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Cerebrovascular DisordersREPEATNCT04950621

Remimazolam and Endovascular Procedures of Cerebrovascular Diseases

A study testing remimazolam and propofol in people with Cerebrovascular Disorders and Anesthesia, run by Air Force Military Medical University, China at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Cerebrovascular Disorders, Anesthesia
What is being tested?
remimazolam and propofol
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
142 participants
Where
1 siteChina
Study dates
13 Jul 2021to 30 Sep 2022
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • aged 18 years or older
  • scheduled for interventional neurosurgery of cerebrovascular disorders under general anesthesia

Who cannot join

  • American Society of Anesthesiologists class Ⅲ or higher
  • Hunt-Hess class Ⅲ or higher
  • body mass index (BMI) < 18 kg/㎡ or > 30kg/㎡
  • large or giant cerebral aneurysms with diameters greater than 15mm and minor cerebral aneurysms with diameters less than 3mm
  • posterior circulation infarction
  • recurrence of an cerebral aneurysms after endovascular procedures or surgical clipping
Show all 13Show fewer
  • severe abnormal coagulation function, severe liver and kidney function damage, or combined with heart and respiratory system failure
  • be allergic or likely to be allergic to the study drugs
  • participate in other clinical researchers within 3 months
  • history of neurological or psychiatric diseases
  • existed or suspected abuse of drug or alcohol
  • use of sedative or analgesics before surgery
  • patients with difficulty in communication

Trial locations and contacts

1 site in 1 country.

China1 site

  • Xijing hospital

    Xi'an, Shaanxi, 710032

Other trials in China

About this study

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

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.

Being tested
remimazolam, propofol
Keywords
propofol, Remimazolam, Endovascular Procedures
Medical subject headings
Cerebrovascular Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • remimazolamDrug

    Remimazolam will be administered during induction and maintenance for general anesthesia.

  • propofolDrug

    Propofol will be administered during induction and maintenance for general anesthesia.

Study groups in NCT04950621
Study groupRoleWhat they receive
RemimazolamExperimentalIn remimazolam group, a 0.1 mg/kg dose of intravenous remimazolam was administered for induction, and 0.3-0.7 mg/kg/h infusion for maintenance after intubation.
Receives: Drug: remimazolam
PropofolActive comparatorIn propofol group, a 2 mg/kg dose of intravenous propofol was administered for induction, and 4-12 mg/kg/h infusion for maintenance after intubation.
Receives: Drug: propofol

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. time to open eye

    Measured: from the stop of trial drugs to open eye to verbal command, at an average of 15 minutes

Secondary outcomes (16)

  1. time to loss of consciousness

    Measured: from initial administration of trial drugs to loss of response to verbal command, at an average of 5 minutes

  2. time to recovery of spontaneous breathing

    Measured: from end of giving trial drugs to recovery of spontaneous breathing ,at an average of 20 minutes

  3. time to endotracheal tube extubation

    Measured: from end of giving trial drugs to removing endotracheal tube ,at an average of 25 minutes

  4. time to orientation

    Measured: from end of giving trial drugs to recovery of orientation to name, location or date ,at an average of 30 minutes

  5. the dosages of vasoactive drugs during surgery

    Measured: from initial administration of trial drugs to end of surgery, at an average of 3 hours

  6. 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

    Measured: from initial administration of trial drugs to end of surgery, at an average of 3 hours

  7. 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

    Measured: from initial administration of trial drugs to end of surgery, at an average of 3 hours

  8. the level of lactic acid of arterial blood

    Measured: at the end of the surgery

  9. The highest Richmond Agitation and Sedation Score during emergence

    Measured: from end of the surgery to 30 minutes after extubation, approximately 50 minutes

  10. Renkin's Score at 30 days and three months after surgery

    Measured: 30 days and three months after surgery

  11. Glasgow outcome Score at discharge

    Measured: at discharge, approximately 3 days after surgery

  12. length of postoperative ICU stay and hospital stay

    Measured: from entering the ICU to leaving the ICU and from admission to discharge, approximately 3 days

  13. the incidence of major complications during postoperative hospitalization

    Measured: from the end of surgery to discharge, approximately 3 days

  14. the incidence of delirium during emergence

    Measured: from end of surgery to 30 minutes after extubation

  15. the incidence of delirium within 3 days after surgery

    Measured: from end of surgery to 3 days after surgery

  16. the level of serum interleukin-6, tumor necrosis factor-α and S100β

    Measured: at the end of the surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Jul 2021
  2. Study start13 Jul 2021
  3. Primary completion30 Jun 2022
  4. Study completion30 Sep 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
142 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04950621
Sponsor's protocol ID
XJH-A-20201225
Acronym
REPEAT
Status last verified
Oct 2022
First submitted
27 Jun 2021
Last updated
20 Oct 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: individual data including protocol and statistical analysis plan will be shared during 3 months and 5 years following article publication after deidentification

Publications

  • Sneyd JR, Rigby-Jones AE. Remimazolam for anaesthesia or sedation. Curr Opin Anaesthesiol. 2020 Aug;33(4):506-511. doi: 10.1097/ACO.0000000000000877.

    PubMed 32530890

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

    PubMed 32274703

  • 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.

    PubMed 30292760

Questions about this trial

What is this clinical trial studying?

A study testing remimazolam and propofol in people with Cerebrovascular Disorders and Anesthesia, run by Air Force Military Medical University, China at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 20 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

time to open eye (time frame: from the stop of trial drugs to open eye to verbal command, at an average of 15 minutes). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04950621, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Oct 2022.

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