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

General Anesthesia Clinical Trial

— LMA  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00972491
• Other study ID #: IRB-8910
• Status: Completed
• Phase: N/A
• First received: September 3, 2009
• Last updated: December 3, 2013
• Start date: September 2009
• Est. completion date: December 2013

Study information

• Verified date: December 2013
• Source: Tufts Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical 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. 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.

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)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 198
• Est. completion date: December 2013
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• General Anesthesia

Intervention

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

Locations

Country	Name	City	State
United States	Tufts Medical Center	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Tufts Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Ease of Mouth opening		From Induction of general anesthesia to satisfactory LMA insertion	No