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Study of adequacy of Local Anesthesia in Upper GI Endoscopy without sedation

Optimizing Topical Pharyngeal Anesthesia in Unsedated Upper Endoscopy Practice.

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2017/05/008560
Enrollment
100
Registered
2017-05-15
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: null- Patients planned for Upper GI Endoscopy for assessment of their symptoms or condition

Interventions

Intervention1: Unsedated Upper GI Endoscopy using topical pharyngeal anaesthesia: After informed consent, pre-procedure assessment of patient anxiety is done using GAD-7 questionnaire. If the patient

Sponsors

Tata Memorial Hospital
Lead Sponsor

Eligibility

Inclusion criteria

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

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

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
1. Testâ??retest reliability of modified DF-GSI between raters 2. Testâ??retest reliability of modified GCS between raters 3. Patient reported pharyngeal numbness pre-procedure 4. Patient reported difficulty in swallowing the scope 5. Endoscopistâ??s rating of difficulty in intubation 6. Endoscopist rating of difficultly in performance of endoscopy related to gagging/ retching 7. Willingness to repeat the examination under similar conditions.Timepoint: Intra and post procedure- during and after upper GI endoscopy

Countries

India

Contacts

Public ContactDr Sridhar Sundaram

Tata Memorial Centre

drsridharsundaram@gmail.com9860096846

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026