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IRCT20100926004819N5 IRCT 2022-01-16 Esfahan University of Medical Sciences Comparison between Ondansetron - Meperidine and Midazolam on postoperative shivering Comparison of the prophylactic use of Ondansetron - Meperidine and Midazolam on shivering after laparoscopic cholecystectomy under general anesthesia 2022-01-15 anticipated 160 Complete https://irct.ir/trial/61080 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Prevention, Randomization description: Randomization is done with simple randomization. Also randomization unit is individual.We do not use stratified randomization. Randomization tool is SPSS software, Blinding description: Patient do not know his group. The person who collect data don,t know it. The person who analyze statistics don,t know too. N/A shivering after laparoscopic cholecystectomy. Intervention 1: Control group: For comparison with patients who give petedine - midazolam or ondansetron with mentioned doses as single dose 30 mins to the end of laparoscopic cholecystectomy and as control group in this level they do not give any drug.Other processes in this group are the same as other groups. Intervention 2: Intervention group:They give 75 microgram/kg midazolam 30 mins to the end of laparoscopic cholecystectomy as single dose.Midazolex 5,15(midazolam ampule 5,15 mg/ml)made in Exir pharmacy as intravenous injection. Intervention 3: Intervention group: 30 mins to the end of laparoscopic cholecystectomy 8 mg Ondansetron as single intravenous dose.Exir Ondansetron 8 will be used.Ondansetron ampule as 2 mg/ml(2,4 ml) is in the market. Intervention 4: Intervention group:30 mins to the end of laparoscopic cholecystectomy Petedine 0.5 mg/kg as single intravenous dose.Petedine 50, 100 ampules are made in Exir company that are 50 , 100 mg/ml(1 , 2 ml). Yes - There is a plan to make this available What will be shared: Research data will be shared after patients become unrecognizable When: reachable after 2022 To whom: Researchers in the universities and scientific centers Conditions: medical sciences researchers for clinical use or more researches Where to obtain: Hezarjarib Ave -Isfahan Medical University or Email: m_heidari@med.mui.ac.ir How to obtain: Isfahan Medical University library or Email address Comments:
public Saied Morteza Heidari Tabaei Zavareh
Hezar Jarib, Isfahan
Isfahan Iran (Islamic Republic of) 8174675731 +98 31 1267 6415 m_heidari@med.mui.ac.ir Esfahan University of Medical Sciences scientific Saied Morteza Heidari Tabaei Zavareh
Hezar Jarib, Isfahan
Isfahan Iran (Islamic Republic of) 8174675731 +98 31 1267 6415 m_heidari@med.mui.ac.ir Esfahan University of Medical Sciences Iran (Islamic Republic of) Patient candidate for laparoscopic cholecystectomy Patient satisfaction for participation ASA1/2 20 years 70 years Both Infectious disease Neuromuscular disease Drug addiction Hurt failure (EF<40%) Chronic mental illness that needs drug Use of alpha and beta blocker Temperature above 38 and below 36.5 T88.5 Other complications of anesthesia Prevention Prevention Prevention Prevention Control group: For comparison with patients who give petedine - midazolam or ondansetron with mentioned doses as single dose 30 mins to the end of laparoscopic cholecystectomy and as control group in this level they do not give any drug.Other processes in this group are the same as other groups. Intervention group:They give 75 microgram/kg midazolam 30 mins to the end of laparoscopic cholecystectomy as single dose.Midazolex 5,15(midazolam ampule 5,15 mg/ml)made in Exir pharmacy as intravenous injection. Intervention group: 30 mins to the end of laparoscopic cholecystectomy 8 mg Ondansetron as single intravenous dose.Exir Ondansetron 8 will be used.Ondansetron ampule as 2 mg/ml(2,4 ml) is in the market. Intervention group:30 mins to the end of laparoscopic cholecystectomy Petedine 0.5 mg/kg as single intravenous dose.Petedine 50, 100 ampules are made in Exir company that are 50 , 100 mg/ml(1 , 2 ml). Shivering under crossley classification. Timepoint: after 15-30-45-60 minute in recovery. Method of measurement: crossley classification. Intensity of pain after surgury. Timepoint: after 15-30-45-60 minute in recovery. Method of measurement: Visual Analogue Scale. Esfahan University of Medical Sciences Approved 2021-07-16 Ethics committee of Isfahan University Of Medical Sciences Ethics commitee of Isfahan University of Medical Sciences;Hezarjarib Ave Isfahan Isfehan Iran (Islamic Republic of)