SedationNCT05305248
Sedation With Remimazolam During Spinal Anesthesia
A study testing Remimazolam and Dexmedetomidine in people with Sedation and Spinal Anesthesia, run by Gangnam Severance Hospital at 1 site in South Korea.
Trial summary
Remimazolam is a benzodiazepine-binding site antagonist of the GABA receptor, metabolized by esterases, and exhibits a stable context-sensitive half-life of 6-7 minutes. Remimazolam has a high clearance rate and a small volume of distribution in the pharmacokinetic model. The US FDA has approved sedation for surgery. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Sedation, Spinal Anesthesia
- 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
- 62 participants
- Where
- 1 siteSouth Korea
- Study dates
- 19 Apr 2022to 15 Sep 2022
- Phase
- Interventional
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Severe cardiovascular or respiratory disease
- Contraindication to spinal anesthesia
- Heart block
- Previous hepatectomy or liver transplant
- Patients with moderate or more hepatic impairment (AST/ALT is more than 2.5 times the upper limit of normal)
- Estimated glomerular filtration rate < 30 mL/min/1.73m2
Show all 9Show fewer
- Acute narrow angle glaucoma
- Myasthesia gravis
- Known allergy to the drugs included in the study
Who cannot join
- Patients 19 years of age or older who are expected to elective orthopedic surgery under spinal anaesthesia
- ASA PS 1-3
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Sedation With Intravenous Remimazolam and Dexmedetomidine During Spinal Anesthesia : Prospective Randomized Study
Remimazolam is a benzodiazepine-binding site antagonist of the GABA receptor, metabolized by esterases, and exhibits a stable context-sensitive half-life of 6-7 minutes. Remimazolam has a high clearance rate and a small volume of distribution in the pharmacokinetic model. The US FDA has approved sedation for surgery. Although there have been studies on the use of remimazolam as a sedative for procedures such as endoscopy, there have been no reports of the use of remimazolam in spinal anesthesia. The purpose of this study is to compare and analyze the hemodynamics and recovery profile of patients undergoing surgery under spinal anesthesia by maintaining sedation with dexmedetomidine or remimazolam.
- Conditions
- Sedation, Spinal Anesthesia
- Being tested
- Remimazolam, Dexmedetomidine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RemimazolamDrug
After spinal anesthesia, 5 mg of remimazolam is injected by intravenous route for 1 minute to induce sedation. To maintain sedation, remimazolam is continuously infused at a rate within the range of 0.1 mg/kg/h to 1 mg/kg/h.
DexmedetomidineDrug
After performing spinal anesthesia, dexmedetomidine is injected at a loading dose of 1 mcg/kg for 10 minutes to induce sedation. Thereafter, to maintain sedation, Dexmedetomidine is continuously infused at a rate within the range of 0.2 to 0.7 mcg/kg/h.
| Study group | Role | What they receive |
|---|---|---|
| Remimazolam group | Experimental | Sedation with remimazolam during spinal anesthesia Receives: Drug: Remimazolam |
| Dexmedetomidine group | Active comparator | Sedation with dexmedetomidine during spinal anesthesia Receives: Drug: Dexmedetomidine |
What is being measured
The primary outcome is the main question the study is designed to answer.
MOAA/S score
MOAA/S score will be evaluated by an 5-point scale from iniation of sedative drugs to 30 minutes after PCAU arrival at 10 minutes intervals.
Measured: up to 30 minutes after PACU arrival
Secondary outcomes (2)
Sedation induction time Sedation induction time
Sedation induction time is defined as from start of drug injection to the first time of MOAA/S ≤ 3
Measured: up to 5 minutes after initation of sedative drugs
Differences in basic vital signs between the two groups
Differences in blood pressure, heart rate, and patient sedation index at different time points during the operation and PACU stay between the two groups
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2022
- Study start19 Apr 2022
- Primary completion15 Sep 2022
- Study completion15 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SedationStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gangnam Severance Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Do-Hyeong Kim, Gangnam Severance Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05305248
- Sponsor's protocol ID
- 3-2021-0489
- Status last verified
- May 2023
- First submitted
- 2 Mar 2022
- Last updated
- 12 May 2023
- Results posted
- No
- Data monitoring committee
- No
- 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 12 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Sedation With Intravenous Remimazolam and Dexmedetomidine During Spinal Anesthesia : Prospective Randomized Study
- ClinicalTrials.gov ID
- NCT05305248
- Acronym / sponsor ID
- 3-2021-0489
- Conditions
- Sedation, Spinal Anesthesia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- Gangnam Severance HospitalUniversity, hospital or other
- Study start
- 19 Apr 2022 (actual)
- Primary completion
- 15 Sep 2022 (actual)
- Study completion
- 15 Sep 2022 (actual)
- First posted
- 31 Mar 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.
