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IRCT20201024049135N1 IRCT 2021-02-06 Iran University of Medical Sciences Comparison of two methods of dose calculating of propofol for induction of general anesthesia according to either Ideal Body Weight(IBW) or Fat Free Mass(FFM), in morbid obese patient: parallel double - blinded clinical trial Comparison of two methods of calculating the dose of propofol for induction of general anesthesia according to either Ideal Body Weight(IBW) or Fat Free Mass(FFM), in morbid obese patient: parallel double - blinded clinical trial 2021-02-19 anticipated 40 Complete https://irct.ir/trial/51969 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Other, Other design features: 40 morbid obese patients with BMI more than 35, aged 18-59 years, ASA ll and lll undergoing bariatric surgery, based on the dose of propofol received to induce general anesthesia, into two groups: Fat Free Mass (FFM) and Ideal Body Weight (IBW) are divided, Randomization description: In this study, we use the block randomization method so that after selecting patients according to the inclusion and exclusion criteria by selecting numbers from the table of random numbers and adapting to the blocks, patients are divided into study groups.To randomize the two treatment methods, we create 4 blocks in six different states, then select a number using the table of numbers, and determine the study groups by matching the numbers with the blocks. For example, if the first digit of our number is 1 to 6, select a block and the division is done, but if, for example, our number is 94071, the digit 9 is not valid and we select the next digit. Here, based on the block, we divide 4 people into groups. 1. TTCC 2. TCTC 3. TCCT 4. CCTT 5. CTCT 6. CTTC, Blinding description: The anesthesiologist who is going to administer the drug is aware of the study group, while data recording is performed by another person who is not aware of the administered dose. This is a randomized double-blind study in which the patient and the person who recording and evaluating the data is not aware of the dose of the drug administered. 3 Morbid obese. Intervention 1: Intervention group1: Propofol 1% (B.Braun Melsungen AG,34209 Melsungen, Germany) administration with the dose of 2 milligram per kilogram according to ideal body weight(IBW). Intervention 2: Intervention group2: Propofol 1% (B.Braun Melsungen AG,34209 Melsungen, Germany) administration with the dose of 2 milligram per kilogram according to body fat free mass(FFM). No - There is not a plan to make this available Justification or reason for not sharing IPD is There is no more information
public Soudabeh ِِِDjalali Motlagh
Firozgar hospital, Valiasr Square
Tehran Iran (Islamic Republic of) 1593747811 +98 21 8214 1600 djalalimotlagh.s@iums.ac.ir Iran University of Medical Sciences scientific Farnoosh Tavakoli
No. 6, 35th St., Gisha Ave..
Tehran Iran (Islamic Republic of) 1447935167 +98 21 8824 9533 tavakoli_f78@yahoo.com Iran University of Medical Sciences Iran (Islamic Republic of) Obesity BMI more than 35 Age 18-59 years ASA ll and lll Undergoing for bariatric surgery 18 years 59 years Both Difficult airway The need for awake intubation Severe systemic diseases Impaired renal and hepatic function History of allergies to the drugs studied Behavioral disorders and the use of psychiatric drugs E66 Overweight and obesity Other Other Intervention group1: Propofol 1% (B.Braun Melsungen AG,34209 Melsungen, Germany) administration with the dose of 2 milligram per kilogram according to ideal body weight(IBW). Intervention group2: Propofol 1% (B.Braun Melsungen AG,34209 Melsungen, Germany) administration with the dose of 2 milligram per kilogram according to body fat free mass(FFM). Onset time of the dose of propofol (electroencephalographic depression) according to the study group which is determined by a decrease in bispectral index to less than 60. Timepoint: During induction of general anesthesia. Method of measurement: evaluated by bispectral index recording. Evaluation of the extent of decrease in mean arterial pressure. Timepoint: During induction of anesthesia and every 3 minutes. Method of measurement: Through noninvasive blood pressure monitoring. Measure the maximum depth of anesthesia. Timepoint: During induction of anesthesia and every 3 minutes. Method of measurement: Bispectral index Monitoring. Evaluation of the extent of heat rate decrease during induction of anesthesia. Timepoint: Continuous monitoring. Method of measurement: Electrocardiography. Iran University of Medical Sciences Approved 2020-10-17 Ethics Committee in Research School of Medicine - Iran University of Medical Sciences No. 6, 35th St., Gisha Ave.. Tehran Tehran Iran (Islamic Republic of)