Under investigation are first the time a patient needs to emerge from anesthesia (stating the date of birth) and second the occurrence of airway complications.
Conditions
Interventions
Trade Name: Suprane
Product Name: Suprane
Pharmaceutical Form: Inhalation vapour, liquid
INN or Proposed INN: DESFLURANE
CAS Number: 57041-67-5
Trade Name: Sevorane
Pharmaceutical Form: Inhalation va
Sponsors
RWTH Aachen University for the Medical Falculty, represented by Clinical Trial Center Aachen (CTC-A)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Planned anesthesia with use of LMA (laryngeal mask airway) 2. Planned duration of anesthesia between 0.5 and 2 hours 3. Age between 18-75 years 4. Both gender 5. Body mass index (BMI) =65 years) yes F.1.3.1 Number of subjects for this age range 117
Exclusion criteria
Exclusion criteria: 1. Planned additional regional and local anesthesia 2. Contra-indication for the use of a laryngeal mask airway 3. Asthma 4. COPD IV 5. Known allergy or hypersensitivity to any drugs administered during this study 6. Women who are pregnant, breast-feeding or women of childbearing potential not using adequate contraceptive methods 7. Participation in a drug or device trial within the previous 30 days 8. Patients legally unable to give written informed consent. 9. Patients with severe psychiatric disorders 10. Recent (<6 months) history of alcohol or drug abuse 11. Patients with severe neuropsychiatric disorders 12. Non-fluency in German language
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 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). a;Secondary Objective: Second aim of this study is to assess 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.;Primary end point(s): 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.;Timepoint(s) of evaluation of this end point: September 2015 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Airway reactions: • 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: • 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)]; Rossaint R et al. Anesthesiology 2003; 98: 6-13) Other: • Gender effects • Measuring depth of anesthesia (BIS) • Hemodynamic parameters (NIBP/HR)) • Requirement of catecholamines • Respiratory parameters (Airway pressures, end-tidal carbon dioxide: CO2) • Modified Aldrete score • VAS Pain in the PACU • Nausea in the PACU • Incidence of vomiting in the PACU • Time to readiness to be discharged from PACU • Pharmacoeconomics • Postoperative Quality Recovery Scale (PQRS) ;Timepoint(s) of evaluation of this end point: September 2015 | — |
Countries
Germany
Contacts
Public ContactClinical Trial Center
Clinical Trial Center Aachen (CTC-A)
Outcome results
None listed