Clinical trial NCT05466279: The Role of Remazolam in Reducing the Incidence of Postoperative Delirium in Elderly Patients
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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Postoperative Delirium
Lead sponsor: Zhejiang Cancer Hospital
Sponsor class: OTHER
First posted: 2022-07-20
Enrollment: 131
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility criteria: 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

Primary outcomes:
measure: Incidence of postoperative delirium
timeFrame: Postoperative, 7 days
Secondary outcomes:
measure: Intraoperative awareness rate
timeFrame: Postoperative, 24 hours
measure: Intraoperative hemodynamic stability
timeFrame: Intraoperative, 6 hours
measure: Richard-campbell Sleep Questionnaire Score
timeFrame: Postoperative, 3 days
measure: Perioperative nutritional status score table(PONS)
timeFrame: Baseline, 1 year
measure: Modified frailty rating scale
timeFrame: Baseline, 1 year
measure: Postoperative hospital stay
timeFrame: Postoperative, 3 months
measure: Postoperative nausea and vomiting
timeFrame: Postoperative, 7 days
Other outcomes:
Locations:
city: Hanzhou
country: China
facility: Zhejiang Cancer Hospital
Study officials:
References: