shahid Modarres Hospital, Saadat Abad Intersection, Yadegar Imam Highway
City
Tehran
Province
Tehran
Postal code
1998734383
Phone
+98 21 2207 4087
Fax
Email
maryamabbasi1986@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
Individual data of participants and information on the main outcome, and the final report of the trial will be presented in an international article. Also, more detailed information will be accessible to researchers in coordination with the correspondence.
When the data will become available and for how long
The access period starts 6 months after the results are published.
To whom data/document is available
researchers working in academic and scientific institutions
Under which criteria data/document could be used
All researchers working in academic and scientific institutions can send their request by mentioning the reason. The use of data and results of this clinical trial for personal and commercial purposes is not allowed.
From where data/document is obtainable
Dr. Nasser Malekpour Alamdari: nassermalekpour@sbmu.ac.ir Dr. Maryam Abbasi: maryamabbasi1986@gmail.com
What processes are involved for a request to access data/document
After sending the request to the given addresses, the responsible persons will check the cases and after inquiring the identity of the requester, they will send the documents to them. This process may take up to a month.
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