Remimazolam and Remifentanil Without Neuromuscular Blocking Agent

NCT05025410 | Completed

• 1 other identifier: B-2109-706-301
• Study Type: observational
• Target: 38
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (3)

• 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 Arms (1)

General anesthesia using remimazolam and remifentanil

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

Drug: Remimazolam

Interventions

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

General anesthesia using remimazolam and remifentanil

Eligibility Criteria

• Age: 20 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult woman scheduled for gynecological surgery under general anesthesia

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Seoul National University Bundang Hospital: lead

Study Sites (1)

Seoul National University Bundang Hospital

Seongnam, South Korea

Location

Related Publications (1)

• Park I, Cho M, Nam SW, Hwang JW, Do SH, Na HS. Total intravenous anesthesia induced and maintained by a combination of remimazolam and remifentanil without a neuromuscular blocking agent: a prospective, observational pilot study. BMC Anesthesiol. 2022 Jul 26;22(1):237. doi: 10.1186/s12871-022-01779-2.

  PMID: 35883039 DERIVED

MeSH Terms

Conditions

Myofibroma

Interventions

remimazolam

Condition Hierarchy (Ancestors)

Neoplasms, Connective Tissue; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Connective Tissue Diseases; Skin and Connective Tissue Diseases

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: August 23, 2021
• First Posted: August 27, 2021
• Study Start: November 1, 2021
• Primary Completion: January 31, 2022
• Study Completion: January 31, 2022
• Last Updated: April 25, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)