Trial- Dysphagia From ETT or GI Endoscopy

NCT02460055 | Withdrawn

• 1 other identifier: H-32691
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief 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

Dysphagia; Respiratory Complications

Keywords

EGD Dysphagia; ETT Intubation dysphagia

Outcome Measures

Primary Outcomes (1)

• Incidence of Dysphagia

  Dysphagia will be determined by a scale ( 0=no sore throat, 1=mild sore throat, 2=moderate sore throat, 3=severe sore throat) and Visual analog scale .

  up to 24 hours

Secondary Outcomes (1)

• Patient Satisfaction

  up to 24 hours

Other Outcomes (2)

• Time efficiency with no ETT Intubation

  up to 24 hours

• Respiratory Compromise

  up to 24 hours

Study Arms (2)

Endotracheal tube

ACTIVE COMPARATOR

Following routine inhalation induction with 8% sevoflurane in oxygen and nitrous oxide, 100% oxygen will be administered and intravenous access will be secured. Intravenous administration of Propofol 3mg/kg and Fentanyl 1mcg/kg will be administered to facilitate endotracheal intubation with an age appropriate endotracheal tube. Presence of an audible air leak around the endotracheal tube will be addressed by inflating the cuff with air until the audible leak is no longer appreciated. The endotracheal tube will not be lubricated prior to intubation. Other medications that will be administered during the procedure include Dexamethasone at a dose of 0.15mg/kg up to 20 mg and Ondansetron 0.15mg/kg up to 4mg.

Device: endotracheal tube; Drug: propofol; Drug: Fentanyl; Drug: Dexamethasone; Drug: Ondansetron; Drug: sevoflurane, nitrous oxide and oxygen

No Endotracheal tube

ACTIVE COMPARATOR

Those not receiving endotracheal intubation will undergo an inhalation induction, have intravenous access secured and intravenous propofol 3mg/kg with Fentanyl 1mcg/kg will be administered prior to placement of the nasal trumpet and connection to the anesthesia circuit.patients will receive a general anesthetic consisting of sevoflurane in oxygen and air at routine concentrations for maintenance of anesthesiaOther medications that will be administered during the procedure to both arms of patients include Dexamethasone which will be administered at a dose of 0.15mg/kg up to 20 mg and Ondansetron 0.15mg/kg up to 4mg for post operative nausea and vomiting prophylaxis.

Drug: propofol; Drug: Fentanyl; Drug: Dexamethasone; Drug: Ondansetron; Drug: sevoflurane, nitrous oxide and oxygen

Interventions

endotracheal tube DEVICE

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

Endotracheal tube

propofol DRUG

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

Endotracheal tube; No Endotracheal tube

Fentanyl DRUG

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

Endotracheal tube; No Endotracheal tube

Dexamethasone DRUG

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

Endotracheal tube; No Endotracheal tube

Ondansetron DRUG

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

Endotracheal tube; No Endotracheal tube

sevoflurane, nitrous oxide and oxygen DRUG

Inhalational agents will be used to induce general anesthesia

Endotracheal tube; No Endotracheal tube

Eligibility Criteria

• Age: 5 Years - 17 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Patients between the ages of 5-17 with normal cognitive function, without medical comorbidities who are scheduled to undergo esophagogastroduodenoscopy under general anesthesia will be recruited for the study

You may not qualify if:

• Patients under the age of five, or those between ages 5-17 years with cognitive delay or neurological disease scheduled to undergo Upper GI endoscopy will be excluded.
• Patients who currently have a sore throat or had a sore throat within the past one week will not be included in this study.
• Other patients with cardiopulmonary disease, coagulopathies, hepatorenal disease, endocrinological disease or airway abnormalities will also be excluded.

Sponsors & Collaborators

• Baylor College of Medicine: lead

MeSH Terms

Conditions

Deglutition Disorders

Interventions

Propofol; Fentanyl; Dexamethasone; Ondansetron; Sevoflurane; Nitrous Oxide; Oxygen

Condition Hierarchy (Ancestors)

Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Pharyngeal Diseases; Otorhinolaryngologic Diseases

Intervention Hierarchy (Ancestors)

Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated; Imidazoles; Azoles; Carbazoles; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds, 3-Ring; Methyl Ethers; Ethers; Hydrocarbons, Fluorinated; Hydrocarbons, Halogenated; Nitrogen Oxides; Gases; Inorganic Chemicals; Nitrogen Compounds; Oxides; Oxygen Compounds; Chalcogens; Elements

Study Officials

• Imelda M Tjia, MD

  Baylor College of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 27, 2015
• First Posted: June 2, 2015
• Study Start: March 1, 2016
• Primary Completion: June 1, 2016
• Study Completion: June 1, 2016
• Last Updated: March 9, 2020

Record last verified: 2020-03