General AnesthesiaLMANCT00972491
The Optimal Time to Put Laryngeal Mask Airway in the Mouth Under General Anesthesia
A study testing Insertion of Laryngeal Mask Airway in people with General Anesthesia, run by Tufts Medical Center at 1 site in United States.
Trial summary
Laryngeal mask airway (LMA) is routinely used for some patients who have surgery under general anesthesia. LMA is placed in the mouth and allow the anesthesia to be given without having to put a breathing tube in the throat. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- General Anesthesia
- What is being tested?
- Insertion of Laryngeal Mask Airway
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 198 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2009to Dec 2013
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- subjects 18 years or older
- ASA status 1-3
Who cannot join
- high risk of aspiration
- anticipated difficult airway
- use of sedative drugs
- patient refusal
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Optimal Time of Insertion of Laryngeal Mask Airway With Propofol Induction
Laryngeal mask airway (LMA) is routinely used for some patients who have surgery under general anesthesia. LMA is placed in the mouth and allow the anesthesia to be given without having to put a breathing tube in the throat. Previous studies have focused on the effect of different anesthesia medicines on optimal condition for LMA use. The objective of the present study is to find the optimal time for LMA insertion.
Read the detailed description
This is a randomized, controlled, blinded trial. Midazolam, 2 mg and fentanyl 1.0 µg/kg, would be given prior to induction with propofol, 2.5 mg/kg.
The investigator who does the induction of general anesthesia will also be responsible for the timekeeping. For this reason, it is not possible for this investigator to be blinded to randomization. The induction would conclude after loss of eyelash reflex (LER). At that point insertion of the LMA (#4 for females, #5 for males) will occur 0, 60 and 90 seconds after LER. The LMA will be lubricated with a water soluble gel and will be inserted with a deflated cuff according to the technique described by Brain.
The investigator who inserts the LMA (Inv1) will be in the operating room and blinded to randomization groups by not seeing the induction of general anesthesia. This investigator will insert the LMA only when called by the investigator who induces general anesthesia (Inv2). Inv1 will also grade ease of LMA insertion.
The primary outcome is Jaw opening at the time of LMA insertion, defined as full 1, partial 2, and nil 3.
Secondary outcomes include:
- Insertion of LMA (easy, difficult, impossible)
- Coughing or gagging (none, some, significant)
- Head or body movement (none, some, significant)
- Laryngospasm or airway obstruction (none, partial, total)
- Conditions
- General Anesthesia
- Being tested
- Insertion of Laryngeal Mask Airway
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Insertion of Laryngeal Mask AirwayProcedure or surgery
Also called Laryngeal Mask Airway
The LMA will be inserted at 0 sec, 60 sec. and 90 sec. after induction of general anesthesia
| Study group | Role | What they receive |
|---|---|---|
| 0 sec, 60 sec, 90 sec | Other | LMA will be inserted at 0, 60, and 90 seconds after eyelash reflex disappears Receives: Procedure: Insertion of Laryngeal Mask Airway |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ease of Mouth opening
Measured: From Induction of general anesthesia to satisfactory LMA insertion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2009 (estimated)
- Study startSep 2009
- Primary completionDec 2013
- Study completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for General AnesthesiaStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 198 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tufts Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Pei-shan Zhao, MD,PhD, Principal investigator, Tufts Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00972491
- Sponsor's protocol ID
- IRB-8910
- Acronym
- LMA
- Status last verified
- Dec 2013
- First submitted
- 3 Sep 2009
- Last updated
- 4 Dec 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Optimal Time of Insertion of Laryngeal Mask Airway With Propofol Induction
- ClinicalTrials.gov ID
- NCT00972491
- Acronym / sponsor ID
- LMA / IRB-8910
- Conditions
- General Anesthesia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 198 participants (actual)
- Lead sponsor
- Tufts Medical CenterUniversity, hospital or other
- Study start
- Sep 2009
- Primary completion
- Dec 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 7 Sep 2009 (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.
Laryngeal mask airway (LMA) is routinely used for some patients who have surgery under general anesthesia. LMA is placed in the mouth and allow the anesthesia to be given without having to put a breathing tube in the throat. Previous studies have focused on the effect of different anesthesia medicines on optimal condition for LMA use. The objective of the present study is to find the optimal time for LMA insertion.
Detailed description
This is a randomized, controlled, blinded trial. Midazolam, 2 mg and fentanyl 1.0 µg/kg, would be given prior to induction with propofol, 2.5 mg/kg.
The investigator who does the induction of general anesthesia will also be responsible for the timekeeping. For this reason, it is not possible for this investigator to be blinded to randomization. The induction would conclude after loss of eyelash reflex (LER). At that point insertion of the LMA (#4 for females, #5 for males) will occur 0, 60 and 90 seconds after LER. The LMA will be lubricated with a water soluble gel and will be inserted with a deflated cuff according to the technique described by Brain.
The investigator who inserts the LMA (Inv1) will be in the operating room and blinded to randomization groups by not seeing the induction of general anesthesia. This investigator will insert the LMA only when called by the investigator who induces general anesthesia (Inv2). Inv1 will also grade ease of LMA insertion.
The primary outcome is Jaw opening at the time of LMA insertion, defined as full 1, partial 2, and nil 3.
Secondary outcomes include:
- Insertion of LMA (easy, difficult, impossible)
- Coughing or gagging (none, some, significant)
- Head or body movement (none, some, significant)
- Laryngospasm or airway obstruction (none, partial, total)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 0 sec, 60 sec, 90 sec | Other | Procedure: Insertion of Laryngeal Mask AirwayLMA will be inserted at 0, 60, and 90 seconds after eyelash reflex disappears |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- subjects 18 years or older
- ASA status 1-3
Key exclusion criteria (4 listed)
- high risk of aspiration
- anticipated difficult airway
- use of sedative drugs
- patient refusal
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 |
|---|---|---|
| Insertion of Laryngeal Mask AirwayAlso: Laryngeal Mask AirwayThe LMA will be inserted at 0 sec, 60 sec. and 90 sec. after induction of general anesthesia | Procedure or surgery | 0 sec, 60 sec, 90 sec |
Primary outcome
Ease of Mouth opening
Time frame: From Induction of general anesthesia to satisfactory LMA insertion
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 4 Dec 2013.
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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.
Pei-shan Zhao, MD,PhD principal investigator
Tufts Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Insertion of Laryngeal Mask Airway in people with General Anesthesia, run by Tufts Medical Center at 1 site in United States.
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 2 inclusion and 4 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 4 Dec 2013. 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 United States. 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?
Ease of Mouth opening (time frame: From Induction of general anesthesia to satisfactory LMA insertion). 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 4 Dec 2013.