The Role of Remazolam in Reducing the Incidence of Postoperative Delirium in Elderly Patients

Study Overview
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Brief Summary
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This study is a prospective, randomized, controlled trial.The selected patients were randomly divided into remazolam general anesthesia group and propofol + midazolam general anesthesia control group according to computer randomization method. There were 65 patients in each group. Remazolam general anesthesia group (R group): Remazolam 0.4 mg/kg for rapid induction of loss of consciousness for anesthesia induction and 1 mg/kg/h for maintenance. Propofol + midazolam general anesthesia control group (group P): propofol 1.5 mg/kg + midazolam 0.05 mg/kg slow intravenous push until the patient's consciousness disappeared, then propofol 4-8 mg/kg/h Anesthesia was maintained. Except for different sedative drugs, the analgesic and muscle relaxant medication regimens were the same between the two groups. In the study, the application of inhaled anesthetics, other benzodiazepines and anticholinergic drugs was restricted, and the mean arterial pressure during the operation was kept above 60 mmHg to avoid perioperative hypotension, hypoxemia, and hypercapnia. Warm measures were used to maintain the patient's intraoperative body temperature above 36.0 °C. POD assessment was performed on the day before surgery and on days 1-7 after surgery.

Official Title
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Department of Anesthesiology, Cancer Hospital of the University of Chinese Academy of Sciences（Zhejiang Cancer Hospital), Research Center for Neuro-Oncology Interaction , Institute of Basic Medicine and Cancer, Chinese Academy of Sciences.

Conditions
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Postoperative Delirium

Intervention / Treatment
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* Drug: remazolam
* Drug: Propofol
* Drug: Midazolam


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Elderly patients with limited abdominal tumor surgery (age ≥65 years) ASA classification I-III. Exclusion Criteria: Refusing to participate in the study Patients with severe arrhythmia or cardiac dysfunction (EF<35%) A clear history of neurological and psychiatric disorders before surgery or long-term use of sedatives or antidepressants History of alcoholism or drug dependence History of brain surgery or trauma Severe vision or hearing impairment Inability to cooperate with the completion of cognitive function tests

Ages Eligible for Study
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Minimum Age: 65 Years

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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Remazolam general anesthesia group (R group)<br> | Drug: remazolam<br>* Remimazolam is a new drug innovation in anesthesia. It combines the properties of two unique drugs already established in anesthesia - Midazolam and remifentanil.<br>|
| Active Comparator: Propofol + midazolam general anesthesia control group (group P)<br> | Drug: Propofol<br>* Propofol (2,6-diisopropylphenol) is a hypnotic agent that is used as an induction agent and as a maintenance anaesthetic delivered by continuous i.v. infusion or intermittent i.v. bolus<br>Drug: Midazolam<br>* Midazolam, like diazepam, is a benzodiazepine anxiolytic drug, which is used to treat anxiety, but its t ½ is much shorter or only about 2 h compared with 43 h for diazepam<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of postoperative delirium | Proportion of patients with postoperative delirium among enrolled patients. The incidence of delirium during recovery was assessed by the Confusion Assessment Method-ICU (CAM-ICU). The assessment time points were: 10 minutes, 30 minutes after entering the anesthesia recovery room (or exiting the recovery room). The incidence of delirium within 7 days after surgery was assessed using 3D-CAM to assess whether patients had delirium. | Postoperative, 7 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intraoperative awareness rate | The modified Brice interview over quality assurance techniques in detecting intraoperative awareness with explicit recall. | Postoperative, 24 hours | 
| Intraoperative hemodynamic stability | The change curve of intraoperative mean arterial blood pressure and heart rate | Intraoperative, 6 hours | 
| Richard-campbell Sleep Questionnaire Score | Richards-Campbell Sleep Questionnaire (RCSQ) is a five-item、 visual analogue scale was designed for assessing sleep quality of patients | Postoperative, 3 days | 
| Perioperative nutritional status score table(PONS) | Perioperative Nutrition Screen (PONS). This algorithmic approach is used to identify perioperative malnutrition risk and guide perioperative nutrition intervention. BMI, body mass index | Baseline, 1 year | 
| Modified frailty rating scale | Modified Frailty Index Frailty index is an important predictive variable in emergency general surgery patients older than 60 years. The modified frailty index can be used to evaluate risk of both morbidity and mortality in these patients. | Baseline, 1 year | 
| Postoperative hospital stay | Taking the operation day as the starting point, calculating the length of stay in the hospital after the operation | Postoperative, 3 months | 
| Postoperative nausea and vomiting | The proportion of patients with nausea and vomiting within 7 days after surgery | Postoperative, 7 days |