Comparison of the effects of preventive injection of 4 mg and 8 mg Ondansetron doses on pain caused by Etomidate injection in patients under general anesthesia
Comparison of the effect of preventive injection of 4 mg and 8 mg Ondansetron on pain caused by Etomidate injection
Design
Clinical trial with control group, with parallel groups, double-blind, randomized, phase 3 on 60 patients. Lottery and sealed envelopes are used for randomization.
Settings and conduct
This is a randomized double-blind clinical trial that will be performed on 60 patients undergoing general anesthesia with Etomidate at Al-Zahra Hospital in Isfahan; After University Ethics Committee approval and patient satisfaction, patients were randomly assigned to the groups. In each group, the desired intervention is applied and the patient's clinical symptoms are recorded. The person who is performing the intervention would be different from the evaluator and they do not know the type of intervention. In spite of the fact that Patients are aware of the study, they are not aware of the type of intervention so they are all blind.
Participants/Inclusion and exclusion criteria
Inclusion criteria: ASA class I and II, age 18 to 60 years, general anesthesia candidate with Etomidate and patient informed consent to participate in the study
Exclusion criteria: heart disease, psycho logic disease and diabetes, allergic to drugs used, addiction
Intervention groups
Intervention group A: They receive 4 mg Ondansetron 2 minutes before inducing anesthesia
Intervention group B: They receive 8 mg Ondansetron 2 minutes before inducing anesthesia
Control group C: They receive 4 ml distilled water 2 minutes before inducing anesthesia, then all three groups will be induced under anesthesia with 20 mg Etomidate, and their clinical signs will be recorded.
Main outcome variables
Pain caused by Etomidate
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20160307026950N38
Registration date:2021-10-25, 1400/08/03
Registration timing:registered_while_recruiting
Last update:2021-10-25, 1400/08/03
Update count:0
Registration date
2021-10-25, 1400/08/03
Registrant information
Name
Behzad Nazemroaya
Name of organization / entity
Isfahan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 31 3212 3543
Email address
behzad_nazem@med.mui.ac.ir
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 the effects of preventive injection of 4 mg and 8 mg Ondansetron doses on pain caused by Etomidate injection in patients under general anesthesia
Public title
The effect of Ondansetron on pain caused by Etomidate injection
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Patients 18 to 60 years
Grade I and II in ASA criteria (American Society of Anesthesia)
Candidate for general anesthesia with Etomidate
Exclusion criteria:
Patients with Heart Disease
Patients with Psychologic disease
Allergic to drugs used in the study
Taking sedatives or painkillers 24 hours before anesthesia
Addiction to drugs
Age
From 18 years old to 60 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
This is a simple randomized clinical trial in which patients are entered the study groups by lottery; The medicines and placebo are placed in the sealed, opaque and similar form packets which are coded. Each code is also written on a piece of paper, folded, and placed inside a box. After entering the
operating room, each patient takes one of the papers out of the box; The pocket with the same number is the intervention that will apply for him. This process continues till the number of patients will reach the desired one.
Blinding (investigator's opinion)
Double blinded
Blinding description
This is a double-blind clinical trial; In this way, before obtaining consent, patients are studied but do not know which group they will be in and therefore are blind. Also, the nurse who injects the drug and the researcher who records the patient's symptoms do not know the type of drug and are blind.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee in Biomedical Research, Isfahan University of Medical Sciences
Street address
Hezar Jarib St
City
Isfahan
Province
Isfehan
Postal code
8174673461
Approval date
2021-07-01, 1400/04/10
Ethics committee reference number
IR.MUI.MED.REC.1399.443
Health conditions studied
1
Description of health condition studied
Pain caused by Etomidate
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
The amount of pain caused by Etomidate injection
Timepoint
During the injection until 30 seconds
Method of measurement
Faces Pain Rating Scale (FPRS)
Secondary outcomes
1
Description
Heart Rate
Timepoint
Before injection, immediately after injection, 5 and 10 minutes after Etomidate injection and then every 15 minutes until the end of the operation.
Method of measurement
ECG monitoring
2
Description
Moderate arterial blood pressure
Timepoint
Before injection, immediately after injection, 5 and 10 minutes after Etomidate injection and then every 15 minutes until the end of the operation.
Method of measurement
Barometer
3
Description
Arterial blood oxygen saturation
Timepoint
Before injection, immediately after injection, 5 and 10 minutes after Etomidate injection and then every 15 minutes until the end of the operation.
Method of measurement
Pulse oximeter
4
Description
Duration of anesthesia
Timepoint
From the beginning of anesthesia to the end of recovery
Method of measurement
Clock
Intervention groups
1
Description
Intervention group A: In this group, eligible patients, after being placed on a surgical bed and monitoring connection, receive 300 ml of normal saline per hour, then they are injected with 4 mg of Ondansetron made by Exir Pharmaceutical Company in 2 minutes and 2 minutes later, they are induced under anesthesia with 20 mg of Etomidate made by Abu Reihan company and the patient's clinical symptoms are recorded.
Category
Prevention
2
Description
Intervention group B: In this group, eligible patients, after being placed on a surgical bed and monitoring connection, receive 300 ml of normal saline per hour, then they are injected with 8 mg of Ondansetron made by Exir Pharmaceutical Company in 2 minutes and 2 minutes later, they are induced under anesthesia with 20 mg of Etomidate made by Abu Reihan company and the patient's clinical symptoms are recorded.
Category
Prevention
3
Description
Control group C: In this group, eligible patients, after being placed on a surgical bed and monitoring connection, receive 300 ml of Normal Saline per hour, then they are injected with 4 ml of distilled water and 2 minutes later under anesthesia. With 20 mg of Etomidate made by Abu Reihan company and the patient's clinical symptoms are recorded.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Alzahra hospital
Full name of responsible person
Behzad Nazemoroaya
Street address
Soffeh boulevard, Shahid Keshvari highway
City
Isfahan
Province
Isfehan
Postal code
8174675731
Phone
+98 31 3620 2020
Email
behzad_nazem@med.mui.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Shaghayegh Haghjoo
Street address
Hezar Jarib
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3668 0048
Email
research@mui.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Esfahan 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
Esfahan University of Medical Sciences
Full name of responsible person
Ruzbeh Akhavanfar
Position
Medical student
Latest degree
Medical doctor
Other areas of specialty/work
General Practitioner
Street address
Hezar Jarib
City
Isfahan
Province
Isfehan
Postal code
8146713543
Phone
+98 31 3620 2020
Email
Roozbeh1372@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Behzad Nazem roaya
Position
Professor assistant of Anesthesia and Intensive carentensive care
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Hezar Jarib
City
Isfahan
Province
Isfehan
Postal code
8146713543
Phone
+98 31 3620 2020
Email
behzad_nazem@med.mui.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Leyla Rafiei
Position
Nurse Anesthetist
Latest degree
Bachelor
Other areas of specialty/work
Anesthesiology
Street address
Hezar Jarib
City
Isfahan
Province
Isfehan
Postal code
8146713543
Phone
+98 31 3620 2020
Email
leylarafiei943@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