RemimazolamPhase 4NCT05688345
Comparison of Recovery Profiles Among Propofol, Remimazolam, and Dexmedetomidine After Intraoperative Sedation
A Phase 4 study testing Remimazolam, Propofol and Dexmedetomidine in people with Remimazolam and Propofol, run by Asan Medical Center at 1 site in South Korea.
Trial summary
A total of 120 patients (American Society of Anesthesiologist Physical Status 1-3) who signed a consent form among patients aged 19-80 years who are scheduled to undergo brachial plexus block and upper extremity surgery under monitored anesthetic care at our hospital were enrolled. Read more about this study
- Who is it for?
- Ages 19 to 80 years
- Conditions the study is for
- Remimazolam, Propofol, Dexmedetomidine
- What is being tested?
- Remimazolam, Propofol and Dexmedetomidine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteSouth Korea
- Study dates
- 23 Feb 2023to 13 Aug 2023
- Phase
- Phase 4
- Are there results?
- None posted in the registry
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 19 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ASA PS 1-3
- Patients scheduled for upper extremity surgery under brachial plexus block and monitored anesthetic care
Who cannot join
- Patients who refuse to participate in this study
- Patients with poorly controlled hypertension, hyperthyroidism, or moderate to severe heart disease
- Patients with severe hepatic or renal disease
- Patients who are chronically using antidepressants, anticonvulsants, or psychoactive drugs
- Patients who abuse drugs or alcohol
- Patients with severe sleep apnea
Show all 9Show fewer
- Patients with cognitive impairment who have severe difficulties in communication
- Patients with allergy to propofol, dexmedetomidine, or remimazolam
- Patients judged to be inappropriate for this study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Recovery Profiles of Propofol, Dexmedetomidine, and Remimazolam for Monitored Anesthetic Care in Patients Undergoing Upper Limb Surgery Under Brachial Plexus Block : a Randomized Controlled Trial
A total of 120 patients (American Society of Anesthesiologist Physical Status 1-3) who signed a consent form among patients aged 19-80 years who are scheduled to undergo brachial plexus block and upper extremity surgery under monitored anesthetic care at our hospital were enrolled.
Recruited patients are divided into three groups through computer-generated randomization by using the patient identification number assigned during patient recruitment. (40 people in each group) Standard monitoring is performed when the patient arrives at the operating room. Patients receive oxygen at 5-6 L/min using a simple facial mask, and receive a brachial plexus block under ultrasound guidance. After confirming the success of brachial plexus block, administration of propofol, remimazolam, or dexmedetomidine is started according to the assigned group. Assess the patient's level of consciousness through the MOAA/S (modified observer's assessment of alertness/sedation scale) scale. The drug injection ends when the skin suture is started after the main procedure. The time from the end of injection of each drug until MOAA/S becomes 5 points is measured. After the patient is transferred to the recovery room, the Aldrete score is assessed.
The recovery profile, perioperative hemodynamic change, desaturation event, block duration, patient movement during surgery, patient satisfaction, and surgeon's satisfaction were investigated and analyzed for comparison.
- Conditions
- Remimazolam, Propofol, Dexmedetomidine, Orthopedic Procedures, Sedatives, Brachial Plexus Block
- Being tested
- Remimazolam, Propofol, Dexmedetomidine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RemimazolamDrug
The patient receives continuous infusion of remimazolam at a rate of 0.3-1.0 mg/kg/hr.
PropofolDrug
Patients are administered propofol at an effective site concentration of 1.0-2.5 mcg/ml through target-controlled infusion.
DexmedetomidineDrug
The patient is administered a dose of dexmedetomidine at 1 mcg/kg for 10 minutes, followed by continuous infusion at a rate of 0.2-1.0 mcg/kg/hr.
| Study group | Role | What they receive |
|---|---|---|
| Remimazolam | Active comparator | Maintenance doses of remimazolam is administered for sedation Receives: Drug: Remimazolam |
| Propofol | Active comparator | Propofol is administered for sedation through target-controlled infusion Receives: Drug: Propofol |
| Dexmedetomidine | Active comparator | Loading and maintenance doses of dexmedetomidine are administered for sedation Receives: Drug: Dexmedetomidine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recovery profile
Time taken for MOAA/S score to reach 5 (MOAA/S: Modified Observer's Alertness/Sedation scale) Awake (5) - Unresponsive (0)
Measured: up to 1 hour after post-anesthesia case unit entry
Secondary outcomes (6)
Length of stay in post-anesthesia care unit
Length of stay from entering PACU to leaving
Measured: up to 3 hours after post-anesthesia case unit entry
Intraoperative hypotension
mean blood pressure less than 60mmHg
Measured: up to 1hour from the initiation of sedative administration
Occurrence of desaturation during surgery
Oxygen saturation less than 92%
Measured: From the start of sedative injection to the end of surgery or assessed up to 3 hours
Duration of nerve block
Measured: From end of surgery until 24 hours after end of surgery
patient satisfaction
7 point Likert scale
Measured: From end of surgery until 24 hours after end of surgery
Surgeon's satisfaction
7 point Likert scale
Measured: From end of surgery until 24 hours after end of surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2023
- Study start23 Feb 2023
- Primary completion12 Aug 2023
- Study completion13 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for RemimazolamStudies of the same condition, open and under way.
