Preoperative Viscous Lidocaine for Upper Gastrointestinal Endoscopy (LIDOGAS)

Bispebjerg Hospital

Status and phase: Terminated; Phase 4

Conditions: Esophagogastroduodenoscopy; Anesthetics, Local

Treatments: Drug: Viscous Lidocaine

Study type: Interventional

Funder types: Other

Identifiers

NCT04725695

2020-005177-27

Details and patient eligibility

About

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

Enrollment: 119 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

119 participants in 2 patient groups, including a placebo group

Viscous lidocaine

Experimental group

Description:

Oral viscous lidocaine 20 mg/ml, 10 ml

Treatment:

Drug: Viscous Lidocaine

Placebo

Placebo Comparator group

Description:

Oral viscous solution without active drug, 10 ml

Treatment:

Drug: Viscous Lidocaine