]>
IRCT20141009019470N85 IRCT 2019-08-07 Shiraz University of Medical Sciences Comparison of prevalence of nausea and vomiting after laparascopic cholecystectomy in case of pretreatment with Haloperidol and Ondansetron Comparison of prevalence of nausea and vomiting after laparascopic cholecystectomy in case of pretreatment with Haloperidol and Ondansetron 2019-08-07 anticipated 60 Complete https://irct.ir/trial/33893 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention, Randomization description: Randomization was performed based on the 6-point perturbation block method from the Randomization.org site and the patients were divided into two groups, one and two, Blinding description: Syringes containing Haloperidol and Ondonestrone will be prepared by an anesthetic expert who are not aware of the study according to the randomized list .Syringes are marked with the letters A, B, respectively, and the volume of the syringe containing both drugs is achieved by the same amount of normal saline (5 cc) .Patient, anesthesiologist and research specialist have been blinded to data collection. 2-3 Laparoscopy Cholecystectomy. Intervention 1: Intervention group: patients in the group one received 0.05 mg/kg IV. Haloperidol during 5 min after induction of anesthesia. Intervention 2: Intervention group: patients in the group two received 0.15 mg/kg IV. Ondansetrone after 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 It is against our policy.
public Elisa Ramedani
Anesthesiology Department, Faghihi Hospital, Zand Street
Shiraz Iran (Islamic Republic of) 7134844119 +98 71 3647 4270 ramedani1363@yahoo.com Shiraz University of Medical Sciences scientific Ali Karami
Anesthesiology Department, Faghihi Hospital, Zand Street
Shiraz Iran (Islamic Republic of) 7134844119 +98 71 3647 4270 alk1380@gmail.com Shiraz University of Medical Sciences Iran (Islamic Republic of) Age 18--60 years old Patients undergoing laparoscopy cholecystectomy under general anesthesia Cholelithiasis Chronic cholecystitis Cholecystic polyp ASA I-II 18 years 60 years Both Underlying medical condition that is currently not under control History of allergy to drugs or use of alcohol; Parkinson History of glaucoma Bone marrow depression Severe liver disease Obstructive bowel disease History of prostate disease History of cardiac arrhythmia History of respiratory failure or respiratory distress Taking antidepressants History of allergy to haloperidol or ondansetron Pregnancy Breast feeding patients Digestive diseases, kidney and hematology History of dizziness or motion Use an anti-nausea and vomiting agent within 24 hours before the surgery Anxiety disorders,Restlessness, loss in time and place Confusion, tremor, chills, seizure, tinnitus History of Bradycardia Reduced cardiac function Low blood pressure Surgery takes more than an hour. Opium addiction K80.1 Calculus of gallbladder with other cholecystitis Prevention Prevention Intervention group: patients in the group one received 0.05 mg/kg IV. Haloperidol during 5 min after induction of anesthesia Intervention group: patients in the group two received 0.15 mg/kg IV. Ondansetrone after induction of anesthesia Post-operative Nausea and Vomiting. Timepoint: Every 15 min at the recovery room and every 1 hour at the ward. Method of measurement: Bellville Scoring. Length of stay in the recovery room and the discharge time from recovery room. Timepoint: Every 15 min at the recovery room. Method of measurement: Aldrete Score. Patients’ Satisfaction. Timepoint: At the end of the trial. Method of measurement: Likert scoring. Shiraz University of Medical Sciences Approved 2018-04-15 Ethics committee of Shiraz University of Medical Sciences Vice chancellor of research,7th floor of central building of Shiraz University of Medical Sciences, Zand street Shiraz Fars Iran (Islamic Republic of)