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Effects of electroencephalography-guided remimazolam vs propofol total intravenous anesthesia on perioperative neurocognitive disorders among patients undergoing major non-cardiac surgery (RAPID)

Effects of electroencephalography-guided remimazolam vs propofol total intravenous anesthesia on perioperative neurocognitive disorders among patients undergoing major non-cardiac surgery (RAPID)

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300078307
Enrollment
Unknown
Registered
2023-12-05
Start date
2023-12-05
Completion date
Unknown
Last updated
2024-07-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

perioperative neurocognitive disorders

Interventions

remimazolam Group :Remazolam 6 to 12 mg/kg/h was used for anesthesia induction until loss of consciousness and remazolam 1.0 to 2.0 mg/kg/h for anesthesia maintenance
propofol group:Propofol (1-2 mg/kg) was used for anesthesia induction until loss of consciousness and propofol (4-12 mg/kg/h) was used for anesthesia maintenance.

Sponsors

The Second Affiliated Hospital of Army Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
60 Years to No maximum

Inclusion criteria

Inclusion criteria: 1) Age= 60 2) Undergoing elective major surgery under general anesthesia under general anaesthesia with tracheal intubation(expected surgery time >2 h, expected length of postoperative stay >2 d); 3) ASA ?-?

Exclusion criteria

Exclusion criteria: 1) A history of psychiatric disorders (including preoperative delirium) or treatment with antipsychotics (chlorpromazine, haloperidol, clozapine, risperidone, olanzapine, quetiapine, etc., typical and atypical antipsychotics); 2) Preoperative Cognitive impairment determined by MMSE score; 3) Severe functional impairment of the auditory, visual, and speech systems; 4) Postoperative coma or seizures; 5) Severe hepatic and renal diseases (Child C or need for Preoperative Dialysis ); 6) Suspicion/evidence of narcotic sedative analgesic abuse or chronic use; 7) Difficult airway requiring awake intubation or adiagnosis of moderate to severe OSAS 8) Planned postoperative prolonged airway protection or need for mechanical ventilation 9) Allergic or contraindication to anaesthetics; 10) Recovering alcoholic; 11) Requirement for reoperation within 5 days after the first surgery;

Design outcomes

Primary

MeasureTime frame
Postoperative delirium;

Secondary

MeasureTime frame
Postoperative delirium severity;Duration of postoperative delirium;Delayed neurocognitive recovery;Postoperative neurocognitive disorder; emergence delirium;activity of daily living;Quality of Life;Quality of recovery;Length of ICU stay;Length of hospital stay;Postoperative pain score;

Countries

China

Contacts

Public ContactLi Hong

The Second Affiliated Hospital of Army Medical University

472151685@qq.com+86 23 6877 4983

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026