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

Sponsor
Tufts Medical Center (Other)
Overall Status
Completed
CT.gov ID
NCT00972491
Collaborator
(none)
198
Enrollment
1
Location
1
Arm
51
Duration (Months)
3.9
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Insertion of Laryngeal Mask Airway
 N/A

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)

Study Design

Study Type:
Interventional
Actual Enrollment :
198 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
The Optimal Time of Insertion of Laryngeal Mask Airway With Propofol Induction
Study Start Date :
Sep 1, 2009
Actual Primary Completion Date :
Dec 1, 2013
Actual Study Completion Date :
Dec 1, 2013

Arms and Interventions

Arm Intervention/Treatment
Other: 0 sec, 60 sec, 90 sec

LMA will be inserted at 0, 60, and 90 seconds after eyelash reflex disappears

Procedure: Insertion of Laryngeal Mask Airway
The LMA will be inserted at 0 sec, 60 sec. and 90 sec. after induction of general anesthesia
Other Names:
  • Laryngeal Mask Airway

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Ease of Mouth opening [From Induction of general anesthesia to satisfactory LMA insertion]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 65 Years
    Sexes Eligible for Study:
    All
    Accepts 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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Tufts Medical Center Boston Massachusetts United States 02111

    Sponsors and Collaborators

    • Tufts Medical Center

    Investigators

    • Principal Investigator: Pei-shan Zhao, MD,PhD, Tufts Medical Center

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Tufts Medical Center
    ClinicalTrials.gov Identifier:
    NCT00972491
    Other Study ID Numbers:
    • IRB-8910
    First Posted:
    Sep 7, 2009
    Last Update Posted:
    Dec 4, 2013
    Last Verified:
    Dec 1, 2013

    Study Results

    No Results Posted as of Dec 4, 2013