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IRCT20210919052515N4 IRCT 2022-04-12 Oroumia University of Medical Sciences Evaluation of the effect of oral clonidine and metoclopramide after laparoscopic cholecystectomy Comparing the effect of oral clonidine and metoclopramide on intraoperative hemodynamic parameters, nausea, and vomiting after laparoscopic cholecystectomy 2022-05-22 anticipated 75 Complete https://irct.ir/trial/62656 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Patients will be divided into intervention and placebo groups using stratified block randomization based on generated numbers by random allocation software. Firstly, patients will be stratified according to sex, and then randomization will be performed in each stratum. So that, in this software, the number of groups and the total number of the sample size will be entered firstly, and then in the block section, the block randomization method will be implemented. Patients will be allocated to intervention or placebo groups based on generated numbers, Blinding description: The study will be conducted as a triple-blind clinical trial. The patient, the researcher who will be evaluating the outcomes, and the data Analyzer will be blinded to the intervention or placebo groups. The drugs will be given to the patient by a nurse in the ward. The names of the groups will be coded to the data analyzer. 3 laparoscopic cholecystectomy. Intervention 1: Intervention group: Patients will receive one tablet of oral clonidine of 200 micrograms (group 1), 90 minutes before induction. Clonidine will be provided by Tolid Darou pharmaceutical company. Intervention 2: Intervention group: Patients will receive one tablet of oral metoclopramide 10 mg (group 2), 90 minutes before induction. metoclopramide will be provided by Amin Pharmaceutical Company. Intervention 3: Control group: Patients will receive placebo (group 3) 90 minutes before induction. No - There is not a plan to make this available Justification or reason for not sharing IPD is Confidentiality of patient information
public Dr. Naser Masoudi
Imam Khomeini hospital., Ershad Ave., Modarres Blvd., Urmia., Iran.
Urmia Iran (Islamic Republic of) 57157-89397 +98 44 3345 7286 masoudi.n@umsu.ac.ir Oroumia University of Medical Sciences scientific Dr. Naser Masoudi
Imam Khomeini hospital., Ershad Ave., Modarres Blvd., Urmia., Iran.
Urmia Iran (Islamic Republic of) 57157-89397 +98 44 3345 7286 masoudi.n@umsu.ac.ir Oroumia University of Medical Sciences Iran (Islamic Republic of) Patients undergoing elective laparoscopic cholecystectomy Patients with the physical status of one and two according to the American Society of Anesthesiology (ASA I and ASA II) Age 20 to 60 years 20 years 60 years Both Hypertension Diabetic patients Cardiovascular diseases Asthma disease Allergy to clonidine and metoclopramide K91.5 Postcholecystectomy syndrome Treatment - Other Treatment - Other Other Intervention group: Patients will receive one tablet of oral clonidine of 200 micrograms (group 1), 90 minutes before induction. Clonidine will be provided by Tolid Darou pharmaceutical company. Intervention group: Patients will receive one tablet of oral metoclopramide 10 mg (group 2), 90 minutes before induction. metoclopramide will be provided by Amin Pharmaceutical Company. Control group: Patients will receive placebo (group 3) 90 minutes before induction. Heart rate. Timepoint: During induction, 5 minutes, 10 minutes after intubation, during skin incision, 15 and 30 minutes after pneumonia, 30 minutes after pneumonia release. Method of measurement: Monitoring. Systolic blood pressure. Timepoint: During induction, 5 minutes, 10 minutes after intubation, during skin incision, 15 and 30 minutes after pneumonia, 30 minutes after pneumonia release. Method of measurement: Monitoring. Diastolic blood pressure. Timepoint: During induction, 5 minutes, 10 minutes after intubation, during skin incision, 15 and 30 minutes after pneumonia, 30 minutes after pneumonia release. Method of measurement: Monitoring. Mean arterial pressure (MAP). Timepoint: During induction, 5 minutes, 10 minutes after intubation, during skin incision, 15 and 30 minutes after pneumonia, 30 minutes after pneumonia release. Method of measurement: Monitoring. Nausea. Timepoint: At the end of surgery. Method of measurement: Yes/No. Vomiting. Timepoint: At the end of surgery. Method of measurement: Yes/No. Complications. Timepoint: At the end of surgery. Method of measurement: Clinical examination. Oroumia University of Medical Sciences Approved 2021-11-17 Ethics committee of Imam Khomeini university hospital- Urmia University of Medical Sciences Imam Khomeini hospital., Ershad Ave., Modarres Blvd., Urmia., Iran. Urmia West Azarbaijan Iran (Islamic Republic of)