Does LMA Instead of ET Tube Affect Incidence of Postoperative Vomiting in Children Undergoing Strabismus Correction?

Sponsor

The University of Texas Health Science Center, Houston (Other)

Overall Status

Completed

CT.gov ID

NCT00338559

Collaborator

(none)

Enrollment

Location

90.1

Duration (Months)

0.8

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The effect of airway management on vomiting after strabismus surgery is unknown. The purpose of this study is to find out whether the use of different airway devices, such as LMA, which is a special mask placed in the throat or Endotracheal tube (ET tube), which is a soft tube placed in the wind pipe, affects the incidence of vomiting after surgery. Two hundred six children between the ages of 2 and 12 years are expected to take part in this study.

Condition or Disease	Intervention/Treatment	Phase
Strabismus

Detailed Description

The child will be checked by the study doctor to determine if he/she qualifies to be part of the study. The study doctor may not want the child to take part in this study if he/she is currently in another research study; or if the child has been in any other research study within the last 30 days, or if the child is extremely obese, or has reflux or another GI problem.

If the child qualifies for the study, he/she will receive routine general anesthesia. For airway management, the child will have either a LMA or ET tube. The child has an equal chance of receiving either one of these airways devices, much like the coin flip.

After surgery, the child will be transferred to the recovery room (PACU). If the child vomits in PACU, he/she will receive rescue medication, which can be repeated if the need arises.

A research coordinator will call the parents the following day to find out whether the child vomited after leaving the hospital, in the car or at home, for any complications and receiving any medications.

Study Design

Study Type:

Observational

Actual Enrollment :

71 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Does Using Laryngeal Mask Airway (LMA) Instead of an Endotracheal Tube (ET Tube) Affect the Incidence of Postoperative Vomiting in Children Undergoing Strabismus Correction? - An Observational Study

Study Start Date :

May 1, 2006

Actual Primary Completion Date :

Nov 1, 2013

Actual Study Completion Date :

Nov 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
LMA group Patients in which laryngeal mask airway (LMA) is used.
ET group Patients in which endotracheal tube (ET) is used.

Outcome Measures

Primary Outcome Measures

Numbers of the patients that will develop postoperative vomiting in children undergoing strabismus correction [2 days]

Eligibility Criteria

Criteria

Ages Eligible for Study:

1 Year to 12 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Patients with Elective Uni- or Bilateral Strabismus repair

Exclusion Criteria:

ASA >2
History of Prematurity
History of Reflux
History of Neurological Disease
Difficult Airway
Obesity

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Memorial Hermann Hospital	Houston	Texas	United States	77030

Sponsors and Collaborators

The University of Texas Health Science Center, Houston

Investigators

Principal Investigator: Samia N Khalil, MD, University of Texas HSC at Houston

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Samia Khalil, Professor - Anesthesiology, The University of Texas Health Science Center, Houston

ClinicalTrials.gov Identifier:

NCT00338559

Other Study ID Numbers:

HSC-MS-06-0059

First Posted:

Jun 20, 2006

Last Update Posted:

Dec 3, 2014

Last Verified:

Dec 1, 2014

Keywords provided by Samia Khalil, Professor - Anesthesiology, The University of Texas Health Science Center, Houston

Additional relevant MeSH terms:

Strabismus

Vomiting

Postoperative Nausea and Vomiting

Study Results

No Results Posted as of Dec 3, 2014