Two-channel IV-PCA With Dexmedetomidine

Korea University

Status: Enrolling

Conditions: Analgesia, Patient-Controlled; Dexmedetomidine

Treatments: Drug: Dexmedetomidine; Drug: Control

Study type: Interventional

Funder types: Other

Identifiers

NCT05672225

2022GR0414

Details and patient eligibility

About

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.

Full 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.

Enrollment: 110 estimated patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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110 participants in 2 patient groups

Control group

Active Comparator group

Description:

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

Treatment:

Drug: Control

Dexmedetomidine group

Experimental group

Description:

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

Treatment:

Drug: Dexmedetomidine