Anesthesia, Cerebrovascular Disorders
Conditions
Keywords
propofol, Remimazolam, Endovascular Procedures
Brief summary
Remimazolam, a novel ultra-short acting benzodiazepine that combined the advantages of midazolam and remifentanil, has been developed for procedural sedation, induction and maintenance of general anesthesia, and sedation in the ICU. Previous studies have suggested that efficacy and safety of remimazolam are not inferior to propofol or midazolam in patients undergoing colonoscopy,bronchoscopy and some other treatments. However, the efficacy and potential adverse effects of remimazolam on patients undergoing endovascular procedures of cerebrovascular disorders is still unclear. In this study, we tend to conduct a single-center, randomized, single-blind ,non-inferiority trial to compare the efficacy and safety of remimazolam and propofol in endovascular procedures of cerebrovascular disorders.
Interventions
DRUGremimazolam
Remimazolam will be administered during induction and maintenance for general anesthesia.
DRUGpropofol
Propofol will be administered during induction and maintenance for general anesthesia.
Sponsors
Air Force Military Medical University, China
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Masking description
Randomization is done by an investigator who is not involved in anesthesia and outcome assessment. Participants are unaware of the group allocation. Due to the different color of remimazolam and propofol, the care provider is not blinded to the group allocation. At the end of the surgery, anesthetics are removed before outcome assessment. And the outcome assessor is blinded to the grouping.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. aged 18 years or older 2. scheduled for interventional neurosurgery of cerebrovascular disorders under general anesthesia
Exclusion criteria
1. American Society of Anesthesiologists class Ⅲ or higher 2. Hunt-Hess class Ⅲ or higher 3. body mass index (BMI) \< 18 kg/㎡ or \> 30kg/㎡ 4. large or giant cerebral aneurysms with diameters greater than 15mm and minor cerebral aneurysms with diameters less than 3mm 5. posterior circulation infarction 6. recurrence of an cerebral aneurysms after endovascular procedures or surgical clipping 7. severe abnormal coagulation function, severe liver and kidney function damage, or combined with heart and respiratory system failure 8. be allergic or likely to be allergic to the study drugs 9. participate in other clinical researchers within 3 months 10. history of neurological or psychiatric diseases 11. existed or suspected abuse of drug or alcohol 12. use of sedative or analgesics before surgery 13. patients with difficulty in communication
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| time to open eye | from the stop of trial drugs to open eye to verbal command, at an average of 15 minutes |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| time to recovery of spontaneous breathing | from end of giving trial drugs to recovery of spontaneous breathing ,at an average of 20 minutes | — |
| time to endotracheal tube extubation | from end of giving trial drugs to removing endotracheal tube ,at an average of 25 minutes | — |
| time to orientation | from end of giving trial drugs to recovery of orientation to name, location or date ,at an average of 30 minutes | — |
| the dosages of vasoactive drugs during surgery | from initial administration of trial drugs to end of surgery, at an average of 3 hours | — |
| Number of episodes of hypotension during surgery | from initial administration of trial drugs to end of surgery, at an average of 3 hours | Hypotension is defined as decrease of mean arterial pressure more than 20% of the baseline, persisting longer than 1 minute |
| Number of episodes of hypertension during surgery | from initial administration of trial drugs to end of surgery, at an average of 3 hours | Hypertension is defined as increase of mean arterial pressure more than 20% of the baseline, persisting longer than 1 minute |
| the level of lactic acid of arterial blood | at the end of the surgery | — |
| time to loss of consciousness | from initial administration of trial drugs to loss of response to verbal command, at an average of 5 minutes | — |
| Renkin's Score at 30 days and three months after surgery | 30 days and three months after surgery | — |
| Glasgow outcome Score at discharge | at discharge, approximately 3 days after surgery | — |
| length of postoperative ICU stay and hospital stay | from entering the ICU to leaving the ICU and from admission to discharge, approximately 3 days | — |
| the incidence of major complications during postoperative hospitalization | from the end of surgery to discharge, approximately 3 days | — |
| the incidence of delirium during emergence | from end of surgery to 30 minutes after extubation | — |
| the incidence of delirium within 3 days after surgery | from end of surgery to 3 days after surgery | — |
| the level of serum interleukin-6, tumor necrosis factor-α and S100β | at the end of the surgery | — |
| The highest Richmond Agitation and Sedation Score during emergence | from end of the surgery to 30 minutes after extubation, approximately 50 minutes | — |
Countries
China
Outcome results
None listed