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Clinical Trials in South Korea / NCT07051109
Recruiting Not applicable

Dual-chamber Patient-controlled Analgesia for Postoperative Recovery

NCT07051109 · tracked via the Priya Life Science South Korea tracker
Sponsor
Seoul National University Bundang Hospital
Phase
Not applicable
Started
2022-10-11
Last updated
2025-07-03

Condition(s) studied

Morbid ObesityPCAAnalgesiaPONV

Investigational drug(s) / intervention(s)

multimodal analgesia via dual-chamber PCAsingle regimen (only fentanyl)

multimodal analgesia via dual-chamber PCA: combination of fentanyl and ketorolac through dual-chamber PCA

single regimen (only fentanyl): fentanyl only through dual-chamber PCA

Study summary

Postoperative nausea and vomiting (PONV) are the most common complications that can occur after general anesthesia. Postoperative use of opioids and morbid obesity have been reported as risk factors of PONV. In this study, the investigators aimed to compare the degree of postoperative side effects and pain control when an intravenous patient-controlled analgesia combining fentanyl and ketorolac via a dual-chamber device was provided to participants undergoing laparoscopic sleeve gastrectomy.

Eligibility

Sex
FEMALE
Min age
19 Years
Max age
65 Years
Healthy volunteers
No
Inclusion Criteria: * Adult females aged 19 to 65 years * American Society of Anesthesiologists physical status (ASA class) 1 to 3 * Patients scheduled for laparoscopic sleeve gastrectomy under general anesthesia * Patients requesting the use of IV-PCA after surgery Exclusion Criteria: * Patients with hypersensitivity to the drugs used in this study (Ketorolac, Fentanyl) * Patients with alcohol or drug dependence, long-term use of opioids or analgesics * Patients with liver disease or renal failure * Patients with peptic ulcer, patients with gastrointestinal bleeding predisposition * Patients with suspected cerebrovascular hemorrhage, organic disorders of the head related to increased intracranial pressure * Patients with bronchial asthma or bronchospasm symptoms * Patients with severe respiratory depression * Nasal polyps, angioedema * Patients with or history of convulsive disease * Patients for whom the use of neuromuscular blocking agents is contraindicated

Primary outcome measure(s)

  • postoperative nausea and vomitting — postoperative 1 day
    The Quality of Recovery score 15

Trial sites (1)

FacilityCityRegionStatus
Seoul National University Bundang Hospital Seongnam-si Gyunggi-do Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07051109 on ClinicalTrials.gov ↗ ← All trials in South Korea