RemimazolamNCT05935657
The Effect of Remimazolam and Dexmedetomidine on the Incidence of Hypotension During Spinal Anesthesia
A study testing Remimazolam and Dexmedetomidine in people with Remimazolam and Spinal Anesthesia, run by Pusan National University Yangsan Hospital.
Trial summary
The goal of this clinical trial is to compare the effect of remimazolam and dexmedetomidine on the incidence of hypotension during spinal anesthesia in adult patients. Read more about this study
- Who is it for?
- Ages 19 to 79 yearsHealthy volunteers can take part
- Conditions the study is for
- Remimazolam, 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
- 72 participants
- Where
- No sites listed yet
- Study dates
- Aug 2023to Jun 2024
- 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 to 79 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patient scheduled for surgery under spinal anesthesia, aged 19-79, of ASA class I, II, or III
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, severe aortic or mitral stenosis, thrombocytopenia or coagulopathy, sepsis)
- Contraindications or allergy to dexmedetomidine or remimazolam administration
- Emergency surgery
- Pregnancy
Trial locations and contacts
No sites are listed yet.
About this study
The goal of this clinical trial is to compare the effect of remimazolam and dexmedetomidine on the incidence of hypotension during spinal anesthesia in adult patients.
Read the detailed description
Sedation during spinal anesthesia can reduce the patient's anxiety and increase satisfaction, but sedatives such as dexmedetomidine and midazolam may cause hemodynamic instability such as hypotension and bradycardia. In previous studies , hypotension occurred in about 33% and bradycardia in about 13% during spinal anesthesia, which is related to reduced cardiac output due to sympathetic blockade and relative activation of the parasympathetic nerve.
In the study comparing remimazolam and dexmedetomidine in patients with delirium after orthopedic surgery, the incidence of hypotension was lower in the remimazolam group (10.8%) than in the dexmedetomidine group (39.5%) (p=0.007) and there was no significant difference between the remimazolam group (2.7%) and the dexmedetomidine group (13.2%) in the incidence of bradycardia (p=0.200).
However, the effect of remimazolam on the incidence of hypotension during spinal anesthesia has not been revealed. Therefore, this study is designed to compare the effect of remimazolam and dexmedetomidine on the incidence of hypotension during spinal anesthesia in adults patients.
- Conditions
- Remimazolam, 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
Also called Byfavo
0.075 mg/kg Remimazolam bolus infusion for 1 min, then 0.1~1.0 mg/kg/h continuous infusion
DexmedetomidineDrug
Also called Precedex
1 mcg/kg Dexmedetomidine infusion for 10 min, then 0.2~0.7 mcg/kg/h continuous infusion
| Study group | Role | What they receive |
|---|---|---|
| Remimazolam Group | Experimental | sedation with remimazolam Receives: Drug: Remimazolam |
| Dexmedetomidine group | Active comparator | sedation with dexmedetomidine Receives: Drug: Dexmedetomidine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of intraoperative hypotension
mean blood pressure lower than 65 mmHg or systolic blood pressure lower than 80% of baseline
Measured: Intraoperative period
Secondary outcomes (6)
Incidence of intraoperative bradycardia
heart rate lower than 45 bpm
Measured: Intraoperative period
Incidence of intraoperative hypertension
mean blood pressure higher than 120 mmHg or 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
Intraoperative Ramsay sedation scale
score of 1~6
Measured: Intraoperative period
Number of phenylephrine, ephedrine, atropine administered
number of administration
Measured: Intraoperative period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2023
- Study startAug 2023 (estimated)
- Primary completionJun 2024 (estimated)
- Study completionJun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for RemimazolamStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 72 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Pusan National University Yangsan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gyeong-Jo Byeon, MD, PhD, Pusan National University Yangsan Hospital
- Investigators
- Gyengjo Byeon, PhD, Study director, Pusan National University Yangsan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05935657
- Sponsor's protocol ID
- 20230608
- Status last verified
- Aug 2023
- First submitted
- 28 Jun 2023
- Last updated
- 8 Aug 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Remimazolam and Dexmedetomidine on the Incidence of Hypotension During Spinal Anesthesia
- ClinicalTrials.gov ID
- NCT05935657
- Acronym / sponsor ID
- 20230608
- Conditions
- Remimazolam, Spinal Anesthesia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 72 participants (estimated)
- Lead sponsor
- Pusan National University Yangsan HospitalUniversity, hospital or other
- Study start
- Aug 2023 (estimated)
- Primary completion
- Jun 2024 (estimated)
- Study completion
- Jun 2024 (estimated)
- First posted
- 7 Jul 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.
