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

NCT05466279 | Completed DMC

• 1 other identifier: IRB-2020-344
• Study Type: interventional
• Target: 131
• Locations: 1 country
• Sites: 1

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.

Conditions

Postoperative Delirium

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Intraoperative awareness rate

  Postoperative, 24 hours

• Intraoperative hemodynamic stability

  Intraoperative, 6 hours

• Richard-campbell Sleep Questionnaire Score

  Postoperative, 3 days

• Perioperative nutritional status score table(PONS)

  Baseline, 1 year

• Modified frailty rating scale

  Baseline, 1 year

Study Arms (2)

Remazolam general anesthesia group (R group)

EXPERIMENTAL

Drug: remazolam

Propofol + midazolam general anesthesia control group (group P)

ACTIVE COMPARATOR

Drug: Propofol; Drug: Midazolam

Interventions

remazolam DRUG

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

Remazolam general anesthesia group (R group)

Propofol DRUG

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

Propofol + midazolam general anesthesia control group (group P)

Midazolam DRUG

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

Propofol + midazolam general anesthesia control group (group P)

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• Elderly patients with limited abdominal tumor surgery (age ≥65 years)
• ASA classification I-III.

You may not qualify if:

• 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

Sponsors & Collaborators

• Fang Jun: lead

Study Sites (1)

Zhejiang Cancer Hospital

Hanzhou, China

Location

MeSH Terms

Conditions

Emergence Delirium

Interventions

Propofol; Midazolam

Condition Hierarchy (Ancestors)

Delirium; Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: July 13, 2022
• First Posted: July 20, 2022
• Study Start: January 7, 2021
• Primary Completion: October 30, 2023
• Study Completion: October 30, 2023
• Last Updated: January 25, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)