]>
IRCT20210508051221N1 IRCT 2021-05-16 Arak University of Medical Sciences The effect of dexmedetomidine on hemodynamics of cholecystectomy patients Evaluation of the Effect of Dexmedetomidine on hemodynamics of Patients and the Mean Rate of Isoflurane Consumption in Laparoscopic Cholecystectomy surgery 2021-06-05 anticipated 80 Complete https://irct.ir/trial/56189 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Randomization in this study will be done using the random number table method. In this way,The main performer randomly selects one of the numbers in the table by determining the direction of movement and moves in the selected direction in order. Then, based on the numbers obtained, odd numbers will be assigned to group A and even numbers will be assigned to group B, Blinding description: Blindness in this study will be double blind. In this way, patients are not aware of the type of drug used and the study groups, and only the main performer is aware of the type of intervention and drugs used and prepares the drugs with labels A and B. Also, the clinical caregiver and outcome assessor are not aware of the study groups and recognize the groups based on the letters A and B. 3 Cholecystitis. Intervention 1: Intervention group: After induction of anesthesia, the mentioned patients are intubated and placed under a ventilator. For all the mentioned patients, isoflurane anesthesia will be used 1-2% per minute and then the surgeon will be allowed to start surgery and cholecystectomy. In the dexmedetomidine group, for patients, 1 μg / kg of dexmedetomidine (Imagen-Iran) is placed in the form of a bolus, the volume of which has reached 20cc by normal saline. They will receive dexmedetomidine as an infusion. Intervention 2: Control group: After induction of anesthesia, the mentioned patients are intubated and placed under a ventilator. For all the mentioned patients, isoflurane anesthesia will be used 1-2% per minute and then the surgeon will be allowed to start surgery and cholecystectomy. In the placebo group, 20 cc of normal saline is placed on the syringe pump during induction and injected for patients. 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 No more information
public Hesam Rezaee
Payambar-e-azam Complex, Sardasht Town
Arak Iran (Islamic Republic of) 3848176341 +98 86 3417 3639 research@arakmu.ac.ir Arak University of Medical Sciences scientific Hesam Rezaee
Payambar-e-azam Complex, Sardasht Town
Arak Iran (Islamic Republic of) 3848176341 +98 86 3417 3639 research@arakmu.ac.ir Arak University of Medical Sciences Iran (Islamic Republic of) Candidate patients for laparoscopic cholecystectomy Age 18 to 65 years 18 years 65 years Both Patients who do not undergo general anesthesia People with cardiopulmonary disease K80.0 Calculus of gallbladder with acute cholecystitis Treatment - Drugs Placebo Intervention group: After induction of anesthesia, the mentioned patients are intubated and placed under a ventilator. For all the mentioned patients, isoflurane anesthesia will be used 1-2% per minute and then the surgeon will be allowed to start surgery and cholecystectomy. In the dexmedetomidine group, for patients, 1 μg / kg of dexmedetomidine (Imagen-Iran) is placed in the form of a bolus, the volume of which has reached 20cc by normal saline. They will receive dexmedetomidine as an infusion. Control group: After induction of anesthesia, the mentioned patients are intubated and placed under a ventilator. For all the mentioned patients, isoflurane anesthesia will be used 1-2% per minute and then the surgeon will be allowed to start surgery and cholecystectomy. In the placebo group, 20 cc of normal saline is placed on the syringe pump during induction and injected for patients. Hemodynamics of patients. Timepoint: 15, 30, 45, 60 and 90 minutes after the start of surgery. Method of measurement: Based on pulse rate and mean systolic pressure. The amount of isoflurane consumed. Timepoint: From the beginning to the end of surgery. Method of measurement: check list. Arak University of Medical Sciences Approved 2020-11-15 Ethics committee of Arak University of Medical Sciences Payambar-e-azam Complex, Sardasht Town Arak Markazi Iran (Islamic Republic of)