Determining the effect of ondansetron with haloperidol in reducing postoperative nausea and vomiting in patients undergoing general anesthesia in Islamic Azad University hospitals in 1400
Design
Clinical trial, with parallel groups, double-blind, simple randomized, phase 4 on 78 patients admitted to the hospitals of the Islamic Azad University from October 2021 to January 2022 .
Settings and conduct
The subjects will be selected from patients undergoing elective surgery with general anesthesia in the hospitals of the Islamic Azad University during the year 2021-2022 who meet the inclusion criteria to reach the desired sample size. Patients are divided into two simple randomized double-blind groups that are matched in terms of age, gender, and type of surgery.
Participants/Inclusion and exclusion criteria
Indication for general anesthesia
Being in ASA 1,2 anesthesia class
Possibility of patients follow up at least 24 hours after surgery
Patient satisfaction to participate in this research project
Intervention groups
Intervention group 1: Ondansetron 4 mg intravenously is injected into the patients of this group 15 minutes before the end of the surgery.
Intervention group 2 : At the same time, 1 mg of haloperidol is injected intravenously to the other group .
All patients are evaluated for postoperative nausea and vomiting in recovery and after transfer to the ward during the first 24 hours after surgery .
Main outcome variables
Comparison of the effect of ondansetron and haloperidol on postoperative nausea in patients
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210926052586N1
Registration date:2021-10-23, 1400/08/01
Registration timing:registered_while_recruiting
Last update:2021-10-23, 1400/08/01
Update count:0
Registration date
2021-10-23, 1400/08/01
Registrant information
Name
Seyedmohammad Karimi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2200 6660
Email address
smkarimi.md@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-10-23, 1400/08/01
Expected recruitment end date
2022-01-21, 1400/11/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of Ondansetron vs Haloperidol to prevent postoperative nausea and vomiting in patients undergoing surgery with general anesthesia
Public title
Comparison of Ondansetron vs Haloperidol to prevent postoperative nausea and vomiting
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
General anesthesia indication
ASA 1,2 class
Possibility of patient follow up at least 24h after surgery
Patient satisfaction to participate in this research project
Exclusion criteria:
Advanced underlying disease
Addiction
Patient dissatisfaction to participate in this research project
Motion Sickness
Excessive bleeding during surgery
Severe postoperative complication
BMI>30
Age
No age limit
Gender
Both
Phase
4
Groups that have been masked
Participant
Investigator
Sample size
Target sample size:
78
Randomization (investigator's opinion)
Randomized
Randomization description
The table of random numbers is prepared and by placing a hand on a number randomly and moving the hand in one of the predetermined directions, each person is given a number. People who have even numbers in will be in intervention group A and individual numbers will be in the group Intervention B.
Blinding (investigator's opinion)
Double blinded
Blinding description
Participants and researchers remain unaware of how the drug is allocated during the study. The patient is informed that there are two types of drugs in a study and will take one of the two drugs at random. Both drugs are in the same package and have are no difference.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
کمیته اخلاق در پژوهش دانشگاه علوم پزشکی آزاد اسلامی تهران
Street address
خیابان شریعتی، خیابان خاقانی، دانشگاه علوم پزشکی آزاد اسلامی واحد تهران
City
Tehran
Province
Tehran
Postal code
1949916656
Approval date
2021-08-03, 1400/05/12
Ethics committee reference number
IR.IAU.TMU.REC.1400.126
Health conditions studied
1
Description of health condition studied
Postoperative nausea and vomiting
ICD-10 code
K91.0
ICD-10 code description
تهوع و استفراغ بعد از عمل جراحی
Primary outcomes
1
Description
Comparison of the effect of ondansetron and haloperidol on postoperative nausea and vomiting
Timepoint
From recovery time to 24 hours after surgery
Method of measurement
Questionnaire number 1
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: 15 mg of ondansetron is injected 15 minutes before the end of the surgery.
Category
Treatment - Drugs
2
Description
Intervention group: 15 mg of haloperidol is injected 15 minutes before the end of the surgery.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
بیمارستان امیرالمومنین
Full name of responsible person
سید محمد کریمی
Street address
نازی آباد ، خ شیرمحمدی ، بیمارستان امیرالمومنین
City
Tehran
Province
Tehran
Postal code
1811694784
Phone
+98 21 5534 6550
Email
amhos@iautmu.ac.ir
Web page address
http://amhos.iautmu.ac.ir/fa/contactus
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Islamic Azad University
Full name of responsible person
فرشاد هاشمیان
Street address
Tehran Islamic Azad University of Medical Sciences , Khaghani St, Shariati Ave
City
Tehran
Province
Tehran
Postal code
1916893813
Phone
+98 21 2200 6660
Email
chancellor@iautmu.ac.ir
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
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
Islamic Azad University
Full name of responsible person
Seyedmohammad Karimi
Position
Student
Latest degree
A Level or less
Other areas of specialty/work
General Practitioner
Street address
Pabarja St , Sheidaei Ave , Darrous
City
Tehran
Province
Tehran
Postal code
1979999999
Phone
+98 21 2200 6660
Fax
Email
smkarimi.md@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Seyedmohammad Karimi
Position
Student
Latest degree
A Level or less
Other areas of specialty/work
General Practitioner
Street address
Pabarja St , Sheidaei Ave , Darrous
City
Tehran
Province
Tehran
Postal code
1979999999
Phone
+98 21 2200 6660
Fax
Email
smkarimi.md@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Seyedmohammad Karimi
Position
Student
Latest degree
A Level or less
Other areas of specialty/work
General Practitioner
Street address
Pabarja St , Sheidaei Ave , Darrous
City
Tehran
Province
Tehran
Postal code
1979999999
Phone
+98 21 2200 6660
Fax
Email
smkarimi.md@gmail.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
There is no more information
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
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