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IRCT201202159026N1 IRCT 2012-04-05 Anesthesia Research Center, Shahid Beheshti University of Medical Sciences Effect of clonidine on intraoperative consumption of propofol The effect of pretreatment with clonidine on propofol consumption in opium abuser and non-abuser patients undergoing elective leg surgery 2012-04-20 anticipated 160 Complete https://irct.ir/trial/9650 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment. N/A general anesthesia. Intervention 1: 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. Intervention 2: 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.
public Dr. Davood Ommi
Madani street- Imam Hossein hospital
Tehran Iran (Islamic Republic of) +98 21 7756 7840 davoodommi@yahoo.com Anesthesia departement , Shahid Beheshti University of Medical Sciences scientific Dr. Alireza Mirkheshti
Madani street, Imam Hossein hospital
Tehran Iran (Islamic Republic of) +98 21 7756 7840 alimirkheshti@yahoo.com Anesthesia departement, Shahid Beheshti University of Medical Sciences Iran (Islamic Republic of) 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. 18 years 65 years Both Treatment - Drugs Placebo 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. 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. Intraoperative consumption of propofol. Timepoint: During operation. Method of measurement: miligram. Intraoperative bleeding. Timepoint: During operation. Method of measurement: Mililiter. Recovery time. Timepoint: At the end of anesthesia. Method of measurement: Minutes. Anesthesia Research Center, Shahid Beheshti University of Medical Sciences Approved 2011-01-23 Shahid Beheshti University of Medical Sciences Ethics Committee Velenjak Tehran Iran (Islamic Republic of)