Preventing nausea and vomiting after gallbladder surgery
Dexmedetomidine Versus Dexamethasone Adding to Ondansetron for Prophylaxis Against Postoperative Nausea and Vomiting After Laparoscopic Cholecystectomy
This study is testing two different combinations of anti-nausea medications to see which one works better at preventing nausea and vomiting after gallbladder surgery in women aged 18 to 65.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 70 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | Female |
| Sponsor | Tanta University Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Tanta, Algharbia) |
| Trial ID | NCT06017167 on ClinicalTrials.gov |
What this trial studies
This study aims to compare the effectiveness of two different combinations of antiemetic medications in preventing postoperative nausea and vomiting (PONV) in patients undergoing laparoscopic cholecystectomy. One group will receive ondansetron combined with dexmedetomidine, while the other group will receive ondansetron combined with dexamethasone. The primary outcome will be the incidence of PONV, and secondary outcomes will include the severity of nausea and vomiting, the need for rescue antiemetic drugs, and postoperative pain and sedation levels. The study will involve 70 female patients aged 18 to 65 who are classified as ASA I or II.
Who should consider this trial
Good fit: Ideal candidates for this study are female patients aged 18 to 65 scheduled for elective laparoscopic cholecystectomy with an ASA classification of I or II.
Not a fit: Patients over 65 years old, those under 18, or individuals with certain comorbidities or contraindications to the study medications may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a more effective strategy for preventing postoperative nausea and vomiting, improving recovery and patient satisfaction.
How similar studies have performed: Previous studies have shown that multimodal antiemetic approaches can be more effective than single-agent therapies in preventing PONV, suggesting potential success for this study's approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 70 Female patients aged between 18 and 65 years * ASA I or II * patients scheduled for elective laparoscopic cholecystectomy surgery will be included in this study. Exclusion Criteria: * Females above 65 years old. * patients under 18 years old. * ASA \> II. * Obesity (BMI\>40 kgm2). * Known hypersensitivity to drugs used in the study protocol. * Comorbidities that were known to increase the risk of PONV (e.g. vestibular disease). * Liver or renal dysfunction (liver enzyme or creatinine 1.5 times higher than normal). * Alcoholism or drug abuse. * Use of antiemetics and psychotropic drugs or glucocorticoids within 24 h before surgery.
Where this trial is running
Tanta, Algharbia
- Tanta University hospitals — Tanta, Algharbia, Egypt (Recruiting)
Study contacts
- Principal investigator: Mohamed A. Lotfy, PHD — Assistant Professor of Anesthesia and Intensive Care, Tanta Univ
- Study coordinator: Yasmine M. Eldeba, BA
- Email: yasmine162078_pg@med.tanta.edu.eg
- Phone: 0021097732321
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.