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Completed

NCT Number: NCT05025410

Remimazolam and Remifentanil Without Neuromuscular Blocking Agent

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.

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Key information

Conditions

Myoma;Uterus Connective Tissue Diseases Myofibroma Neoplasms Neoplasms by Histologic Type Neoplasms, Connective Tissue Neoplasms, Connective and Soft Tissue Polyp Endometrium Skin and Connective Tissue Diseases Unspecified Condition Associated With Female Genital Organs and Menstrual Cycle

Age range

20 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Seoul National University Bundang Hospital

Seongnam, South Korea

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Remimazolam

Drug

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

Primary outcomes

  1. Remimazolam induction dose

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

  2. Remimazolam maintenance dose

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

Secondary outcomes

  1. Use of rescue midazolam

    Time frame: During the anesthesia (from initiation of anesthesia until stopping remimazolam infusion)

  2. Use of rescue rocuronium

    Time frame: During the anesthesia (from initiation of anesthesia until stopping remimazolam infusion)

  3. Use of flumazenil

    Time frame: During the anesthesia recovery (from stopping remimazolam infusion until the recovery of consciousness)

Sponsors and collaborators

Lead sponsor

Seoul National University Bundang Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Aug 27, 2021
Registry last updated
Apr 25, 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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