]>
IRCT20141009019470N96 IRCT 2020-01-20 Shiraz University of Medical Sciences The effect of dexmedetomedine and clonidine on hemodynamics and postoperative pain of laparoscopic cholecystectomy Comparison Effects of Dexmedetomidine and Clonidine as Premedication in Perioperative Hemodynamic Stability and Post-op Pain in Laparoscopic Cholecystectomy 2020-02-04 anticipated 135 Complete https://irct.ir/trial/44572 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Prevention, Randomization description: Samples were divided into 3 groups of 45 individuals using permutation block randomization method, obtained from WWW.Randomization.org, Blinding description: The anesthesiologist in charge of carrying out the study based on a randomization chart divides the patients into three groups. Clonidine and placebo tablets are given to patients by a ward nurse who is unaware of the study groups. And the infusion of dexmedomidine and normal saline (placebo) is also provided by an anesthesiologist who is unaware of study groups and is provided by anesthesia staff in the operating room. After the patient is transferred to the recovery room, no information will be given to the recovery staff. And the patient, the anesthesia resident, the recovery nurse, and the inpatient and nurse analyzer are all blind to the study. 2-3 Laparoscopic Cholecystectomy. Intervention 1: Intervention group: Dexmedetomidine infusion (Hospira, INC, Lake Forest, IL 60045 USA) is initiated 5 min before surgical incision at a dose of 0.2 μg / kg.One dose of clonidine similar to placebo (placebo made by Shiraz University of Medical Sciences Pharmacy) was given to patients 30 minutes before induction. Intervention 2: Intervention group:Oral administration of 0.2 mg clonidine (Razavi Pharmaceutical Service Institute) 30 minutes prior to surgery and normal saline infusion begins with the same volume of dexmedomidine group (40 cc) as placebo (placebo made by Shiraz University of Medical Sciences Pharmacy) . Intervention 3: Control group:The control group received only oral placebo (placebo made by Shiraz University of Medical Sciences Pharmacy) and normal saline in the same volume as the dexmedomidine group (40 cc). No - There is not a plan to make this available Justification or reason for not sharing IPD is Its against our policies.
public Zahra Rafati
Anesthesiology Department, Faghihi Hospital, Zand Street
Shiraz Iran (Islamic Republic of) 7134844119 +98 71 3647 4270 rafati.z@yahoo.com Shiraz University of Medical Sciences scientific Mohammad Hosein Eghbal
Anesthesiology Department, Faghihi Hospital, Zand Street
Shiraz Iran (Islamic Republic of) 7134844119 +98 71 3647 4270 hosineghbal@yahoo.com Shiraz University of Medical Sciences Iran (Islamic Republic of) Patients Candidate for Laparoscopic Cholecystectomy Surgery Age 18-65 years Class (ASA) I, II 18 years 65 years Both Communication problem Hypertension Heart disease Anemia Liver and Kidney Diseases Hormonal diseases Concurrent acute or chronic pain Gastrointestinal problems Sexual disorders CNS disorders Respiratory allergy Diabetes Pregnancy Duration of surgery more than 120 minutes K80.44 Calculus of bile duct with chronic cholecystitis without obstruction Prevention Prevention Placebo Intervention group: Dexmedetomidine infusion (Hospira, INC, Lake Forest, IL 60045 USA) is initiated 5 min before surgical incision at a dose of 0.2 μg / kg.One dose of clonidine similar to placebo (placebo made by Shiraz University of Medical Sciences Pharmacy) was given to patients 30 minutes before induction. Intervention group:Oral administration of 0.2 mg clonidine (Razavi Pharmaceutical Service Institute) 30 minutes prior to surgery and normal saline infusion begins with the same volume of dexmedomidine group (40 cc) as placebo (placebo made by Shiraz University of Medical Sciences Pharmacy) . Control group:The control group received only oral placebo (placebo made by Shiraz University of Medical Sciences Pharmacy) and normal saline in the same volume as the dexmedomidine group (40 cc). Blood Pressure. Timepoint: Before induction, after induction, at the onset of surgery and every 5 minutes until the end of the surgery. Method of measurement: Monitoring. Pain. Timepoint: At the onset of recovery and thereafter every 15 minutes until recovery discharge . Method of measurement: Visual Analogue Scale. Nausea and Vomiting. Timepoint: At the onset of recovery and thereafter every 15 minutes until recovery discharge . Method of measurement: Nausea and vomiting grading scale. Sedation. Timepoint: At the onset of recovery and thereafter every 15 minutes until recovery discharge. Method of measurement: Ramsay sedation scale. Shiraz University of Medical Sciences Approved 2019-12-16 Ethics committee of Shiraz University of Medical Sciences Vice Chancellor of research, Shiraz University of Medical Sciences, 7th floor, central building of Shiraz University of Medical Sciences, Zand street Shiraz Fars Iran (Islamic Republic of)