Actively Recruiting

Phase Not Applicable
Age: 20Years +
All Genders
ID05672225

Effectiveness of Two-channel Intravenous Patient-Controlled Analgesia With Dexmedetomidine on Opioid Use After Major Laparoscopic Abdominal Surgery

Led by Korea University Guro Hospital · Updated on 2025-01-03

110

Participants Needed

1

Research Sites

151 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are evaluating the use of dexmedetomidine delivered through a new two-channel intravenous patient-controlled analgesia (IV-PCA) device called Bellomic4. This device allows separate infusion of drugs through two channels, one with continuous infusion plus patient-controlled bolus and the other with constant rate continuous infusion. The study focuses on patients undergoing major laparoscopic abdominal surgery, aiming to compare opioid use and pain control with and without dexmedetomidine. In this randomized controlled trial, one group receives dexmedetomidine at 0.2 mcg/kg/hr via the continuous channel of the dual-channel IV-PCA, while the control group receives normal saline at the same rate. Fentanyl is administered through the other channel in both groups with patient-controlled bolus options. This method allows researchers to study the impact of dexmedetomidine on opioid consumption and related side effects during postoperative care. Participants will be monitored for fentanyl consumption during the first 24 hours after surgery, intensity of pain, incidence of postoperative nausea and vomiting, and occurrence of postoperative delirium. The study involves tracking these outcomes alongside safety assessments to understand how dexmedetomidine influences recovery and pain management following surgery.

CONDITIONS

Official Title

Two-channel IV-PCA With Dexmedetomidine

Who Can Participate

Age: 20Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients scheduled for laparoscopic major abdominal surgery (gastrectomy, hepatectomy, colectomy, pancreatectomy) under general anesthesia
  • Aged 20 years or older
Not Eligible

You will not qualify if you...

  • Body mass index greater than 35 kg/m2
  • American Society of Anesthesiologists physical status greater than 3
  • Severe cardiovascular disorder
  • Severe liver or renal dysfunction
  • Preoperative dyspnea
  • Contraindication to dexmedetomidine (preoperative severe bradycardia with heart rate less than 50, atrioventricular block, allergy to dexmedetomidine)
  • Preoperative use of opioid, anticonvulsant, or antidepressant

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

1
2
3
+1

Trial Site Locations

Total: 1 location

1

Korea University Guro Hospital

Seoul, South Korea

Actively Recruiting

Loading map...

Research Team

S

Seok Kyeong Oh, M.D., Ph.D

How is the study designed?

Study Type

INTERVENTIONAL

Masking

TRIPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

Frequently Asked Questions

Have more questions? Get in touch with our team for quick support

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here