Dose Finding Study of Remimazolam for Laryngeal Mask Airway Insertion

NCT05298228 | Unknown

• 1 other identifier: 4-2021-1706
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

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.

Conditions

Orthopedic Surgery

Outcome Measures

Primary Outcomes (1)

• Dose of remimazolam associated with 50% (ED50) probability for adequate depth of anesthesia for LMA insertion without muscle relaxants.

  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.

  During procedure (Immediately after LMA insertion attempt)

Study Arms (1)

Remimazolam

EXPERIMENTAL

A bolus dose of remimazolam is administered to facilitate LMA insertion

Drug: Remimazolam bolus does administration

Interventions

Remimazolam bolus does administration DRUG

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.

Remimazolam

Eligibility Criteria

• Age: 19 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Yonsei University: lead

Study Sites (1)

Yonsei University Health System, Severance Hospital

Seoul, South Korea

RECRUITING

Related Publications (1)

• Cho E, Roh YH, Moon J, Kim Y, Shin S. Effective bolus dose of remimazolam for i-gel(R) insertion in nonparalyzed patients: a dose-finding study. Can J Anaesth. 2024 Sep;71(9):1251-1260. doi: 10.1007/s12630-024-02762-w. Epub 2024 Apr 26.

  PMID: 38671251 DERIVED

Central Study Contacts

Seokyung Shin

CONTACT

82-2-2228-5785; skshin@yuhs.ac

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 6, 2022
• First Posted: March 28, 2022
• Study Start: March 1, 2022
• Primary Completion: July 26, 2023
• Study Completion: July 27, 2023
• Last Updated: March 28, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)