Tokyo, Nov. 25 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000059821) titled 'Treatment of postoperative nausea and vomiting (PONV) after prophylactic administration of ondansetron in oral surgery' on Nov. 25.

Study Type: Interventional

Study Design: Basic Design - Parallel Randomization - Randomized Blinding - Double blind -all involved are blinded Control - Active

Primary Sponsor: Institute - Tokyo Dental College

Condition: Condition - jaw deformity Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - To address the optimal treatment for patients who develop PONV after prophylactic administration of ondansetron during oral surgery under general anesthesia. Basic objectives2 - Efficacy

Intervention: Interventions/Control_1 - In the ondansetron group, patients who develop PONV after prophylactic administration of ondansetron receive an additional 4 mg of ondansetron. If PONV does not improve, 10 mg of metoclopramide is administered. Interventions/Control_2 - In the metoclopramide group, patients who develop PONV after prophylactic administration of ondansetron receive 10 mg of metoclopramide. If PONV does not improve, 4 mg of ondansetron is administered.

Eligibility: Age-lower limit - 20 years-old = Gender - Male and Female Key inclusion criteria - Patients undergoing orthognathic surgery ASA-PS 1-2 Patient who gave consent for this study Key exclusion criteria - 50 years of age, ASA-PS 3 or higher, patient who did not give consent for this study,use of antiemetics within 24 h before surgery, contraindicated for administration of medications used in this study, emergency surgery Target Size - 70

Recruitment Status: Recruitment status - Preinitiation Date of protocol fixation - 2025 Year 11 Month 07 Day Date of IRB - 2025 Year 11 Month 07 Day Anticipated trial start date - 2025 Year 11 Month 25 Day Last follow-up date - 2028 Year 03 Month 31 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068376

Disclaimer: Curated by HT Syndication.