Esophageal Manometry During Recovery From Anesthesia: Pilot Study
Status unconfirmed · Not applicable
Conditions studied: Motility Function
In brief
1. An intact pharyngoesophageal reflex is essential to protect the upper airway from aspiration of either mouth contents or regurgitated gastric refluxate. This reflex is essential at protecting the airway in all patients. 2. In patients, while under general anesthesia, it is postulated that an identifiable upper esophageal sphincter and esophageal peristalsis are not present. 3. With the cessation of general anesthetics, accompanied by the reversal of nerve block, normal pharyngoesophageal peristaltic activity correlates with awakening the patient from anesthesia. This would be identified by the performance of esophageal manometry. 4. A return of normal verbally stimulated pharyngoesophageal swallowing sequence accurately identifies a safe time to remove endotracheal tubes and/or reverse anesthesia. This verbally stimulated swallowing sequence correlated precisely with the return of objective pharyngoesophageal function.
Key facts
- Study ID
- NCT02661386
- Run by
- University of California, San Francisco
- People needed
- 10
- Starts
- 2016-01-01
- Expected to finish
- 2021-12-01
- Last updated by the study team
- 2021-02-11
Who can join
Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Patients between 18 and 70 years of age (ASA I or II).
- Already scheduled for routine general anesthetic procedure requiring an endotracheal tube for anesthesia administration.
- Scheduled abdominal surgical procedure including endoscopy, colonoscopy, ERCP, cholecystectomy, appendectomy, colectomy or small bowel resection.
- Willing and able to give informed consent in either English or Spanish.
You may not qualify if…
- Pregnant, breastfeeding, or unwilling to practice birth control during participation in the study.
- Presence of a condition or abnormality that in the opinion of the Investigator would compromise the safety of the patient or the quality of the data.
- Patients not meeting entry criteria above.
- Refusal to give informed consent.
- Coagulopathy (INR > 2 and/or platelet count < 100,000.
- White Blood Cell count < 5,000/mm3
- Arrhythmia
- Serum creatinine > 2 mg/dl
- Prior known or suspected nasal obstruction.
- Known or suspected Zenker's diverticulum of esophagus, esophageal stricture, head/neck radiation therapy, hereditary telangiectasis, esophageal varices, cirrhosis.
- Anticoagulant usage such as heparin or Plavix
Where it is running
- Zuckerberg San Francisco General Hospital — San Francisco, California, United States (enrolling)
Full record on ClinicalTrials.gov
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