Postoperative nausea and vomiting (PONV) is one of the most common and distressing complications after anaesthesia and surgery, and may lead to serious postoperative complications This prospective, randomized study designed to evaluate the best injection time to get the prophylactic anti-emetic efficacy of ramosetron, a newly developed 5-HT(3) antagonist in patients undergoing facial bone surgery.
1. Participants * 100 patients with undergoing facial bone surgery are going to be randomly allocated to one of the 3 groups 2. Randomization * G1(n=33) - Ramosetron 0.3mg i.v. just before the beginning of the surgery * G2(n=33) - Ramosetron 0.3mg i.v. just after the end of the surgery and moving into the Recovery room * G3(n=33) - No medication but regular antiemetics i.v. if the patient wants 3. The primary endpoint * the incidence of nausea and vomiting for 24 h after surgery at 0-6h, 6-12 h and 12-24 h 4. The secondary endpoints * the severity of nausea, need for rescue medication * patient satisfaction with efficacy
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Enrollment
49
G1 - Ramosetron 0.3mg i.v. just before the beginning of the surgery G2 - Ramosetron 0.3mg i.v. just after the end of the surgery and moving into the Recovery room G3 - No medication but regular antiemetics injection if the patient want
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, South Korea
incidence and severity of nausea and vomiting
Time frame: for 24 h after surgery at 0-6h, 6-12 h and 12-24 h
patient satisfaction with the effect
Time frame: at 24 h after surgery
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