Emergence Times and Airway Reactions in General Laryngeal Mask Airway Anesthesia

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

Detailed Description
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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.

Official Title
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Emergence Times and Airway Reactions in General Laryngeal Mask Airway Anesthesia: a Randomized Multicenter Controlled Trial (ACC Baxter)

Conditions
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Anesthesia With Use of LMA (Laryngeal Mask Airway)

Intervention / Treatment
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* Drug: Desflurane
* Drug: Sevoflurane
* Drug: propofol


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: desflurane<br>Suprane® Dose: 0.8 MAC / 4-5 vol. % Mode of administration: inhalation with laryngeal mask One application | Drug: Desflurane<br>* inhalation with laryngeal mask to maintain anaesthesia<br>* Other names: Suprane;|
| Active Comparator: sevoflurane<br>Sevoflurane: Dose: 0.8 MAC / 1.2-1.4 vol.% Mode of administration: inhalation with laryngeal mask One application | Drug: Sevoflurane<br>* inhalation with laryngeal mask to maintain anaesthesia<br>* Other names: Sevorane;|
| Active Comparator: propofol<br>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 | Drug: propofol<br>* intravenous injection to maintain anaesthesia<br>* Other names: Anesia;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| time of emergence from anesthesia | 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 | up to 15 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Airway reactions (Incidence of intraoperative coughs, laryngospasm) | 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 | up to 2 hours | 
| Emergence times | 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)] | up to 15 minutes | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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laryngeal mask airway, desflurane, sevoflurane, propofol