A Study Comparing Xylocaine Lozenges and Xylocaine Spray to Reduce Discomfort During Upper GI Endoscopy Under Mild Sedation.

TO COMPARE THE EFFICACY OF XYLOCAINE LOZENGES VS XYLOCAINE SPRAY FOR TOPICAL ANAESTHESIA IN UPPER GI ENDOSCOPY UNDER CONSCIOUS SEDATION - Nil

Status

Active, not recruiting

Phases

Phase 3Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2026/05/111463

Enrollment

134

Registered

2026-05-29

Start date

Unknown

Completion date

Unknown

Last updated

2026-06-01

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

Conditions

Health Condition 1: K20-K31- Diseases of esophagus, stomach and duodenum

Interventions

Intervention1: xylocaine lozenges 200 mg: xylocaine lozenges 200mg given 15 minutes prior to upper GI endoscopy procedure Control Intervention1: 10% xylocaine spray: 10% 20 xylocaine spray given 15 mi

Eligibility

Inclusion criteria

Inclusion criteria: ASA physical status grades I, II, or III.

Exclusion criteria

Exclusion criteria: 1.Known allergy to xylocaine or other local anaesthetics. 2.Severe cardiopulmonary disease, liver failure 3.Pregnancy or lactation. 4.Previous surgery altering oropharyngeal anatomy. 5.Emergency cases with unstable vital signs. 6.Patients with prior UGIE experience 7.Duration of procedure exceeding 45 min 8.Known history of seizure disorders or neurological conditions impacting swallowing and gag reflex. 9.Patients on sedatives, antipsychotics. 10.Patients with severe anxiety

Design outcomes

Primary

Measure	Time frame
Comparison of suppression of gag reflex between both groups will be noted as the primary outcome.Timepoint: Comparison of suppression of gag reflex between both groups will be noted as the primary outcome.	—

Secondary

Measure	Time frame
Duration from the start of the procedure until the procedure was tolerated without significant gagging, total dose of fentanyl required, patient-reported discomfort score, procedural ease, patient satisfaction, & adverse effects, if any, will be noted as secondary outcomes.Timepoint: At 60 minutes post-procedure for patient discomfort NRS score, patient satisfaction Likert scale, & adverse events (intra-procedural & up to 60 minutes post-procedure).	—

Measure

Time frame

Duration from the start of the procedure until the procedure was tolerated without significant gagging, total dose of fentanyl required, patient-reported discomfort score, procedural ease, patient satisfaction, & adverse effects, if any, will be noted as secondary outcomes.Timepoint: At 60 minutes post-procedure for patient discomfort NRS score, patient satisfaction Likert scale, & adverse events (intra-procedural & up to 60 minutes post-procedure).

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Countries

India

Contacts

Public ContactDr Anugreh

Dayanand Medical College and Hospital

anugreh029@gmail.com9779327153

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Jun 11, 2026