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

NCT ID: NCT00972491

Last Updated: 2013-12-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 198 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-09-30
• Study Completion Date: 2013-12-31

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)

Conditions

General Anesthesia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

0 sec, 60 sec, 90 sec

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

Group Type: OTHER

Insertion of Laryngeal Mask Airway

Intervention Type: PROCEDURE

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

Interventions

Insertion of Laryngeal Mask Airway

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

Intervention Type: PROCEDURE

Other Intervention Names

Laryngeal Mask Airway

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Tufts Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Pei-shan Zhao, MD,PhD

Role: PRINCIPAL_INVESTIGATOR

Tufts Medical Center

Locations

Tufts Medical Center

Boston, Massachusetts, United States

Countries

United States

Other Identifiers

IRB-8910

Identifier Type: -

Identifier Source: org_study_id