Skip to main content
OpenTrials
Recruiting

NCT Number: NCT05672225

Two-channel IV-PCA With Dexmedetomidine

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.

Recruiting

Interested in participating?

Request Info

Key information

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Korea University Guro Hospital

Seoul, South Korea

Location status: Recruiting

Location contact

Seok Kyeong Oh, MD, PhD

CONTACT

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Dexmedetomidine

Drug

Dexmedetomidine 0.2mcg/kg/hr (2ml/hr) administration via continuous channel in the experimental group

Control

Drug

Normal saline 2ml/hr administration via continuous channel in the experimental group

Primary outcomes

  1. Fentanyl consumption during 24 hours

    Time frame: 24 hours after surgery

    Cumulative consumption of fentanyl during 24 hours

Secondary outcomes

  1. Additional analgesic consumption at post-anesthesia care unit

    Time frame: 1 hour after surgery

    Opioid, NSAID, or acetaminophen consumption

  2. Fentanyl consumption during 1,6,48 hours

    Time frame: 1,6,24,48 hours after surgery

    Cumulative consumption of fentanyl during 1,6,48 hours

  3. Pain scores at 1,6,24,48 hours

    Time frame: 1,6,24,48 hours after surgery

    11-pointed numerical rating scale pain score (0 [no pain]-10 [Extreme pain])

  4. Rescue analgesic consumption at 1,6,24,48 hours

    Time frame: 1,6,24,48 hours after surgery

    Additional opioid, NSAID, or acetaminophen consumption

  5. Adverse events during 1,6,24,48 hours

    Time frame: 1,6,24,48 hours after surgery

    Nausea, vomiting, hypotension, sedation, respiratory depression, pruritus

  6. Delirium during 1,6,24,48 hours

    Time frame: 1,6,24,48 hours after surgery

    Confusion assessment method (CAM)-evaluated delirium

  7. Satisfaction score at 24 hours

    Time frame: 24 hours after surgery

    Satisfaction score evaluated with quality of recovery (QoR)-15 (0[poor] to 10[excellent]), 7-pointed Likert scale (1 [very dissatisfied]- 7[very satisfied])

Study contacts

Contact information is provided by the study sponsor or research team.

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

CONTACT

[email protected]

82-2-2626-3237

Sponsors and collaborators

Lead sponsor

Korea University Guro Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Jan 5, 2023
Registry last updated
Jan 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.