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Trial- Dysphagia From ETT or GI Endoscopy

NCT02460055 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2020-03-09

No results posted yet for this study

Summary

The purpose of this study is to conduct a randomized clinical trial to compare the incidence of dysphagia in patients receiving general anesthesia with and without an endotracheal tube for Upper gastrointestinal endoscopy. If the incidence of dysphagia is found to be increased following endotracheal intubation for this procedure it could influence the investigators practice as anesthesiologists and may mandate the future routine use of laryngeal tracheal application of lidocaine at the time of intubation for example.

Conditions

Interventions

DEVICE

endotracheal tube

This study will determine if the placement of an ETT will lead to dysphagia.

DRUG

propofol

propofol 3mg/kg will be administered to facilitate endotracheal intubation

DRUG

Fentanyl

Fentanyl 1mcg/kg will be administered to facilitate endotracheal intubation

DRUG

Dexamethasone

Dexamethasone 0.15mg/kg up to 20 mg will be used for anti-emesis prophylaxis

DRUG

Ondansetron

Ondansetron 0.15mg/kg up to 4mg will be used for anti-emesis prophylaxis

DRUG

sevoflurane, nitrous oxide and oxygen

Inhalational agents will be used to induce general anesthesia

Sponsors & Collaborators

  • Baylor College of Medicine

    lead OTHER

Principal Investigators

  • Imelda M Tjia, MD · Baylor College of Medicine

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
5 Years
Max Age
17 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2016-03-31
Primary Completion
2016-06-30
Completion
2016-06-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02460055 on ClinicalTrials.gov