Airway ResponseNCT01371968
Optimal Dose of Alfentanil for Removal of Supreme Laryngeal Mask Airway During Emergence From Desflurane Anaesthesia
A study testing alfentanil in people with Airway Response, run by University of Malaya at 1 site in Malaysia.
Trial summary
This study aims to determine the optimal dose of alfentanil in suppressing the airway reflexes during supreme LMA removal in anaesthetized adult. Read more about this study
- Who is it for?
- Ages 18 to 49 yearsHealthy volunteers can take part
- Conditions the study is for
- Airway Response
- What is being tested?
- alfentanil
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteMalaysia
- Study dates
- Feb 2011to Nov 2011
- 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 I and II patients
- Age 18 to 49 years old
- Minor elective day care surgery (> 20 minute and less than 2 hours) which require local anaesthetic infiltration and does not require use of long acting opioids.
Who cannot join
- Potential difficult airway
- Reactive airway disease or sign and symptoms of upper respiratory tract infection.
- History of cardiac, pulmonary and renal diseases
- Body Mass Index > 30 kgm2.
- Risk of aspiration.
- Poor dentition with high risk of damage.
- Patient refusal.
Trial locations and contacts
1 site in 1 country.
About this study
This study aims to determine the optimal dose of alfentanil in suppressing the airway reflexes during supreme LMA removal in anaesthetized adult.
Read the detailed description
The removal of LMA may be associated with coughing, biting, agitation and airway complication such as laryngospasm. Thus it is advisable to remove the LMA when the patient is breathing spontaneously and when the airway reflexes are still depressed. A number of techniques have been used to prevent this adverse emergence phenomenon, such as removing the tube while the patient is in deep plane of anaesthesia or administration of local anaesthetic and intravenous opioids
The administration of intravenous opioids before emergence may be useful for preventing cough, agitation and hemodynamic response. Alfentanyl is proven to suppress cough and agitation during the endotracheal tube emergence. However, its use in suppressing cough in LMA patient has not been evaluated.
- Conditions
- Airway Response
- Being tested
- alfentanil
- Keywords
- Alfentanil, optimal dose, laryngeal mask airway
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
alfentanilDrug
Also called Rapifen
Alfentanil is administered intravenously at the end of surgery.
| Study group | Role | What they receive |
|---|---|---|
| alfentanil | Experimental | patient will received a dose of alfentanil in which the dose of alfentanil is determined by response of previously tested patient using Dixon up and down methods Receives: Drug: alfentanil |
What is being measured
The primary outcome is the main question the study is designed to answer.
Optimal dose of alfentanil for successful LMA removal in spontaneously breathing anaesthetized adults
Measured: 6 months
Secondary outcomes (1)
Number of patient with airway complication
Measured: after administration of alfentanil and within 1 min of LMA removal
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2011 (estimated)
- Study startFeb 2011
- Primary completionAug 2011
- Study completionNov 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Airway ResponseStudies 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 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, Lee Chew Kiok, University of Malaya
- Investigators
- Lee Chew Kiok, MBBS, Principal investigator, Department of Anaesthesiogy, UMMC.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01371968
- Sponsor's protocol ID
- Alfentanil LMA
- Status last verified
- Oct 2017
- First submitted
- 4 May 2011
- Last updated
- 27 Oct 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimal Dose of Alfentanil for Removal of Supreme Laryngeal Mask Airway During Emergence From Desflurane Anaesthesia
- ClinicalTrials.gov ID
- NCT01371968
- Acronym / sponsor ID
- Alfentanil LMA
- Conditions
- Airway Response
- Keywords
- Alfentanil, optimal dose, laryngeal mask airway
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University of MalayaUniversity, hospital or other
- Collaborators
- Malaysian Society of Anaesthesiologists
- Study start
- Feb 2011
- Primary completion
- Aug 2011 (actual)
- Study completion
- Nov 2011 (actual)
- First posted
- 13 Jun 2011 (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.
This study aims to determine the optimal dose of alfentanil in suppressing the airway reflexes during supreme LMA removal in anaesthetized adult.
Detailed description
The removal of LMA may be associated with coughing, biting, agitation and airway complication such as laryngospasm. Thus it is advisable to remove the LMA when the patient is breathing spontaneously and when the airway reflexes are still depressed. A number of techniques have been used to prevent this adverse emergence phenomenon, such as removing the tube while the patient is in deep plane of anaesthesia or administration of local anaesthetic and intravenous opioids
The administration of intravenous opioids before emergence may be useful for preventing cough, agitation and hemodynamic response. Alfentanyl is proven to suppress cough and agitation during the endotracheal tube emergence. However, its use in suppressing cough in LMA patient has not been evaluated.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| alfentanil | Experimental | Drug: alfentanilpatient will received a dose of alfentanil in which the dose of alfentanil is determined by response of previously tested patient using Dixon up and down methods |
Who may qualify
- Ages
- 18 to 49 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- ASA I and II patients
- Age 18 to 49 years old
- Minor elective day care surgery (> 20 minute and less than 2 hours) which require local anaesthetic infiltration and does not require use of long acting opioids.
Key exclusion criteria (7 listed)
- Potential difficult airway
- Reactive airway disease or sign and symptoms of upper respiratory tract infection.
- History of cardiac, pulmonary and renal diseases
- Body Mass Index > 30 kgm2.
- Risk of aspiration.
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 |
|---|---|---|
| alfentanilAlso: RapifenAlfentanil is administered intravenously at the end of surgery. | Drug | alfentanil |
Primary outcome
Optimal dose of alfentanil for successful LMA removal in spontaneously breathing anaesthetized adults
Time frame: 6 months
1 secondary outcome
Number of patient with airway complication
Time frame: after administration of alfentanil and within 1 min of LMA removal
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 27 Oct 2017.
- Individual participant dataSharing planned: Yes
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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.
Lee Chew Kiok, MBBS principal investigator
Department of Anaesthesiogy, 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 alfentanil in people with Airway Response, 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 7 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 27 Oct 2017. 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 dose of alfentanil for successful LMA removal in spontaneously breathing anaesthetized adults (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 27 Oct 2017.