Dose Finding Study of Remimazolam for Laryngeal Mask Airway Insertion

Status Recruiting

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.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Orthopedic Surgery

Clinical Trial Details

NCT number	NCT05298228
Study type	Interventional
Source	Yonsei University
Contact	Seokyung Shin
Phone	82-2-2228-5785
Email	skshin@yuhs.ac
Status	Recruiting
Phase	N/A
Start date	March 2022
Completion date	July 27, 2023

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT03657368` - Ventilation Strategy During General Anesthesia for Orthopedic Surgery	N/A
Withdrawn	`NCT02771041` - Assessment of the Influence of Early Preoperative Consultation on Satisfaction and the Average Length of Stay of Patients Who Underwent Total Hip Arthroplasty	N/A
Completed	`NCT02278627` - Impact of a Technique of Massage During the First Week of Hospitalization on the Recycling of the Mobility of the Knee Further to the Installation of Knee Replacement	N/A
Recruiting	`NCT01205295` - Patient Anxiety and Concern as Predictors for the Perceived Quality and Efficacy of Treatment	N/A
Completed	`NCT01389011` - Perfusion Index (PI) and Pleth Variability Index (PVI) in Patients With Interscalene Blocks in Orthopedic Surgery	N/A
Completed	`NCT01063543` - Pharmacokinetics of Fondaparinux in Patients With Major Orthopedic Surgery	N/A
Active, not recruiting	`NCT03629262` - Dexmedetomidine Supplemented Intravenous Analgesia in Elderly After Orthopedic Surgery	Phase 4
Not yet recruiting	`NCT05537155` - Buccal Acupuncture for Delirium Treatment in Older Patients Recovering From Orthopedic Surgery	N/A
Completed	`NCT03532256` - Post-op Crowd Sourcing Health Data Via Text-messaging
Active, not recruiting	`NCT03366805` - A Patient Education Video Program for Post-Operative Recovery After Upper Extremity Surgery	N/A
Completed	`NCT03769077` - Cycle to Fun - 'Exergames' for Inpatient Rehabilitation for Children/Youth With CP	N/A
Recruiting	`NCT05401058` - Low-dose Droperidol for Prevention of Postoperative Delirium in Elderly Patients After Non-cardiac Surgery	N/A
Completed	`NCT00293631` - Study of Lornoxicam or Ketorolac or Placebo for Post-Operative Pain After Bunionectomy	Phase 2
Completed	`NCT05110690` - Behavioral Activation and Medication Optimization for Perioperative Mental Health Feasibility Study	N/A
Completed	`NCT05120739` - Efficacy of CHX Cloths Versus CHX Soaps for Bathes Before Orthopedic Surgery	N/A
Completed	`NCT00724035` - Ultrasound-Guided Axillary or Infraclavicular Nerve Block for Upper Limb Surgery	Phase 4
Completed	`NCT00702416` - Ultrasound Guidance for Interscalene Brachial Plexus Block	Phase 4
Completed	`NCT00192894` - New Methods to Detect a Decrease in Heart Function	Phase 4
Completed	`NCT05424211` - The Effect of Music Therapy on Pain Level and Analgesic Consumption	N/A
Withdrawn	`NCT00269971` - A Study to Determine an Effective Dose of Epoetin Alfa to Decrease the Number of Units of Blood Required to be Transfused During Hip Replacement Surgery.	Phase 3