Anesthesia With Use of LMA (Laryngeal Mask Airway)
Conditions
Keywords
laryngeal mask airway, desflurane, sevoflurane, propofol
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.
Interventions
DRUGDesflurane
inhalation with laryngeal mask to maintain anaesthesia
DRUGSevoflurane
inhalation with laryngeal mask to maintain anaesthesia
DRUGpropofol
intravenous injection to maintain anaesthesia
Sponsors
RWTH Aachen University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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/\[(2xextubation time) + 1 x opening eyes time)\] |
Countries
Germany
Outcome results
None listed