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

Capital Medical University

Status: Not yet enrolling

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

Treatments: Drug: Remimazolam besylate

Study type: Observational

Funder types: Other

Identifiers

NCT06427785

2024-ke-75

Details and patient eligibility

About

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.

Full 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.

Enrollment: 30 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

30 participants in 1 patient group

Remimazolam group

Description:

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.

Treatment:

Drug: Remimazolam besylate