Orthopedic DisorderPhase 4NCT05447507

Comparison of Remimazolam and Dexmedetomidine for Intraoperative Sedation

A Phase 4 study testing Remimazolam and Dexmedetomidine in people with Orthopedic Disorder, run by Seoul National University Hospital at 1 site in South Korea.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The purpose of this study is to compare the sedation efficacy of dexmedetomidine and remimazolam for intraoperative sedation during regional block. Read more about this study

Who is it for?: Ages 19 to 70 yearsHealthy volunteers can take part
Conditions the study is for: Orthopedic Disorder
What is being tested?: Remimazolam and Dexmedetomidine
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 104 participants
Where: 1 siteSouth Korea
Study dates: 8 Jul 2022to 26 Oct 2022
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 70 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Patient scheduled for lower extremity surgery under regional anesthesia, aged 19-70, of ASA class I or II.

Who cannot join

Patient refusal
Contraindications to regional or neuraxial anesthesia (patient refusal, increased intracranial pressure, infection at puncture site, underlying neurologic disease, severe hypovolemia, aortic or mitral stenosis, thrombocytopenia or coagulopathy)
Contraindications to dexmedetomidine or remimazolam administration
Allergy to dexmedetomidine or remimazolam
Baseline MOAA/S score of 4 or less
Pregnancy
Other conditions considered unsuitable by the investigators

Trial locations and contacts

1 site in 1 country.

South Korea1 site

Seoul National University Hospital
Seoul, Jongno-gu, 03080

Other trials in South Korea

About this study

Official title: Comparison of Remimazolam and Dexmedetomidine for Intraoperative Sedation During Regional Block

The purpose of this study is to compare the sedation efficacy of dexmedetomidine and remimazolam for intraoperative sedation during regional block.

Conditions: Orthopedic Disorder
Being tested: Remimazolam, Dexmedetomidine
Medical subject headings: Musculoskeletal Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

RemimazolamDrug
0.075 mg/kg Remimazolam bolus infusion for 1 min, then 0.5~1.0 mg/kg/h continuous infusion
DexmedetomidineDrug
1 mcg/kg Dexmedetomidine infusion for 10 min, then 0.2~0.7 mcg/kg/h continuous infusion

Study groups in NCT05447507
Study group	Role	What they receive
Remimazolam	Active comparator	Not described Receives: Drug: Remimazolam
Dexmedetomidine	Active comparator	Not described Receives: Drug: Dexmedetomidine

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of rescue sedative doses administered
Measured: Intraoperative period

Secondary outcomes (16)

Incidence of intraoperative bradycardia (heart rate lower than 45 bpm)
Measured: Intraoperative period
Incidence of intraoperative hypotension (mean blood pressure lower than 65 mmHg or systolic blood pressure lower than 80% of baseline)
Measured: Intraoperative period
Incidence of intraoperative hypertension (systolic blood pressure higher than 120% of baseline)
Measured: Intraoperative period
Incidence of respiratory depression (respiratory rate lower than 8 per minute)
Measured: Intraoperative period
Incidence of hypoxia (oxygen saturation detected by pulse oxymetry less than 93%)
Measured: Intraoperative period
MOAA/S score (Modified Observer's Assessment of Alertness and Sedation, 0=unarousable, 5=alert)
Measured: Intraoperative period
Intraoperative PSi (Patient State index)
Measured: Intraoperative period
Electroencephalogram data (alpha, beta, delta, theta waves)
Measured: Intraoperative period
Time to reach MOAA/S = 5 after end of drug infusion
Measured: Intraoperative period and post-anesthesia care period (immediate post-operative period)
Oxygen supply at the post-anesthesia care unit
Measured: Post-anesthesia care period (immediate post-operative period)
Incidence of postoperative delirium
Measured: Immediately after the surgery, up to 5 days after surgery
Incidence of nausea/vomiting
Measured: Intraoperative period and post-anesthesia care period (immediate post-operative period)
Postoperative spinal anesthesia block level
Measured: Postoperative period, up to 12h hours after end of surgery
Duration of stay in the post-anesthsia care unit(PACU)
Measured: Immediate postoperative period
Patient satisfaction (numerical rating scale of 0~10)
0 Not at all satisfied, 10 very satisfied
Measured: Immediately after the surgery, up to 5 days after surgery
Serum CRP level
Measured: Preoperative baseline and second postoperative day

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

8 Jul 202226 Oct 2022

First posted7 Jul 2022
Study start8 Jul 2022
Primary completion26 Oct 2022
Study completion26 Oct 2022

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 Orthopedic DisorderStudies of the same condition, open and under way.
More trials run by Seoul National University HospitalThe 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: Double blind
Who is masked: Participant, Outcomes assessor
Enrolment: 104 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05447507
Sponsor's protocol ID: 2205-011-1320
Status last verified: Nov 2022
First submitted: 21 Jun 2022
Last updated: 29 Nov 2022
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Undecided

