Study of adequacy of Local Anesthesia in Upper GI Endoscopy without sedatio
Not Applicable
- Conditions
- Health Condition 1: null- Patients planned for Upper GI Endoscopy for assessment of their symptoms or condition
- Registration Number
- CTRI/2017/05/008560
- Lead Sponsor
- Tata Memorial Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 100
Inclusion Criteria
Consecutive patients aged between 18 and 75 years referred for diagnostic upper GI endoscopy will be considered for inclusion in the study
Exclusion Criteria
1.Refusal to participate or refusal for unsedated upper GI endoscopy
2.ECOG performance score > 2
3.Co-morbid illness with ASA risk of > 2 or critically ill
4.Known oropharyngeal/ pharyngeal disorder
5.Vocal cord palsy or head and neck cancers
6.Known psychiatric illness
7.Generalized Anxiety Disorder Questionnaire: GAD-7 score >10
8.Endoscopy performed by trans-nasal route or using an ultra-thin endoscope
9.Emergency Endoscopy
10.Therapeutic endoscopy
11.Limited examinations
12.Known lidocaine allergy
13.Pregnant Women
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Suppression of gagging after topical pharyngeal anesthesia scored by the Modified Dickinson and Fiske Gagging Severity Index (DF-GSI).Timepoint: Intraprocedure- during upper GI endoscopy the mDF-GSI will be measured
- Secondary Outcome Measures
Name Time Method 1. Testâ??retest reliability of modified DF-GSI between raters <br/ ><br>2. Testâ??retest reliability of modified GCS between raters <br/ ><br>3. Patient reported pharyngeal numbness pre-procedure <br/ ><br>4. Patient reported difficulty in swallowing the scope <br/ ><br>5. Endoscopistâ??s rating of difficulty in intubation <br/ ><br>6. Endoscopist rating of difficultly in performance of endoscopy related to gagging/ retching <br/ ><br>7. Willingness to repeat the examination under similar conditions.Timepoint: Intra and post procedure- during and after upper GI endoscopy