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HIPAA Compliant
ISO 27001 Certified

Actively Recruiting

Phase Not Applicable
Age: 19Years - 65Years
FEMALE
ID07051109

Comparing Dual-Chamber and Single-Channel Patient-Controlled Analgesia for Recovery After Laparoscopic Sleeve Gastrectomy in Adult Women

Led by Seoul National University Bundang Hospital · Updated on 2025-07-03

92

Participants Needed

1

Research Sites

30 weeks

Total Duration

AI-Summary

What this Trial Is About

Morbidly obese women undergoing laparoscopic sleeve gastrectomy often face postoperative nausea and vomiting PONV, which are common complications after general anesthesia. This trial evaluates whether using a dual-chamber patient-controlled analgesia PCA device combining fentanyl and ketorolac can reduce opioid use and decrease PONV compared to a single-chamber PCA with fentanyl alone. The study aims to improve recovery quality and patient satisfaction after surgery and explore broader applications for PONV prevention. Participants are randomly assigned to receive either a dual-chamber PCA delivering both fentanyl and ketorolac or a single-chamber PCA delivering only fentanyl after surgery. These devices allow intravenous patient-controlled analgesia to manage postoperative pain. The trial is a prospective, randomized controlled study with quadruple masking to compare recovery outcomes between the two PCA methods. During the study, female patients aged 19 to 65 who undergo laparoscopic sleeve gastrectomy will be monitored for postoperative nausea and vomiting within the first day after surgery. Researchers will assess pain control, opioid use, and side effects. Safety monitoring includes tracking adverse reactions to medications, and participants recovery progress is observed throughout the postoperative period. The total participation time aligns with the immediate recovery phase after surgery.

CONDITIONS

Brief Title

Dual-chamber Patient-controlled Analgesia for Postoperative Recovery

Research Team

I

Insun Park, M.D./Ph.D.

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