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

Postoperative Delirium Clinical Trial

Official title:

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05466279
• Other study ID #: IRB-2020-344
• Status: Completed
• Phase: N/A
• Start date: January 7, 2021
• Est. completion date: October 30, 2023

Study information

• Verified date: January 2024
• Source: Zhejiang Cancer Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 131
• Est. completion date: October 30, 2023
• Est. primary completion date: October 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Delirium
• Emergence Delirium
• Postoperative Delirium

Intervention

Drug:
• remazolam
Remimazolam is a new drug innovation in anesthesia. It combines the properties of two unique drugs already established in anesthesia - Midazolam and remifentanil.
• Propofol
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
• Midazolam
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

Locations

Country	Name	City	State
China	Zhejiang Cancer Hospital	Hanzhou

Sponsors (1)

Lead Sponsor	Collaborator
Fang Jun

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Intraoperative awareness rate	The modified Brice interview over quality assurance techniques in detecting intraoperative awareness with explicit recall.	Postoperative, 24 hours
Secondary	Intraoperative hemodynamic stability	The change curve of intraoperative mean arterial blood pressure and heart rate	Intraoperative, 6 hours
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Postoperative nausea and vomiting	The proportion of patients with nausea and vomiting within 7 days after surgery	Postoperative, 7 days