Effect of Remimazolam Use During Perioperative Period on Brain Waves and Postoperative Recovery Indicators

Study Overview
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Brief Summary
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Benzodiazepine sedative hypnotics are commonly used intravenous anesthetics in clinical practice. Remimazolam is a new benzodiazepine with the characteristics of rapid onset, short maintenance and recovery time, no accumulation, metabolism independent of liver and kidney function, and no serious side effects, which has a good prospect for clinical application. Now we will study the emotional response caused by remimazolam during induction of general anesthesia and the postoperative recovery indicators, in order to further understand the clinical application of remimazolam.

Official Title
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Effect of Remimazolam Use During Perioperative Period on Brain Waves and Postoperative Recovery Indicators

Conditions
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Benzodiazepine

Intervention / Treatment
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* Drug: Remimazolam with a dose of 0.05mg/kg for induction of general anesthesia
* Drug: Remimazolam with a dose of 0.1mg/kg for induction of general anesthesia
* Drug: Remimazolam with a dose of 0.2mg/kg for induction of general anesthesia
* Drug: midazolam with a dose of 0.05mg/kg for induction of general anesthesia


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: ASAⅠ-Ⅱ Patients undergoing elective surgery under general anesthesia. Age, sex, and weight were not limited. Exclusion Criteria: Allergic or contraindication to remimazolam/midazolam/remifentanil; Abnormal liver and kidney function; Alcohol abuse; Long-term use of sedative, analgesic or anxiolytic drugs; Hearing and language communication disorders; Complicated with severe cardiovascular lesions or neurological diseases.
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Remimazolam 1<br> | Drug: Remimazolam with a dose of 0.05mg/kg for induction of general anesthesia<br>* Remimazolam with a dose of 0.05mg/kg for induction of general anesthesia<br>|
| Experimental: Remimazolam 2<br> | Drug: Remimazolam with a dose of 0.1mg/kg for induction of general anesthesia<br>* Remimazolam with a dose of 0.1mg/kg for induction of general anesthesia<br>|
| Experimental: Remimazolam 3<br> | Drug: Remimazolam with a dose of 0.2mg/kg for induction of general anesthesia<br>* Remimazolam with a dose of 0.2mg/kg for induction of general anesthesia<br>|
| Other: Control<br> | Drug: midazolam with a dose of 0.05mg/kg for induction of general anesthesia<br>* midazolam with a dose of 0.05mg/kg for induction of general anesthesia<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in the level of Systolic Blood Pressure/Diastolic Blood Pressure(Mean Arterial Pressure) | All the outcomes above should be measured at the time before surgery，the above indicators were measured every minute within five minutes after the injection of Remimazolam, the time of intubation, the time of extubation, and every minute within five minutes after extubation, one hour after turn into Postanesthesia care unit. | before surgery, the time of intubation, the time of extubation, 1min,2min, 3min, 4min, 5min after intubation, 1min,2min, 3min, 4min, 5min after extubation, one hour after turn into Postanesthesia care unit. | 
| Changes in the level of Heart Rate | The outcome above should be measured at the time before surgery，the above indicators were measured every minute within five minutes after the injection of Remimazolam, the time of intubation, the time of extubation, and every minute within five minutes after extubation, one hour after turn into PACU. | before surgery, the time of intubation, the time of extubation, 1min,2min, 3min, 4min, 5min after intubation, 1min,2min, 3min, 4min, 5min after extubation, one hour after turn into Postanesthesia care unit. | 
| Changes in brain waves during general anesthesia | The outcome above should be measured at the time after induction of general anesthesia | before surgery, the time of intubation, the time of extubation, 1min,2min, 3min, 4min, 5min after intubation, 1min,2min, 3min, 4min, 5min after extubation, one hour after turn into Postanesthesia care unit. | 
| Changes in the value and waveform of Narcotrend | The outcome above should be measured at the time before surgery，the above indicators were measured every minute within five minutes after the injection of Remimazolam, the time of intubation, the time of extubation, and every minute within five minutes after extubation, one hour after turn into PACU. | before surgery, the time of intubation, the time of extubation, 1min,2min, 3min, 4min, 5min after intubation, 1min,2min, 3min, 4min, 5min after extubation, one hour after turn into Postanesthesia care unit. | 
| Changes in the score of Modified Observer's Assessment of Alertness/Sedation | The outcome above should be measured at the time before surgery，the above indicators were measured every minute within five minutes after the injection of Remimazolam, the time of intubation, the time of extubation, and every minute within five minutes after extubation, one hour after turn into PACU. the score of 6 was Agitated the score of 5 was Responds readily to name spoken in normal tone the score of 4 was Lethargic response to name spoken in normal tone the score of 3 was Responds only after name is called loudly and/or repeatedly the score of 2 was Responds only after mild prodding or shaking the score of 1 was Does not respond to mild prodding or shaking the score of 0 was Does not respond to deep stimulus | before surgery, the time of intubation, the time of extubation, 1min,2min, 3min, 4min, 5min after intubation, 1min,2min, 3min, 4min, 5min after extubation, one hour after turn into Postanesthesia care unit. | 
| Changes in the score of MMSE | The outcome above should be measured the day before surgery and 1,2,3,5,7 days after surgery | The outcome above should be measured the day before surgery and 1,2,3,5,7 days after surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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remimazolam, recovery