Clinical trial NCT05672225: Two-channel IV-PCA With Dexmedetomidine
Official title: Effectiveness of Two-channel Intravenous Patient-controlled Analgesia With Dexmedetomidine on Postoperative Opioid Consumption After Major Laparoscopic Abdominal Surgery
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Analgesia, Patient-Controlled
Dexmedetomidine
Lead sponsor: Korea University Guro Hospital
Sponsor class: OTHER
First posted: 2023-01-05
Enrollment: 110
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Fentanyl consumption during 24 hours
timeFrame: 24 hours after surgery
Secondary outcomes:
measure: Additional analgesic consumption at post-anesthesia care unit
timeFrame: 1 hour after surgery
measure: Fentanyl consumption during 1,6,48 hours
timeFrame: 1,6,24,48 hours after surgery
measure: Pain scores at 1,6,24,48 hours
timeFrame: 1,6,24,48 hours after surgery
measure: Rescue analgesic consumption at 1,6,24,48 hours
timeFrame: 1,6,24,48 hours after surgery
measure: Adverse events during 1,6,24,48 hours
timeFrame: 1,6,24,48 hours after surgery
measure: Delirium during 1,6,24,48 hours
timeFrame: 1,6,24,48 hours after surgery
measure: Satisfaction score at 24 hours
timeFrame: 24 hours after surgery
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Korea University Guro Hospital
Study officials:
affiliation: Korea University Guro Hospital
name: Seok Kyeong Oh, M.D., Ph.D
role: PRINCIPAL_INVESTIGATOR
References: