Using dexmedetomidine and fentanyl for pain control after major abdominal surgery
Effectiveness of Two-channel Intravenous Patient-controlled Analgesia With Dexmedetomidine on Postoperative Opioid Consumption After Major Laparoscopic Abdominal Surgery
This study is testing a new pain management method using a special device that gives patients dexmedetomidine and fentanyl after major abdominal surgery to see if it helps control pain better while using less opioids.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 110 (estimated) |
| Ages | 20 Years and up |
| Sex | All |
| Sponsor | Korea University Guro Hospital Academic / other |
| Locations | 1 site (Seoul) |
| Trial ID | NCT05672225 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effectiveness of a dual-channel intravenous patient-controlled analgesia (IV-PCA) device that administers dexmedetomidine and fentanyl separately for pain management following laparoscopic major abdominal surgery. The study compares opioid consumption and evaluates pain intensity, postoperative nausea/vomiting, and delirium in patients receiving this novel analgesic approach. By utilizing a new IV-PCA device, the trial aims to enhance pain control while minimizing opioid use and associated side effects.
Who should consider this trial
Good fit: Ideal candidates are adults aged 20 and older scheduled for laparoscopic major abdominal surgeries such as gastrectomy, hepatectomy, colectomy, or pancreatectomy.
Not a fit: Patients with severe cardiovascular disorders, significant liver or renal dysfunction, or contraindications to dexmedetomidine will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to improved pain management and reduced opioid consumption for patients undergoing major abdominal surgery.
How similar studies have performed: While the use of dexmedetomidine in postoperative settings has been reported, this specific dual-channel IV-PCA approach is novel and has not been extensively tested in similar studies.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients who was scheduled for laparoscopic major abdominal surgery (Gastrectomy, Hepatectomy, Colectomy, Pancreatectomy) under general anesthesia * Aged ≥ 20 years old Exclusion Criteria: * Body mass index ≥35 kg/m2 * American Society of Anesthesiologists physical status \> 3 * Severe cardiovascular disorder * Severe liver or renal dysfunction * Preoperative dyspnea * Contraindication to dexmedetomidine (preoperative severe bradycardia (Heart rate \<50), atrioventricular block, allergy to dexmedetomidine) * Preoperative use of opioid, anticonvulsant, antidepressant
Where this trial is running
Seoul
- Korea University Guro Hospital — Seoul, South Korea (Recruiting)
Study contacts
- Principal investigator: Seok Kyeong Oh, M.D., Ph.D — Korea University Guro Hospital
- Study coordinator: Seok Kyeong Oh, M.D., Ph.D
- Email: nanprayboy@korea.ac.kr
- Phone: 82-2-2626-3237
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.