Study Results
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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RECRUITING
NA
110 participants
INTERVENTIONAL
2023-02-07
2025-12-31
Brief Summary
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Detailed Description
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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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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
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
Control
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
Dexmedetomidine
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
Control
Normal saline 2ml/hr administration via continuous channel in the experimental group
Eligibility Criteria
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Inclusion Criteria
* Aged ≥ 20 years old
Exclusion Criteria
* 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
20 Years
ALL
No
Sponsors
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Korea University Guro Hospital
OTHER
Responsible Party
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Seok Kyeong Oh
Associate Professor
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
Countries
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Central Contacts
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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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