BenzodiazepinesrimazolamNCT05519371
Remimazolam and Scoliosis Orthopedics
A study testing Remimazolam and Propofol in people with Benzodiazepines, run by Beijing Chao Yang Hospital.
Trial summary
Spinal cord injury is one of the most dangerous complications of scoliosis orthopedic surgery, and the Stagnara awakening test has been used in orthopedic spine surgery and is considered the "gold standard" for detecting spinal cord injury. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Benzodiazepines
- What is being tested?
- Remimazolam and Propofol
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 148 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2022to 1 Oct 2023
- 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 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Age greater than 18 years and less than 60 years
- Elective scoliosis orthopaedic surgery under general anesthesia.
- ASA Physical Score I-III
- Signed informed consent.
Who cannot join
- Patients who cannot understand the method and requirements of the arousal test and cannot cooperate in completing the arousal test.
- Patients with limb sensory-motor dysfunction.
- Patients with a history of severe neurological disorders.
- Patients with psychiatric disorders.
- Patients who have taken benzodiazepines and/or opioids daily for one month or intermittently for the last three months.
- Patients with concomitant severe respiratory and circulatory disorders, including acute heart failure, unstable angina, resting ECG heart rate <50 beats/min, QTc: ≥ 470ms in men and ≥ 480ms in women, third-degree AV block, severe arrhythmia, moderate to severe heart valve disease, chronic obstructive pulmonary disease, and history of asthma.
- Abnormal liver and kidney function: ALT and/or AST exceeding 2.5 times the upper limit of the medical reference range; urea or urea nitrogen ≥1.5 × ULN, blood creatinine greater than the upper limit of normal values.
About this study
Official title: Efficacy and Safety Evaluation of Injectable Remimazolam for Intraoperative Arousal in Scoliosis Orthopedics
Spinal cord injury is one of the most dangerous complications of scoliosis orthopedic surgery, and the Stagnara awakening test has been used in orthopedic spine surgery and is considered the "gold standard" for detecting spinal cord injury. During the awakening test, the patient is awakened from anesthesia and, in conjunction with a neurological assessment, moves his or her fingers and toes to determine the integrity of spinal cord motor function in order to avoid spinal cord injury. During this procedure, the patient still requires a degree of sedation and analgesia to tolerate tracheal intubation and surgical pain. Remazolam benzoate for injection is a new class of benzodiazepines that are ultra-short-acting sedative/anesthetic drugs. It has the advantages of rapid onset, rapid elimination, and no drug accumulation by continuous infusion, and has the advantage of being applied to wake up during spinal orthopedic surgery, but its effectiveness and safety are still unclear. This study aims to elucidate the safety and efficacy of rimazolam benzoate for injection for arousal in spinal orthopedic surgery through a single-center, randomized, single-blind, positive drug-controlled trial, with the aim of providing a basis for the development of a safe and effective anesthetic protocol for such surgery.
- Conditions
- Benzodiazepines
- Being tested
- Remimazolam, Propofol
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RemimazolamDrug
During induction of anesthesia, the rimazolam group was given rimazolam pumped at a rate of 12 mg/kg/h
During the maintenance phase of anesthesia, the rimazolam group was given 1.0-2.0 mg/kg/h of rimazolam continuously pumped.
PropofolDrug
During induction of anesthesia, propofol 2mg/kg was given, and during the maintenance phase of anesthesia, propofol 6-8mg/kg/h was given as a continuous pump.
| Study group | Role | What they receive |
|---|---|---|
| remimazolam group | Experimental | For induction of anesthesia, rimazolam benzoate was pumped at a rate of 12 mg/kg/h; for maintenance of anesthesia, 1.0-2.0 mg/kg/h rimazolam was given as a continuous pump. Receives: Drug: Remimazolam |
| propoful group | Active comparator | For induction of anesthesia, propofol medium-length chain fatty milk injection 2 mg/kg was given by intravenous push; for maintenance of anesthesia, 6-8 mg/kg/h propofol medium-length chain fatty milk injection was given by continuous pumping. Receives: Drug: Propofol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean time to arousal
the time between the cessation of intraoperative drug infusion and the subject's ability to move the toes on command.
Measured: Perioperative period
Secondary outcomes (5)
Quality of arousal
Class I: the patient wakes up when called, is quiet and moves the limbs as instructed; Class II, the patient wakes up suddenly, moves the limbs involuntarily, does not endanger the internal fixation and tracheal tube, and can move the limbs as instructed; Class III, the patient wakes up suddenly, moves the trunk violently and requires pressure to not endanger the internal fixation and tracheal tube
Measured: Perioperative period
Proportion of successful induction of anesthesia
The criteria for successful induction of anesthesia were that both of the following two requirements were met: completion of tracheal intubation; and no use of remedial sedative drugs
Measured: Perioperative period
Mean time from initiation of dosing to MOAA/S score ≤1
Mean time from initiation of dosing to MOAA/S score ≤1
Measured: Perioperative period
Mean time from discontinuation at the end of surgery to full awakening of the subject
time to the first of three consecutive MOAA/S scores of 5
Measured: Perioperative period
EEG characteristics during the induction, maintenance and awakening periods
EEG power in alpha band, beta band, theta band, and gamma band
Measured: Perioperative period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2022
- Study start1 Oct 2022 (estimated)
- Primary completion1 Oct 2022 (estimated)
- Study completion1 Oct 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BenzodiazepinesStudies of the same condition, open and under way.
