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Clinical Trials/jRCTs021240059
jRCTs021240059RecruitingNot Applicable

A study of the Rapid Sequence Awakeness method by reversing remimazolam with flumazenil in pediatric anesthesia, A randomized controlled study

Not provided0 sites108 target enrollmentStarted: TBDLast updated:
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Trial Snapshot

Phase
Not Applicable
Status
Recruiting
Enrollment
108
Primary Endpoint
-
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

No summary available.

Study Design

Study Type
Interventional
Allocation
Randomized Controlled Trial
Intervention Model
Parallel Assignment
Primary Purpose
Other
Masking
Open(masking Not Used)

Eligibility Criteria

Ages
1age 0month old over to 6age 12month old under (—)
Sex
All

Inclusion Criteria

  • •Patients scheduled for surgery under general anesthesia who meet the following criteria.
  • •Patients 1-6 years of age at the time of consent.
  • •Patients with an American Society of Anesthesiologists physical status (ASA-PS) of 1-2 at the preoperative visit.
  • •Patients scheduled to have their airway secured by oral tracheal intubation.
  • •Patients scheduled for extubation in the operating room.
  • •Patients who have been fully informed about the study and have provided written informed consent from a surrogate.

Exclusion Criteria

  • •Patients scheduled to undergo craniotomy
  • •Patients whose scheduled operation time is less than 20 minutes but longer than 4 hours
  • •Patients who are expected to bleed heavily (more than 15% of circulating blood volume) during surgery
  • •Patients who are expected to have difficulty with mask ventilation, intubation, but extubation
  • •At risk of vomiting or aspiration during the perioperative period
  • •Patients with a history of severe allergy to benzodiazepines, flumazenil citrate, remifentanil hydrochloride, fentanyl citrate, rocuronium bromide, or sugammadex sodium
  • •Patients who have been taking benzodiazepines regularly before surgery or have a history of tolerance to benzodiazepines
  • •Patients with a history of epilepsy
  • •Patients with a history of glaucoma
  • •Other patients deemed inappropriate by the principal investigator or subinvestigator

Outcomes

Primary Outcomes

-

Incidence of EA/ED up to 15 minutes after awakening and extubating

Secondary Outcomes

  • PAEDs score(at the time of admission to the PICU + 10 minutes and 30 minutes +/- 10 minutes, 60 minutes +/- 10 minutes, and 120 minutes +/- 10 minutes after admission to the PICU)
  • Percentage of EAs/EDs(at the time of admission to the PICU + 10 minutes and 30 minutes +/- 10 minutes, 60 minutes +/- 10 minutes, and 120 minutes +/- 10 minutes after admission to the PICU)
  • Percentage of PRAEs in the operating room
  • Percentage of PRAEs occurring up to 2 hours after PICU admission(up to 2 hours after PICU admission)
  • Percentage of cases requiring airway/respiratory intervention within 2 hours of PICU admission(within 2 hours of PICU admission)
  • Percentage of resuscitations within 2 hours of PICU admission(within 2 hours of PICU admission)
  • Time from end of surgical procedure to patient leaving the operating room
  • FLACCs score after extubation
  • FLACCs score on admission to PICU and at each assessment time point(at the time of admission to the PICU + 10 minutes and 30 minutes +/- 10 minutes, 60 minutes +/- 10 minutes, and 120 minutes +/- 10 minutes after admission to the PICU)
  • Subjective assessment by anesthesiologist of quality of emergence and extubation from general anesthesia

Investigators

Sponsor
Not provided

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