RecruitingNot ApplicableNCT07051109

Dual-chamber Patient-controlled Analgesia for Postoperative Recovery

Comparison of Postoperative Recovery Between Dual-channel Pump for Intravenous Patient-controlled Analgesia(IV-PCA) and Conventional Single-channel Pump After Laparoscopic Sleeve Gastrectomy: a Prospective Randomized Controlled Trial


Sponsor

Seoul National University Bundang Hospital

Enrollment

92 participants

Start Date

Oct 11, 2022

Study Type

INTERVENTIONAL

Conditions

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: FEMALEMin Age: 19 YearsMax Age: 65 Years

Inclusion Criteria4

  • 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 Criteria10

  • 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

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Interventions

DEVICEmultimodal analgesia via dual-chamber PCA

combination of fentanyl and ketorolac through dual-chamber PCA

DEVICEsingle regimen (only fentanyl)

fentanyl only through dual-chamber PCA


Locations(1)

Seoul National University Bundang Hospital

Seongnam-si, Gyunggi-do, South Korea

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NCT07051109


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