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IRCT201108147324N1 IRCT 2012-07-18 Vice Chancellor for Research, Tabriz University of Medical Sciences Prophylactic effects of ondansetrone Comparison of prophylactic effects of intravenous metochlopramide and ondansetrone on postoperative nausea and vomiting (PONV) in maxillofacial surgery 2011-06-22 anticipated 175 Complete https://irct.ir/trial/7766 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention. 2-3 Maxillofacial operations: trauma-orthognathic surgery. Intervention 1: Patients in group Ob will receive a single dose of ondansetrone (0.15 mg/kg) 30 minutes before surgery. Intervention 2: Patients in group Oa will receive a single dose of ondansetrone (0.15 mg/kg) 30 minutes before the end of surgery. Intervention 3: Patients in group Mb will receive a single dose of metochlopramide (0.5 mg/kg) 30 minutes before surgery. Intervention 4: Patients in group Ma will receive a single dose of metochlopramide (0. 5 mg/kg) 30 minutes before the end of surgery. Intervention 5: Patients in group C (control group) will not receive any prophylaxis and drugs before surgery or at the end of surgery and metochlopramide will be used PRN after surgery.
public Dr. Hossein Dabbagh Asadolahi Pour
department of OMFS, Imam Rreza hospital,Ggolgasht ave, Azadi.st
Tabriz Iran (Islamic Republic of) +98 41 1666 1218 hdabbagha@gmail.com Tabriz university of medical sciences, Imam Reza hospital scientific Dr.Saeed Nezafati
department of OMFS, dental faculty, Golgasht Ave, Azadi . St
Tabriz Iran (Islamic Republic of) +98 41 1556 2352 nezaf2000@yahoo.com nezafatis@tbzmed.ac.ir Tabriz university of medical sceinces Iran (Islamic Republic of) Inclusion criteria: patients candidate for maxillofacial surgery; 18-50 years of age; Patients undergoing IMF. Exclusion criteria: systemic diseases affecting nausea and vomiting; brain trauma in traumatic patients, as a factor influencing nausea and vomiting; clinical conditions indicating presence of factors for being placed in a high risk group; duration of surgery more than 3 hours; use of nausea- and vomiting-inducing drugs such as opiates. 18 years 50 years Both Y83.4 Surgical operation and other surgical procedures as the cause of abnormal reaction of the patient, or of later complication, without mention of misadventure at the time of the procedure Treatment - Drugs Treatment - Drugs Treatment - Drugs Treatment - Drugs Treatment - Drugs Patients in group Ob will receive a single dose of ondansetrone (0.15 mg/kg) 30 minutes before surgery Patients in group Oa will receive a single dose of ondansetrone (0.15 mg/kg) 30 minutes before the end of surgery Patients in group Mb will receive a single dose of metochlopramide (0.5 mg/kg) 30 minutes before surgery. Patients in group Ma will receive a single dose of metochlopramide (0. 5 mg/kg) 30 minutes before the end of surgery. Patients in group C (control group) will not receive any prophylaxis and drugs before surgery or at the end of surgery and metochlopramide will be used PRN after surgery Nausea. Timepoint: On arrival at the ward (full consciousness),Thirty minutes after full consciousness,An hour after full consciousness Thirty minutes after PO (nearly 4.5 hours after full consciousness),Eight hours after full consciousness,. Twenty hours after surgery. Method of measurement: Recorded by inspection of nausea and asking after recovery. Vomiting. Timepoint: On arrival at the ward (full consciousness),Thirty minutes after full consciousness,An hour after full consciousness Thirty minutes after PO (nearly 4.5 hours after full consciousness),Eight hours after full consciousness,. Twenty hours after surgery. Method of measurement: recorded by inspection of vomiting. Vertigo. Timepoint: On arrival at the ward (full consciousness),Thirty minutes after full consciousness,An hour after full consciousness Thirty minutes after PO (nearly 4.5 hours after full consciousness),Eight hours after full consciousness,. Twenty hours after surgery. Method of measurement: Inspection and asking from the patient. Vice Chancellor for Research, Tabriz University of Medical Sciences Approved 2011-06-12 Ethic committee of Tabriz university of medical sciences Golgasht,Azadi street Tabriz Iran (Islamic Republic of)