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Completed

NCT Number: NCT00972491

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

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.

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Key information

Conditions

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Tufts Medical Center

Boston, Massachusetts, 02111, United States

About this study

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)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Insertion of Laryngeal Mask Airway

Procedure

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

Other names: Laryngeal Mask Airway

Primary outcomes

  1. Ease of Mouth opening

    Time frame: From Induction of general anesthesia to satisfactory LMA insertion

Sponsors and collaborators

Lead sponsor

Tufts Medical Center

Other

Registry information

Official study title

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

Acronym: LMA

Important dates

Study start
2009
Primary completion
2013
Study completion
2013
First posted
Sep 7, 2009
Registry last updated
Dec 4, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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