Preoperative Viscous Lidocaine for Upper Gastrointestinal Endoscopy

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

TERMINATED

Clinical Phase

PHASE4

Total Enrollment

119 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-03-29

Study Completion Date

2024-10-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Prophylactic Pyloric Balloon Dilatation During Ivor Lewis Oesophagectomy

NCT05085951

Postprocedural Delayed Gastric Emptying

COMPLETED NA

Chlorhexidine Mouthwash and Bacterial Contamination During Endoscopy

NCT01154530

Gastroscopy

COMPLETED NA

Prospective Randomized Trial Evaluating the Utility of Esophageal Stitches During Laparoscopic Fundoplication

NCT01509352

Reflux

COMPLETED NA

Prospective Evaluation of the Efficacy and Safety of Endoscopic Tissue Apposition

NCT03626194

Endoscopic Tissue Apposition Endoscopic Suturing Endoscopic Clipping +3 more

RECRUITING

Closure of Anastomotic Leaks in the Stomach and Esophagus by Endoscopic Suturing

NCT01139424

Postoperative Anastomosis, Surgical

UNKNOWN NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Anesthetics, Local Esophagogastroduodenoscopy

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Viscous lidocaine

Oral viscous lidocaine 20 mg/ml, 10 ml

Group Type EXPERIMENTAL

Viscous Lidocaine

Intervention Type DRUG

The patients will be randomized to either viscous lidocaine or placebo

Placebo

Oral viscous solution without active drug, 10 ml

Group Type PLACEBO_COMPARATOR

Viscous Lidocaine

Intervention Type DRUG

The patients will be randomized to either viscous lidocaine or placebo

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Viscous Lidocaine

The patients will be randomized to either viscous lidocaine or placebo

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No