Remimazolam is a benzodiazepine-binding site antagonist of the GABA receptor, metabolized by esterases, and exhibits a stable context-sensitive half-life of 6-7 minutes. Remimazolam has a high clearance rate and a small volume of distribution in the pharmacokinetic model. The US FDA has approved sedation for surgery. Although there have been studies on the use of remimazolam as a sedative for procedures such as endoscopy, there have been no reports of the use of remimazolam in spinal anesthesia. The purpose of this study is to compare and analyze the hemodynamics and recovery profile of patients undergoing surgery under spinal anesthesia by maintaining sedation with dexmedetomidine or remimazolam.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Remimazolam group | Experimental | Drug: RemimazolamSedation with remimazolam during spinal anesthesia |
| Dexmedetomidine group | Active comparator | Drug: DexmedetomidineSedation with dexmedetomidine during spinal anesthesia |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Severe cardiovascular or respiratory disease
- Contraindication to spinal anesthesia
- Heart block
- Previous hepatectomy or liver transplant
- Patients with moderate or more hepatic impairment (AST/ALT is more than 2.5 times the upper limit of normal)
Key exclusion criteria (2 listed)
- Patients 19 years of age or older who are expected to elective orthopedic surgery under spinal anaesthesia
- ASA PS 1-3
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 |
|---|---|---|
| RemimazolamAfter spinal anesthesia, 5 mg of remimazolam is injected by intravenous route for 1 minute to induce sedation. To maintain sedation, remimazolam is continuously infused at a rate within the range of 0.1 mg/kg/h to 1 mg/kg/h. | Drug | Remimazolam group |
| DexmedetomidineAfter performing spinal anesthesia, dexmedetomidine is injected at a loading dose of 1 mcg/kg for 10 minutes to induce sedation. Thereafter, to maintain sedation, Dexmedetomidine is continuously infused at a rate within the range of 0.2 to 0.7 mcg/kg/h. | Drug | Dexmedetomidine group |
Primary outcome
MOAA/S score
Time frame: up to 30 minutes after PACU arrival
MOAA/S score will be evaluated by an 5-point scale from iniation of sedative drugs to 30 minutes after PCAU arrival at 10 minutes intervals.
2 secondary outcomes
Sedation induction time Sedation induction time
Time frame: up to 5 minutes after initation of sedative drugs
Differences in basic vital signs between the two groups
Time frame: Baseline
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 12 May 2023.
- Individual participant dataSharing planned: No
Related trials for Sedation
RecruitingPhase 3
Optimizing Pain Treatment in Children On Mechanical Ventilation
Mechanical Ventilation, Pediatric Acute Respiratory Failure
Not yet recruiting
Dexametedomidine Ketamine Infusion Versus Dexametedomidine Propofol Infusion in Non-compliant Agitated Patients on Continuous Positive Airway Pressure (CPAP) Mask Ventilation in the Intensive Care Unit
CPAP Ventilation, Sedation
Not yet recruitingPhase 3
Remimazolam vs Propofol for Long-Term Sedation in Mechanically Ventilated ICU Patients
Long-term Sedation for Mechanical Ventilation, Critically Ill Intensive Care Unit Patients
Enrolling by invitationObservational study
A Prospective Multicenter Registry Study of Sedation and Analgesia in Critically Ill Patients
Sedation, Analgesia Assessment
Active, not recruitingPhase 3
Goal-Directed Sedation in Mechanically Ventilated Infants and Children
Delirium, Critical Illness
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 study testing Remimazolam and Dexmedetomidine in people with Sedation and Spinal Anesthesia, run by Gangnam Severance 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 9 inclusion and 2 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 12 May 2023. 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?
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?
MOAA/S score (time frame: up to 30 minutes after PACU arrival). 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 12 May 2023; AzTrials last refreshed its copy on 31 Oct 2026.