Korea University Guro Hospital
Seoul, South Korea
Location status: Recruiting
Location contact
Seok Kyeong Oh, MD, PhD
CONTACT
NCT Number: NCT05672225
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.
Interested in participating?
Request Info20 year and older
All sexes
Interventional
Not applicable
Seoul, South Korea
Location status: Recruiting
Seok Kyeong Oh, MD, PhD
CONTACT
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Dexmedetomidine 0.2mcg/kg/hr (2ml/hr) administration via continuous channel in the experimental group
Normal saline 2ml/hr administration via continuous channel in the experimental group
Time frame: 24 hours after surgery
Cumulative consumption of fentanyl during 24 hours
Time frame: 1 hour after surgery
Opioid, NSAID, or acetaminophen consumption
Time frame: 1,6,24,48 hours after surgery
Cumulative consumption of fentanyl during 1,6,48 hours
Time frame: 1,6,24,48 hours after surgery
11-pointed numerical rating scale pain score (0 [no pain]-10 [Extreme pain])
Time frame: 1,6,24,48 hours after surgery
Additional opioid, NSAID, or acetaminophen consumption
Time frame: 1,6,24,48 hours after surgery
Nausea, vomiting, hypotension, sedation, respiratory depression, pruritus
Time frame: 1,6,24,48 hours after surgery
Confusion assessment method (CAM)-evaluated delirium
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])
Contact information is provided by the study sponsor or research team.
Korea University Guro Hospital
Other
Effectiveness of Two-channel Intravenous Patient-controlled Analgesia With Dexmedetomidine on Postoperative Opioid Consumption After Major Laparoscopic Abdominal Surgery
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