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IRCT20160307026950N53 IRCT 2023-07-08 Esfahan University of Medical Sciences The effect of intravenous and intraperitoneal dexmedetomidine in combination with intraperitoneal bupivacaine on postoperative pain A comparative study of the effect of adding intravenous dexmedetomidine or intraperitoneal dexmedetomidine to intraperitoneal bupivacaine on pain after laparoscopic cholecystectomy. 2023-07-23 anticipated 90 Complete https://irct.ir/trial/70530 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Prevention, Randomization description: Randomization will be done by the simple method , the samples are randomly placed in three intervention groups 1 and 2 and control by random allocation software. Sampling continues until the samples in all three groups reach the set limit, Blinding description: This study is a triple blind clinical trial,in this way, the patient is included in the study but does not know the type of intervention applied and is blind, the person who records the patient's symptoms is also different from the person who injects the drug And without knowing the type of drug, only records the patient's symptoms during the study and therefore is kept blind. The analysts who analyze the data collected during the study also do not know the type of intervention applied in each group and are blind. 3 postoperative pain. Intervention 1: Intervention group1: In this group of patients who dont eat anything for at least 8 hours before the operation, 20 ml of bupivacaine 0.25% with 1 μg/kg of dexmedetomidine was injected intraperitonealy in the bedside of the gallbladder after the last clamp and just before the removal of the trocar of laparascope. Intervention 2: Intervention group 2: In this group of patients who dont eat anything for at least 8 hours before the operation, at the end of the operation and after the last clamp and just before the removal of trocar of laparascope , 20 ml bupivacaine 0.25% intraperitoneally and 1 microgram/kg dexmedetomidine are injected into the patients. Intervention 3: Control group: In this group, 22 cc of normal saline is injected intraperitoneally at the end of the operation to patients who have not eaten anything for at least 8 hours before the operation. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is There is no more information
public Zahra molaei
,Alzahra hospital, soffeh boulevard, shahid keshvari highway
Isfahan Iran (Islamic Republic of) 8174673461 +98 31 3822 2532 Zmolaei78@gmail.com Esfahan University of Medical Sciences scientific Behzad Nazemroaya
Alzahra hospital, soffeh boulevard, shahid keshvari highway
Isfahan Iran (Islamic Republic of) 8174673461 0098 31 822 2532 Behzad_nazem@med.mui.ac.ir Esfahan University of Medical Sciences Iran (Islamic Republic of) Candidates for laparoscopic cholecystectomy surgery ASA I & II(American society of anesthesiologist) Informed Consent to participate in the study 18 years 65 years Both Patients with a history of allergy to the drugs used in the study (dexmedetomidine and bupivacaine) Patients with psychological problems Patients with a history of drug addiction Patients with the inability to express the intensity of pain based on the vas criterion Prevention Prevention Placebo Intervention group1: In this group of patients who dont eat anything for at least 8 hours before the operation, 20 ml of bupivacaine 0.25% with 1 μg/kg of dexmedetomidine was injected intraperitonealy in the bedside of the gallbladder after the last clamp and just before the removal of the trocar of laparascope. Intervention group 2: In this group of patients who dont eat anything for at least 8 hours before the operation, at the end of the operation and after the last clamp and just before the removal of trocar of laparascope , 20 ml bupivacaine 0.25% intraperitoneally and 1 microgram/kg dexmedetomidine are injected into the patients. Control group: In this group, 22 cc of normal saline is injected intraperitoneally at the end of the operation to patients who have not eaten anything for at least 8 hours before the operation. The severity of postoperative pain. Timepoint: In base time9before intervention), every 15 minutes in recovery,in 2, 4, 6, 12, 24 hours after surgery. Method of measurement: Visual Analogue Scale(0-10). Mean arterial pressure. Timepoint: In base time(before intervention), every 30 minutes during operation and then in recovery. Method of measurement: barometer. Heart Rate. Timepoint: In base time(before intervention), every 30 minutes during operation and then in recovery. Method of measurement: ECG. Arterial blood oxygen saturation. Timepoint: In base time(before intervention), every 30 minutes during operation and then in recovery. Method of measurement: pulse oximeter. Complication(nausea and vomiting). Timepoint: In base time(before intervention), every 30 minutes during operation and then in recovery. Method of measurement: asking. Esfahan University of Medical Sciences Approved 2023-04-24 Research ethics committees of School of Medicine-Isfahan university of Medical Sciences Hezar jerib Isfahan Isfehan Iran (Islamic Republic of)