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Clinical Trials/NCT05025410
NCT05025410
Completed
Not Applicable

General Anesthesia Using Remimazolam and Remifentanil Without Neuromuscular Blocking Agent: Prospective Observational Study

Seoul National University Bundang Hospital1 site in 1 country38 target enrollmentNovember 1, 2021

Overview

Phase
Not Applicable
Intervention
Remimazolam
Conditions
Myoma;Uterus
Sponsor
Seoul National University Bundang Hospital
Enrollment
38
Locations
1
Primary Endpoint
Remimazolam induction dose
Status
Completed
Last Updated
4 years ago

Overview

Brief Summary

Remimazolam is a novel drug approved for induction and maintenance of general anesthesia. This study aims to check the appropriate dose and patient response by administering remimazolam and remifentanil in surgery that does not require a neuromuscular blocking agents.

Registry
clinicaltrials.gov
Start Date
November 1, 2021
End Date
January 31, 2022
Last Updated
4 years ago
Study Type
Observational
Sex
Female

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Hyo-Seok Na

Principal investigator

Seoul National University Bundang Hospital

Eligibility Criteria

Inclusion Criteria

  • Adult woman scheduled for gynecological surgery under general anesthesia
  • American Society of Anesthesiology grade 1 or 2
  • When using a laryngeal mask airway to maintain general anesthesia

Exclusion Criteria

  • Underlying diseases: liver, kidney, brain nervous system, glaucoma
  • Patients with BMI greater than 30 and less than 18.5
  • Patients diagnosed with sleep apnea
  • Alcohol or drug dependent patients
  • Patients with severe or acute respiratory failure
  • Lactose intolerance
  • Dextran 40 hypersensitivity
  • Patients in shock or coma

Arms & Interventions

General anesthesia using remimazolam and remifentanil

Adult female patients scheduled for gynecological surgery under general anesthesia using remimazolam and remifentanil

Intervention: Remimazolam

Outcomes

Primary Outcomes

Remimazolam induction dose

Time Frame: During the anesthesia induction (from initiation of anesthesia until the insertion of laryngeal mask airway)

Remimazolam maintenance dose

Time Frame: During the anesthesia maintenance (from the insertion of laryngeal mask airway until stopping remimazolam infusion)

Secondary Outcomes

  • Use of rescue midazolam(During the anesthesia (from initiation of anesthesia until stopping remimazolam infusion))
  • Use of rescue rocuronium(During the anesthesia (from initiation of anesthesia until stopping remimazolam infusion))
  • Use of flumazenil(During the anesthesia recovery (from stopping remimazolam infusion until the recovery of consciousness))

Study Sites (1)

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