Analgesia, Patient-ControlledNCT05672225
Two-channel IV-PCA With Dexmedetomidine
A study testing Dexmedetomidine in people with Analgesia, Patient-Controlled and Dexmedetomidine, run by Korea University Guro Hospital at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Analgesia, Patient-Controlled, Dexmedetomidine
- What is being tested?
- Dexmedetomidine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 1 siteSouth Korea
- Study dates
- 7 Feb 2023to 31 Dec 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients who was scheduled for laparoscopic major abdominal surgery (Gastrectomy, Hepatectomy, Colectomy, Pancreatectomy) under general anesthesia
- Aged ≥ 20 years old
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
South Korea1 site, 1 recruiting
- Recruiting
Korea University Guro Hospital
Seoul
Seok Kyeong Oh, MD, PhD
About this study
Official title: Effectiveness of Two-channel Intravenous Patient-controlled Analgesia With Dexmedetomidine on Postoperative Opioid Consumption After Major Laparoscopic Abdominal Surgery
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.
Read the 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.
- Conditions
- Analgesia, Patient-Controlled, Dexmedetomidine
- Being tested
- Dexmedetomidine, Control
- Medical subject headings
- Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DexmedetomidineDrug
Dexmedetomidine 0.2mcg/kg/hr (2ml/hr) administration via continuous channel in the experimental group
ControlDrug
Normal saline 2ml/hr administration via continuous channel in the experimental group
| Study group | Role | What they receive |
|---|---|---|
| Control group | Active comparator | 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 Receives: Drug: Control |
| Dexmedetomidine group | Experimental | 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 Receives: Drug: Dexmedetomidine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fentanyl consumption during 24 hours
Cumulative consumption of fentanyl during 24 hours
Measured: 24 hours after surgery
Secondary outcomes (7)
Additional analgesic consumption at post-anesthesia care unit
Opioid, NSAID, or acetaminophen consumption
Measured: 1 hour after surgery
Fentanyl consumption during 1,6,48 hours
Cumulative consumption of fentanyl during 1,6,48 hours
Measured: 1,6,24,48 hours after surgery
Pain scores at 1,6,24,48 hours
11-pointed numerical rating scale pain score (0 [no pain]-10 [Extreme pain])
Measured: 1,6,24,48 hours after surgery
Rescue analgesic consumption at 1,6,24,48 hours
Additional opioid, NSAID, or acetaminophen consumption
Measured: 1,6,24,48 hours after surgery
Adverse events during 1,6,24,48 hours
Nausea, vomiting, hypotension, sedation, respiratory depression, pruritus
Measured: 1,6,24,48 hours after surgery
Delirium during 1,6,24,48 hours
Confusion assessment method (CAM)-evaluated delirium
Measured: 1,6,24,48 hours after surgery
Satisfaction score at 24 hours
Satisfaction score evaluated with quality of recovery (QoR)-15 (0[poor] to 10[excellent]), 7-pointed Likert scale (1 [very dissatisfied]- 7[very satisfied])
Measured: 24 hours after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2023
- Study start7 Feb 2023
- Primary completion31 Oct 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Analgesia, Patient-ControlledStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 110 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Korea University Guro Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Seok Kyeong Oh, Korea University Guro Hospital
- Investigators
- Seok Kyeong Oh, M.D., Ph.D, Principal investigator, Korea University Guro Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05672225
- Sponsor's protocol ID
- 2022GR0414
- Status last verified
- Jan 2025
- First submitted
- 3 Jan 2023
- Last updated
- 3 Jan 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Two-channel Intravenous Patient-controlled Analgesia With Dexmedetomidine on Postoperative Opioid Consumption After Major Laparoscopic Abdominal Surgery
- ClinicalTrials.gov ID
- NCT05672225
- Acronym / sponsor ID
- 2022GR0414
- Conditions
- Analgesia, Patient-Controlled, Dexmedetomidine
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 110 participants (estimated)
- Lead sponsor
- Korea University Guro HospitalUniversity, hospital or other
- Study start
- 7 Feb 2023 (actual)
- Primary completion
- 31 Oct 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 5 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group | Active comparator | Drug: ControlContinuous channel: normal saline 100ml, 2ml/h (fixed rate) Selector \& Bolus channel: fentanyl 20mcg/kg (Total 50ml with normal saline), bolus 1ml/10min lock-out |
| Dexmedetomidine group | Experimental | Drug: DexmedetomidineContinuous 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 |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients who was scheduled for laparoscopic major abdominal surgery (Gastrectomy, Hepatectomy, Colectomy, Pancreatectomy) under general anesthesia
- Aged ≥ 20 years old
Key exclusion criteria (7 listed)
- Body mass index ≥35 kg/m2
- American Society of Anesthesiologists physical status > 3
- Severe cardiovascular disorder
- Severe liver or renal dysfunction
- Preoperative dyspnea
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DexmedetomidineDexmedetomidine 0.2mcg/kg/hr (2ml/hr) administration via continuous channel in the experimental group | Drug | Dexmedetomidine group |
| ControlNormal saline 2ml/hr administration via continuous channel in the experimental group | Drug | Control group |
Primary outcome
Fentanyl consumption during 24 hours
Time frame: 24 hours after surgery
Cumulative consumption of fentanyl during 24 hours
7 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jan 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Seok Kyeong Oh, M.D., Ph.D principal investigator
Korea University Guro Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dexmedetomidine in people with Analgesia, Patient-Controlled and Dexmedetomidine, run by Korea University Guro Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 3 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Seok Kyeong Oh, M.D., Ph.D (82-2-2626-3237, nanprayboy@korea.ac.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fentanyl consumption during 24 hours (time frame: 24 hours after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jan 2025; AzTrials last refreshed its copy on 26 Oct 2026.