Dual-chamber Patient-controlled Analgesia for Postoperative Recovery
Recruiting · NCT07051109 · Interventional (participants receive a specific treatment) · Lead sponsor: Seoul National University Bundang Hospital
View the official record on ClinicalTrials.gov →Interventions studied
multimodal analgesia via dual-chamber PCAsingle regimen (only fentanyl)
What this trial is about
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.
Who can take part
Age range
19 Years to 65 Years
Sex
Female
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
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
Where it is running
1 location listed.
- Seoul National University Bundang Hospital - Seongnam-si, Gyunggi-do, South Korea