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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

131 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-01-07

Study Completion Date

2023-10-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Effect of Remimazolam on Postoperative Delirium

NCT06180876

General Anesthetic Drug Adverse Reaction

RECRUITING NA

Clinical Application Value of Remazolam Combined With Sugammadex Sodium in Anesthesia for Endotracheal Surgery Under Bronchoscopy

NCT05468671

Endobronchial Metastases Bronchoesophageal Fistula General Anesthetic Drug Adverse Reaction

COMPLETED PHASE4

Impact of Remimazolam on Prognosis After Bladder Cancer Surgery

NCT04532606

Benzodiazepines Bladder Cancer Delirium +2 more

RECRUITING PHASE4

Comparison of Postoperative Delirium in Elders Anaesthetised With Midazolam and Without Midazolam

NCT05456230

Postoperative Delirium

COMPLETED

Remifentanil and Midazolam on Propofol for Loss of Consciousness in Elderly Patients

NCT02818387

Anesthesia

UNKNOWN NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Postoperative Delirium

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Remazolam general anesthesia group (R group)

Group Type EXPERIMENTAL

remazolam

Intervention Type DRUG

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

Propofol + midazolam general anesthesia control group (group P)

Group Type ACTIVE_COMPARATOR

Propofol

Intervention Type 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

Midazolam

Intervention Type 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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

remazolam

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

Intervention Type DRUG

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

Intervention Type DRUG

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

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No