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The Effect of Lidocaine, Magnesium Sulfate and Ketamine on the Pain of Propofol Intravenous Injection

Protocol summary

Summary
The current protocol was aimed to compare effects of three drugs such as Lidocaine, Magnesium sulfate and Ketamine on the pain of Propofol intravenous injection. Patients needed anesthesia divided into four groups including Lidocaine (L), Ketamine (K), Magnesium sulfate (MS) and Normal saline (NS). Eighty patients conducted in this survey. This study was double blind that anesthesiologist who was unaware of the contents of the syringe. Also, the specialist assessing pain was not aware of patients assigned to groups. Patients were allocated in to 4 groups using block allocation method. All patients were provided by Normal Saline prior to induction and venipuncture was also done from upper limb distal using vein catheter no 18 and anesthesia methods were similar for all groups. Groups L, K, MS, and NS received respectively 40 mg Lidocaine, 25 mg Ketamine, 1 gr Magnesium Sulfate, and 5 ml Normal Saline. Inclusion criteria were as follow: 1) people aged 18-65 years that categorized into class 1 and 2 based on America Society of Anesthesiologists (ASA. Exclusion criteria were considered as: 1) having allergies or symptoms of heart disease. To measure pain, Verbal Rating Scale was used (0= no pain, 1= low pain, 2= moderate, and 3= severe pain).

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2016051410340N10
Registration date: 2016-07-01, 1395/04/11
Registration timing: na

Last update:
Update count: 0
Registration date
2016-07-01, 1395/04/11
Registrant information
Name
Mohammad Aryaie
Name of organization / entity
Golestan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 911 277 1798
Email address
aryaie@goums.ac.ir
Recruitment status
Not enough for processing
Funding source
Golestan University of Medical Science
Expected recruitment start date
2015-03-20, 1393/12/29
Expected recruitment end date
2006-03-20, 1384/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effect of Lidocaine, Magnesium Sulfate and Ketamine on the Pain of Propofol Intravenous Injection
Public title
Pain of Propofol Intravenous Injection
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: people aged 18-65 years that categorized into class 1 and 2 based on America Society of Anesthesiologists (ASA); hypertension between 90 and 140 until 24 hours before surgery; lack of neurological disorders, kidney and liver failure; lack of drug allergy; no history of allergy to eggs or anaphylaxis. Exclusion criteria were considered as: having allergies or symptoms of heart disease and arrhythmias; saturation drops below 90%; operation duration more than 3 hours.
Age
From 18 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 80
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethic Committee of Golestan University of Medical Science
Street address
4 Kilometer of Gorgan-sari Road, Falsafi educational campus, Vice Chancellor of Technology and Information, Gorgan
City
Gorgan
Postal code
Approval date
2010-08-20, 1389/05/29
Ethics committee reference number
3107869312242

Health conditions studied

1

Description of health condition studied
pain
ICD-10 code
M79.6
ICD-10 code description
Pain in limb

Primary outcomes

1

Description
Pain
Timepoint
After intervention
Method of measurement
Verbal Rating Scale

Secondary outcomes

1

Description
Hemodynamic Change
Timepoint
Before Intervention, 1,3 and 5 minutes after intervention
Method of measurement
Sphygmomanometer, Pols oximeter

Intervention groups

1

Description
40 mg Lidocaine was intravenously administered as a premedication before propofol injection
Category
Prevention

2

Description
25 mg Ketamine was intravenously administered as a premedication before propofol injection
Category
Prevention

3

Description
1 gr Magnesium sulfate was intravenously administered as a premedication before propofol injection
Category
Prevention

4

Description
5 ml Normal saline was intravenously administered as a premedication before propofol injection
Category
Prevention

Recruitment centers

1

Recruitment center
Name of recruitment center
5 Azar Hospital
Full name of responsible person
Peyman Asghari
Street address
5 Azar Hospital, 5 Azar Street, Gorgan City, Golestan Province
City
Gorgan

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Golestan University of Medical Science
Full name of responsible person
Homeira Khodam
Street address
4 Kilometer of Gorgan-sari Road, Falsafi educational campus, Vice Chancellor of Technology and Information, Gorgan
City
Gorgan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Golestan University of Medical Science
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact
Name of organization / entity
Golestan University of Medical Science
Full name of responsible person
Homeira Khodam
Position
Research and Technolgy Managment
Other areas of specialty/work
Street address
4 Kilometer of Gorgan-sari Road, Falsafi educational campus, Vice Chancellor of Technology and Information, Gorgan
City
Gorgan
Postal code
Phone
+98 17 3242 4377
Fax
Email
homeira_khoddam@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Golsestan University of Medical Sciences
Full name of responsible person
Peiman Asghari
Position
Anesthesia Specialist
Other areas of specialty/work
Street address
4 Kilometer of Gorgan-sari Road, Falsafi educational campus, Vice Chancellor of Technology and Information, Gorgan
City
Gorgan
Postal code
Phone
+98 17 3242 4256
Fax
Email
paymanasghari5@gmail.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Golsestan University of Medical Sciences
Full name of responsible person
Mohamma Aryaied
Position
MSc in Epidemiology
Other areas of specialty/work
Street address
4 Kilometer of Gorgan-sari Road, Falsafi educational campus, Vice Chancellor of Technology and Information, Gorgan
City
Postal code
Phone
+98 17 3242 4377
Fax
Email
aryaie@goums.ac.ir
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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