## Protocol Section
### Identification Module
**NCT ID:** NCT06427785

**Brief Title:** The Effect of Wavelet Index in Monitoring the Sedation Depth of Remimazolam Besylate

**Official Title:** The Effect of Wavelet Index in Monitoring the Sedation Depth of Remimazolam Besylate

#### Organization Study ID Info
**ID:** 2024-ke-75
#### Organization
**Class:** OTHER
**Full Name:** Beijing Chao Yang Hospital
### Status Module
#### Completion Date
**Date:** 2025-05-15

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-24

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-22

**Overall Status:** NOT_YET_RECRUITING

#### Primary Completion Date
**Date:** 2024-05-17

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-05-15

**Type:** ESTIMATED

**Status Verified Date:** 2024-04

#### Study First Post Date
**Date:** 2024-05-24
**Type:** ACTUAL
**Study First Submit Date:** 2024-04-11
**Study First Submit QC Date:** 2024-05-22
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Beijing Chao Yang Hospital

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

### Description Module

**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.

**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.

### Conditions Module

**Conditions:**

- Remimazolam

- Anesthesia Awareness

- Sedative, Hypnotic, or Anxiolytic Withdrawal

**Keywords:**

- Wavelet Index

- Remimazolam

- Depth of Sedation

### Design Module

#### Design Info

**Observational Model:** CASE_ONLY

**Time Perspective:** PROSPECTIVE

#### Enrollment Info

**Count:** 30

**Type:** ESTIMATED

**Study Type:** OBSERVATIONAL

### Arms Interventions Module

#### Arm Group 1

**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.

**Intervention Names:**

- Drug: Remimazolam besylate

**Label:** Remimazolam group

### Interventions

#### Intervention 1

**Arm Group Labels:**

- 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.

**Name:** Remimazolam besylate

**Type:** DRUG

### Outcomes Module

#### Primary Outcomes

**Description:** 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.

**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

#### Secondary Outcomes

**Description:** 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.

**Measure:** 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

**Description:** 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

**Measure:** The average time from drug withdrawal to full recovery

**Time Frame:** Through study completion, an average of 1 day

### Eligibility Module

**Eligibility Criteria:** 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

**Maximum Age:** 65 Years

**Minimum Age:** 18 Years

**Sampling Method:** PROBABILITY_SAMPLE

**Sex:** ALL

**Standard Ages:**

- 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.

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** wuanshi88@163.com

**Name:** Anshi Wu, doctor

**Phone:** 010-85231330

**Role:** CONTACT

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000007431

- Term: Intraoperative Complications

- ID: D000010335

- Term: Pathologic Processes

### Condition Browse Module - Browse Branches

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: All

- Name: All Conditions

### Condition Browse Module - Browse Leaves

- ID: M29299

- Name: Intraoperative Awareness

- Relevance: HIGH

- As Found: Anesthesia Awareness

- ID: M10465

- Name: Intraoperative Complications

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000058926

- Term: Intraoperative Awareness

### Intervention Browse Module - Browse Branches

- Abbrev: CNSDep

- Name: Central Nervous System Depressants

- Abbrev: All

- Name: All Drugs and Chemicals

### Intervention Browse Module - Browse Leaves

- ID: M4107

- Name: Anesthetics

- Relevance: LOW

- As Found: Unknown

### Misc Info Module

- Version Holder: 2024-05-31
