Analgesia, Patient-Controlled, Dexmedetomidine
Conditions
Brief summary
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
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.
Interventions
DRUGDexmedetomidine
Dexmedetomidine 0.2mcg/kg/hr (2ml/hr) administration via continuous channel in the experimental group
DRUGControl
Normal saline 2ml/hr administration via continuous channel in the experimental group
Sponsors
Korea University Guro Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Fentanyl consumption during 24 hours | 24 hours after surgery | Cumulative consumption of fentanyl during 24 hours |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Fentanyl consumption during 1,6,48 hours | 1,6,24,48 hours after surgery | Cumulative consumption of fentanyl during 1,6,48 hours |
| Pain scores at 1,6,24,48 hours | 1,6,24,48 hours after surgery | 11-pointed numerical rating scale pain score (0 \[no pain\]-10 \[Extreme pain\]) |
| Rescue analgesic consumption at 1,6,24,48 hours | 1,6,24,48 hours after surgery | Additional opioid, NSAID, or acetaminophen consumption |
| Additional analgesic consumption at post-anesthesia care unit | 1 hour after surgery | Opioid, NSAID, or acetaminophen consumption |
| Delirium during 1,6,24,48 hours | 1,6,24,48 hours after surgery | Confusion assessment method (CAM)-evaluated delirium |
| Satisfaction score at 24 hours | 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\[very satisfied\]) |
| Adverse events during 1,6,24,48 hours | 1,6,24,48 hours after surgery | Nausea, vomiting, hypotension, sedation, respiratory depression, pruritus |
Countries
South Korea
Contacts
Primary ContactSeok Kyeong Oh, M.D., Ph.D
Outcome results
None listed