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

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ClinicalTrials.gov Identifier: NCT00972491
Recruitment Status : Completed
First Posted : September 7, 2009
Last Update Posted : December 4, 2013
Sponsor:
Information provided by (Responsible Party):
Tufts Medical Center

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
General Anesthesia Procedure: Insertion of Laryngeal Mask Airway Not Applicable

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 Type : Interventional  (Clinical Trial)
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 : September 2009
Actual Primary Completion Date : December 2013
Actual Study Completion Date : December 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anesthesia

Arm Intervention/treatment
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 Name: Laryngeal Mask Airway




Primary Outcome Measures :
  1. Ease of Mouth opening [ Time Frame: From Induction of general anesthesia to satisfactory LMA insertion ]


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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00972491


Locations
United States, Massachusetts
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

Responsible Party: Tufts Medical Center
ClinicalTrials.gov Identifier: NCT00972491     History of Changes
Other Study ID Numbers: IRB-8910
First Posted: September 7, 2009    Key Record Dates
Last Update Posted: December 4, 2013
Last Verified: December 2013