Determination of Metoclopramide and Ondansetron effect in relieving pain caused by Etomidate injection in patients under general anesthesia
Design
Clinical trial with control group, with parallel groups, double-blind, randomized, phase 2 on 90 patients. Randomization is also done in a simple way
Settings and conduct
The type of study was a three-way randomized blind clinical trial with the control group in Alzahra Hospital of Isfahan in 2009-2010 and was performed on 90 patients in Alzahra Hospital of Isfahan.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Patients aged 18 to 65 years with grade 1 and 2 anesthesia according to ASA (American society Anesthesia) criteria, candidate for elective surgery and in need of general anesthesia with Etomidate
Non-entry conditions: Allergy to any of the drugs Etomidate, Ondansetron and Metoclopramide
Intervention groups
Group A: Patients in this group receive 10 mg of Metoclopramide and then 10 minutes later 5 ml of normal saline.
Group B: Patients in this group receive 8 mg of Ondansetron and then 10 minutes later 5 ml of normal saline.
Group C: Patients in this group receive 5 ml of normal saline and then 10 minutes later receive 5 ml of normal saline.
All groups are given one cc of 2% Lidocaine ampoule equivalent to 20 mg, then Etomidate 3 mg at a rate of one cc per second (counting 1001, 1002, etc.) and pain intensity will be measured immediately.
Main outcome variables
Severe pain due to atomoditis injection
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20160307026950N32
Registration date:2021-03-07, 1399/12/17
Registration timing:prospective
Last update:2021-03-07, 1399/12/17
Update count:0
Registration date
2021-03-07, 1399/12/17
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
2021-04-04, 1400/01/15
Expected recruitment end date
2021-07-06, 1400/04/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the efficacy of Metoclopramide and Ondansetron on altering the pain of Etomidate injection under general anesthesia
Public title
The effect of Metoclopramide and Ondansetron on Etomidate injection pain
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Aged 18 to 65 years criteria
Anesthesia grade 1 and 2 according to ASA (American society Anesthesia)
Candidates for elective surgery and
Require general anesthesia with atomiditis
Exclusion criteria:
Allergy to the Etomidate
Allergy to the Metocloramide
Allergy to the Ondansetrone
Age
From 18 years old to 65 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
90
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization is done in a simple way; In this way, the eligible patients enter groups B, A and C, respectively, depending on the time of their arrival, and this sequence is repeated until the number of patients reaches 30 in each group.
Blinding (investigator's opinion)
Double blinded
Blinding description
This is a two-blind study in which the clinical caregiver and the person injecting the drug are different from the person performing the intervention and are unaware of the intervention. Also, patients in each group are explained that in order to reduce the pain caused by Types of intervention are applied to them without explaining the type of intervention. Therefore, patients are not aware of the type of intervention and are kept blind.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Isfahan University of Medical Sciences Committe for Ethics in Biomedical Research
Street address
Hezar Jarib St
City
Isfahan
Province
Isfehan
Postal code
8174673461
Approval date
2020-08-11, 1399/05/21
Ethics committee reference number
IR.MUI.MED.REC.1399.521
Health conditions studied
1
Description of health condition studied
Pain due to Etomidate injection
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Pain due to atomeditis injection
Timepoint
Immediately after the intervention
Method of measurement
By scoring with VAS (visual analog scale) from 1 (painless) to 2 (worst pain imaginable)
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group A: Patients in this group after receiving the surgical bed and monitoring connection receive 10 mg of Metoclopramide and 10 minutes later 5 ml of distilled water, then Etomidate is injected and the patient's pain is measured immediately.
Category
Prevention
2
Description
Intervention group B: Patients in this group after receiving the surgical bed and monitoring connection receive 10 mg of Metoclopramide and 10 minutes later 5 ml of distilled water, then Etomidate is injected and the patient's pain is measured immediately.
Category
Prevention
3
Description
Control group C: Patients in this group receive 5 ml of distilled water after being placed on a surgical bed and monitoring connection and 5 minutes later receive 5 ml of distilled water, then Etomidate is injected and the patient's pain is measured immediately.
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?
No
Title of funding source
Vice Chancellor for Research, Isfahan 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
Ziba Zekavat
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
behzad_nazem@med.mui.ac.ir
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 Anesthesia
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