Acupuncture to prevent nausea and vomiting after gallbladder surgery
Acupuncture For Prevention Of Postoperative Nausea And Vomiting In Patients Undergoing Laparoscopic Cholecystectomy - A Randomized Controlled Trial
This study is testing if adding acupuncture during gallbladder surgery can help adults feel less nausea and vomiting afterward compared to just using standard medications.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 300 (estimated) |
| Ages | 18 Years to 64 Years |
| Sex | All |
| Sponsor | Baylor College of Medicine Academic / other |
| Locations | 1 site (Houston, Texas) |
| Trial ID | NCT05975385 on ClinicalTrials.gov |
What this trial studies
This study investigates the effectiveness of intraoperative acupuncture at specific points to reduce postoperative nausea and vomiting in patients undergoing laparoscopic cholecystectomy. Patients will receive acupuncture in addition to standard prophylactic medications, ondansetron and dexamethasone. The goal is to determine if this combined approach leads to a lower incidence of nausea and vomiting compared to those receiving only the medications. The study focuses on adults aged 18-64 who are scheduled for this type of surgery at a specific hospital.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18-64 scheduled for laparoscopic cholecystectomy with an American Society of Anesthesiology Physical Status of I, II, or III.
Not a fit: Patients scheduled for open cholecystectomy or those with renal dysfunction, allergies to anesthetic agents, or communication barriers may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce postoperative nausea and vomiting, improving recovery and patient satisfaction.
How similar studies have performed: Previous studies have shown promising results for acupuncture in reducing postoperative nausea and vomiting, suggesting this approach may be effective.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Patient ages 18-64 2. American Society of Anesthesiology Physical Status I, II or III 3. Patients scheduled to undergo laparoscopic cholecystectomy at Harris Health System Ben Taub Hospital Exclusion Criteria: 1. Scheduled open cholecystectomy - excluded due to increased levels of pain in open procedures 2. Renal dysfunction (Serum Cr \> 1.2) - excluded due to potential altered metabolism of anesthetic and perioperative medications 3. Allergy to any of the standard anesthetic agents 4. Patient inability to properly communicate with investigators (language barrier, dementia, delirium, psychiatric disorder) 5. Patient or surgeon refusal
Where this trial is running
Houston, Texas
- Ben Taub Hospital — Houston, Texas, United States (Recruiting)
Study contacts
- Study coordinator: Jaime Ortiz, MD, MBA
- Email: jaimeo@bcm.edu
- Phone: 713-873-2860
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.