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IRCT20190325043107N87 IRCT 2026-09-20 Tabriz University of Medical Sciences Effect of Low-Dose Ondansetron Plus Dexamethasone on Postoperative Nausea and Vomiting in Total Knee Arthroplasty Efficacy of Low-Dose Ondansetron Combined with Dexamethasone for the Prevention of Postoperative Nausea and Vomiting Following Total Knee Arthroplasty 2026-10-06 anticipated 110 Recruiting https://irct.ir/trial/93425 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: In this study, with a sample size of 110 , participants will be assigned to three groups using permuted block randomization. A block size of four will be employed, utilizing all possible combinations, including: Block 1 (BBAA), Block 2 (AABB), Block 3 (ABAB), Block 4 (BABA), Block 5 (ABBA), and Block 6 (BAAB). To accommodate 110 participants, 28 blocks will be generated using Random Allocation Software, with blocks randomly selected from numbers 1 to 6. For instance, if block 6 and block 2 are selected sequentially, the allocation sequence will be BAABAABB, assigning individuals to Intervention Group (A)and the Control Group (B). To ensure allocation concealment, the randomization list will be prepared and numbered by an independent researcher who is not involved in patient recruitment or assessment. The assignments will be placed in sequentially numbered, opaque, sealed envelopes (SNOSE). The study investigator will open the envelopes in numerical order only after a patient has been formally enrolled and their code has been recorded, ensuring that the allocation sequence remains unpredictable, Blinding description: In this study, to ensure proper patient blinding, the medications for groups A and B will be prepared in identical appearance, color, packaging, and administration method, making them indistinguishable to participants. Each medication will be labeled with a unique code (A or B), known only to an independent researcher who is not involved in patient recruitment or evaluation. The envelopes containing the coded medication will be provided to the study investigator in sequential order, without any indication of treatment type. Consequently, both patients and the investigator will remain unaware of group allocation, thus maintaining a practical and effective double‑blind design throughout the trial. 2-3 Postoperative nausea and vomiting. Intervention 1: Intervention group: In the intervention group, ondansetron (0.05 mg/kg) combined with dexamethasone (0.2 mg/kg) will be administered intravenously over 10 minutes, three minutes prior to the induction of general anesthesia. Patients will be monitored for 24 hours post-anesthesia at time intervals of 1, 2, 4, 6, 12, 18, and 24 hours.All medications will be supplied by Abidi Pharmaceuticals. Intervention 2: Control group: In the control group, a placebo combined with dexamethasone (0.2 mg/kg) will be administered intravenously over 10 minutes, three minutes prior to the induction of general anesthesia. Patients will be monitored for 24 hours post-anesthesia at time intervals of 1, 2, 4, 6, 12, 18, and 24 hours.All medications will be supplied by Abidi Pharmaceuticals. 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 No further information is available.
public Mehdi Khanbabayi Gol
Imam Reza Hospital, Azadi Ave
Tabriz Iran (Islamic Republic of) 5981764863 +98 41 3334 7054 Khanbabayimehdi69@gmail.com Tabriz University of Medical Sciences scientific Mehdi Khanbabayi Gol
Imam Reza Hospital, Azadi Ave
Tabriz Iran (Islamic Republic of) 5981764863 +98 41 3334 7054 Khanbabayimehdi69@gmail.com Tabriz University of Medical Sciences Iran (Islamic Republic of) American Society of Anesthesiologists (ASA) Physical Status Classification I and II Patients undergoing total knee arthroplasty under general anesthesia 45 years 75 years Both Patients with known hypersensitivity to the study medications Patients with a history of postoperative nausea and vomiting (PONV) R11 Nausea and vomiting Treatment - Drugs Treatment - Drugs Intervention group: In the intervention group, ondansetron (0.05 mg/kg) combined with dexamethasone (0.2 mg/kg) will be administered intravenously over 10 minutes, three minutes prior to the induction of general anesthesia. Patients will be monitored for 24 hours post-anesthesia at time intervals of 1, 2, 4, 6, 12, 18, and 24 hours.All medications will be supplied by Abidi Pharmaceuticals. Control group: In the control group, a placebo combined with dexamethasone (0.2 mg/kg) will be administered intravenously over 10 minutes, three minutes prior to the induction of general anesthesia. Patients will be monitored for 24 hours post-anesthesia at time intervals of 1, 2, 4, 6, 12, 18, and 24 hours.All medications will be supplied by Abidi Pharmaceuticals. Postoperative nausea and vomiting. Timepoint: For 24 hours post-anesthesia at time intervals of 1, 2, 4, 6, 12, 18, and 24 hours. Method of measurement: To observe. Tabriz University of Medical Sciences Approved 2026-06-07 Ethics committee of Tabriz University of Medical Sciences Imam Reza Hospital, Azadi Ave Tabriz East Azarbaijan Iran (Islamic Republic of)