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IRCT20171004036548N1 IRCT 2018-01-22 Kashan University of Medical Sciences Comparison of the Effect of General Anesthesia with Opioids vs Opioid Free Anesthesia on Postoperative Pain in Patients Undergoing Laparoscopic Cholecystectomy Comparison of the Effect of General Anesthesia with Opioids vs Opioid Free Anesthesia on Postoperative Pain in Patients Undergoing Laparoscopic Cholecystectomy 2016-09-22 anticipated 160 Complete https://irct.ir/trial/27288 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: After referral of patients for elective Laparoscopic Cholecystectomy and evaluation of inclusion criteria and removal of patients who have exit criteria, they are divided into 2 groups using randomized block assignment (Permuted block randomization). The first group received an Opioid free anesthesia and the second group received a routine anesthesia (with Opioid), Blinding description: After admitting the patients, the Anesthetist's Assistant assesses them in terms of Inclusion Criteria and Exclusion Criteria., and then the Volunteers are selected from among them, and after obtaining Informed Written Consent from them, they are enrolled in the study without knowing the group in which they are placed. The Code assigned to each participant will be the order of Admission time. The position of each Code in the two groups is determined by the Statistics Consultant (Before commencing the admission of patients). The Anesthetic process is performed by the Senior Assistant and the Researcher does not play a direct role in the anesthetic process. Patient evaluators are different in the Operating Room and Recovery Room and Post-Surgical Ward, and are unaware of the anesthetic method. By doing this, Double-blind study method is provided. N/A Cholelithiasis. Intervention 1: The second group: Conventional Anesthesia Metod (with Opioid). The anesthesia will be administered by following drugs, including: Midazolam 0.03 mg/kg IV, Fentanyl 3 µ/kg, Propofol 2 mg/kg IV, Atracurium 0.5 mg/kg IV, Lidocaine 1.5 mg/kg IV, and Iso. Intervention 2: First group: Opioid-free anesthesia.The anesthesia will be administered by following drugs, including: Midazolam 0.03 mg/kg IV, Propofol 2 mg/kg IV, Atracurium 0.5 mg/kg IV, Lidocaine 1.5 mg/kg IV, followed by 2 mg/kg/h, and Isoflurane 1.5%. Opioids will . 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 Ahmad Haddad
Ghotbe Ravandi Blvd., Shaheed Beheshti Hospital
Kashan Iran (Islamic Republic of) 8715981151 +98 31 5542 0269 Dr.ahmadhaddad@yahoo.com Kashan University of Medical Sciences scientific Dr.Seyed Mohammad Reza Razavizadeh
Ghotbe Ravandi Blv.,Shaheed Beheshti Hospital
Kashan Iran (Islamic Republic of) 8715981151 +98 31 5554 0026 mr_razavi48@yahoo.com Kashan University of Medical Sciences Iran (Islamic Republic of) Age 18 - 65 years old Candidate for non-emergency Laparoscopic Cholecystectomy ASA Class 1, 2 18 years 65 years Both Use of Opioid drugs within 24 hours before surgery Allergy to any medication used in the study Motion sickness Addiction Cardiac disease, Hypertention History of Sleep Apnea Gastrointestinal bleeding Parkinson's disease Liver and Kidney Diseases Emergency surgery Pregnancy BMI> 35 K80.1 Calculus of gallbladder with other cholecystitis Treatment - Drugs Treatment - Drugs The second group: Conventional Anesthesia Metod (with Opioid). The anesthesia will be administered by following drugs, including: Midazolam 0.03 mg/kg IV, Fentanyl 3 µ/kg, Propofol 2 mg/kg IV, Atracurium 0.5 mg/kg IV, Lidocaine 1.5 mg/kg IV, and Iso First group: Opioid-free anesthesia.The anesthesia will be administered by following drugs, including: Midazolam 0.03 mg/kg IV, Propofol 2 mg/kg IV, Atracurium 0.5 mg/kg IV, Lidocaine 1.5 mg/kg IV, followed by 2 mg/kg/h, and Isoflurane 1.5%. Opioids will Nausa. Timepoint: In recovery and 3,6,12,24 hour after surgery. Method of measurement: Visual Analogue Scale. Intensity of pain. Timepoint: In recovery and 3,6,12,24 hour after surgery. Method of measurement: Visual Analogue Scale. Kashan University of Medical Sciences Approved 2016-08-28 Ethics Committee of Kashan University of Medical Sciences Kashan University of Medical Sciences, Ghotbe Ravandi Blvd, Kashan, Iran Kashan Isfehan Iran (Islamic Republic of)