1. Home
  2. Approved trials
  3. » فارسی

The effect of pretreatment with clonidine on propofol consumption in opium abuser and non-abuser patients undergoing elective leg surgery

Protocol summary

Summary
Comparison of effect of pretreatment with clonidine on propofol consumption in opium abuser and non-abuser patients undergoing elective leg surgery. A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study. Study population: patient between 18-65 y/o addict & non addict with ASA class 1&2 undergoing elective leg surgery with max time of surgery<180min in imam hossein hospital. Inclusion criteria: ASA classification score 1 or 2 (I or II); age range of 18 to 65 years and maximum length of surgery up to 180 min. Exclusion criteria: patient disagreement; hemodynamic instability and maximum length of surgery>180min. Sample size: 160 cases. Intervention: In a randomized clinical trial, 160 cases were selected and assigned into the study groups. 80 patients were selected among the opium abusers and 80 were selected among the non-abuser patients. Then, both groups were randomly assigned and divided into one of the 2 groups, either receiving or not receiving clonidine. The patients were anesthetized using the same predetermined method, The depth of anesthesia was controlled and kept between 40 and 60 by recording the Bispectral index. If any deviation was noted, the level of anesthesia was corrected to reach the determined range.Finally, after termination of the surgery, the results for the length of operation, the detailed BIS number recordings, the total administered dose of propofol ,the length of anesthesia, and the patients, Recovery time, Intraoperative bleeding, recorded. Time duration: 60 day. Outcome: clonidine decrease propofol consumption in addict & non addict patients.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201202159026N1
Registration date: 2012-04-05, 1391/01/17
Registration timing: prospective

Last update:
Update count: 0
Registration date
2012-04-05, 1391/01/17
Registrant information
Name
Davood Ommi
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 7756 7840
Email address
mjabbarym@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Shahid Beheshti University of Medical Sciences
Expected recruitment start date
2012-04-20, 1391/02/01
Expected recruitment end date
2012-06-21, 1391/04/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of pretreatment with clonidine on propofol consumption in opium abuser and non-abuser patients undergoing elective leg surgery
Public title
Effect of clonidine on intraoperative consumption of propofol
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria patient informed written consent for entering study; American Society of Anesthesiologists (ASA) classification score 1 or 2 (I or II); age range of 18 to 65 years and maximum length of surgery up to 180 minutes Exclusion criteria patient disagreement; ASA class>2; SBP>140mmhg or SBP<90mmhg; maximum length of surgery>180min; age<18y or age>65y; cardiac arrhythmias; SaO2<90%; history of egg or propofol sensitivity; multiple trauma; addict in withdrawal phase coagulopathy.
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: 160
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
Shahid Beheshti University of Medical Sciences Ethics Committee
Street address
Velenjak
City
Tehran
Postal code
Approval date
2011-01-23, 1389/11/03
Ethics committee reference number
400/8014

Health conditions studied

1

Description of health condition studied
general anesthesia
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Intraoperative consumption of propofol
Timepoint
During operation
Method of measurement
miligram

Secondary outcomes

1

Description
Intraoperative bleeding
Timepoint
During operation
Method of measurement
Mililiter

2

Description
Recovery time
Timepoint
At the end of anesthesia
Method of measurement
Minutes

Intervention groups

1

Description
In first Intervention(case) group (non addicted)& second Intervention(case) group (addicted) tab clonidine(5mic/kg)90min before operation will prescribe and then The patients will anesthetize using the same predetermined method, The depth of anesthesia will controll and keep between 40 and 60(range of surgical anesthesia ) by recording the Bispectral index. If any deviation will note (BIS>60 or BIS<40) & by increasing or decreasing dose of propofol the level of anesthesia will correct to reach the determined range.Finally,during&after termination of the surgery, the results for the length of operation, the detailed BIS number recordings, the total administered dose of propofol ,the length of anesthesia, the patients, Recovery time, and Intraoperative bleeding will record.
Category
Treatment - Drugs

2

Description
In first Control(placebo) group(non addicted)& second Control(placebo) group(addicted) tab Vit. C(2mg/kg)90min before operation will prescribe and then The patients will anesthetize using the same predetermined method, The depth of anesthesia will controll and keep between 40 and 60(range of surgical anesthesia ) by recording the Bispectral index. If any deviation will note (BIS>60 or BIS<40) & by increasing or decreasing dose of propofol the level of anesthesia will correct to reach the determined range.Finally,during&after termination of the surgery, the results for the length of operation, the detailed BIS number recordings, the total administered dose of propofol ,the length of anesthesia, the patients, Recovery time, and Intraoperative bleeding will record.
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Imam Hossein hospital
Full name of responsible person
Dr. Alireza Mirkheshti
Street address
Madani street
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Anesthesia Research Center, Shahid Beheshti University of Medical Sciences
Full name of responsible person
Dr. Ali Dabbagh
Street address
Velenjak
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Anesthesia Research Center, Shahid Beheshti 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
Anesthesia departement , Shahid Beheshti University of Medical Sciences
Full name of responsible person
Dr. Davood Ommi
Position
MD, Anesthesiology Resident
Other areas of specialty/work
Street address
Madani street- Imam Hossein hospital
City
Tehran
Postal code
Phone
+98 21 7756 7840
Fax
Email
davoodommi@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Anesthesia departement, Shahid Beheshti University of Medical Sciences
Full name of responsible person
Dr. Alireza Mirkheshti
Position
Assistant professor
Other areas of specialty/work
Street address
Madani street, Imam Hossein hospital
City
Tehran
Postal code
Phone
+98 21 7756 7840
Fax
Email
alimirkheshti@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Anesthesia departement, Shahid Beheshti University of Medical Sciences
Full name of responsible person
Dr. Davood Ommi
Position
MD
Other areas of specialty/work
Street address
Madani street, Imam Hossein hospital
City
Tehran
Postal code
Phone
+98 21 7756 7840
Fax
+98 21 7756 7840
Email
davoodommi@yahoo.com
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
Loading...