Dual-chamber Patient-controlled Analgesia for Postoperative Recovery

NCT07051109 | Recruiting

• 1 other identifier: B-2208-775-002
• Study Type: interventional
• Target: 92
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Morbid Obesity; PCA; Analgesia; PONV

Outcome Measures

Primary Outcomes (1)

• postoperative nausea and vomitting

  The Quality of Recovery score 15

  postoperative 1 day

Study Arms (2)

dual-chamber PCA

EXPERIMENTAL

Device: multimodal analgesia via dual-chamber PCA

single regimen PCA

ACTIVE COMPARATOR

Device: single regimen (only fentanyl)

Interventions

multimodal analgesia via dual-chamber PCA DEVICE

combination of fentanyl and ketorolac through dual-chamber PCA

dual-chamber PCA

single regimen (only fentanyl) DEVICE

fentanyl only through dual-chamber PCA

single regimen PCA

Eligibility Criteria

• Age: 19 Years - 65 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Seoul National University Bundang Hospital: lead

Study Sites (1)

Seoul National University Bundang Hospital

Seongnam-si, Gyunggi-do, 13620, South Korea

RECRUITING

MeSH Terms

Conditions

Obesity, Morbid; Agnosia; Postoperative Nausea and Vomiting

Interventions

Clinical Protocols

Condition Hierarchy (Ancestors)

Obesity; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Postoperative Complications; Pathologic Processes; Nausea; Signs and Symptoms, Digestive; Vomiting

Intervention Hierarchy (Ancestors)

Therapeutics; Epidemiologic Study Characteristics; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation

Central Study Contacts

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

CONTACT

823178777499; pis121@hanmail.net

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: January 12, 2025
• First Posted: July 3, 2025
• Study Start: October 11, 2022
• Primary Completion: August 11, 2025
• Study Completion: March 11, 2026
• Last Updated: July 3, 2025

Record last verified: 2025-06

Locations

KR (1)