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IRCT20141209020258N202 IRCT 2026-04-25 Vice chancellor for research, Arak University Of Medical Sciences Comparison of droperidol and granisetron with dexamethasone and granisetron in the control of postoperative nausea and vomiting (PONV) in laparoscopic cholecystectomy Comparison of droperidol and granisetron with dexamethasone and granisetron in the control of postoperative nausea and vomiting (PONV) in laparoscopic cholecystectomy 2026-04-19 anticipated 120 Recruiting https://irct.ir/trial/89581 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Patients will be allocated into 3 groups using a permuted balanced block randomization method with the size of blocks 6. Random sequence will be generated by an epidemiologist by running an online program in sealed envelope website (https://www.sealedenvelope.com/). Random chain concealment is done by opaque envelope method, Blinding description: This study will be established as a double-blind trial. None of the patients will be aware of the type of medication they are receiving. These medications will be administered to the patients by the anesthesiologist. Each medication will be drawn into a separate syringe, which will be covered with a label, and its contents will not be identifiable. Furthermore, the medications in each syringe will be coded, and only the primary supervisor, who is an anesthesiologist, will know their contents. The intern responsible for recording outcomes will not be aware of the patient grouping or the coding system. Patients will be assessed based on their medical record number, and the collected data will be handed over to the attending physician. 2-3 Cholecystectomy surgery. Intervention 1: Intervention group 1: Patients will receive Granisetron (Caspian Tamin Rasht Pharmaceutical Company – Iran) at a dose of 20 micrograms per kilogram and 1.25 mg of Droperidol (Panpharma Pharmaceutical Company – France), both administered intravenously. Intervention 2: Intervention group 2: Patients will receive Granisetron (Caspian Tamin Rasht Pharmaceutical Company – Iran) at a dose of 20 micrograms per kilogram and 8 mg of Dexamethasone (Caspian Tamin Rasht Pharmaceutical Company – Iran). Intervention 3: Intervention group 3: Patients will receive Granisetron (Caspian Tamin Rasht Pharmaceutical Company – Iran) at a dose of 20 micrograms per kilogram along with normal saline. 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 Dr Alireza Sosanabadi
Valiasr Hospital, Valiasr Squre, Shahid Shirodi Street
Arak Iran (Islamic Republic of) 3814957558 +98 86 3222 2003 sosanabadi@arakmu.ac.ir Arak University of Medical Sciences scientific Dr Hesamedin Modir
Valiasr Hospital, Valiasr squre, Shahid Shirodi street
Arak Iran (Islamic Republic of) 3814957558 +98 86 3222 2003 modir.he@gmail.com Arak University of Medical Sciences Iran (Islamic Republic of) Patients who are candidates for laparoscopic cholecystectomy ASA class I or II both of gender Having informed consent to participate in the study Patients with no history of renal, hepatic, or cardiovascular disease Absence of any history of drug abuse, alcohol use, or chronic analgesic consumption Absence of a history of malignancy No history of hypertension, diabetes, or hematologic/vascular disorders No history of psychiatric or psychotic disorders No history of Parkinson’s disease, movement disorders, or chemotherapy No known sensitivity to study medications and no seasonal allergies All patients undergoing general anesthesia Surgery performed by a surgeon Surgical duration ranging from 60 to 150 minutes 18 years 65 years Both Lack of consent to continue participation in the study Possible death of the patient K91.86 Retained cholelithiasis following cholecystectomy Treatment - Drugs Treatment - Drugs Treatment - Drugs Intervention group 1: Patients will receive Granisetron (Caspian Tamin Rasht Pharmaceutical Company – Iran) at a dose of 20 micrograms per kilogram and 1.25 mg of Droperidol (Panpharma Pharmaceutical Company – France), both administered intravenously. Intervention group 2: Patients will receive Granisetron (Caspian Tamin Rasht Pharmaceutical Company – Iran) at a dose of 20 micrograms per kilogram and 8 mg of Dexamethasone (Caspian Tamin Rasht Pharmaceutical Company – Iran). Intervention group 3: Patients will receive Granisetron (Caspian Tamin Rasht Pharmaceutical Company – Iran) at a dose of 20 micrograms per kilogram along with normal saline. Incidence of nausea. Timepoint: Recovery and 2, 4, 6, 12 and 24 hours after surgery. Method of measurement: Score 0 to 10. Vomiting. Timepoint: Recovery and 2, 4, 6, 12 and 24 hours after surgery. Method of measurement: Score 0 to 4. Sedation. Timepoint: Recovery and 2, 4, 6, 12 and 24 hours after surgery. Method of measurement: Ramsay score. Vice chancellor for research, Arak University Of Medical Sciences Approved 2026-04-12 Ethics comittee of Arak University of Medical Sciences Ethics comittee, Research center, Payambar Azam complex, Basij squre ,Sardasht,Arak Arak Markazi Iran (Islamic Republic of)