Two-channel IV-PCA With Dexmedetomidine
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Dexmedetomidine, Control.
- Who it may be relevant to
- Registry conditions: Analgesia, Patient-Controlled, Dexmedetomidine. Basic parameters: from 20 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- South Korea
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Effectiveness of Two-channel Intravenous Patient-controlled Analgesia With Dexmedetomidine on Postoperative Opioid Consumption After Major Laparoscopic Abdominal Surgery
Overview
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
- Drug Dexmedetomidine
Dexmedetomidine 0.2mcg/kg/hr (2ml/hr) administration via continuous channel in the experimental group - Drug Control
Normal saline 2ml/hr administration via continuous channel in the experimental group
Primary outcome measures
- Fentanyl consumption during 24 hours [Time frame: 24 hours after surgery]
Secondary outcome measures (7)
- Additional analgesic consumption at post-anesthesia care unit [Time frame: 1 hour after surgery]
- Fentanyl consumption during 1,6,48 hours [Time frame: 1,6,24,48 hours after surgery]
- Pain scores at 1,6,24,48 hours [Time frame: 1,6,24,48 hours after surgery]
- Rescue analgesic consumption at 1,6,24,48 hours [Time frame: 1,6,24,48 hours after surgery]
- Adverse events during 1,6,24,48 hours [Time frame: 1,6,24,48 hours after surgery]
- Delirium during 1,6,24,48 hours [Time frame: 1,6,24,48 hours after surgery]
- Satisfaction score at 24 hours [Time frame: 24 hours after surgery]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Triple blind
- Primary purpose
- Treatment
Study locations
South Korea · 1 center
- Korea University Guro Hospital — Seoul
Identifiers
NCT: NCT05672225 · 2022GR0414