Actively Recruiting
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
Eligibility Criteria
You may qualify if you...
- Patients scheduled for laparoscopic major abdominal surgery (gastrectomy, hepatectomy, colectomy, pancreatectomy) under general anesthesia
- Aged 20 years or older
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
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Trial Site Locations
Total: 1 location
1
Korea University Guro Hospital
Seoul, South Korea
Actively Recruiting
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
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