Dose Finding Study of Remimazolam for Laryngeal Mask Airway Insertion

Orthopedic Surgery Clinical Trial

Official title:

Dose Finding Study of Remimazolam for Laryngeal Mask Airway Insertion

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05298228
• Other study ID #: 4-2021-1706
• Status: Recruiting
• Phase: N/A
• Start date: March 2022
• Est. completion date: July 27, 2023

Study information

• Verified date: March 2022
• Source: Yonsei University
• Contact: Seokyung Shin
• Phone: 82-2-2228-5785
• Email: skshin[@]yuhs.ac
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 25
• Est. completion date: July 27, 2023
• Est. primary completion date: July 26, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Orthopedic Surgery

Intervention

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.

Locations

Country	Name	City	State
Korea, Republic of	Yonsei University Health System, Severance Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Yonsei University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)