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Comparison of three methods of Valsalva maneuver, Lidocaine, and Valsalva maneuvers along with administration of Lidocaine to reduce the pain associated with administration of Propofol

Protocol summary

Study aim
To compare Valsalva maneuver, Lidocaine, and Valsalva maneuvers along with administration of Lidocaine to reduce the pain associated with administration of Propofol in Alzahra hospital in 2020
Design
Open label randomized clinical trial, with three parallel groups, randomized with block randomization, phase 3, on 111 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,2.lidocaine, and 3.Valsalva maneuver along with prescription of lidocaine. It will be carried out in October 2020, in Alzahra hospital, Isfahan, Iran. After informed consent, Candidates for sedation with propofol are divided in 3 groups and their demographic information and VAS 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. Propofol administration as sedative. Exclusion criteria: 1. History of mental, cardiac and respiratory disease 2. Chronic pain disorders 3. Long history of analgesic use 4. History of allergic reactions propofol or lidocaine 5. History of drug abuse
Intervention groups
Group 1- Performing Valsalva maneuver by the patient; 2- Lidocaine injection; and 3- Lidocaine injection while the patient is performing Valsalva maneuver. Lidocaine dose is 1 mg/Kg of body patient's weight slow bolus intravenous (over 2-3 min)
Main outcome variables
Visual Analog Scale (VAS) for pain Objective physician-assessed pain score; with: 0= no pain; 1= mild pain, pain that only is reported by the patient, and no signs of pain are observed by the physician; 2= Moderate pain, one pain sign is observed in addition to patient's report 3= Severe pain with loud noise or moaning.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20160307026950N27
Registration date: 2020-11-18, 1399/08/28
Registration timing: prospective

Last update: 2020-11-18, 1399/08/28
Update count: 0
Registration date
2020-11-18, 1399/08/28
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
2020-11-24, 1399/09/04
Expected recruitment end date
2020-12-13, 1399/09/23
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of three methods of Valsalva maneuver, Lidocaine, and Valsalva maneuvers along with administration of Lidocaine to reduce the pain associated with administration of Propofol
Public title
The effect of Valsalva maneuver, Lidocaine and Valsalva maneuver and Lidocaine injection on reducing the pain of Propofol injection
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Candidates for general anesthesia Physical condition in ASA class I and II Age 18 to 65 years old Able to perform Valsalva maneuver
Exclusion criteria:
History of mental, cardiac and respiratory diseases Chronic pain disorders Long history of analgesic use History of allergies to propofol and Lidocaine History of drug abuse
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: 111
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
Not 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
Isfahan
Province
Isfehan
Postal code
8174673461
Approval date
2020-10-27, 1399/08/06
Ethics committee reference number
IR.MUI.MED.REC.1399.658

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 propofol injection site pain measured by visual analog scale
Timepoint
Right after propofol injection
Method of measurement
visual analog scale / Objective physician-assessed pain score; with: 0= no pain;1= mild pain, pain that only is reported by the patient, and no signs of pain are observed by the physician;2= Moderate pain, one pain sign is observed in addition to patient's report3= Severe pain with loud noise or moaning

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: The patient is asked to perform Valsalva maneuver at the time of propofol 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 propofol 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
Soffeh blvd
City
isfahan
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
Vice Chancellor for Research, Isfahan University of Medical Sciences
Full name of responsible person
Shaghayegh Haghjoo
Street address
Hezar Jarib blvd, Esfahan University of Medical science
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
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
Behzad Nazem roaya
Position
Associate Professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Hezar Jarib blvd.
City
Isfahan
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
Hezar Jarib blvd
City
Isfahan
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
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
Analytic Code
Not applicable
Data Dictionary
Not applicable
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