A comparative study of lidocaine, lidocaine and melatonin and Valsalva maneuver, lidocaine and Valsalva maneuver to reduce the pain associated with administration of ethomidate
A comparative study of lidocaine, lidocaine and melatonin and Valsalva maneuver, lidocaine and Valsalva maneuver to reduce the pain associated with administration of ethomidate
Design
Open label randomized clinical trial, with three parallel groups, randomized with block randomization, phase 3, on 135 patients overall.
Settings and conduct
The study is a clinical trial, in which cases are devided into 3 groups by block randomization: 1.Valsalva maneuver, melatonin injection and lidocaine injection 2.lidocaine, and 3.Valsalva maneuver along with prescription of lidocaine. It will be carried out in January and February 2021, in Alzahra hospital, Isfahan, Iran. After informed consent, candidates for sedation with ethomidate are divided in 3 groups and their demographic information and visual analog scores are recorded. Only data analyst is blinded in this study.
Participants/Inclusion and exclusion criteria
Inclusion criteria: 1. Physical class I or II 2. Age between 18 to 65 years old 3.ethomidate administration as sedative.
Exclusion criteria: patient with sepsis; history of allergic reaction; kidney function disease; liver function disease; patient with history of hypertension and uncontrolled diabetes.
Intervention groups
1- performing Valsalva maneuver, melatonin injection and lidocaine injection; 2- Lidocaine injection 3- Lidocaine injection while the patient is performing Valsalva maneuver.
Main outcome variables
Pain
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20160307026950N31
Registration date:2021-01-27, 1399/11/08
Registration timing:prospective
Last update:2021-01-27, 1399/11/08
Update count:0
Registration date
2021-01-27, 1399/11/08
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
2021-02-03, 1399/11/15
Expected recruitment end date
2021-03-05, 1399/12/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A comparative study of lidocaine, lidocaine and melatonin and Valsalva maneuver, lidocaine and Valsalva maneuver to reduce the pain associated with administration of ethomidate
Public title
A comparation of lidocaine, lidocaine and melatonin and Valsalva maneuver, lidocaine and Valsalva maneuver to reduce the pain associated with administration of ethomidate
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Physical condition in ASA class I and II
Age 18 to 65 years old
Candidates for general anesthesia with ethomidate
Exclusion criteria:
Patient with sepsis
History of allergic reactions
Kidney function disease
Liver function disease
Patient with hypertension and uncontrolled diabetes
Age
From 18 years old to 65 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
135
Randomization (investigator's opinion)
Randomized
Randomization description
Block randomization is used in this study to devide cases in 3 groups. SAS algorithm was used to perform blocked randomization.
Blinding (investigator's opinion)
Not blinded
Blinding description
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
Isfahan University of Medical Sciences, Hezar Jerib street
City
Esfahan
Province
Isfehan
Postal code
8174673461
Approval date
2021-01-18, 1399/10/29
Ethics committee reference number
IR.MUI.MED.REC.1399.968
Health conditions studied
1
Description of health condition studied
Local injection site pain
ICD-10 code
G89.18
ICD-10 code description
Other acute postprocedural pain
Primary outcomes
1
Description
Local ethomidate injection site pain measured by visual analog scale
Timepoint
Right after injection
Method of measurement
1)Visual analog scale 2) Objective physician-assessed pain score
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: first inject lidocaine and melatonin, then the patient is asked to perform Valsalva maneuver at the time of ethomidate injection
Category
Prevention
2
Description
Intervention group: intravenous Lidocaine bolus injection of 1mg/Kg of body weight, over 2-3 minutes
Category
Prevention
3
Description
Intervention group: the patient is asked to perform Valsalva maneuver at the time of ethomidate injection. In the meantime intravenous Lidocaine bolus dose of 1mg/Kg of body weight, is injected over 2-3 minutes.
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Alzahra hospital
Full name of responsible person
Behzad Nazem Roaya
Street address
Alzahra hospital, Soffe blvd.
City
Esfahan
Province
Isfehan
Postal code
81746 75731
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
Isfahan University of Medical sciences, Hezar Jarib blvd.
City
Esfahan
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
Behzad Nazem Roaya
Position
Associate Professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Alzahra hospital, Soffe blvd.
City
Esfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3662 0048
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
Associate Professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Isfahan University of Medical Sciences, Hezar Jarib blvd.
City
Esfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3668 8597
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
Behzad Nazem Roaya
Position
Associate Professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Isfahan University of Medical Sciences, Hezar Jarib blvd.
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3668 0048
Email
behzad_nazem@med.mui.ac.ir
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 a possibility that our subjects would not be willing to consent to their data being shared.
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