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

Not Applicable

Completed

• Conditions: Postoperative Delirium
• Interventions: Drug: remazolam; Drug: Propofol; Drug: Midazolam

• Registration Number: NCT05466279
• Lead Sponsor: Fang Jun

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-01-07
• Study First Submitted: 2022-07-13
• Study First Submitted QC: 2022-07-17
• Study First Posted: 2022-07-20
• Primary Completion: 2023-10-30
• Study Completion: 2023-10-30
• Status Verified: 2024-01
• Last Update Submitted: 2024-01-24
• Last Update Posted: 2024-01-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 131

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Remazolam general anesthesia group (R group)	remazolam	-
Propofol + midazolam general anesthesia control group (group P)	Propofol	-
Propofol + midazolam general anesthesia control group (group P)	Midazolam	-

Primary Outcome Measures

Name	Time	Method
Incidence of postoperative delirium	Postoperative, 7 days	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.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Zhejiang Cancer Hospital; 🇨🇳 Hanzhou, China