Using Remimazolam to Reduce Nausea After Surgery
Effect of Remimazolam on Postoperative Nausea and Vomiting in Patients Undergoing Laparoscopic Cholecystectomy
This study is testing if a low dose of remimazolam can help women who are at high risk for nausea and vomiting after gallbladder surgery feel better compared to standard treatments.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 108 (estimated) |
| Ages | 19 Years to 65 Years |
| Sex | Female |
| Sponsor | Inje University Academic / other |
| Locations | 1 site (Seoul) |
| Trial ID | NCT05439057 on ClinicalTrials.gov |
What this trial studies
This trial investigates the effectiveness of low-dose remimazolam in preventing postoperative nausea and vomiting (PONV) in women at high risk for PONV undergoing laparoscopic cholecystectomy. The study focuses on patients who are likely to experience PONV due to factors such as being female, receiving opioids post-surgery, and being nonsmokers. By comparing the effects of remimazolam to standard prophylactic treatments, the trial aims to determine if this short-acting benzodiazepine can provide better outcomes for these patients. The study is designed to address the limitations of current anti-emetic strategies and improve patient comfort after surgery.
Who should consider this trial
Good fit: Ideal candidates for this study are women undergoing laparoscopic cholecystectomy who are at high risk for postoperative nausea and vomiting.
Not a fit: Patients with moderate to severe liver or renal dysfunction, those with a history of benzodiazepine tolerance, or those who are pregnant or breastfeeding may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved management of postoperative nausea and vomiting, enhancing patient comfort and recovery.
How similar studies have performed: Previous studies have shown some success with benzodiazepines in preventing PONV, but the specific use of remimazolam in this context is novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * women undergoing laparoscopic cholecystectomy under general anesthesia. Exclusion Criteria: * moderate to severe liver dysfunction (total bilirubin ≧ 3.0 mg/dL / aspartate aminotransferase(AST) or alanine aminotransferase(ALT) ≧ 2.5 times more than normal range) * moderate to severe renal dysfunction (serum creatinine ≧ 2.0 mg/dL / end-stage renal disease undergoing hemodialysis) * tolerance to benzodiazepines * hypersensitivity to anesthetic drugs (Benzodiazepines, Propofol, Remifentanil, Fentanyl citrate, Rocuronium bromide, Flumazenil) * acute angle glaucoma * alcohol dependence * Galactose intolerance, Lactase deficiency, glucose-galactose malabsorption * pregnant, breast feeding women * BMI \>35 kg/m2 * uncontrolled diabetes mellitus
Where this trial is running
Seoul
- Sanggye Paik hospital — Seoul, Korea, Republic of (Recruiting)
Study contacts
- Principal investigator: In-Jung Jun, MD.PhD. — Associate professor
- Study coordinator: In-Jung Jun
- Email: christine17@hanmail.net
- Phone: 82-10-9312-0162
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.