- More trials run by Asan Medical CenterThe sponsor's other registered studies.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Asan Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hajung Kim, Asan Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05688345
- Sponsor's protocol ID
- 2021-1591
- Status last verified
- Jan 2024
- First submitted
- 30 Dec 2022
- Last updated
- 31 Jan 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Kim HJ, Kim YJ, Lee J, Jeong D, Shin YH, Ro YJ, Kim H, Koh WU. Comparison of the recovery profiles of propofol, dexmedetomidine, and remimazolam for intraoperative sedation in patients undergoing upper limb surgery under brachial plexus blockade: a randomized controlled trial. Can J Anaesth. 2025 Jul;72(7):1090-1100. doi: 10.1007/s12630-025-02987-3. Epub 2025 Jun 13.
PubMed 40514628
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Recovery Profiles of Propofol, Dexmedetomidine, and Remimazolam for Monitored Anesthetic Care in Patients Undergoing Upper Limb Surgery Under Brachial Plexus Block : a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05688345
- Acronym / sponsor ID
- 2021-1591
- Conditions
- Remimazolam, Propofol, Dexmedetomidine, Orthopedic Procedures, Sedatives, Brachial Plexus Block
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Asan Medical CenterUniversity, hospital or other
- Study start
- 23 Feb 2023 (actual)
- Primary completion
- 12 Aug 2023 (actual)
- Study completion
- 13 Aug 2023 (actual)
- First posted
- 18 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.
A total of 120 patients (American Society of Anesthesiologist Physical Status 1-3) who signed a consent form among patients aged 19-80 years who are scheduled to undergo brachial plexus block and upper extremity surgery under monitored anesthetic care at our hospital were enrolled.
Recruited patients are divided into three groups through computer-generated randomization by using the patient identification number assigned during patient recruitment. (40 people in each group) Standard monitoring is performed when the patient arrives at the operating room. Patients receive oxygen at 5-6 L/min using a simple facial mask, and receive a brachial plexus block under ultrasound guidance. After confirming the success of brachial plexus block, administration of propofol, remimazolam, or dexmedetomidine is started according to the assigned group. Assess the patient's level of consciousness through the MOAA/S (modified observer's assessment of alertness/sedation scale) scale. The drug injection ends when the skin suture is started after the main procedure. The time from the end of injection of each drug until MOAA/S becomes 5 points is measured. After the patient is transferred to the recovery room, the Aldrete score is assessed.
The recovery profile, perioperative hemodynamic change, desaturation event, block duration, patient movement during surgery, patient satisfaction, and surgeon's satisfaction were investigated and analyzed for comparison.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Remimazolam | Active comparator | Drug: RemimazolamMaintenance doses of remimazolam is administered for sedation |
| Propofol | Active comparator | Drug: PropofolPropofol is administered for sedation through target-controlled infusion |
| Dexmedetomidine | Active comparator | Drug: DexmedetomidineLoading and maintenance doses of dexmedetomidine are administered for sedation |
Who may qualify
- Ages
- 19 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- ASA PS 1-3
- Patients scheduled for upper extremity surgery under brachial plexus block and monitored anesthetic care
Key exclusion criteria (9 listed)
- Patients who refuse to participate in this study
- Patients with poorly controlled hypertension, hyperthyroidism, or moderate to severe heart disease
- Patients with severe hepatic or renal disease
- Patients who are chronically using antidepressants, anticonvulsants, or psychoactive drugs
- Patients who abuse drugs or alcohol
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 |
|---|---|---|
| RemimazolamThe patient receives continuous infusion of remimazolam at a rate of 0.3-1.0 mg/kg/hr. | Drug | Remimazolam |
| PropofolPatients are administered propofol at an effective site concentration of 1.0-2.5 mcg/ml through target-controlled infusion. | Drug | Propofol |
| DexmedetomidineThe patient is administered a dose of dexmedetomidine at 1 mcg/kg for 10 minutes, followed by continuous infusion at a rate of 0.2-1.0 mcg/kg/hr. | Drug | Dexmedetomidine |
Primary outcome
Recovery profile
Time frame: up to 1 hour after post-anesthesia case unit entry
Time taken for MOAA/S score to reach 5 (MOAA/S: Modified Observer's Alertness/Sedation scale) Awake (5) - Unresponsive (0)
6 secondary outcomes
Length of stay in post-anesthesia care unit
Time frame: up to 3 hours after post-anesthesia case unit entry
Intraoperative hypotension
Time frame: up to 1hour from the initiation of sedative administration
Occurrence of desaturation during surgery
Time frame: From the start of sedative injection to the end of surgery or assessed up to 3 hours
Duration of nerve block
Time frame: From end of surgery until 24 hours after end of surgery
patient satisfaction
Time frame: From end of surgery until 24 hours after end of surgery
Surgeon's satisfaction
Time frame: From end of surgery until 24 hours after end of surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 2024.
- Derived from this study: PubMed 40514628Kim HJ, Kim YJ, Lee J, Jeong D, Shin YH, Ro YJ, Kim H, Koh WU. Comparison of the recovery profiles of propofol, dexmedetomidine, and remimazolam for intraoperative sedation in patients undergoing upper limb surgery under brachial plexus blockade: a randomized controlled trial. Can J Anaesth. 2025 Jul;72(7):1090-1100. doi: 10.1007/s12630-025-02987-3. Epub 2025 Jun 13.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Remimazolam, Propofol and Dexmedetomidine in people with Remimazolam and Propofol, run by Asan Medical Center 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 9 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: finished, as of the sponsor's last update on 31 Jan 2024. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recovery profile (time frame: up to 1 hour after post-anesthesia case unit entry). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05688345, which also lists 1 linked publication.
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 31 Jan 2024.