Clinical Trial Comparison Between Lidocaine And Magnesium sulfate On Pain Of Interavenouse Etomidate In Patients Undergoing Any Type Of Surgery With General Anesthesia Except Cesarean Section
This study is a randomized double-blind clinical trial. The aim of this study is comparison between lidocaine and magnesium sulfate on pain of interavenouse etomidate in 99 patients 18-60 years old undergoing any type of surgery except cesarean section. Patients with Neuromuscular disease, Heart disease, epilepsy, pregnancy, receiving pain medications in twenty-four hours before surgery and thrombophlebitis will be excluded. Patients are randomly divided into three groups. The patients are not aware of the type of drug which received and evaluation of patients is performed by anesthesiologist who does not know about the protocol of the study. Anesthesia induction in three groups is identical and with 0.3 mg/Kg of etomidate. First group before injection of etomidate receives 2.48 mmol (60 mg) intravenous magnesium sulfate diluted in 2 mL of saline. Second group before injection of etomidate receives 30 mg of lidocaine 1% diluted in 2 ml of saline. Third group before injection of etomidate receives 5 ml of saline. After injection of etomidate injection site pain in patients will be assessed with 4 point ambesh scal.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2014121420304N1
Registration date:2015-01-13, 1393/10/23
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2015-01-13, 1393/10/23
Registrant information
Name
Jamileh Leilaten
Name of organization / entity
Ahvaz Jondishapour Univercity Of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 61 3221 6504
Email address
leilaten.j@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor For Research Of Ahvaz Jondishapour University of Medical Sciences
Expected recruitment start date
2014-06-14, 1393/03/24
Expected recruitment end date
2015-03-15, 1393/12/24
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Clinical Trial Comparison Between Lidocaine And Magnesium sulfate On Pain Of Interavenouse Etomidate In Patients Undergoing Any Type Of Surgery With General Anesthesia Except Cesarean Section
Public title
The Effect Of Lidocaine And Magnesium Sulfate On Pain Of Interavenouse Etomidate
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: Age range 18-60; Patients undergoing surgery with The anesthetic etomidate
except for cesarean section. Exclusion criteria: Neuromuscular diseases; Heart disease; Epilepsy; pregnancy; Receiving pain medications in twenty-four hours before surgery; Thrombophlebitis; Neurological and psychiatric disorders.
Age
From 18 years old to 60 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
99
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
The table of random numbers used for randomization. Each patient is assigned a code by who does not know about the protocol of the study.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Ahvaz Jondishapour University Of Medical Sciences
Street address
Ground Floor, Central Library, Ahvaz Jondishapour University of Medical Sciences, Golestan BLvd., Ahvaz
City
Ahvaz
Postal code
Approval date
2014-05-17, 1393/02/27
Ethics committee reference number
Ajums.REC.1393.53
Health conditions studied
1
Description of health condition studied
pain
ICD-10 code
Y45.9
ICD-10 code description
Analgesic, antipyretic and anti-inflammatory drug, unspecified
Primary outcomes
1
Description
Pain
Timepoint
After injection of etomidate and during twenty-four hours after surgery
Method of measurement
4 point Ambesh scal
Secondary outcomes
empty
Intervention groups
1
Description
Group1: injection of 2.48 mmol (60 mg) intravenous magnesium sulfate diluted in 2 mL of saline before injection of etomidate
Category
Prevention
2
Description
Group2: injection of 30 mg of lidocaine 1% diluted in 2 ml of saline before injection of etomidate .
Category
Prevention
3
Description
Group3: injection of 5 ml of saline before injection of etomidate.
Vice chancellor For Research Of Ahvaz Jondishapour University of Medical Sciences
Full name of responsible person
Nader Saki
Street address
Vice chancellor For Research Of Ahvaz Jondishapour University of Medical Sciences, Ground Floor, Central Library, Ahvaz Jondishapour University of Medical Sciences, Golestan BLvd., Ahvaz
City
Ahvaz
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 Of Ahvaz Jondishapour University of Medical Sciences
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
Ahvaz Jondishapour University of Medical Sciences
Full name of responsible person
Jamileh Leilaten
Position
Resident Of Anesthesiology
Other areas of specialty/work
Street address
Ahvaz Jondishapour University of Medical Sciences, Golestan Blvd., Ahvaz
City
Ahvaz
Postal code
6193673166
Phone
+98 61 3221 6504
Fax
Email
J.Leil@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ahvaz Jondishapour University of Medical Sciences
Full name of responsible person
Zahra Poormehdi
Position
Anesthesiologist
Other areas of specialty/work
Street address
College of Medicine, Ahvaz Jondishapour University of Medical Sciences, Golestan BLvd., Ahvaz
City
Ahvaz
Postal code
6193673166
Phone
+98 61 3221 6504
Fax
Email
Z_pourmehdi@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Pain Research Center
Full name of responsible person
Sanaz Nazari
Position
Nurse Anesthesia
Other areas of specialty/work
Street address
Pain Research Center, Fourth Floor of Imam Khomeini Hospital, Shahid Ahvazian St., Ahvaz
City
Ahvaz
Postal code
6193673166
Phone
+98 61 3221 6504
Fax
Email
s.nz1990@yahoo.com; nazari_s@ajums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)