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NCT Number: NCT05466279

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

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.

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Key information

Conditions

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

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Zhejiang Cancer Hospital

Hanzhou, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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

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

Primary outcomes

  1. Incidence of postoperative delirium

    Time frame: 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 outcomes

  1. Intraoperative awareness rate

    Time frame: Postoperative, 24 hours

    The modified Brice interview over quality assurance techniques in detecting intraoperative awareness with explicit recall.

  2. Intraoperative hemodynamic stability

    Time frame: Intraoperative, 6 hours

    The change curve of intraoperative mean arterial blood pressure and heart rate

  3. Richard-campbell Sleep Questionnaire Score

    Time frame: Postoperative, 3 days

    Richards-Campbell Sleep Questionnaire (RCSQ) is a five-item、 visual analogue scale was designed for assessing sleep quality of patients

  4. Perioperative nutritional status score table(PONS)

    Time frame: 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

  5. Modified frailty rating scale

    Time frame: 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.

  6. Postoperative hospital stay

    Time frame: Postoperative, 3 months

    Taking the operation day as the starting point, calculating the length of stay in the hospital after the operation

  7. Postoperative nausea and vomiting

    Time frame: Postoperative, 7 days

    The proportion of patients with nausea and vomiting within 7 days after surgery

Sponsors and collaborators

Lead sponsor

Fang Jun

Other

Registry information

Official study 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.

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Jul 20, 2022
Registry last updated
Jan 25, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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