Remimazolam and Remifentanil Without Neuromuscular Blocking Agent

April 21, 2022 updated by: Hyo-Seok Na, Seoul National University Bundang Hospital

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

38

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
      • Seongnam, Korea, Republic of
        • Seoul National University Bundang Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

Adult woman scheduled for gynecological surgery under general anesthesia

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
General anesthesia using remimazolam and remifentanil
Adult female patients scheduled for gynecological surgery under general anesthesia using remimazolam and remifentanil
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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Time Frame
Use of rescue midazolam
Time Frame: During the anesthesia (from initiation of anesthesia until stopping remimazolam infusion)
During the anesthesia (from initiation of anesthesia until stopping remimazolam infusion)
Use of rescue rocuronium
Time Frame: During the anesthesia (from initiation of anesthesia until stopping remimazolam infusion)
During the anesthesia (from initiation of anesthesia until stopping remimazolam infusion)
Use of flumazenil
Time Frame: During the anesthesia recovery (from stopping remimazolam infusion until the recovery of consciousness)
During the anesthesia recovery (from stopping remimazolam infusion until the recovery of consciousness)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Seoul National University Bundang Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

November 1, 2021

Primary Completion (ACTUAL)

January 31, 2022

Study Completion (ACTUAL)

January 31, 2022

Study Registration Dates

First Submitted

August 23, 2021

First Submitted That Met QC Criteria

August 23, 2021

First Posted (ACTUAL)

August 27, 2021

Study Record Updates

Last Update Posted (ACTUAL)

April 25, 2022

Last Update Submitted That Met QC Criteria

April 21, 2022

Last Verified

April 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • B-2109-706-301

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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