Clinical trial · Interventional
The Role of Remazolam in Reducing the Incidence of Postoperative Delirium in Elderly Patients
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.
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Postoperative Delirium | — | UNRESOLVED | — |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Midazolam | Drug | — | UNRESOLVED |
| Propofol | Drug | — | UNRESOLVED |
| remazolam | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Remazolam general anesthesia group (R group)
- interventionNames
- Drug: remazolam
- type
- ACTIVE_COMPARATOR
- label
- Propofol + midazolam general anesthesia control group (group P)
- interventionNames
- Drug: Propofol
- Drug: Midazolam
Primary outcomes (1)
- measure
- Incidence of postoperative delirium
- timeFrame
- Postoperative, 7 days
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 65 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available