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The Optimal Time to Put Laryngeal Mask Airway in the Mouth Under General Anesthesia

The Optimal Time of Insertion of Laryngeal Mask Airway With Propofol Induction

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00972491
Acronym
LMA
Enrollment
198
Registered
2009-09-07
Start date
2009-09-30
Completion date
2013-12-31
Last updated
2013-12-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

General Anesthesia

Brief 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. 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: 1. Insertion of LMA (easy, difficult, impossible) 2. Coughing or gagging (none, some, significant) 3. Head or body movement (none, some, significant) 4. Laryngospasm or airway obstruction (none, partial, total)

Interventions

PROCEDUREInsertion of Laryngeal Mask Airway

The LMA will be inserted at 0 sec, 60 sec. and 90 sec. after induction of general anesthesia

Sponsors

Tufts Medical Center
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No

Inclusion criteria

* subjects 18 years or older * ASA status 1-3

Exclusion criteria

* high risk of aspiration * anticipated difficult airway * use of sedative drugs * patient refusal

Design outcomes

Primary

MeasureTime frame
Ease of Mouth openingFrom Induction of general anesthesia to satisfactory LMA insertion

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026