General Anesthetic Drug Adverse Reaction
Conditions
Keywords
general anesthesia, elderly patients, remimazolam, propofol
Brief summary
Remimazolam is a novel benzodiazepine with ultra-short onset and offset of its effect. It can be used for general anesthesia. However, classical benzodiazepine such as midazolam was reported to increase the risk of postoperative delirium. Thus, the investigators aim to investigate the effect of remimazolam general anesthesia on postoperative delirium in elderly patients.
Interventions
DRUGremimazolam
continuous infusion
DRUGpropofol
continuous infusion
Sponsors
Zhihong LU
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
60 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age ≥60 years * patients scheduled for elective surgery under general anesthesia
Exclusion criteria
* American Society of Anesthesiologists status ≥Ⅳ * history of neurologic or psychiatric diseases * difficulty in communication * abuse of drug or alcohol * suspected allergy to propofol or benzodiazepines * significant cardiac, pulmonary, hepatic, or renal dysfunction
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| incidence of delirium by 3 days after surgery | from end of surgery to 3 days after surgery, in a total of 3 days |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| incidence of delirium by 30 minutes after extubation (emergence delirium) | from extubation of tracheal tube to 30 minutes after extubation, in a total of 30 minutes | — |
| incidence of delirium by 1 day after surgery | from end of surgery to 1 day after surgery, in a total of 1 day | — |
| time to eye opening | from end of surgery to open eye response to verbal command, in an average of 10 minutes | — |
| time to orientation | from end of surgery to being able to speak out name in an average of 10 minutes | — |
| incidence of hypotension during surgery | from start of anesthesia induction to extubation, in an average of 2 hours | hypotension is defined as systolic blood pressure decreasing by more than 20% of baseline value |
| dosage of vasoactive drugs during surgery | from start of anesthesia induction to extubation, in an average of 2 hours | vasoactive drugs refer to norepinephrine and epinephrine |
| Duration of sleep on the first night after surgery | from end of surgery to 24 hours after surgery, in a total of 24 hours | sleep is monitored by a wrist acti-graphy |
| the visual analogue scale of sleep on the next day after surgery | from end of surgery to 24 hours after surgery, in a total of 24 hours | 0 is the worst quality of sleep, 10 is the best quality of sleep |
| the Athens Insomnia scale (AIS) of sleep on the next day after surgery | from end of surgery to 24 hours after surgery, in a total of 24 hours | The AIS is a self-reported questionnaire designed to quantify sleep difficulty based on ICD-10 diagnostic criteria. It consists of 8 items rated on a 4-point scale (0 = no problem, 3 = severe problem), yielding a total score ranging from 0 to 24. A cutoff score of 6 provides optimal sensitivity and specificity for screening insomnia. |
| the time to onset of delirium | from end of surgery to onset of delirium, in an average of 1 days | — |
| the duration of delirium | from onset of delirium to the last day of delirium, in an average of 3 days | the time between the first and last delirium-positive days |
Countries
China
Outcome results
None listed