Comparison of prophylactic effect on PONV between ramosetron and ondansetron

A randomized, double-blinded, active-controlled multicenter clinical trial to evaluate prophylactic anti-emetic efficacy of ramosetron and ondansetron on post-operative nausea and vomiting in patients with intravenous patient-controlled analgesia

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CRIS

Registry ID

KCT0001499

Enrollment

1214

Registered

2015-05-21

Start date

2010-11-08

Completion date

Unknown

Last updated

2019-03-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Drug : Bolus of intravenous ramosetron 0.3 mg is injected before the end of surgery in the ramosetron group, and bolus of intravenous ondansetron 4 mg is injected before the end of surgery in the ond

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Patients who undergo any surgery listed below 1) general surgery ? Laparoscopic general surgery ? Stomach surgery* ? Colon surgery* * Included as 'general laparoscopic surgery' if done by laparoscopy 2) gynecologic surgery ? Laparoscopic gynecologic surgery ? Total abdominal hysterectomy* ? Radical hysterectomy* ? Vaginal hysterectomy* ? Salphingo-oophorectomy* ? Myomectomy* * Included as 'gynecologic laparoscopic surgery' if done by laparoscopy 3) breast surgery ? Simple mastectomy ? Modified radical mastectomy 4) major orthopedic surgery ? Spine surgery with instrumentation ? Total hip replacement ? Total knee replacement ? Shoulder operation

Exclusion criteria

Exclusion criteria: 1) Age less than 19 2) History of anaphylactic response to fentanyl, ketorolac, ramosetron, or ondansetron 3) Patients who received antiemetics, steroids, antihistamines, or antipsychotic drugs that can affect PONV, within 24 hours before surgery 4) ASA physical status over 3 5) Patients planned for maintaning nasogastric tube postoperatively 6) Patients who eats other than clear liquid per os within 8 hours postoperatively 7) Patients who participated in clinical trial on other drugs, within 30 days before screening 8) Patients who donated blood over 450 ml, within 30 days before screening 9) Active hepatitis (HIV postitive, history of HBV, HCV, and positive on serologic tests) 10) Heavy alcoholics

Design outcomes

Primary

Measure	Time frame
Rhodes index of nausea, vomiting and retching (RINVR);Incidence of rescue antiemetics	—

Secondary

Measure	Time frame
safety or adverse effect incidence	—

Countries

Korea, Republic of

Contacts

Public ContactByungmoon Choi

Asan Medical Center

rios76@hanmail.net+82-2-3010-4612

Outcome results