Airway ComplicationsNCT01083953
Optimal End-Tidal (ET) Sevoflurane and Desflurane Concentration for Extubation of Supreme Laryngeal Mask Airway (LMA) in Adults
A study testing Sevoflurane and Desflurane in people with Airway Complications, run by University of Malaya at 1 site in Malaysia.
Trial summary
The purpose of this study is to determine the optimal volatile anaesthetic (sevoflurane and desflurane) to remove a Supreme LMA in adults in which there is minimal airway response. Read more about this study
- Who is it for?
- Ages 18 to 49 yearsHealthy volunteers can take part
- Conditions the study is for
- Airway Complications
- What is being tested?
- Sevoflurane and Desflurane
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 1 siteMalaysia
- Study dates
- Nov 2009to Jul 2010
- Phase
- Interventional
- 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 49 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- ASA 1-2 patients
- Age 18 - 49 years old
- Elective surgery of short duration ( < 2 hours ) which require local anaesthetic infiltration
Who cannot join
- Upper respiratory tract symptoms in the previous 10 days
- Risk of gastric oesophageal reflux or regurgitation
- Known or predicted difficult airway
- Poor dentition with high risk of damage
- BMI > 30 kg/m2
- Refusing to participate
Trial locations and contacts
1 site in 1 country.
Malaysia1 site
University Malaya Medical Centre
Kuala Lumpur, Kuala Lumpur, 59100
About this study
Official title: Optimal End-Tidal Concentration of Sevoflurane and Desflurane for Removal of Supreme Laryngeal Mask Airway in Anaesthetized Adults
The purpose of this study is to determine the optimal volatile anaesthetic (sevoflurane and desflurane) to remove a Supreme LMA in adults in which there is minimal airway response.
Null hypothesis: there is no significant difference between the optimal end tidal concentration of sevoflurane and desflurane for Supreme LMA removal.
Read the detailed description
The manufactures' instructions for removal of the LMA recommend waiting until protective reflexes have returned. However, the appropriate timing for removal remains controversial. A more frequent incidence of airway hyperreactivity and complications has been reported by some studies when the LMA was removed in the awake state versus the anesthetized state. Techniques that reduce the time from LMA removal to the return of protective airway reflexes would minimize the risk of aspiration, contamination, or airway obstruction.
With increasingly common use of Supreme LMA in anaesthetic practice, a safe and suitable depth for removal of the Supreme LMA requires research.
Thus the determination of the optimal end-tidal concentration of commonly used volatile agents ie. Sevoflurane and Desflurane for Supreme LMA removal requires research, both for patient safety and minimising anaesthetic costs in dealing with airway complications.
- Conditions
- Airway Complications
- Being tested
- Sevoflurane, Desflurane
- Keywords
- end tidal concentration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SevofluraneDrug
Comparing the optimal end-tidal concentration sevoflurane and desflurane for LMA extubation
DesfluraneDrug
Comparing the optimal end-tidal concentration sevoflurane and desflurane for LMA extubation
| Study group | Role | What they receive |
|---|---|---|
| Sevoflurane | Experimental | 1 arm will receive sevoflurane at varying concentrations at which extubation is attempted according to the Dixon up and down method Receives: Drug: Sevoflurane |
| Desflurane | Experimental | 1 arm will receive desflurane at varying end tidal concentration at which extubation will be attempted according to Dixon up and down method Receives: Drug: Desflurane |
What is being measured
The primary outcome is the main question the study is designed to answer.
Optimal end tidal concentration of sevoflurane/ desflurane
Measured: 6 months
Secondary outcomes (1)
presence of airway response
Measured: 10 mins after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2010 (estimated)
- Study startNov 2009
- Primary completionJul 2010
- Study completionJul 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Airway ComplicationsStudies of the same condition, open and under way.
- More trials run by University of MalayaThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Malaya
- Sponsor type
- University, hospital or other
- Collaborators
- Malaysian Society of Anaesthesiologists
- Responsible party
- Principal investigator, Cindy Thomas Joseph, University of Malaya
- Investigators
- Cindy Thomas Joseph, Principal investigator, Department of Anaesthesiology, UMMC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01083953
- Sponsor's protocol ID
- supreme sevo vs des
- Status last verified
- Dec 2015
- First submitted
- 8 Mar 2010
- Last updated
- 3 Dec 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimal End-Tidal Concentration of Sevoflurane and Desflurane for Removal of Supreme Laryngeal Mask Airway in Anaesthetized Adults
- ClinicalTrials.gov ID
- NCT01083953
- Acronym / sponsor ID
- supreme sevo vs des
- Conditions
- Airway Complications
- Keywords
- end tidal concentration
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- University of MalayaUniversity, hospital or other
- Collaborators
- Malaysian Society of Anaesthesiologists
- Study start
- Nov 2009
- Primary completion
- Jul 2010 (actual)
- Study completion
- Jul 2010 (actual)
- First posted
- 10 Mar 2010 (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 purpose of this study is to determine the optimal volatile anaesthetic (sevoflurane and desflurane) to remove a Supreme LMA in adults in which there is minimal airway response.
Null hypothesis: there is no significant difference between the optimal end tidal concentration of sevoflurane and desflurane for Supreme LMA removal.
Detailed description
The manufactures' instructions for removal of the LMA recommend waiting until protective reflexes have returned. However, the appropriate timing for removal remains controversial. A more frequent incidence of airway hyperreactivity and complications has been reported by some studies when the LMA was removed in the awake state versus the anesthetized state. Techniques that reduce the time from LMA removal to the return of protective airway reflexes would minimize the risk of aspiration, contamination, or airway obstruction.
With increasingly common use of Supreme LMA in anaesthetic practice, a safe and suitable depth for removal of the Supreme LMA requires research.
Thus the determination of the optimal end-tidal concentration of commonly used volatile agents ie. Sevoflurane and Desflurane for Supreme LMA removal requires research, both for patient safety and minimising anaesthetic costs in dealing with airway complications.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sevoflurane | Experimental | Drug: Sevoflurane1 arm will receive sevoflurane at varying concentrations at which extubation is attempted according to the Dixon up and down method |
| Desflurane | Experimental | Drug: Desflurane1 arm will receive desflurane at varying end tidal concentration at which extubation will be attempted according to Dixon up and down method |
Who may qualify
- Ages
- 18 to 49 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- ASA 1-2 patients
- Age 18 - 49 years old
- Elective surgery of short duration ( < 2 hours ) which require local anaesthetic infiltration
Key exclusion criteria (6 listed)
- Upper respiratory tract symptoms in the previous 10 days
- Risk of gastric oesophageal reflux or regurgitation
- Known or predicted difficult airway
- Poor dentition with high risk of damage
- BMI > 30 kg/m2
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 |
|---|---|---|
| SevofluraneComparing the optimal end-tidal concentration sevoflurane and desflurane for LMA extubation | Drug | Sevoflurane |
| DesfluraneComparing the optimal end-tidal concentration sevoflurane and desflurane for LMA extubation | Drug | Desflurane |
Primary outcome
Optimal end tidal concentration of sevoflurane/ desflurane
Time frame: 6 months
1 secondary outcome
presence of airway response
Time frame: 10 mins after surgery
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 3 Dec 2015.
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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.
Cindy Thomas Joseph principal investigator
Department of Anaesthesiology, UMMC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sevoflurane and Desflurane in people with Airway Complications, run by University of Malaya at 1 site in Malaysia.
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 3 inclusion and 6 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 3 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Malaysia. 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.
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?
Optimal end tidal concentration of sevoflurane/ desflurane (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 3 Dec 2015.