Emergence Times and Airway Reactions in General Laryngeal Mask Airway Anesthesia

RWTH Aachen University

Status and phase: Completed; Phase 3

Conditions: Anesthesia With Use of LMA (Laryngeal Mask Airway)

Treatments: Drug: propofol; Drug: Desflurane; Drug: Sevoflurane

Study type: Interventional

Funder types: Other

Identifiers

NCT02322502

14-073

Details and patient eligibility

About

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

Full 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.

Enrollment: 352 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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352 participants in 3 patient groups

desflurane

Experimental group

Description:

Suprane® Dose: 0.8 MAC / 4-5 vol. % Mode of administration: inhalation with laryngeal mask One application

Treatment:

Drug: Desflurane

sevoflurane

Active Comparator group

Description:

Sevoflurane: Dose: 0.8 MAC / 1.2-1.4 vol.% Mode of administration: inhalation with laryngeal mask One application

Treatment:

Drug: Sevoflurane

propofol

Active Comparator group

Description:

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

Treatment:

Drug: propofol