Dose Finding Study of Remimazolam for Laryngeal Mask Airway Insertion

Sponsor

Yonsei University (Other)

Overall Status

Recruiting

CT.gov ID

NCT05298228

Collaborator

(none)

Enrollment

Location

Arm

16.9

Anticipated Duration (Months)

1.5

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Laryngeal mask airways (LMA) are widely used in patients receiving general anesthesia and are known to have the following advantages over the endotracheal tube: lower incidence of postoperative sore throat, lower incidence of cough during emergence, and lower incidence of postoperative vomiting. Although LMAs can be inserted without the use of muscle relaxants, a sufficient depth of anesthesia is necessary for placement. Remimazolam is a newer anesthetic that is ultra-short acting with a rapid onset and short context-sensitive half-life allowing for fast recovery. However, the dose of remimazolam needed for LMA insertion without muscle relaxants is not well known. This dose-finding study aims to find the ED50 and ED95 of a single bolus dose of remimazolam for LMA insertion without muscle relaxants in adult patients.

This is an interventional study done in a single group using the Dixon's up-and-down method which requires at least six success/failure pairs in the same direction. The primary endpoint of this study is to investigate the dose of remimazolam associated with 50% (ED50) and 95% (ED95) probability for adequate depth of anesthesia for LMA insertion without muscle relaxants. The beginning dose of remimazolam is 0.3 mg/kg, and when LMA insertion is successful, the dose will be decreased by 0.05 mg/kg in the next patient. When LMA insertion is unsuccessful (failed), the dose will be increased by 0.05 mg/kg in the next patient. Successful LMA insertion is defined as symmetrical chest wall movement and square-wave capnographic traces observed with manual ventilation.

Condition or Disease	Intervention/Treatment	Phase
Orthopedic Surgery	Drug: Remimazolam bolus does administration	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

25 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Other

Official Title:

Dose Finding Study of Remimazolam for Laryngeal Mask Airway Insertion

Anticipated Study Start Date :

Mar 1, 2022

Anticipated Primary Completion Date :

Jul 26, 2023

Anticipated Study Completion Date :

Jul 27, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Remimazolam A bolus dose of remimazolam is administered to facilitate LMA insertion	Drug: Remimazolam bolus does administration The beginning dose of remimazolam is 0.3 mg/kg, and when LMA insertion is successful, the dose will be decreased by 0.05 mg/kg in the next patient. When LMA insertion is unsuccessful (failed), the dose will be increased by 0.05 mg/kg in the next patient.

Arm

Intervention/Treatment

Experimental: Remimazolam

A bolus dose of remimazolam is administered to facilitate LMA insertion

Drug: Remimazolam bolus does administration

The beginning dose of remimazolam is 0.3 mg/kg, and when LMA insertion is successful, the dose will be decreased by 0.05 mg/kg in the next patient. When LMA insertion is unsuccessful (failed), the dose will be increased by 0.05 mg/kg in the next patient.

Outcome Measures

Primary Outcome Measures

Dose of remimazolam associated with 50% (ED50) probability for adequate depth of anesthesia for LMA insertion without muscle relaxants. [During procedure (Immediately after LMA insertion attempt)]
The primary outcome of this study will be determined based on the data of "success" or "failure" of LMA insertion at predetermined doses of remimazolam. Successful LMA insertion is defined as symmetrical chest wall movement and square-wave capnographic traces observed with manual ventilation which will be assessed immediately after LMA insertion attempt.

Eligibility Criteria

Criteria

Ages Eligible for Study:

19 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Adult patients aged 19~65 year
ASA class I~III
Patients scheduled for orthopedic surgery under general anesthesia and eligible for LMA use.

Exclusion Criteria:

Patient refusal
Patients unable to read consent form
Anticipated difficult mask ventilation
Active URI or uncontrolled asthma
Pneumonia
Risk of aspiration such as GERD
History of allergies to benzodiazepines
Decreased liver or kidney function
Pregnant or breastfeeding patients
BMI > 30kg/m2
History of substance abuse/addiction

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Yonsei University Health System, Severance Hospital	Seoul		Korea, Republic of

Sponsors and Collaborators

Yonsei University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Yonsei University

ClinicalTrials.gov Identifier:

NCT05298228

Other Study ID Numbers:

4-2021-1706

First Posted:

Mar 28, 2022

Last Update Posted:

Mar 28, 2022

Last Verified:

Mar 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Study Results

No Results Posted as of Mar 28, 2022