NCT06220175

Brief Summary

This is a comparative study on patient and endoscopist experience during upper gastrointestinal endoscopy with NSAIDs (flurbiprofen) topical analgesia plus xilocaine spray topical anesthesia of the pharynx versus xilocaine spray topical anesthesia of the pharynx alone, before procedure.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
37

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 11, 2024

Completed
12 days until next milestone

First Posted

Study publicly available on registry

January 23, 2024

Completed
1 month until next milestone

Study Start

First participant enrolled

March 1, 2024

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2024

Completed
Last Updated

November 12, 2024

Status Verified

November 1, 2024

Enrollment Period

6 months

First QC Date

January 11, 2024

Last Update Submit

November 9, 2024

Conditions

Upper Gastrointestinal Endoscopy

Outcome Measures

Primary Outcomes (1)

  • Patient satisfaction score

    Evaluation on visual score 0 - 10 (0 - minimum, 10 - maximum)

    24 hours

Secondary Outcomes (4)

  • Patient discomfort score

    24 hours

  • Patient pain score

    24 hours

  • Patient gag score

    24 hours

  • Endoscopist satisfaction score

    24 hours

Study Arms (2)

Strepsils Intensiv Arm + Xilocaine Spray

EXPERIMENTAL

Patient will take one pill of Strepsils Intensiv containing 8.75mg flurbiprofen 10 to 15 minutes before endoscopy. The patient will have pharyngeal topical xilocaine spray before upper GI endoscopy, 5 puffs in two applications immediately before examination.

Drug: Strepsils Intensiv plus Xilocaine spray Arm

Xilocaine Spray Arm

ACTIVE COMPARATOR

The patient will have pharyngeal topical xilocaine spray before upper GI endoscopy, 5 puffs in two applications immediately before examination.

Drug: Xilocaine Spray Arm

Interventions

Strepsils Intensiv plus Xilocaine spray ArmDRUG

After Stepsils Intensiv ingestion, upper GI endoscopy will be performed with a standard diameter tube, with SpO2 non invasive monitoring.

Also known as: Strepsils + Xilocaine Spray
Strepsils Intensiv Arm + Xilocaine Spray
Xilocaine Spray ArmDRUG

After Xilocaine Spray pharyngeal topical anestesia, upper GI endoscopy will be performed with a standard diameter tube, with SpO2 non invasive monitoring.

Also known as: Xilocaine
Xilocaine Spray Arm

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patient with indication of upper gastrointestinal endoscopy with topical pharyngeal anesthesia with xilocaine spray
  • Age above 18 years
  • Informed consent

You may not qualify if:

  • Allergy to xilocaine and/or flurbiprofen
  • Absence of informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

"Agrippa Ionescu" Hospital

Bucharest, Romania

Location

Related Publications (3)

  • Amornyotin S, Srikureja W, Chalayonnavin W, Kongphlay S, Chatchawankitkul S. Topical viscous lidocaine solution versus lidocaine spray for pharyngeal anesthesia in unsedated esophagogastroduodenoscopy. Endoscopy. 2009 Jul;41(7):581-6. doi: 10.1055/s-0029-1214865. Epub 2009 Jul 8.

    PMID: 19588284BACKGROUND

  • Chan CK, Fok KL, Poon CM. Flavored anesthetic lozenge versus Xylocaine spray used as topical pharyngeal anesthesia for unsedated esophagogastroduodenoscopy: a randomized placebo-controlled trial. Surg Endosc. 2010 Apr;24(4):897-901. doi: 10.1007/s00464-009-0687-9.

    PMID: 19730942BACKGROUND

  • Mahawongkajit P, Talalak N, Soonthornkes N. Comparison of Lidocaine Spray and Lidocaine Ice Popsicle in Patients Undergoing Unsedated Esophagogastroduodenoscopy: A Single Center Prospective Randomized Controlled Trial. Clin Exp Gastroenterol. 2021 May 25;14:209-216. doi: 10.2147/CEG.S301163. eCollection 2021.

    PMID: 34079324BACKGROUND

MeSH Terms

Interventions

Strepsils

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor of Gastroenterology

Study Record Dates

First Submitted

January 11, 2024

First Posted

January 23, 2024

Study Start

March 1, 2024

Primary Completion

August 31, 2024

Study Completion

August 31, 2024

Last Updated

November 12, 2024

Record last verified: 2024-11

Data Sharing

IPD Sharing
Will not share

Locations

RO(1)