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NCT Number: NCT04950621

Remimazolam and Endovascular Procedures of Cerebrovascular Diseases

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.

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Key information

Conditions

Cerebrovascular Disorders Anesthesia Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Nervous System Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Xijing hospital

Xi'an, Shaanxi, 710032, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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
  • 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

Treatment and study plan

Remimazolam

Drug

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

Propofol

Drug

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

Primary outcomes

  1. time to open eye

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

Secondary outcomes

  1. time to loss of consciousness

    Time frame: 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

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

  3. time to endotracheal tube extubation

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

  4. time to orientation

    Time frame: 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

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

  6. Number of episodes of hypotension during surgery

    Time frame: 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

  7. Number of episodes of hypertension during surgery

    Time frame: 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

  8. the level of lactic acid of arterial blood

    Time frame: at the end of the surgery

  9. The highest Richmond Agitation and Sedation Score during emergence

    Time frame: 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

    Time frame: 30 days and three months after surgery

  11. Glasgow outcome Score at discharge

    Time frame: at discharge, approximately 3 days after surgery

  12. length of postoperative ICU stay and hospital stay

    Time frame: 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

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

  14. the incidence of delirium during emergence

    Time frame: from end of surgery to 30 minutes after extubation

  15. the incidence of delirium within 3 days after surgery

    Time frame: from end of surgery to 3 days after surgery

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

    Time frame: at the end of the surgery

Sponsors and collaborators

Lead sponsor

Air Force Military Medical University, China

Other

Registry information

Official study 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

Acronym: REPEAT

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Jul 6, 2021
Registry last updated
Oct 20, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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