NCT02733471

Brief Summary

This study evaluates the efficacy and safety of the administration of lidocaine spray in oesophago-gastro-duodenoscopies. Half of the patients will receive lidocaine spray, while the other half will receive a placebo.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
586

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Apr 2016

Shorter than P25 for phase_4

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

March 2, 2016

Completed
1 month until next milestone

Study Start

First participant enrolled

April 1, 2016

Completed
10 days until next milestone

First Posted

Study publicly available on registry

April 11, 2016

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2017

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2017

Completed
Last Updated

January 29, 2018

Status Verified

January 1, 2018

Enrollment Period

1 year

First QC Date

March 2, 2016

Last Update Submit

January 26, 2018

Conditions

Tolerance

Keywords

LidocaineEndoscopyTolerance

Outcome Measures

Primary Outcomes (1)

  • Degree of tolerance referred by the endoscopist in each group.

    Establish degree of tolerance referred by the endoscopist in each group according to the scale defined by Leich et al ( Gastrointestinal Endosc 1993;39:384-7)

    Up to 15 minutes after endoscopy

Secondary Outcomes (9)

  • Degree of tolerance referred by the patient in each group

    Up to 15 minutes after endoscopy

  • Endoscopist's level of satisfaction with the procedure in each group

    Up to 15 minutes after endoscopy

  • Patient's level of satisfaction with the procedure in each group.

    Up to 15 minutes after endoscopy

  • Number of completed procedures in control and lidocaine group

    Up to 15 minutes after endoscopy

  • Estimate the total dose of propofol used in each group

    15 minutes before endoscopy

  • +4 more secondary outcomes

Study Arms (2)

Lidocaine

EXPERIMENTAL

Five lidocaine solution puffs (10mg lidocaine/puff) on the four posterior quadrants of the pharynx and on the base of the tongue, 3 minutes before the oesophago-gastro-duodenoscopy.

Drug: Lidocaine

Control

PLACEBO COMPARATOR

Five placebo solution puffs on the four posterior quadrants of the pharynx and on the base of the tongue, 3 minutes before the oesophago-gastro-duodenoscopy

Drug: Placebo

Interventions

LidocaineDRUG
Lidocaine
PlaceboDRUG

Placebo

Control

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients aged over 18
  • ASA I, II and III
  • Non allergic to lidocaine or any of the drugs used in the study
  • Consent form signed by the patient

You may not qualify if:

  • Stomach or esophagus diagnosed cancer
  • Giant hiatal hernia diagnosed
  • Zenker's diverticulum diagnosed
  • Achalasia diagnosed
  • Patients aged over 70
  • Medical history of moderate to severe liver disease
  • Medical history of moderate to severe renal insufficiency
  • Medical history of moderate to severe Obstructive Sleep Apnea Syndrome (OSA) (AHI≥15).
  • Severe respiratory insufficiency(asmtha or COPD) diagnosed
  • Patients with encephalopaty active
  • Patients with medical history of methemoglobinemia
  • Patients with history of drug abuse
  • Patients with mental impairment
  • Patients with BMI≥ 35
  • Use of pediatric tube

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Araba University Hospital

Vitoria-Gasteiz, Alava, 01009, Spain

Location

Related Publications (1)

  • Martin-Marcos I, Fernandez-Morte N, Balsategui-Martin M, Ortiz-Cantero A, Bermudez-Ampudia C, Lopez-Picado A, Perez-Vaquero P, Salvador-Perez M, Cristobal-Dominguez E. Evaluation of pharyngeal lidocaine anesthesia for esophagogastroduodenoscopy: Double-blind randomized control trial. Dig Endosc. 2022 May;34(4):808-815. doi: 10.1111/den.14168. Epub 2021 Nov 17.

    PMID: 34644419DERIVED

MeSH Terms

Interventions

Lidocaine

Intervention Hierarchy (Ancestors)

AcetanilidesAnilidesAmidesOrganic ChemicalsAniline CompoundsAmines

Study Officials

  • Irene Martin Marcos, RN

    Basque Health System

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Registered Nurse

Study Record Dates

First Submitted

March 2, 2016

First Posted

April 11, 2016

Study Start

April 1, 2016

Primary Completion

April 1, 2017

Study Completion

May 1, 2017

Last Updated

January 29, 2018

Record last verified: 2018-01

Locations

ES(1)