Remimazolam and Endovascular Procedures of Cerebrovascular Diseases

Anesthesia Clinical Trial

— REPEAT  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04950621
• Other study ID #: XJH-A-20201225
• Status: Completed
• Phase: N/A
• Start date: July 13, 2021
• Est. completion date: September 30, 2022

Study information

• Verified date: October 2022
• Source: Air Force Military Medical University, China
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 142
• Est. completion date: September 30, 2022
• Est. primary completion date: June 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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 ? or higher

2. Hunt-Hess class ? 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

Related Conditions & MeSH terms

• Anesthesia
• Cerebrovascular Disorders

Intervention

Drug:
• remimazolam
Remimazolam will be administered during induction and maintenance for general anesthesia.
• propofol
Propofol will be administered during induction and maintenance for general anesthesia.

Locations

Country	Name	City	State
China	Xijing hospital	Xi'an	Shaanxi

Sponsors (1)

Lead Sponsor	Collaborator
Air Force Military Medical University, China

Country where clinical trial is conducted

China, 

References & Publications (3)

Keam SJ. Remimazolam: First Approval. Drugs. 2020 Apr;80(6):625-633. doi: 10.1007/s40265-020-01299-8. Review. — View 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 M — View 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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	time to open eye		from the stop of trial drugs to open eye to verbal command, at an average of 15 minutes
Secondary	time to loss of consciousness		from initial administration of trial drugs to loss of response to verbal command, at an average of 5 minutes
Secondary	time to recovery of spontaneous breathing		from end of giving trial drugs to recovery of spontaneous breathing ,at an average of 20 minutes
Secondary	time to endotracheal tube extubation		from end of giving trial drugs to removing endotracheal tube ,at an average of 25 minutes
Secondary	time to orientation		from end of giving trial drugs to recovery of orientation to name, location or date ,at an average of 30 minutes
Secondary	the dosages of vasoactive drugs during surgery		from initial administration of trial drugs to end of surgery, at an average of 3 hours
Secondary	Number of episodes of hypotension during surgery	Hypotension is defined as decrease of mean arterial pressure more than 20% of the baseline, persisting longer than 1 minute	from initial administration of trial drugs to end of surgery, at an average of 3 hours
Secondary	Number of episodes of hypertension during surgery	Hypertension is defined as increase of mean arterial pressure more than 20% of the baseline, persisting longer than 1 minute	from initial administration of trial drugs to end of surgery, at an average of 3 hours
Secondary	the level of lactic acid of arterial blood		at the end of the surgery
Secondary	The highest Richmond Agitation and Sedation Score during emergence		from end of the surgery to 30 minutes after extubation, approximately 50 minutes
Secondary	Renkin's Score at 30 days and three months after surgery		30 days and three months after surgery
Secondary	Glasgow outcome Score at discharge		at discharge, approximately 3 days after surgery
Secondary	length of postoperative ICU stay and hospital stay		from entering the ICU to leaving the ICU and from admission to discharge, approximately 3 days
Secondary	the incidence of major complications during postoperative hospitalization		from the end of surgery to discharge, approximately 3 days
Secondary	the incidence of delirium during emergence		from end of surgery to 30 minutes after extubation
Secondary	the incidence of delirium within 3 days after surgery		from end of surgery to 3 days after surgery
Secondary	the level of serum interleukin-6, tumor necrosis factor-a and S100ß		at the end of the surgery