The Effect of Wavelet Index in Monitoring the Sedation Depth of Remimazolam Besylate

June 24, 2024 updated by: Beijing Chao Yang Hospital
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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Estimated)

30

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

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.

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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.
Drug: Remimazolam besylate
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Through study completion, an average of 1 day

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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.
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
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
Through study completion, an average of 1 day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Beijing Chao Yang Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

August 15, 2024

Primary Completion (Estimated)

August 17, 2024

Study Completion (Estimated)

August 15, 2025

Study Registration Dates

First Submitted

April 11, 2024

First Submitted That Met QC Criteria

May 22, 2024

First Posted (Actual)

May 24, 2024

Study Record Updates

Last Update Posted (Actual)

June 25, 2024

Last Update Submitted That Met QC Criteria

June 24, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2024-ke-75

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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