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IRCT20150125020795N7 IRCT 2019-11-11 Tabriz University of Medical Sciences Effect of diphenhydramine and granisetron on the prevention of postoperative nausea and vomiting and pain after laparoscopic cholecystectomy Effect of diphenhydramine and granisetron on the prevention of postoperative nausea and vomiting and pain after laparoscopic cholecystectomy 2019-08-23 anticipated 120 Complete https://irct.ir/trial/43280 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention, Randomization description: The sampling is done by easy burst method and according to patient referral to operating room. Randomization method is pre and post accidental blocks and will be done by Randlist software, Blinding description: All of Patients do not Know about used Drugs in this Study. and the anesthesiologist who evaluated clinical response to administerated drugs. N/A Condition 1: Postoperative nausea and vomiting. Condition 2: Postoperative pain. Intervention 1: Intervention group: Group 1, will recieve 3 mg IV granisetron before induction of anesthesia. Intervention 2: Control group: Group 1, will recieve50 mg IV diphenhydramine before induction of anesthesia. 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 There is no further information
public Samad Eslam Jamal Golzari
Departement of Anesthesiology, Faculty of Medicine, Golgasht Street
Tabriz Iran (Islamic Republic of) 5166614766 +98 41 3334 1994 golzaris@tbzmed.ac.ir Tabriz University of Medical Sciences scientific Samad Eslam Jamal Golzari
Departement of Anesthesiology, Faculty of Medicine, Golgasht Street
Tabriz Iran (Islamic Republic of) 5166614766 +98 41 3334 1994 golzaris@tbzmed.ac.ir Tabriz University of Medical Sciences Iran (Islamic Republic of) All of Patients at age of 18 to 59 who Being a Candidate for Elective Surgery and Based on ASA Classification are 1 or 2 ASA Class. 18 years 59 years Both Patients under Prescription of anti-nausea Drugs in the last 24 hours. Patients with Cardiovascular, Hepatic , Kidney ,blood pressure and hyperadiposis Disease pregnant women and during menstruation Y84 T88.59 Other medical procedures as the cause of abnormal reaction of the patient, or of later complication, without mention of misadventure at the time of the procedure Other complications of anesthesia Treatment - Drugs Treatment - Drugs Intervention group: Group 1, will recieve 3 mg IV granisetron before induction of anesthesia Control group: Group 1, will recieve50 mg IV diphenhydramine before induction of anesthesia Severity of postoperative nausea and vomiting. Timepoint: Recovery and at 3, 6, and 24 h postoperatively. Method of measurement: scoring by (0=non, 1=nausea, 2=vomiting, 3=vomiting >2 times). Severity of pain after injection of diphenhydramine and granisetron. Timepoint: Amount of pain evaluate on 5, 10, 15 and 20 seconds after injection of diphenhydramine and granisetron. Method of measurement: Four Numerical Verbal Rating Scale. Tabriz University of Medical Sciences Approved 2019-07-15 Ethics committee of Tabriz University of Medical Sciences Faculity of Medicine, Golgasht Street Tabriz East Azarbaijan Iran (Islamic Republic of)