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

NCT06427785 | Not Yet Recruiting

• 1 other identifier: 2024-ke-75
• Study Type: observational
• Target: 30
• Locations: 0 countries
• Sites: N/A

Brief 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 between MOAA/S score and WLi value at the same time.

Conditions

Remimazolam; Anesthesia Awareness; Sedative, Hypnotic, or Anxiolytic Withdrawal

Keywords

Wavelet Index; Remimazolam; Depth of Sedation

Outcome Measures

Primary Outcomes (1)

• 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.

  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

  Through study completion, an average of 1 day

• The average time from drug withdrawal to full recovery

  Through study completion, an average of 1 day

Study Arms (1)

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

Interventions

Remimazolam besylate DRUG

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.

Remimazolam group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Beijing Chao Yang Hospital: lead

MeSH Terms

Conditions

Intraoperative Awareness

Condition Hierarchy (Ancestors)

Intraoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Anshi Wu, doctor

CONTACT

010-85231330; wuanshi88@163.com

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 11, 2024
• First Posted: May 24, 2024
• Study Start: August 15, 2024
• Primary Completion: August 17, 2024
• Study Completion: August 15, 2025
• Last Updated: June 25, 2024

Record last verified: 2024-04