RemimazolamNCT06427785
The Effect of Wavelet Index in Monitoring the Sedation Depth of Remimazolam Besylate
An observational study of Remimazolam and Anesthesia Awareness, run by Beijing Chao Yang Hospital.
Trial summary
To explore the sedative effect of remimazolam in patients undergoing spinal anesthesia without pain stimulation. Both the Modified Observer's Assessment of Alertness/Sedation (MOAA/S) and the Wavelet index (WLi) were used to monitor the depth of anesthesia of remimazolam, and exploring the correlation and consistency… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Remimazolam, Anesthesia Awareness, Sedative, Hypnotic, or Anxiolytic Withdrawal
- What is being tested?
- Remimazolam besylate
- Type of treatment
- Injection or infusion
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- 15 Aug 2024to 15 Aug 2025
- Phase
- Observational
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: This was an unrandomized, single-group study. The sample size was calculated using PASS 15™(NCSS, LLC. Kaysville, Utah, USA.) software. The degree of confidence (1-β) was set at 0.90, and the α value was set at 0.05. ρ0, the baseline correlation, was set to 0. The ρ1, alternating correlation, was set to 0.3 based on the expected minimum r value of 0.3 obtained in previous literature. Final calculations show that 112 pairs of data were needed to complete the experiments. Approximately 20 pairs of data were expected to be recorded per participant, and 30 participants were expected to be enrolled in this study. So, the sample size was adequate.
Who may be able to join
- ASA was classified as I-III
- The operation time was less than 120 minutes
- Informed consent is signed by all study participants
- Elective lower extremity surgery under spinal anesthesia was performed
Who cannot join
- Pregnant or lactating women
- Patients with Difficult Airways
- History of severe neurological and muscular diseases and mental retardation
- Patients with severe respiratory and circulatory diseases, including acute heart failure. Unstable angina pectoris. Resting ECG heart rate <50 beats/min. QTc: ≥470ms in men and ≥480ms in women. Third degree atrioventricular block. Severe arrhythmia. Moderate to severe heart valve disease. Chronic obstructive pulmonary disease. A history of severe asthma.
- Abnormal liver and kidney function: ALT and/or AST exceeding 2.5 times the upper limit of the medical reference range
- Take diazole drugs and/or opioids in one month or nearly three months
- Patients who were allergic to or contraindicated to benzodiazepines, opioids, propofol, flumazenil, naloxone, etc
- Patients who could not monitor the depth of anesthesia for various reasons
Trial locations and contacts
No sites are listed yet.
About this study
To explore the sedative effect of remimazolam in patients undergoing spinal anesthesia without pain stimulation. Both the Modified Observer's Assessment of Alertness/Sedation (MOAA/S) and the Wavelet index (WLi) were used to monitor the depth of anesthesia of remimazolam, and exploring the correlation and consistency between MOAA/S score and WLi value at the same time.
Read the detailed description
Patients undergoing spinal anesthesia were received remimazolam besylate for sedation continuously. Both the Modified Observer's Assessment of Alertness/Sedation (MOAA/S) and the Wavelet index (WLi) were used to monitor the depth of anesthesia of remimazolam, and exploring the correlation and consistency between MOAA/S score and WLi value at the same time.
- Being tested
- Remimazolam besylate
- Keywords
- Wavelet Index, Remimazolam, Depth of Sedation
- Medical subject headings
- Intraoperative Awareness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Remimazolam besylateDrug
Thirty patients underwent elective lower extremity surgery receive spinal anesthesia, and then remimazolam besylate was given intravenously with an induction dose of 3mg/min. When the MOAA/S (Modified Observer's Assessment of Alertness/Sedation) score was ≤1, remimazolam besylate was maintained at 1mg/min for 24min, and finally stopped. Wavelet index, MOAA/S score, blood pressure, heart rate, respiratory rate, and pulse oxygen saturation were continuously monitored during the period.
| Study group | Role | What they receive |
|---|---|---|
| Remimazolam group | Thirty patients underwent elective lower extremity surgery receive spinal anesthesia, and then, remimazolam besylate was given intravenously with an induction dose of 3mg/min. When the MOAA/S (Modified Observer's Assessment of Alertness/Sedation) score was ≤1, remimazolam besylate was maintained at 1mg/min for 24min, and finally stopped. Wavelet index, MOAA/S score, blood pressure, heart rate, respiratory rate, and pulse oxygen saturation were continuously monitored during the period. Receives: Drug: Remimazolam besylate |
What is being measured
The primary outcome is the main question the study is designed to answer.
The value of the Wavelet index (WLi) when MOAA/S (Modified Observer's Assessment of Alertness/Sedation) score ≤ 1.
Sedation was assessed using the MOAA/S (Modified Observer's Assessment of Alertness/Sedation) scale. It ranges from 5(alert) to 0(deep sedation). Wavelet index (WLi) is a parameter that potentially could be used to regulate the sedative depth of anesthesia. The range of WLi values is 0-100, with a value of 0 indicating no EEG activity, a value of 100 indicating complete wakefulness, and a value of 40-60 taken to indicate an appropriate level of general anesthesia.
Measured: Through study completion, an average of 1 day
Secondary outcomes (2)
Mean time from initiation of drug administration to MOAA/S (Modified Observer's Assessment of Alertness/Sedation) score ≤1
Sedation was assessed using the MOAA/S (Modified Observer's Assessment of Alertness/Sedation) scale. It ranges from 5(alert) to 0(deep sedation). The mean time from drug administration to MOAA/S score ≤1 was recorded.