Publications

Kim H, Kim Y, Bae J, Yoo S, Lim YJ, Kim JT. Comparison of remimazolam and dexmedetomidine for intraoperative sedation in patients undergoing lower extremity surgery under spinal anesthesia: a randomized clinical trial. Reg Anesth Pain Med. 2024 Feb 5;49(2):110-116. doi: 10.1136/rapm-2023-104415.
PubMed 37280081

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Orthopedic Disorder trials

Study at a glance

From the registry record, last updated by the sponsor on 29 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Comparison of Remimazolam and Dexmedetomidine for Intraoperative Sedation During Regional Block
ClinicalTrials.gov ID: NCT05447507
Acronym / sponsor ID: 2205-011-1320
Conditions: Orthopedic Disorder
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 104 participants (actual)
Lead sponsor: Seoul National University HospitalUniversity, hospital or other
Study start: 8 Jul 2022 (actual)
Primary completion: 26 Oct 2022 (actual)
Study completion: 26 Oct 2022 (actual)
First posted: 7 Jul 2022 (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.

The purpose of this study is to compare the sedation efficacy of dexmedetomidine and remimazolam for intraoperative sedation during regional block.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Remimazolam	Active comparator	Drug: Remimazolam
Dexmedetomidine	Active comparator	Drug: Dexmedetomidine

Who may qualify

Ages: 19 to 70 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (1 listed)

Patient scheduled for lower extremity surgery under regional anesthesia, aged 19-70, of ASA class I or II.

Key exclusion criteria (7 listed)

Patient refusal
Contraindications to regional or neuraxial anesthesia (patient refusal, increased intracranial pressure, infection at puncture site, underlying neurologic disease, severe hypovolemia, aortic or mitral stenosis, thrombocytopenia or coagulopathy)
Contraindications to dexmedetomidine or remimazolam administration
Allergy to dexmedetomidine or remimazolam
Baseline MOAA/S score of 4 or less

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
Remimazolam0.075 mg/kg Remimazolam bolus infusion for 1 min, then 0.5~1.0 mg/kg/h continuous infusion	Drug	Remimazolam
Dexmedetomidine1 mcg/kg Dexmedetomidine infusion for 10 min, then 0.2~0.7 mcg/kg/h continuous infusion	Drug	Dexmedetomidine

Primary outcome

Number of rescue sedative doses administered
Time frame: Intraoperative period

16 secondary outcomes

Incidence of intraoperative bradycardia (heart rate lower than 45 bpm)
Time frame: Intraoperative period
Incidence of intraoperative hypotension (mean blood pressure lower than 65 mmHg or systolic blood pressure lower than 80% of baseline)
Time frame: Intraoperative period
Incidence of intraoperative hypertension (systolic blood pressure higher than 120% of baseline)
Time frame: Intraoperative period
Incidence of respiratory depression (respiratory rate lower than 8 per minute)
Time frame: Intraoperative period
Incidence of hypoxia (oxygen saturation detected by pulse oxymetry less than 93%)
Time frame: Intraoperative period
MOAA/S score (Modified Observer's Assessment of Alertness and Sedation, 0=unarousable, 5=alert)
Time frame: Intraoperative period
Intraoperative PSi (Patient State index)
Time frame: Intraoperative period
Electroencephalogram data (alpha, beta, delta, theta waves)
Time frame: Intraoperative period
Time to reach MOAA/S = 5 after end of drug infusion
Time frame: Intraoperative period and post-anesthesia care period (immediate post-operative period)
Oxygen supply at the post-anesthesia care unit
Time frame: Post-anesthesia care period (immediate post-operative period)
Incidence of postoperative delirium
Time frame: Immediately after the surgery, up to 5 days after surgery
Incidence of nausea/vomiting
Time frame: Intraoperative period and post-anesthesia care period (immediate post-operative period)
Postoperative spinal anesthesia block level
Time frame: Postoperative period, up to 12h hours after end of surgery
Duration of stay in the post-anesthsia care unit(PACU)
Time frame: Immediate postoperative period
Patient satisfaction (numerical rating scale of 0~10)
Time frame: Immediately after the surgery, up to 5 days after surgery
Serum CRP level
Time frame: Preoperative baseline and second postoperative day

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 29 Nov 2022.
Derived from this study: PubMed 37280081Kim H, Kim Y, Bae J, Yoo S, Lim YJ, Kim JT. Comparison of remimazolam and dexmedetomidine for intraoperative sedation in patients undergoing lower extremity surgery under spinal anesthesia: a randomized clinical trial. Reg Anesth Pain Med. 2024 Feb 5;49(2):110-116. doi: 10.1136/rapm-2023-104415.
Individual participant dataSharing planned: Undecided

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RecruitingPhase 2
Study of PTC844 in Participants With Active Rheumatoid Arthritis
Rheumatoid Arthritis
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X-linked Hypophosphatemia
Recruiting
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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 and Dexmedetomidine in people with Orthopedic Disorder, run by Seoul National University 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 1 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: finished, as of the sponsor's last update on 29 Nov 2022. 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?

Number of rescue sedative doses administered (time frame: Intraoperative period). 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 NCT05447507, 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 29 Nov 2022.