Dual-chamber Patient-controlled Analgesia for Postoperative Recovery
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age19-65
SponsorSeoul National University Bundang Hospital
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
multimodal analgesia via dual-chamber PCA
Devicecombination of fentanyl and ketorolac through dual-chamber PCA
single regimen (only fentanyl)
Devicefentanyl only through dual-chamber PCA
Treatment groups
92 Participants
are divided into 2 treatment groupsGroup A: dual-chamber PCAExperimental treatment 1 intervention
Group B: single regimen PCAActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
postoperative nausea and vomitting
The Quality of Recovery score 15
Time frame
postoperative 1 daySponsors and contacts
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Source ClinicalTrials.gov