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IRCT20101211005362N31 IRCT 2022-11-07 Esfahan University of Medical Sciences Comparison study of the pre emptive of the two dose of dexmedetomidine (bolus and infusion) on post operative pain, nausea and vomiting for laparoscopic cholecystectomy پره امپتیو، دکسمدتومیدین، درد و تهوع و استفراغ، کولهسیستکتومی لاپاراسکوپی Comparison study of the preemptive of the two dose of dexmedetomidine (bolus and infusion) on post operative pain, nausea and vomiting for laparoscopic cholecystectomy 2022-07-23 anticipated 90 Complete https://irct.ir/trial/57694 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Supportive, Other design features: In a clinical trial study, we should compare the administration of two bolus doses and infusion of dexmedetomidine on pain, nausea and vomiting in patients undergoing laparoscopic cholecystectomy, Randomization description: The sampling method is based on simple random method that means, all the samples which are eligible to participate in the study will be included in the study until the sample size is completed. Then, the patients who entered the study will be randomly divided into three groups using the Randomize Allocation software. Random Allocation software (version 2.0) will be used. Sampling will be done by the method of 3 permutation blocks. In this way, we will have 15 blocks of 6 and each block contains 6 letters from A, C and B, including AABBCC-ABCABC-BCBACA-BABACC and etc. (three groups of 30). Each patient is given a card at random. The cards are in sealed envelopes and the anesthesiologist takes the envelopes in order and delivers them to the patients. People with card A receive intravenous dexmedetomidine at a rate of 1 μg per kg of body weight as a bolus dose 20 minutes before induction of anesthesia and then receive 0.5 μg per kg of body weight as an infusion over 15 minutes. People who have card B receive intravenous dexmedetomidine at the rate of 1 μg per kg of body weight as a bolus dose 20 minutes before induction of anesthesia and then 0.7 μg per kg of body weight as an infusion for 15 minutes. People who have card C routinely faint. The person who collects the data does not know whether the data is related to group A, group B or group C, Blinding description: The method of blinding in this study is that the drugs are used by coding method and with syringes of equal volume for all patients. Also, the first anesthesiologist injects the drug based on simple random method then data collection is done by the second anesthesiologist. In addition the patients and the interventionist doctor do not know about studied groups, during the research project. 1-2 Pain, nausea and vomiting. Intervention 1: Intervention group: Intravenous dexmedetomidine at a dose of 1 microgram per kilogram of body weight is given as a bolus dose 20 minutes before induction of anesthesia and then 0.5 micrograms per kilogram of body weight for infusion for 15 minutes. Intervention 2: Intervention group: Intravenous dexmedetomidine at a dose of 1 microgram per kilogram of body weight is given as a bolus dose 20 minutes before induction of anesthesia and then 0.7 micrograms per kilogram of body weight is infused for 15 minutes. Intervention 3: Control group: instead of dexmedetomidine, we use 10 cc of normal saline before induction of anesthesia. No - There is not a plan to make this available Justification or reason for not sharing IPD is There is no more information
public Mohammadreza Safavi
Anesthesiology and Critical Care Research Center,Isfahan University of Medical Sciences, Isfahan, Iran
isfahan Iran (Islamic Republic of) 8174675731 +98 31 1625 5555 safavi@med.mui.ac.ir Esfahan University of Medical Sciences scientific Mohammadreza Safavi
Anesthesiology and Critical Care Research Center,Isfahan University of Medical Sciences, Isfahan, Iran
isfahan Iran (Islamic Republic of) 8174675731 +98 31 1625 5555 safavi@med.mui.ac.ir Esfahan University of Medical Sciences Iran (Islamic Republic of) patient candidate to be operated laparoscopic cholecystectomy one and two ASA age between 18 - 65 year Patient consent to participate in the study 18 years 65 years Both Drug addiction History of dexmedetomidine allergy People with a BMI above 30 Use of sleeping pills and analgesics chronically Treatment - Drugs Treatment - Drugs Placebo Intervention group: Intravenous dexmedetomidine at a dose of 1 microgram per kilogram of body weight is given as a bolus dose 20 minutes before induction of anesthesia and then 0.5 micrograms per kilogram of body weight for infusion for 15 minutes. Intervention group: Intravenous dexmedetomidine at a dose of 1 microgram per kilogram of body weight is given as a bolus dose 20 minutes before induction of anesthesia and then 0.7 micrograms per kilogram of body weight is infused for 15 minutes. Control group: instead of dexmedetomidine, we use 10 cc of normal saline before induction of anesthesia. Comparison of the effect of different doses of dexmedetomidine on amount of pain. Timepoint: The first hour of recovery every 15 minutes, then 6 hours later, every two hours, and then 12, 24 and 48 hours later is evaluated. Method of measurement: Pain intensity based on VAS scoring system and severity of nausea and vomiting using PONV system. Comparing the effect of different doses of dexmedetomidine on nausea severity. Timepoint: The first hour of recovery every 15 minutes, then 6 hours later every two hours, and then 12, 24 and 48 hours later is evaluated. Method of measurement: The severity of nausea is measured using the PONV system. Comparing the effect of different doses of dexmedetomidine on vomiting severity. Timepoint: The first hour of recovery every 15 minutes, then 6 hours later, every two hours, and then 12, 24 and 48 hours later is evaluated. Method of measurement: The severity of vomiting is measured using the PONV system. Blood pressure. Timepoint: The first hour of recovery is evaluated every 15 minutes, then 6 hours later, every two hours, and then 12, 24 and 48 hours later. Method of measurement: Blood pressure is measured using a sphygmomanometer. Heart beat. Timepoint: The first hour of recovery is evaluated every 15 minutes, then every two hours after 6 hours, and then 12, 24, and 48 hours later. Method of measurement: Heart rate is measured using a pulse oximeter. Blood oxygen level. Timepoint: The first hour of recovery is evaluated every 15 minutes, then every two hours after 6 hours, and then 12, 24, and 48 hours later. Method of measurement: Blood oxygen is measured using a pulse oximeter. Amount of drugs. Timepoint: The first hour of recovery is evaluated every 15 minutes, then every two hours after 6 hours, and then 12, 24, and 48 hours later. Method of measurement: Using the volume in cc used. Esfahan University of Medical Sciences Approved 2022-03-26 Isfahan university of medical science Hezar jarib Isfahan Isfehan Iran (Islamic Republic of)