Two-channel IV-PCA With Dexmedetomidine

NCT ID: NCT05672225

Last Updated: 2025-01-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

110 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-02-07

Study Completion Date

2025-12-31

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.

Conditions

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Analgesia, Patient-Controlled Dexmedetomidine

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

Study Groups

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Control group

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

Group Type ACTIVE_COMPARATOR

Control

Intervention Type DRUG

Normal saline 2ml/hr administration via continuous channel in the experimental group

Dexmedetomidine group

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

Group Type EXPERIMENTAL

Dexmedetomidine

Intervention Type DRUG

Dexmedetomidine 0.2mcg/kg/hr (2ml/hr) administration via continuous channel in the experimental group

Interventions

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Dexmedetomidine

Dexmedetomidine 0.2mcg/kg/hr (2ml/hr) administration via continuous channel in the experimental group

Intervention Type DRUG

Control

Normal saline 2ml/hr administration via continuous channel in the experimental group

Intervention Type DRUG

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
Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Korea University Guro Hospital

OTHER

Sponsor Role lead

Responsible Party

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Seok Kyeong Oh

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Seok Kyeong Oh, M.D., Ph.D

Role: PRINCIPAL_INVESTIGATOR

Korea University Guro Hospital

Locations

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Korea University Guro Hospital

Seoul, , South Korea

Site Status RECRUITING

Countries

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South Korea

Central Contacts

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Seok Kyeong Oh, M.D., Ph.D

Role: CONTACT

82-2-2626-3237

Facility Contacts

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Seok Kyeong Oh, MD, PhD

Role: primary

Other Identifiers

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2022GR0414

Identifier Type: -

Identifier Source: org_study_id

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