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

Remimazolam Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06427785
• Other study ID #: 2024-ke-75
• Status: Not yet recruiting
• Start date: May 15, 2024
• Est. completion date: May 15, 2025

Study information

• Verified date: April 2024
• Source: Beijing Chao Yang Hospital
• Contact: Anshi Wu, doctor
• Phone: 010-85231330
• Email: wuanshi88[@]163.com
• Is FDA regulated: No
• Study type: Observational

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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: May 15, 2025
• Est. primary completion date: May 17, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Anesthesia Awareness
• Intraoperative Awareness
• Remimazolam

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Beijing Chao Yang Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.	Through study completion, an average of 1 day
Secondary	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	Through study completion, an average of 1 day