Remimazolam and Remifentanil Without Neuromuscular Blocking Agent

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT05025410

Enrollment

Registered

2021-08-27

Start date

2021-11-01

Completion date

2022-01-31

Last updated

2022-04-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Myoma;Uterus, Polyp Endometrium, Unspecified Condition Associated With Female Genital Organs and Menstrual Cycle

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.

Interventions

DRUGRemimazolam

Loading for anesthesia induction: Remimazolam 6 mg/kg/h until loss of consciousness Continuous infusion for anesthesia maintenance: Remimazolam 1-2 mg/kg/h under the Bispectral index monitoring

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

FEMALE

Age

20 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Remimazolam induction dose	During the anesthesia induction (from initiation of anesthesia until the insertion of laryngeal mask airway)
Remimazolam maintenance dose	During the anesthesia maintenance (from the insertion of laryngeal mask airway until stopping remimazolam infusion)

Secondary

Measure	Time frame
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)

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 11, 2026