Status:
COMPLETED
Study on General Population of the Effect on Airway Protection of Drugs Used During Induction of General Anesthesia
Lead Sponsor:
Hospital San Carlos, Madrid
Conditions:
Aspiration
Eligibility:
All Genders
35-85 years
Brief Summary
Upper esophageal sphincter is a high pressure zone of the pharynx and protects airway from aspiration of esophageal or gastric contents. Existing literature concludes that many of the drugs employed t...
Detailed Description
BACKGROUND Upper esophageal sphincter is a high pressure zone, behind the cricoid cartilage, which protects airway from aspiration. It consists on striated muscle fibers distributed in two zones: rap...
Eligibility Criteria
Inclusion
- Candidates ought to comply with all these conditions:
- Had been classified by an anesthesiologist (not participating in the study) , at the preanesthetic consult as I, II or III class from the ASA (American Society of Anesthesiologists) classification in reference to his/her anesthetic risk.
- Patients of any gender.
- Patients aged 35 to 85 years old.
- Candidates to planned general surgery to be given general anesthesia.
- Be correctly informed through orally and in writing about the study.
- Voluntary acceptance to participate in the study, voluntary signing the informed consent , which could be revoked at any time through the study.
- Not presenting any of the exclusion criteria.
Exclusion
- Presenting known allergy or hypersensitivity to any of the drugs to be potentially administered.
- Pregnancy.
- Psychiatric history or being on treatment with psychotropic drugs.
- Being on treatment with any of these drugs (which can cause alterations in esophageal motility): prokinetics, sedatives, calcium channel antagonists, nitrates, anticholinergics, tricyclic antidepressants, teophyline.
- Having had esophageal surgery.
- Those who, from an anesthetic or medical point of view could present complications during the process. For example: difficult airway or problems with ventilation.
- Renal or hepatic alteration which may interfere with hypnotics pharmacokinetics.
- Renounce to sign informed consent, therefore not authorizing to participate in the study.
- Not presenting any of the inclusion criteria.
- Esophageal pathology, including gastroesophageal reflux or dysphagia. Given the high frequency of presenting any of these two lasts, tests were given to the candidates to discard their presence. Two questionnaires were employed: "GERD-Q" (GastroEsophageal Disease- Questionnaire) and "EAT-10" (Eating Assesment Tool) for dysphagia.
Key Trial Info
Start Date :
January 10 2017
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
July 18 2019
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT04413422
Start Date
January 10 2017
End Date
July 18 2019
Last Update
June 4 2020
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