Emergence Times and Airway Reactions in General Laryngeal Mask Airway Anesthesia

Sponsor

RWTH Aachen University (Other)

Overall Status

Completed

CT.gov ID

NCT02322502

Collaborator

(none)

352

Enrollment

Locations

Arms

Duration (Months)

Patients Per Site

7.3

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Anesthesia With Use of LMA (Laryngeal Mask Airway)	Drug: Desflurane Drug: Sevoflurane Drug: propofol	Phase 3

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 Design

Study Type:

Interventional

Actual Enrollment :

352 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Feb 1, 2015

Actual Primary Completion Date :

Feb 1, 2016

Actual Study Completion Date :

Feb 1, 2016

Arms and Interventions

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

Arm

Intervention/Treatment

Experimental: desflurane

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

Drug: Desflurane

inhalation with laryngeal mask to maintain anaesthesia

Other Names:

Suprane

Active Comparator: sevoflurane

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

Drug: Sevoflurane

inhalation with laryngeal mask to maintain anaesthesia

Other Names:

Sevorane

Active Comparator: 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

Drug: propofol

intravenous injection to maintain anaesthesia

Other Names:

Anesia

Outcome Measures

Primary Outcome Measures

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

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)]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	Country	Postal Code
1	RWTH Aachen University; Department of Anesthesia	Aachen	Germany	D-52074
2	Martha-Maria Hospital Halle Dölau gGmbH, Department of Anesthesia	Halle	Germany	06120
3	Kreiskliniken Reutlingen, Department of Anesthesia	Reutlingen	Germany	73764
4	University Hospital Ulm, Department of Anesthesia	Ulm	Germany	89075