An interventional study of remazolam and Propofol in Postoperative Delirium, sponsored by Fang Jun. Completed at 1 site in China. Open to participants aged 65 Years and older. Per ClinicalTrials.gov, last updated 2024-01-25.
Sponsored by Fang Jun · Not applicable, Interventional, and Prevention
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.
1,057 studies on the registry are indexed under Delirium; 238 are open to participants now.
This study's enrollment of 131 is close to the median of 120 across 599 interventional studies indexed under Delirium.
Browse Delirium studies →This is the only study on the registry with Fang Jun as lead sponsor.
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Exclusion Criteria:
Drug: remazolam
Drug: Propofol · Drug: Midazolam
Remimazolam is a new drug innovation in anesthesia. It combines the properties of two unique drugs already established in anesthesia - Midazolam and remifentanil.
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, 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
Incidence of postoperative delirium
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.
Time frame: Postoperative, 7 days
Intraoperative awareness rate
The modified Brice interview over quality assurance techniques in detecting intraoperative awareness with explicit recall.
Time frame: Postoperative, 24 hours
Intraoperative hemodynamic stability
The change curve of intraoperative mean arterial blood pressure and heart rate
Time frame: Intraoperative, 6 hours
Richard-campbell Sleep Questionnaire Score
Richards-Campbell Sleep Questionnaire (RCSQ) is a five-item、 visual analogue scale was designed for assessing sleep quality of patients
Time frame: Postoperative, 3 days
Perioperative nutritional status score table(PONS)
Perioperative Nutrition Screen (PONS). This algorithmic approach is used to identify perioperative malnutrition risk and guide perioperative nutrition intervention. BMI, body mass index
Time frame: Baseline, 1 year
Modified frailty rating scale
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.
Time frame: Baseline, 1 year
Postoperative hospital stay
Taking the operation day as the starting point, calculating the length of stay in the hospital after the operation
Time frame: Postoperative, 3 months
Postoperative nausea and vomiting
The proportion of patients with nausea and vomiting within 7 days after surgery
Time frame: Postoperative, 7 days
Plan to share: No
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This study is completed, as verified in Jan 2024. You cannot join it, but the record below documents what was studied.
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