Two-channel IV-PCA With Dexmedetomidine

Effectiveness of Two-channel Intravenous Patient-controlled Analgesia With Dexmedetomidine on Postoperative Opioid Consumption After Major Laparoscopic Abdominal Surgery

Dexmedetomidine was administered in the 'selector' channel and fentanyl in the 'basic & bolus' channel of dual channel intravenous patient-controlled analgesia (IV-PCA) and the amount of opioid consumption was compared. In addition, intensity of pain, postoperative nausea/vomiting, and postoperative delirium was evaluated.

Study Overview

• Status: Recruiting
• Conditions: Dexmedetomidine; Analgesia, Patient-Controlled
• Intervention / Treatment: Drug: Control; Drug: Dexmedetomidine

Detailed Description

Bellomic® (Cebika, Uiwang-si, Gyeonggi-do, South Korea), a new IV-PCA device consisting of two separate drug pump channels, can be used in various ways and is expanding its scope of use. Unlike conventional IV-PCA devices, which have been used to mix and administer all drugs in one channel, the device can inject drugs separately in two channels. One channel (Selector & Bolus) allows the patient to control whether to take additional bolus medication by pressing the button with adjustable continuous infusion, while the other channel (Continuous) allows constant rate continuous infusion.

Dexmedetomidine is a selective alpha-2 agonist, which is widely used in intensive care unit management, surgery, and various procedures because it has the advantage of less respiratory suppression along with sedation/anesthesia and pain effects. It has been previously reported that postoperative pain, morphine usage, and nausea/vomiting can be reduced when used during/after surgery in addition to general anesthetic drugs. However, in terms of major abdominal surgery, there is no research related to the use of dexmedetomidine after surgery, even though a large amount of opioid agents are required due to severe acute pain.

Thus, the investigators planned a randomized controlled trial to investigate the effectiveness dexmedetomidine using dual-chamber IV-PCA.

• Study Type: Interventional
• Enrollment (Estimated): 110
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Seok Kyeong Oh, M.D., Ph.D; Phone Number: 82-2-2626-3237; Email: nanprayboy@korea.ac.kr

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of
    • Recruiting
    • Korea University Guro Hospital
    • Contact: Seok Kyeong Oh, MD, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Control group; Continuous channel: normal saline 100ml, 2ml/h (fixed rate) Selector & Bolus channel: fentanyl 20mcg/kg (Total 50ml with normal saline), bolus 1ml/10min lock-out	Drug: Control; Normal saline 2ml/hr administration via continuous channel in the experimental group
Experimental: Dexmedetomidine group; Continuous channel: dexmedetomidine 10mcg/kg (Total 100ml with normal saline), 2ml/h (fixed rate) Selector & Bolus channel: fentanyl 20mcg/kg (Total 50ml with normal saline), bolus 1ml/10min lock-out	Drug: Dexmedetomidine; Dexmedetomidine 0.2mcg/kg/hr (2ml/hr) administration via continuous channel in the experimental group

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Fentanyl consumption during 24 hours	Cumulative consumption of fentanyl during 24 hours	24 hours after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Additional analgesic consumption at post-anesthesia care unit	Opioid, NSAID, or acetaminophen consumption	1 hour after surgery
Fentanyl consumption during 1,6,48 hours	Cumulative consumption of fentanyl during 1,6,48 hours	1,6,24,48 hours after surgery
Rescue analgesic consumption at 1,6,24,48 hours	Additional opioid, NSAID, or acetaminophen consumption	1,6,24,48 hours after surgery
Delirium during 1,6,24,48 hours	Confusion assessment method (CAM)-evaluated delirium	1,6,24,48 hours after surgery
Pain scores at 1,6,24,48 hours	11-pointed numerical rating scale pain score (0 [no pain]-10 [Extreme pain])	1,6,24,48 hours after surgery
Adverse events during 1,6,24,48 hours	Nausea, vomiting, hypotension, sedation, respiratory depression, pruritus	1,6,24,48 hours after surgery
Satisfaction score at 24 hours	Satisfaction score evaluated with quality of recovery (QoR)-15 (0[poor] to 10[excellent]), 7-pointed Likert scale (1 [very dissatisfied]- 7[very satisfied])	24 hours after surgery

Collaborators and Investigators

• Sponsor: Korea University Guro Hospital
• Investigators: Principal Investigator: Seok Kyeong Oh, M.D., Ph.D, Korea University Guro Hospital

Study record dates

Study Major Dates

• Study Start (Actual): February 7, 2023
• Primary Completion (Estimated): October 31, 2025
• Study Completion (Estimated): December 31, 2025

Study Registration Dates

• First Submitted: January 3, 2023
• First Submitted That Met QC Criteria: January 3, 2023
• First Posted (Actual): January 5, 2023

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 2, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Central Nervous System Depressants; Sensory System Agents; Analgesics, Non-Narcotic; Analgesics; Neurotransmitter Agents; Hypnotics and Sedatives; Adrenergic alpha-2 Receptor Agonists; Adrenergic alpha-Agonists; Adrenergic Agonists; Adrenergic Agents; Dexmedetomidine
• Other Study ID Numbers: 2022GR0414

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No