Clinical trial NCT04950621: Remimazolam and Endovascular Procedures of Cerebrovascular Diseases
Official title: Comparison of Efficacy and Safety of Remimazolam and Propofol in Patients Undergoing Endovascular Procedures of Cerebrovascular Disorders: A Single-center,Randomized,Single-blind, Non-inferiority Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cerebrovascular Disorders
Anesthesia
Keywords: propofol
Remimazolam
Endovascular Procedures
Lead sponsor: Air Force Military Medical University, China
Sponsor class: OTHER
First posted: 2021-07-06
Enrollment: 142
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: time to open eye
timeFrame: from the stop of trial drugs to open eye to verbal command, at an average of 15 minutes
Secondary outcomes:
measure: time to loss of consciousness
timeFrame: from initial administration of trial drugs to loss of response to verbal command, at an average of 5 minutes
measure: time to recovery of spontaneous breathing
timeFrame: from end of giving trial drugs to recovery of spontaneous breathing ,at an average of 20 minutes
measure: time to endotracheal tube extubation
timeFrame: from end of giving trial drugs to removing endotracheal tube ,at an average of 25 minutes
measure: time to orientation
timeFrame: from end of giving trial drugs to recovery of orientation to name, location or date ,at an average of 30 minutes
measure: the dosages of vasoactive drugs during surgery
timeFrame: from initial administration of trial drugs to end of surgery, at an average of 3 hours
measure: Number of episodes of hypotension during surgery
timeFrame: from initial administration of trial drugs to end of surgery, at an average of 3 hours
measure: Number of episodes of hypertension during surgery
timeFrame: from initial administration of trial drugs to end of surgery, at an average of 3 hours
measure: the level of lactic acid of arterial blood
timeFrame: at the end of the surgery
measure: The highest Richmond Agitation and Sedation Score during emergence
timeFrame: from end of the surgery to 30 minutes after extubation, approximately 50 minutes
measure: Renkin's Score at 30 days and three months after surgery
timeFrame: 30 days and three months after surgery
measure: Glasgow outcome Score at discharge
timeFrame: at discharge, approximately 3 days after surgery
measure: length of postoperative ICU stay and hospital stay
timeFrame: from entering the ICU to leaving the ICU and from admission to discharge, approximately 3 days
measure: the incidence of major complications during postoperative hospitalization
timeFrame: from the end of surgery to discharge, approximately 3 days
measure: the incidence of delirium during emergence
timeFrame: from end of surgery to 30 minutes after extubation
measure: the incidence of delirium within 3 days after surgery
timeFrame: from end of surgery to 3 days after surgery
measure: the level of serum interleukin-6, tumor necrosis factor-α and S100β
timeFrame: at the end of the surgery
Other outcomes:
Locations:
city: Xi'an
country: China
facility: Xijing hospital
state: Shaanxi
Study officials:
References:
citation: Sneyd JR, Rigby-Jones AE. Remimazolam for anaesthesia or sedation. Curr Opin Anaesthesiol. 2020 Aug;33(4):506-511. doi: 10.1097/ACO.0000000000000877.
citation: Keam SJ. Remimazolam: First Approval. Drugs. 2020 Apr;80(6):625-633. doi: 10.1007/s40265-020-01299-8.
citation: Pastis NJ, Yarmus LB, Schippers F, Ostroff R, Chen A, Akulian J, Wahidi M, Shojaee S, Tanner NT, Callahan SP, Feldman G, Lorch DG Jr, Ndukwu I, Pritchett MA, Silvestri GA; PAION Investigators. Safety and Efficacy of Remimazolam Compared With Placebo and Midazolam for Moderate Sedation During Bronchoscopy. Chest. 2019 Jan;155(1):137-146. doi: 10.1016/j.chest.2018.09.015. Epub 2018 Oct 4.