Postoperative Nausea and Vomiting
Conditions
Brief summary
Many patients receiving opioid based analgesia after gynecologic laparoscopic surgery experience postoperative nausea and vomiting (PONV) despite prophylaxis and treatment with HT3 receptor antagonists. Although a high dose of ramosetron can cause adverse effects such as headache or dizziness, the minimal effective dose of ramosetron in a high-risk patients is unknown. The aim of this study is to determine the effective dose of ramosetron for prophylaxis of PONV in a high-risk patients receiving intravenous opioid-based patient-controlled analgesia after gynecological laparoscopic surgery.
Interventions
DRUGramosetron 0.3
The ramosetron 0.3 group receives ramosetron 0.3 mg at the end of surgery.
DRUGramosetron 0.45
The ramosetron 0.45 group receives ramosetron 0.45 mg at the end of surgery.
DRUGramosetron 0.6
The ramosetron 0.6 group receives ramosetron 0.6 mg at the end of surgery.
Sponsors
Yonsei University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
20 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* patient between 20 and 70 of age with ASA physical status Ⅰ-Ⅱ * patient scheduled for elective gynecological laparoscopic surgery.
Exclusion criteria
* hepatorenal disease * BMI \> 35 kg/m2 * allergy to ramosetron * gastrointestinal disease * vomiting within 24h * administration of antiemetics or opioids within 24h * QT prolongation (QTc \> 440ms) * pregnant * problem with communication
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| postoperative nausea and vomiting | within 48h after surgery | incidence of nausea and vomiting during the first 48 h after surgery |
Countries
South Korea
Outcome results
None listed