Measured: Through study completion, an average of 1 day
The average time from drug withdrawal to full recovery
Sedation was assessed using the MOAA/S (Modified Observer's Assessment of Alertness/Sedation) scale. It ranges from 5(alert) to 0(deep sedation). The mean time from drug withdrawal to MOAA/S score = 5 was recorded
Measured: Through study completion, an average of 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2024
- Study start15 Aug 2024 (estimated)
- Primary completion17 Aug 2024 (estimated)
- Study completion15 Aug 2025 (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.
- 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Chao Yang Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06427785
- Sponsor's protocol ID
- 2024-ke-75
- Status last verified
- Apr 2024
- First submitted
- 11 Apr 2024
- Last updated
- 25 Jun 2024
- 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 25 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Wavelet Index in Monitoring the Sedation Depth of Remimazolam Besylate
- ClinicalTrials.gov ID
- NCT06427785
- Acronym / sponsor ID
- 2024-ke-75
- Keywords
- Wavelet Index, Remimazolam, Depth of Sedation
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Beijing Chao Yang HospitalUniversity, hospital or other
- Study start
- 15 Aug 2024 (estimated)
- Primary completion
- 17 Aug 2024 (estimated)
- Study completion
- 15 Aug 2025 (estimated)
- First posted
- 24 May 2024 (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.
To explore the sedative effect of remimazolam in patients undergoing spinal anesthesia without pain stimulation. Both the Modified Observer's Assessment of Alertness/Sedation (MOAA/S) and the Wavelet index (WLi) were used to monitor the depth of anesthesia of remimazolam, and exploring the correlation and consistency between MOAA/S score and WLi value at the same time.
Detailed description
Patients undergoing spinal anesthesia were received remimazolam besylate for sedation continuously. Both the Modified Observer's Assessment of Alertness/Sedation (MOAA/S) and the Wavelet index (WLi) were used to monitor the depth of anesthesia of remimazolam, and exploring the correlation and consistency between MOAA/S score and WLi value at the same time.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Remimazolam group | – | Drug: Remimazolam besylateThirty patients underwent elective lower extremity surgery receive spinal anesthesia, and then, remimazolam besylate was given intravenously with an induction dose of 3mg/min. When the MOAA/S (Modified Observer's Assessment of Alertness/Sedation) score was ≤1, remimazolam besylate was maintained at 1mg/min for 24min, and finally stopped. Wavelet index, MOAA/S score, blood pressure, heart rate, respiratory rate, and pulse oxygen saturation were continuously monitored during the period. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This was an unrandomized, single-group study. The sample size was calculated using PASS 15™(NCSS, LLC. Kaysville, Utah, USA.) software. The degree of confidence (1-β) was set at 0.90, and the α value was set at 0.05. ρ0, the baseline correlation, was set to 0. The ρ1, alternating correlation, was set to 0.3 based on the expected minimum r value of 0.3 obtained in previous literature. Final calculations show that 112 pairs of data were needed to complete the experiments. Approximately 20 pairs of data were expected to be recorded per participant, and 30 participants were expected to be enrolled in this study. So, the sample size was adequate.
Key inclusion criteria (4 listed)
- ASA was classified as I-III
- The operation time was less than 120 minutes
- Informed consent is signed by all study participants
- Elective lower extremity surgery under spinal anesthesia was performed
Key exclusion criteria (8 listed)
- Pregnant or lactating women
- Patients with Difficult Airways
- History of severe neurological and muscular diseases and mental retardation
- Patients with severe respiratory and circulatory diseases, including acute heart failure. Unstable angina pectoris. Resting ECG heart rate <50 beats/min. QTc: ≥470ms in men and ≥480ms in women. Third degree atrioventricular block. Severe arrhythmia. Moderate to severe heart valve disease. Chronic obstructive pulmonary disease. A history of severe asthma.
- Abnormal liver and kidney function: ALT and/or AST exceeding 2.5 times the upper limit of the medical reference range
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 |
|---|---|---|
| Remimazolam besylateThirty patients underwent elective lower extremity surgery receive spinal anesthesia, and then remimazolam besylate was given intravenously with an induction dose of 3mg/min. When the MOAA/S (Modified Observer's Assessment of Alertness/Sedation) score was ≤1, remimazolam besylate was maintained at 1mg/min for 24min, and finally stopped. Wavelet index, MOAA/S score, blood pressure, heart rate, respiratory rate, and pulse oxygen saturation were continuously monitored during the period. | Drug | Remimazolam group |
Primary outcome
The value of the Wavelet index (WLi) when MOAA/S (Modified Observer's Assessment of Alertness/Sedation) score ≤ 1.
Time frame: Through study completion, an average of 1 day
Sedation was assessed using the MOAA/S (Modified Observer's Assessment of Alertness/Sedation) scale. It ranges from 5(alert) to 0(deep sedation). Wavelet index (WLi) is a parameter that potentially could be used to regulate the sedative depth of anesthesia. The range of WLi values is 0-100, with a value of 0 indicating no EEG activity, a value of 100 indicating complete wakefulness, and a value of 40-60 taken to indicate an appropriate level of general anesthesia.
2 secondary outcomes
Mean time from initiation of drug administration to MOAA/S (Modified Observer's Assessment of Alertness/Sedation) score ≤1
Time frame: Through study completion, an average of 1 day
The average time from drug withdrawal to full recovery
Time frame: Through study completion, an average of 1 day
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2024.
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Remimazolam and Anesthesia Awareness, 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 8 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 25 Jun 2024. 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 Anshi Wu, doctor (010-85231330, wuanshi88@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The value of the Wavelet index (WLi) when MOAA/S (Modified Observer's Assessment of Alertness/Sedation) score ≤ 1. (time frame: Through study completion, an average of 1 day). 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 25 Jun 2024.