- More trials run by Beijing Chao Yang 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 148 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Chao Yang Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Anshi Wu, Beijing Chao Yang Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05519371
- Sponsor's protocol ID
- 20220817
- Acronym
- rimazolam
- Status last verified
- Aug 2022
- First submitted
- 16 Aug 2022
- Last updated
- 29 Aug 2022
- Results posted
- 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 29 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety Evaluation of Injectable Remimazolam for Intraoperative Arousal in Scoliosis Orthopedics
- ClinicalTrials.gov ID
- NCT05519371
- Acronym / sponsor ID
- rimazolam / 20220817
- Conditions
- Benzodiazepines
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 148 participants (estimated)
- Lead sponsor
- Beijing Chao Yang HospitalUniversity, hospital or other
- Study start
- 1 Oct 2022 (estimated)
- Primary completion
- 1 Oct 2022 (estimated)
- Study completion
- 1 Oct 2023 (estimated)
- First posted
- 29 Aug 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.
Spinal cord injury is one of the most dangerous complications of scoliosis orthopedic surgery, and the Stagnara awakening test has been used in orthopedic spine surgery and is considered the "gold standard" for detecting spinal cord injury. During the awakening test, the patient is awakened from anesthesia and, in conjunction with a neurological assessment, moves his or her fingers and toes to determine the integrity of spinal cord motor function in order to avoid spinal cord injury. During this procedure, the patient still requires a degree of sedation and analgesia to tolerate tracheal intubation and surgical pain. Remazolam benzoate for injection is a new class of benzodiazepines that are ultra-short-acting sedative/anesthetic drugs. It has the advantages of rapid onset, rapid elimination, and no drug accumulation by continuous infusion, and has the advantage of being applied to wake up during spinal orthopedic surgery, but its effectiveness and safety are still unclear. This study aims to elucidate the safety and efficacy of rimazolam benzoate for injection for arousal in spinal orthopedic surgery through a single-center, randomized, single-blind, positive drug-controlled trial, with the aim of providing a basis for the development of a safe and effective anesthetic protocol for such surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| remimazolam group | Experimental | Drug: RemimazolamFor induction of anesthesia, rimazolam benzoate was pumped at a rate of 12 mg/kg/h; for maintenance of anesthesia, 1.0-2.0 mg/kg/h rimazolam was given as a continuous pump. |
| propoful group | Active comparator | Drug: PropofolFor induction of anesthesia, propofol medium-length chain fatty milk injection 2 mg/kg was given by intravenous push; for maintenance of anesthesia, 6-8 mg/kg/h propofol medium-length chain fatty milk injection was given by continuous pumping. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Age greater than 18 years and less than 60 years
- Elective scoliosis orthopaedic surgery under general anesthesia.
- ASA Physical Score I-III
- Signed informed consent.
Key exclusion criteria (7 listed)
- Patients who cannot understand the method and requirements of the arousal test and cannot cooperate in completing the arousal test.
- Patients with limb sensory-motor dysfunction.
- Patients with a history of severe neurological disorders.
- Patients with psychiatric disorders.
- Patients who have taken benzodiazepines and/or opioids daily for one month or intermittently for the last three months.
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 |
|---|---|---|
| RemimazolamDuring induction of anesthesia, the rimazolam group was given rimazolam pumped at a rate of 12 mg/kg/h During the maintenance phase of anesthesia, the rimazolam group was given 1.0-2.0 mg/kg/h of rimazolam continuously pumped. | Drug | remimazolam group |
| PropofolDuring induction of anesthesia, propofol 2mg/kg was given, and during the maintenance phase of anesthesia, propofol 6-8mg/kg/h was given as a continuous pump. | Drug | propoful group |
Primary outcome
Mean time to arousal
Time frame: Perioperative period
the time between the cessation of intraoperative drug infusion and the subject's ability to move the toes on command.
5 secondary outcomes
Quality of arousal
Time frame: Perioperative period
Proportion of successful induction of anesthesia
Time frame: Perioperative period
Mean time from initiation of dosing to MOAA/S score ≤1
Time frame: Perioperative period
Mean time from discontinuation at the end of surgery to full awakening of the subject
Time frame: Perioperative period
EEG characteristics during the induction, maintenance and awakening periods
Time frame: Perioperative period
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Aug 2022.
- 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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Remimazolam and Propofol in people with Benzodiazepines, run by Beijing Chao Yang 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 4 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: status not confirmed, as of the sponsor's last update on 29 Aug 2022. 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?
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?
Mean time to arousal (time frame: Perioperative 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 29 Aug 2022.