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| Sponsored by: |
The University of Texas Health Science Center, Houston |
|---|---|
| Information provided by: | The University of Texas Health Science Center, Houston |
| ClinicalTrials.gov Identifier: | NCT00338559 |
Purpose
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.
| Study Type: | Observational |
| Study Design: | Cohort, Retrospective |
| 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 |
| Estimated Enrollment: | 206 |
| Study Start Date: | May 2006 |
| Estimated Study Completion Date: | June 2009 |
| Estimated Primary Completion Date: | November 2008 (Final data collection date for primary outcome measure) |
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.
Eligibility| Ages Eligible for Study: | 1 Year to 12 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Probability Sample |
Two hundred six children between the ages of 1 and 12 years are expected to take part in this study.
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Samia Khalil, MD | 713-500-6242 | Samia.Khalil@uth.tmc.edu |
| Contact: Ranasinghe Perera, MD | 713-500-6194 | Ranasinghe.Perera@uth.tmc.edu |
| United States, Texas | |
| Memorial Hermann Hospital | Recruiting |
| Houston, Texas, United States, 77030 | |
| Principal Investigator: Samia N Khalil, MD | |
| Principal Investigator: | Samia N Khalil, MD | University of Texas HSC at Houston |
| Study Director: | Ranasinghe Perera, MD | University of Texas HSC at Houston |
More Information
| Responsible Party: | University of Texas Health Science Center ( Samia N. Khalil, M.D. ) |
| Study ID Numbers: | HSC-MS-06-0059 |
| Study First Received: | June 15, 2006 |
| Last Updated: | January 5, 2009 |
| ClinicalTrials.gov Identifier: | NCT00338559 |
| Health Authority: | United States: Institutional Review Board |
|
Strabismus LMA ET Tube POV |
|
Signs and Symptoms Ocular Motility Disorders Motor neuro-ophthalmic disorders Postoperative Nausea and Vomiting Vomiting Signs and Symptoms, Digestive |
Postoperative Complications Eye Diseases Strabismus Nausea Ocular motility disorders |
|
Pathologic Processes Nervous System Diseases Cranial Nerve Diseases |
