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Clinical Trials/EUCTR2015-000923-10-ES
EUCTR2015-000923-10-ES
Active, not recruiting
Phase 1

Evaluation of the efficacy and safety of administering lidocaine spray in oesophagogastroduodenoscopies: A randomized clinical trial. - lidocaine in gastroscopies

BASQUE HEALTH SYSTEM0 sites552 target enrollmentAugust 25, 2015
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ConditionsElective gastroscopyMedDRA version: 18.0 Level: LLT Classification code 10018047 Term: Gastroscopy System Organ Class: 100000004848Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]
DrugsXilonibsa

Overview

Phase
Phase 1
Intervention
Not specified
Conditions
Elective gastroscopy
Sponsor
BASQUE HEALTH SYSTEM
Enrollment
552
Status
Active, not recruiting
Last Updated
6 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
August 25, 2015
End Date
TBD
Last Updated
6 years ago
Study Type
Interventional clinical trial of medicinal product

Investigators

Sponsor
BASQUE HEALTH SYSTEM

Eligibility Criteria

Inclusion Criteria

  • •\-Patients aged over 18
  • •\-ASA I, II and III
  • •\-Non allergic to lidocaine or any of the drugs used in the study
  • •\-Conset form signed by the patient
  • •Are the trial subjects under 18? no
  • •Number of subjects for this age range:
  • •F.1\.2 Adults (18\-64 years) yes
  • •F.1\.2\.1 Number of subjects for this age range 500
  • •F.1\.3 Elderly (\>\=65 years) yes
  • •F.1\.3\.1 Number of subjects for this age range 52

Exclusion Criteria

  • •\-Pregnancy or lactation
  • •\-Patients aged over 70
  • •\-Poorly controlled insulin\-treated type I or II diabetes (Hb1Ac\=8\).
  • •\-Moderate to severe liver disease
  • •\-Moderate to severe renal insufficiency
  • •\-Moderate to severe Obstructive Sleep Apnea Syndrome (OSA) (AHI\=15\).
  • •\-Severe respiratory insufficiency
  • •\-Open angle glaucoma
  • •\-Patients with encephalopaty
  • •\-Patients with medical history of methemoglobinemia

Outcomes

Primary Outcomes

Not specified

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