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IRCT20170805035510N3 IRCT 2018-06-22 Tehran University of Medical Sciences Comparing the effect of a combination of Promethazine, Dexamethasone, Ondansetron in comparison with Haloperidol, Dexamethasone, Ondansetron for prophylaxis of nausea and vomiting after bariatric surgery Determining the effect of a combination of Promethazine, Dexamethasone, and Ondansetron in comparison with Haloperidol, Dexamethasone, Ondansetron for prophylaxis of nausea and vomiting after laparoscopic bariatric surgery in Sina hospital, 2018. 2018-03-06 anticipated 80 Complete https://irct.ir/trial/26807 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention, Randomization description: This is randomized double blind clinical trial.80 patients were assigned in two group of 40 people according to random numbers.Patients and researcher have no data of this randomization, Blinding description: This is double blind clinical trial.Patients and researcher are not informed of randomization. Questionnaire designed in three pages; Page 1 including patients' name and group (A or B) which is selected by randomization,is recorded at operation room by Anesthetic technician.On the next pages which include demogarphic and post operative data, only patients' name is recorded. Pages 2 and 3 will be filled in by researcher who doesn't know patients' group. Page 1 will be kept in a separate folder and pages 2 and 3 will be kept together in another folder. Finally, we'll open the two folders and sort the pages according to pharmacological groups. 2-3 post operative nausea and vomiting after Bariatric surgery. Intervention 1: Group A receives a three-drug regimen (Ondansetron 4 mg, Dexamethasone 8 mg, and Haloperidol 2 mg) Patients receive Dexamethasone 8 mg after induction and at the beginning of surgery and Ondansetron 4 mg IV at the end of the operation and Haloperidol 2mg IM at the begining of surgery. Intervention 2: Group B receives a different three-drug regimen (Ondansetron 4 mg, Dexamethasone 8 mg and Promethazine 25 mg) Patients receive Dexamethasone 8 mg after induction and at the beginning of surgery, Ondansetron 4 mg IV at the end of the surgery and Promethaizine 25 mg IM 30 minutes before extubation. 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 more information.
public Niusha Momeni
Ghods Ave., Keshavarz Blvd.
Tehran Iran (Islamic Republic of) 18488-36578 +98 21 5593 8580 n.barid@yahoo.com Tehran University of Medical Sciences scientific Pejman Pourfakhr
Sina hospital, Hasan abad square, Emam Khomeini Ave., Tehran
Tehran Iran (Islamic Republic of) 1136746911 +98 21 8863 5770 pourfakhr@tums.ac.ir Tehran University of Medical Sciences Iran (Islamic Republic of) • Age 18-65 years • BMI>30 • ASA class I or II • At least 2 risk factors for postoperative nausea and vomiting according to the Apfel criteria 18 years 65 years Both • Contraindication to Dexamethasone, Ondansetron, Haloperidol, and Promethazine • Use of illegal drugs, hormonal anti-inflammatory drugs, and antiemetics within 24 hours before surgery • Serious adverse reaction like shock, cardiac arrest, and hemorrhage requiring transfusion • Pregnancy and lactation • Psychiatric diseases treated with antipsychotics • History of migraines • Cardiac pacemaker • History of prolonged QT E66.0 Obesity due to excess calories Prevention Prevention Group A receives a three-drug regimen (Ondansetron 4 mg, Dexamethasone 8 mg, and Haloperidol 2 mg) Patients receive Dexamethasone 8 mg after induction and at the beginning of surgery and Ondansetron 4 mg IV at the end of the operation and Haloperidol 2mg IM at the begining of surgery. Group B receives a different three-drug regimen (Ondansetron 4 mg, Dexamethasone 8 mg and Promethazine 25 mg) Patients receive Dexamethasone 8 mg after induction and at the beginning of surgery, Ondansetron 4 mg IV at the end of the surgery and Promethaizine 25 mg IM 30 minutes before extubation. Post operative nausea and vomiting score. Timepoint: Recovery room,6hours after surgery,24hours after surgery. Method of measurement: NVRS(Nausea Verbal Rating Scale). First time of antiemetic prescription after surgery. Timepoint: Until 24hours after surgery. Method of measurement: according to physician's orders and nursing notes. Accumulative dose of antiemetics prescription after surgery. Timepoint: 24hours after surgery ended. Method of measurement: according to recorded physician's orders and nursing notes. Recovery time. Timepoint: Until discharge of recovery room. Method of measurement: According to medical records. Post operative adverse effects. Timepoint: Until 24 hours after surgery. Method of measurement: Occurrence of Life threatening complications or annoying complaints for patients. Accumulative dose of prescribed narcotics. Timepoint: 6 hours and 24 hours after surgery. Method of measurement: according to physician's orders and nursing note. Post operative pain score. Timepoint: recovery room,6hours after surgery,24hours after surgery. Method of measurement: patients rate pain severity according to tutored scale (0-10). Tehran University of Medical Sciences Approved 2016-11-22 Ethics Committee of Tehran University of Medical Sciences and Health services Tehran University of Medical Sciences, Central Building, Ghods Ave., Keshavarz Blvd. Tehran Tehran Iran (Islamic Republic of)