Anesthesia With Use of LMA (Laryngeal Mask Airway)Phase 3NCT02322502
Emergence Times and Airway Reactions in General Laryngeal Mask Airway Anesthesia
A Phase 3 study testing Desflurane, Sevoflurane and propofol in people with Anesthesia With Use of LMA (Laryngeal Mask Airway), run by RWTH Aachen University at 4 sites in Germany.
Trial summary
The aim of this study is first to assess if desflurane is superior in order to achieve a faster emergence from anesthesia. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Anesthesia With Use of LMA (Laryngeal Mask Airway)
- What is being tested?
- Desflurane, Sevoflurane and propofol
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 352 participants
- Where
- 4 sitesGermany
- Study dates
- Feb 2015to Feb 2016
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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 locations and contacts
4 sites in 1 country.
Germany4 sites
RWTH Aachen University; Department of Anesthesia
Aachen, D-52074
Martha-Maria Hospital Halle Dölau gGmbH, Department of Anesthesia
Halle, 06120
Kreiskliniken Reutlingen, Department of Anesthesia
Reutlingen, 73764
University Hospital Ulm, Department of Anesthesia
Ulm, 89075
About this study
Official title: Emergence Times and Airway Reactions in General Laryngeal Mask Airway Anesthesia: a Randomized Multicenter Controlled Trial (ACC Baxter)
The aim of this study is first to assess if desflurane is superior in order to achieve a faster emergence from anesthesia.
Read the 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.
- Being tested
- Desflurane, Sevoflurane, propofol
- Keywords
- laryngeal mask airway, desflurane, sevoflurane, propofol
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DesfluraneDrug
Also called Suprane
inhalation with laryngeal mask to maintain anaesthesia
SevofluraneDrug
Also called Sevorane
inhalation with laryngeal mask to maintain anaesthesia
propofolDrug
Also called Anesia
intravenous injection to maintain anaesthesia
| Study group | Role | What they receive |
|---|---|---|
| desflurane | Experimental | Suprane® Dose: 0.8 MAC / 4-5 vol. % Mode of administration: inhalation with laryngeal mask One application Receives: Drug: Desflurane |
| sevoflurane | Active comparator | Sevoflurane:
Dose: 0.8 MAC / 1.2-1.4 vol.% Mode of administration: inhalation with laryngeal mask One application Receives: Drug: Sevoflurane |
| propofol | Active comparator | 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 Receives: Drug: propofol |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: up to 15 minutes
Secondary outcomes (2)
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
Measured: 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)]
Measured: up to 15 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2014 (estimated)
- Study startFeb 2015
- Primary completionFeb 2016
- Study completionFeb 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Anesthesia With Use of LMA (Laryngeal Mask Airway)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 352 participants (actual)
Sponsor and investigators
- Lead sponsor
- RWTH Aachen University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mark Coburn, Prof., Principal investigator, University Hospital, Aachen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02322502
- Sponsor's protocol ID
- 14-073
- Status last verified
- Oct 2016
- First submitted
- 12 Dec 2014
- Last updated
- 6 Oct 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Kowark A, Rossaint R, Puhringer F, Keszei AP, Fritz H, Froba G, Rex C, Haas H, Otto V, Coburn M; Study Collaborators. Emergence times and airway reactions during general anaesthesia with remifentanil and a laryngeal mask airway: A multicentre randomised controlled trial. Eur J Anaesthesiol. 2018 Aug;35(8):588-597. doi: 10.1097/EJA.0000000000000852.
PubMed 29916859Stevanovic A, Rossaint R, Keszei AP, Fritz H, Froba G, Puhringer F, Coburn M. Emergence times and airway reactions in general laryngeal mask airway anesthesia: study protocol for a randomized controlled trial. Trials. 2015 Jul 26;16:316. doi: 10.1186/s13063-015-0855-2.
PubMed 26210907
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Emergence Times and Airway Reactions in General Laryngeal Mask Airway Anesthesia: a Randomized Multicenter Controlled Trial (ACC Baxter)
- ClinicalTrials.gov ID
- NCT02322502
- Acronym / sponsor ID
- 14-073
- Keywords
- laryngeal mask airway, desflurane, sevoflurane, propofol
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 352 participants (actual)
- Lead sponsor
- RWTH Aachen UniversityUniversity, hospital or other
- Study start
- Feb 2015
- Primary completion
- Feb 2016 (actual)
- Study completion
- Feb 2016 (actual)
- First posted
- 23 Dec 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| desflurane | Experimental | Drug: DesfluraneSuprane® Dose: 0.8 MAC / 4-5 vol. % Mode of administration: inhalation with laryngeal mask One application |
| sevoflurane | Active comparator | Drug: SevofluraneSevoflurane: Dose: 0.8 MAC / 1.2-1.4 vol.% Mode of administration: inhalation with laryngeal mask One application |
| propofol | Active comparator | Drug: propofolPropofol Dose: 5-7 mg kg-1 h-1 to maintain a BIS index value between 40 and 60 Mode of administration: intravenous One application |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DesfluraneAlso: Supraneinhalation with laryngeal mask to maintain anaesthesia | Drug | desflurane |
| SevofluraneAlso: Sevoraneinhalation with laryngeal mask to maintain anaesthesia | Drug | sevoflurane |
| propofolAlso: Anesiaintravenous injection to maintain anaesthesia | Drug | propofol |
Primary outcome
time of emergence from anesthesia
Time frame: 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
2 secondary outcomes
Airway reactions (Incidence of intraoperative coughs, laryngospasm)
Time frame: up to 2 hours
Emergence times
Time frame: up to 15 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2016.
- Derived from this study: PubMed 29916859Kowark A, Rossaint R, Puhringer F, Keszei AP, Fritz H, Froba G, Rex C, Haas H, Otto V, Coburn M; Study Collaborators. Emergence times and airway reactions during general anaesthesia with remifentanil and a laryngeal mask airway: A multicentre randomised controlled trial. Eur J Anaesthesiol. 2018 Aug;35(8):588-597. doi: 10.1097/EJA.0000000000000852.
- Derived from this study: PubMed 26210907Stevanovic A, Rossaint R, Keszei AP, Fritz H, Froba G, Puhringer F, Coburn M. Emergence times and airway reactions in general laryngeal mask airway anesthesia: study protocol for a randomized controlled trial. Trials. 2015 Jul 26;16:316. doi: 10.1186/s13063-015-0855-2.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mark Coburn, Prof. principal investigator
University Hospital, Aachen
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Desflurane, Sevoflurane and propofol in people with Anesthesia With Use of LMA (Laryngeal Mask Airway), run by RWTH Aachen University at 4 sites in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
time of emergence from anesthesia (time frame: up to 15 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02322502, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Oct 2016.