Preoperative Viscous Lidocaine for Upper Gastrointestinal Endoscopy

Phase 4TerminatedNCT04725695

Bispebjerg Hospital119 enrolled

Overview

In this randomized placebo-controlled clinical trial, patients will be randomized to be administered viscous lidocaine or placebo preoperatively to elective upper GI endoscopy

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

QUADRUPLE

Enrollment

119

Conditions

Anesthetics, Local Esophagogastroduodenoscopy

Interventions

Viscous LidocaineDRUG

The patients will be randomized to either viscous lidocaine or placebo

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Patients referred to and found fit for upper GI endoscopy in an out patient setting * Between 18 and 75 years old * Speaks and understands Danish Exclusion Criteria: * Patients admitted for upper GI endoscopy in an in-patient setting * Patients with dementia and/or other cognitive dysfunction disorders * Patients primarily complaining of dysphagia * Patients allergic to lidocaine * Patients with suspected retention * Patients who will undergo upper GI endoscopy with nurse-assisted propofol sedation * Patients who will undergo upper GI endoscopy with assistance of anesthesia-personnel

Locations (1)

Department of Endoscopy, Digestive Disease Center, Bispebjerg Hospital

Copenhagen, Denmark

Outcomes

Primary Outcomes

Ease of intubation

The endoscopist will rate the difficulty of intubating the esophagus on a numeric rating scale (NRS) from 0 (worst) to 10 (best)

Time frame: Immediately after the procedure

Secondary Outcomes

Ease of examination

The endoscopist will rate the difficulty of performing the endoscopy on a numeric rating scale (NRS) from 0 (worst) to 10 (best)

Time frame: Immediately after the procedure

Number of intubation attempts

Total number of intubation attempts until the esophagus is reached

Time frame: Peroperatively counted by the assisting nurse

Number of gag reflexes

Total number of gag reflexes during the examination

Time frame: Peroperatively counted by the assisting nurse

Patient's perception of discomfort

The patient's self-evaluation of discomfort during the examination on a numeric rating scale (NRS) from 0 (worst) to 10 (best)

Time frame: Immediately after the procedure

Patient's willingness to be reexamined

The patient's willingness to have the procedure performed again in the future on a numeric rating scale (NRS) from 0 (worst) to 10 (best)

Time frame: Immediately after the procedure

Sedation 1

Number of milligrams midazolam administered during the procedure

Time frame: Peroperatively

Sedation 2

Data from ClinicalTrials.gov

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