Sang-Hyun Kim1, Su-Myung Lee2, Young-Kwon Kim2, Sun-Young Park3, Joon-Ho Lee2, Sung-Hwan Cho2, Won-Seok Chai2, Hee-Cheol Jin2. 1. Department of Anesthesiology and Pain Medicine, Soonchunhyang University Bucheon Hospital, Gyeonggi-Do, Republic of Korea. Electronic address: skim@schmc.ac.kr. 2. Department of Anesthesiology and Pain Medicine, Soonchunhyang University Bucheon Hospital, Gyeonggi-Do, Republic of Korea. 3. Soon Chun Hyang University Hospital, 657 Hannam-dong, Yongsan-gu, Seoul 140-210, South Korea.
Abstract
STUDY OBJECTIVE: To evaluate whether ramosetron increases the corrected QT (QTc) interval. DESIGN: Prospective, randomized, controlled study. SETTING: Operating room. PATIENTS: 135 patients undergoingelective laparoscopic cholecystectomy. INTERVENTION: Patients were allocated to three groups to receive ondansetron 4 mg (Group O4), ramosetron 0.3 mg (Group R), or ondansetron 8 mg (Group O8). The study drugs were administered intravenously approximately 15 minutes before the end of surgery. MEASUREMENT: The QT interval for 10 minutes after administration was recorded. The QTc interval was calculated according to the Fridericia (QTcF) formula. The primary outcome was the QTcF interval among the three groups during the 10 minutes after administration of the study drugs. MAIN RESULTS: The QTcF interval was not significantly prolonged after administration of ondansetron 4 mg and ramosetron. It was significantly increased from one minute after administration until 7 minutes after ondansetron 8 mg (Group O8). The QTcF interval was significantly longer in Group O8 at 1, 2, 3, 4, and 5 minutes. CONCLUSIONS: The prophylactic administration 0.3 mg of ramosetron does not increase the QTc interval. Ondansetron 8 mg increases the QTc interval more so than 4 mg of ondansetron.
RCT Entities:
STUDY OBJECTIVE: To evaluate whether ramosetron increases the corrected QT (QTc) interval. DESIGN: Prospective, randomized, controlled study. SETTING: Operating room. PATIENTS: 135 patients undergoing elective laparoscopic cholecystectomy. INTERVENTION: Patients were allocated to three groups to receive ondansetron 4 mg (Group O4), ramosetron 0.3 mg (Group R), or ondansetron 8 mg (Group O8). The study drugs were administered intravenously approximately 15 minutes before the end of surgery. MEASUREMENT: The QT interval for 10 minutes after administration was recorded. The QTc interval was calculated according to the Fridericia (QTcF) formula. The primary outcome was the QTcF interval among the three groups during the 10 minutes after administration of the study drugs. MAIN RESULTS: The QTcF interval was not significantly prolonged after administration of ondansetron 4 mg and ramosetron. It was significantly increased from one minute after administration until 7 minutes after ondansetron 8 mg (Group O8). The QTcF interval was significantly longer in Group O8 at 1, 2, 3, 4, and 5 minutes. CONCLUSIONS: The prophylactic administration 0.3 mg of ramosetron does not increase the QTc interval. Ondansetron 8 mg increases the QTc interval more so than 4 mg of ondansetron.
Authors: Stephanie Weibel; Gerta Rücker; Leopold Hj Eberhart; Nathan L Pace; Hannah M Hartl; Olivia L Jordan; Debora Mayer; Manuel Riemer; Maximilian S Schaefer; Diana Raj; Insa Backhaus; Antonia Helf; Tobias Schlesinger; Peter Kienbaum; Peter Kranke Journal: Cochrane Database Syst Rev Date: 2020-10-19