The goal of this clinical trial is to compare the effect of remimazolam and dexmedetomidine on the incidence of hypotension during spinal anesthesia in adult patients.
Detailed description
Sedation during spinal anesthesia can reduce the patient's anxiety and increase satisfaction, but sedatives such as dexmedetomidine and midazolam may cause hemodynamic instability such as hypotension and bradycardia. In previous studies , hypotension occurred in about 33% and bradycardia in about 13% during spinal anesthesia, which is related to reduced cardiac output due to sympathetic blockade and relative activation of the parasympathetic nerve.
In the study comparing remimazolam and dexmedetomidine in patients with delirium after orthopedic surgery, the incidence of hypotension was lower in the remimazolam group (10.8%) than in the dexmedetomidine group (39.5%) (p=0.007) and there was no significant difference between the remimazolam group (2.7%) and the dexmedetomidine group (13.2%) in the incidence of bradycardia (p=0.200).
However, the effect of remimazolam on the incidence of hypotension during spinal anesthesia has not been revealed. Therefore, this study is designed to compare the effect of remimazolam and dexmedetomidine on the incidence of hypotension during spinal anesthesia in adults patients.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Remimazolam Group | Experimental | Drug: Remimazolamsedation with remimazolam |
| Dexmedetomidine group | Active comparator | Drug: Dexmedetomidinesedation with dexmedetomidine |
Who may qualify
- Ages
- 19 to 79 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patient scheduled for surgery under spinal anesthesia, aged 19-79, of ASA class I, II, or III
Key exclusion criteria (5 listed)
- Patient refusal
- Contraindications to regional or neuraxial anesthesia (patient refusal, increased intracranial pressure, infection at puncture site, underlying neurologic disease, severe hypovolemia, severe aortic or mitral stenosis, thrombocytopenia or coagulopathy, sepsis)
- Contraindications or allergy to dexmedetomidine or remimazolam administration
- Emergency surgery
- Pregnancy
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 |
|---|---|---|
| RemimazolamAlso: Byfavo0.075 mg/kg Remimazolam bolus infusion for 1 min, then 0.1~1.0 mg/kg/h continuous infusion | Drug | Remimazolam Group |
| DexmedetomidineAlso: Precedex1 mcg/kg Dexmedetomidine infusion for 10 min, then 0.2~0.7 mcg/kg/h continuous infusion | Drug | Dexmedetomidine group |
Primary outcome
Incidence of intraoperative hypotension
Time frame: Intraoperative period
mean blood pressure lower than 65 mmHg or systolic blood pressure lower than 80% of baseline
6 secondary outcomes
Incidence of intraoperative bradycardia
Time frame: Intraoperative period
Incidence of intraoperative hypertension
Time frame: Intraoperative period
Incidence of respiratory depression
Time frame: Intraoperative period
Incidence of hypoxia
Time frame: Intraoperative period
Intraoperative Ramsay sedation scale
Time frame: Intraoperative period
Number of phenylephrine, ephedrine, atropine administered
Time frame: Intraoperative period
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Aug 2023.
Related trials for Remimazolam
RecruitingPhase 4
Remimazolam Versus Propofol for Maintenance of Anaesthesia During Major Hepatectomy Under Low Central Venous Pressure
Intraoperative Hypotension, Hepatectomy
Recruiting
Remimazolam for Reducing Postoperative Delirium in Elderly Patients Undergoing Laparoscopic Gastrectomy
Gastric Cancer, Postoperative Delirium
Recruiting
Patient-controlled Remimazolam Sedation Under Spinal Anesthesia
Hip Arthroplasty, Spinal Anesthesia
Recruiting
The Effect of Remimazolam Tosylate on the Incidence of Postoperative Delirium in Older Patients Undergoing Cardiac Surgery: A Prospective Randomized Controlled Trial
Delirium - Postoperative
RecruitingPhase 4
Effect of Remimazolam Versus Propofol Total Intravenous Anesthesia on Intraoperative Hemodynamic Stability in Patients Undergoing Thoracic or Abdominal Endovascular Aortic Repair
Aortic Aneurysm, Thoracoabdominal, Aortic Aneurysm, Abdominal
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.
Gyengjo Byeon, PhD study director
Pusan National University Yangsan Hospital
Questions about this trial
What is this clinical trial studying?
A study testing Remimazolam and Dexmedetomidine in people with Remimazolam and Spinal Anesthesia, run by Pusan National University Yangsan Hospital.
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 5 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: status not confirmed, as of the sponsor's last update on 8 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jieun Jung, MD (820553602129, jungje0308@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of intraoperative hypotension (time frame: Intraoperative period). 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 8 Aug 2023.