Remimazolam and Remifentanil Without Neuromuscular Blocking Agent

Myoma;Uterus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05025410
• Other study ID #: B-2109-706-301
• Status: Completed
• Start date: November 1, 2021
• Est. completion date: January 31, 2022

Study information

• Verified date: April 2022
• Source: Seoul National University Bundang Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 38
• Est. completion date: January 31, 2022
• Est. primary completion date: January 31, 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Leiomyoma
• Myoma;Uterus

Intervention

Drug:
• Remimazolam
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

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Bundang Hospital	Seongnam

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Bundang Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Remimazolam induction dose		During the anesthesia induction (from initiation of anesthesia until the insertion of laryngeal mask airway)
Primary	Remimazolam maintenance dose		During the anesthesia maintenance (from the insertion of laryngeal mask airway until stopping remimazolam infusion)
Secondary	Use of rescue midazolam		During the anesthesia (from initiation of anesthesia until stopping remimazolam infusion)
Secondary	Use of rescue rocuronium		During the anesthesia (from initiation of anesthesia until stopping remimazolam infusion)
Secondary	Use of flumazenil		During the anesthesia recovery (from stopping remimazolam infusion until the recovery of consciousness)