Comparison of the effectiveness of Fentanyl administration and Valsalva maneuver in relieving pain caused by Etomidate injection to induce general anesthesia
Comparison of the effect of Valsalva maneuver and Fentanyl injection on pain caused by Etomidate injection
Design
Clinical trial with control group, with parallel groups, double-blind, randomized, phase 3 per 96 patients. Randomization will be done by lottery.
Settings and conduct
This study is a double-blind randomized clinical trial that will be performed on patients undergoing general anesthesia at Isfahan Al-Zahra Hospital after obtaining an ethics license. Intervention groups. In each group, one of the interventions is applied and the results are recorded. The person performing the intervention, the patients and the person recording the results are uninformed and blind. The data is encrypted and therefore the data analyzer is also blind.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Age 18 to 65 years, Candidate of General Anesthesia, ASA Class I and II Anesthesia, Able to perform Valsalva maneuver
Exclusion criteria: history of mental illness, Cardiorespiratory, chronic pain disorders, use of painkillers, allergy to Etomidate and Fentanyl, history of drug use.
Intervention groups
Intervention group A: Patients in this group are assigned to perform a Valsalva maneuver by blowing into a plastic tube attached to a sphygmomanometer hand and raising the mercury column to 30 mmHg for at least 20 seconds just before the etomidate injection. Fentanyl injection is given falsely.
Intervention group B: Patients in this group receive Fentanyl intravenously at a dose of 2 Micrograms per kilogram of body weight 3 minutes before receiving etomidate, and a plastic tube with an open end is placed in the patient's mouth to perform a fake Valsalva maneuver.
Main outcome variables
Pain due to Etomidate injection
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20160307026950N33
Registration date:2021-03-30, 1400/01/10
Registration timing:registered_while_recruiting
Last update:2021-03-30, 1400/01/10
Update count:0
Registration date
2021-03-30, 1400/01/10
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
2021-01-04, 1399/10/15
Expected recruitment end date
2021-06-05, 1400/03/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effectiveness of Fentanyl administration and Valsalva maneuver in relieving pain caused by Etomidate injection to induce general anesthesia
Public title
The effect of Fentanyl injection and Valsalva maneuver on pain caused by Etomidate injection
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Patients 18 to 65 years
Candidate for General Anesthesia
ASA Class I and II Anesthesia
Able to perform Valsalva maneuver
Exclusion criteria:
History of mental, Cardiorespiratory and chronic pain disorders
Use of painkillers
History of allergy to Etomidate and Fentanyl
History of drug use
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:
96
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization is done by block method; If the number of patients in both groups is the same, the first patient enters one of the groups by lottery, then from the second patient, patients enter one of the groups one by one according to their arrival time, so that the sample size reaches the required number in each Reach the group.
Blinding (investigator's opinion)
Double blinded
Blinding description
This is a randomized, double-blind clinical trial; Patients are explained that in order to reduce the pain caused by anesthesia injection, two interventions of Fentanyl injection and Valsalva maneuver are performed on them and depending on their group, only one of the interventions is performed completely, but patients are of the intervention type. The one who will be fully applied are unaware. Also, the person injecting the drug and the person recording the patient's symptoms are unaware of the type of intervention applied. The data is encrypted and therefore the analyzers are also blind.
Placebo
Used
Assignment
Parallel
Other design features
In this study, the two groups are compared in terms of intervention and the control group does not exist separately.
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
City
Isfahan
Province
Isfehan
Postal code
8174673461
Approval date
2020-08-22, 1399/06/01
Ethics committee reference number
IR.MUI.MED.REC.1399.635
Health conditions studied
1
Description of health condition studied
The pain caused by injection of Etomidate
ICD-10 code
G89
ICD-10 code description
Pain, not elsewhere classified
Primary outcomes
1
Description
The amount of pain caused by Etomidate injection
Timepoint
Before intervention, after intervention, immediately after injection and 1, 2, 3, 5, 10 and 15 minutes after injection of initial dose of Etomidate
Method of measurement
withdrawal response score
Secondary outcomes
1
Description
Blood Pressure
Timepoint
Before intervention, after intervention, immediately after injection and 1, 2, 3, 5, 10 and 15 minutes after injection of initial dose of atomidite
Method of measurement
Manometer
2
Description
Heart Rate
Timepoint
Before intervention, after intervention, immediately after injection and 1, 2, 3, 5, 10 and 15 minutes after injection of initial dose of atomidite
Method of measurement
ECG
3
Description
Blood oxygen saturation
Timepoint
Before intervention, after intervention, immediately after injection and 1, 2, 3, 5, 10 and 15 minutes after injection of initial dose of atomidite
Method of measurement
Pulse Oximeter
Intervention groups
1
Description
Intervention group A: In this group, patients first receive 2 cc of normal saline intravenously and after 3 minutes, perform the Valsalva maneuver by blowing in a plastic tube (where the hole is closed on the tube) for at least 26 seconds. At the end of the Valsalva maneuver, Etomidate injection is started.
Category
Prevention
2
Description
Intervention group B: Patients in this group first receive Fentanyl at a dose of 2 micrograms per kilogram of body weight intravenously and 3 minutes later a plastic tube is placed in the patient's mouth and the patient blows into the tube (while the hole is inserted on Is open on the pipe). Etomidate injection is started after 26 seconds.
Category
Prevention
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
Golshan Mazahery
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
www.g.mazaheri@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Behzad Nazemoroaya
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