Postoperative Delirium
Conditions
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.
Interventions
DRUGremazolam
Remimazolam is a new drug innovation in anesthesia. It combines the properties of two unique drugs already established in anesthesia - Midazolam and remifentanil.
DRUGPropofol
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
DRUGMidazolam
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
Sponsors
Fang Jun
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of postoperative delirium | 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
| Measure | Time frame | Description |
|---|---|---|
| Intraoperative hemodynamic stability | Intraoperative, 6 hours | The change curve of intraoperative mean arterial blood pressure and heart rate |
| Richard-campbell Sleep Questionnaire Score | Postoperative, 3 days | Richards-Campbell Sleep Questionnaire (RCSQ) is a five-item、 visual analogue scale was designed for assessing sleep quality of patients |
| Perioperative nutritional status score table(PONS) | 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 |
| Intraoperative awareness rate | Postoperative, 24 hours | The modified Brice interview over quality assurance techniques in detecting intraoperative awareness with explicit recall. |
| Postoperative hospital stay | Postoperative, 3 months | Taking the operation day as the starting point, calculating the length of stay in the hospital after the operation |
| Postoperative nausea and vomiting | Postoperative, 7 days | The proportion of patients with nausea and vomiting within 7 days after surgery |
| Modified frailty rating scale | 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. |
Countries
China
Outcome results
None listed