Comparison of the efficacy of Midazolam, Propofol , and Midazolam-Propofol in prevention of pruritis induced by intrathecal Sufentanil in patients under surgery
Itching after surgery in patients under intrathecal anesthesia with opioid is a common complication that proposed treatment is not effective in all patients. we decided to compare the efficacy of 2 drugs previousely disscused for pruritis treatment. inclusion criteria include elective surgery and major surgery ; ASA class 1 or 2 . And exclusion criteria include opium addicted patients and emergent surgery. Study population are patients admitted in Imam Khomeini hospital operating room for surgery. Sample size is 90 patients, which receive one of the 3 drug groups ;propofol, midazolam and propofol and midazolam combined .outcome is the incidence and severity of pruritis every 30 minuetes during the surgery and in 24 hours after end of surgery.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201203059213N1
Registration date:2013-07-23, 1392/05/01
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2013-07-23, 1392/05/01
Registrant information
Name
Jalil Makarem
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 6658 1576
Email address
j-makarem@tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Because the drugs were routinely used for anesthesia, the patient is responsible for project cost ,it includes his medical expenses
Expected recruitment start date
2012-07-22, 1391/05/01
Expected recruitment end date
2013-08-22, 1392/05/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the efficacy of Midazolam, Propofol , and Midazolam-Propofol in prevention of pruritis induced by intrathecal Sufentanil in patients under surgery
Public title
Comparison of the efficacy of 3 drug groups :Midazolam, Propofol , and Midazolam- Propofol in prevention of pruritis induced by anesthetic drug used for syrgery
Purpose
Prevention
Inclusion/Exclusion criteria
inclusion criteria:
age:18-65 each sex; elective surgery; major surgery ; ASA class 1 or 2; informed cosent
exclusion criteria:
spinal anesthesia contraindication; opium addicted patients; emergent surgery; severe COPD; drug allergy to used drug in this study
Age
From 18 years old to 65 years old
Gender
Male
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
90
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Tehran University of Medical Sciences Ethics Committee
Street address
Tehran University of Medical Sciences, Qods street, Keshavarz Blvd, Tehran
City
Tehran
Postal code
Approval date
2012-04-21, 1391/02/02
Ethics committee reference number
2708/130/د/90
Health conditions studied
1
Description of health condition studied
pruritus
ICD-10 code
L29.9
ICD-10 code description
Pruritus, unspecified
Primary outcomes
1
Description
pruritus
Timepoint
24 hours after begining the surgery
Method of measurement
questioning the patient about the time, area and the severity of itching
Secondary outcomes
empty
Intervention groups
1
Description
group1 : 20 mg propofol is injected as bolus ,then 50 mcg/kg/min IV infusion.
Category
Prevention
2
Description
group2 :midazolam:
0.03 mg/kg midazolam is injected as bolus dose,then 0.02 mcg/kg/min IV infusion
Category
Prevention
3
Description
group3:
10 mg propofol and 0.015 mg/kg midazolam are injectes as bolus doses , then 25 mcg/kg/min propofol and 0.01 mcg/kg/min midazolam IV infusion.
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Khomeini Hospital
Full name of responsible person
Dr.Jalil Makarem
Street address
Tohid square ,Tohid street , Azadi street ,Tehran ,Imam Khomeini Hospital
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Jalil Makarem
Street address
Tehran University of Medical Sciences, Poursina st, 16th Azar st, Enghelab Eslami square, Tehran
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran 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
Tehran University of Medical Sciences
Full name of responsible person
Dr.Jalil Makarem
Position
Assistant Professor
Other areas of specialty/work
Street address
Tehran University of Medical Sciences, Poursina st, 16th Azar st, Enghelab Eslami square, Tehran
City
Tehran
Postal code
Phone
+98 21 6658 1576
Fax
Email
makaremj@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr.Jalil Makarem
Position
Assistant Professor
Other areas of specialty/work
Street address
Tehran University of Medical Sciences, Poursina st, 16th Azar st, Enghelab Eslami square, Tehran
City
Tehran
Postal code
Phone
+98 21 6658 1576
Fax
Email
makaremj@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr.Jalil Makarem
Position
Assistant Professor
Other areas of specialty/work
Street address
Tehran University of Medical Sciences, Poursina st, 16th Azar st, Enghelab Eslami square, Tehran
City
Tehran
Postal code
Phone
+98 21 6658 1576
Fax
Email
makaremj@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)