Two-channel IV-PCA With Dexmedetomidine

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Analgesia, Patient-Controlled, Dexmedetomidine

Intervention / Treatment
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* Drug: Dexmedetomidine
* Drug: Control


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Control group<br>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<br>* Normal saline 2ml/hr administration via continuous channel in the experimental group<br>|
| Experimental: Dexmedetomidine group<br>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<br>* Dexmedetomidine 0.2mcg/kg/hr (2ml/hr) administration via continuous channel in the experimental group<br>|

What is the study measuring?
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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 | 
| 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 | 
| Rescue analgesic consumption at 1,6,24,48 hours | Additional opioid, NSAID, or acetaminophen consumption | 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 | 
| Delirium during 1,6,24,48 hours | Confusion assessment method (CAM)-evaluated delirium | 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 |