Emergence Times and Airway Reactions in General Laryngeal Mask Airway Anesthesia

Phase 3

Completed

• Conditions: Anesthesia With Use of LMA (Laryngeal Mask Airway)
• Interventions: Drug: Desflurane; Drug: propofol; Drug: Sevoflurane

• Registration Number: NCT02322502
• Lead Sponsor: RWTH Aachen University

Brief Summary

The aim of this study is first to assess if desflurane is superior in order to achieve a faster emergence from anesthesia.

Detailed Description

The aim of this study is first to assess if desflurane is superior in order to achieve a faster emergence from anesthesia (stating the date of birth) and second if desflurane is non-inferior in the occurrence of airway complications compared to sevoflurane or total intravenous anesthesia with propofol in the setting of laryngeal mask airway.

Study Timeline

• Study First Submitted: 2014-12-12
• Study First Submitted QC: 2014-12-22
• Study First Posted: 2014-12-23
• Study Start: 2015-02
• Primary Completion: 2016-02
• Study Completion: 2016-02
• Status Verified: 2016-10
• Last Update Submitted: 2016-10-05
• Last Update Posted: 2016-10-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 352

Inclusion Criteria

• Planned anesthesia with use of LMA (laryngeal mask airway)
• Planned duration of anesthesia between 0.5 and 2 hours
• Age between 18-75 years
• Both gender
• Body mass index (BMI) <35
• ASA 1-3
• Written informed consent prior to study participation

Exclusion Criteria

• Planned additional regional and local anesthesia
• Contra-indication for the use of a laryngeal mask airway
• Asthma
• COPD IV
• Known allergy or hypersensitivity to any drugs administered during this study
• Women who are pregnant, breast-feeding or women of childbearing potential not using adequate contraceptive methods
• Participation in a drug or device trial within the previous 30 days.
• Patients legally unable to give written informed consent.
• Patients with severe psychiatric disorders
• Recent (<6 months) history of alcohol or drug abuse
• Patients with severe neuropsychiatric disorders
• Non-fluency in German language

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
desflurane	Desflurane	Suprane® Dose: 0.8 MAC / 4-5 vol. % Mode of administration: inhalation with laryngeal mask One application
propofol	propofol	Propofol Dose: 5-7 mg kg-1 h-1 to maintain a BIS index value between 40 and 60 Mode of administration: intravenous One application
sevoflurane	Sevoflurane	Sevoflurane: Dose: 0.8 MAC / 1.2-1.4 vol.% Mode of administration: inhalation with laryngeal mask One application

Primary Outcome Measures

Name	Time	Method
time of emergence from anesthesia	up to 15 minutes	time of emergence from anesthesia defined as time between cessation of anesthesia until patient is able to state his/her date of birth on command

Secondary Outcome Measures

Name	Time	Method
Airway reactions (Incidence of intraoperative coughs, laryngospasm)	up to 2 hours	Incidence of intraoperative coughs (induction/maintenance) - non-inferiority design Incidence of intraoperative laryngospasm (induction/maintenance) Incidence of cough at emergence Incidence of laryngospasms at emergence
Emergence times	up to 15 minutes	Time to remove laryngeal mask Time to open eyes on command Time to respond on command (press hand) Time to state the name on command Recovery Index (RI = 1 + Aldrete5min/\[(2xextubation time) + 1 x opening eyes time)\]

Trial Locations

Locations (4)

RWTH Aachen University; Department of Anesthesia; 🇩🇪 Aachen, Germany

Kreiskliniken Reutlingen, Department of Anesthesia; 🇩🇪 Reutlingen, Germany

University Hospital Ulm, Department of Anesthesia; 🇩🇪 Ulm, Germany

Martha-Maria Hospital Halle Dölau gGmbH, Department of Anesthesia; 🇩🇪 Halle, Germany