Preoperative Viscous Lidocaine for Upper Gastrointestinal Endoscopy

Anesthetics, Local Clinical Trial

— LIDOGAS  

Official title:

Preoperative Viscous Lidocaine for Upper Gastrointestinal Endoscopy - a Blinded, Randomized, Placebo-controlled Clinical Trial

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT04725695
• Other study ID #: 2020-005177-27
• Status: Enrolling by invitation
• Phase: Phase 4
• Start date: March 29, 2022
• Est. completion date: January 2024

Study information

• Verified date: December 2022
• Source: Bispebjerg Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 248
• Est. completion date: January 2024
• Est. primary completion date: December 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Anesthetics, Local
• Esophagogastroduodenoscopy

Intervention

Drug:
• Viscous Lidocaine
The patients will be randomized to either viscous lidocaine or placebo

Locations

Country	Name	City	State
Denmark	Department of Endoscopy, Digestive Disease Center, Bispebjerg Hospital	Copenhagen

Sponsors (1)

Lead Sponsor	Collaborator
Bispebjerg Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	Immediately after the procedure
Secondary	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)	Immediately after the procedure
Secondary	Number of intubation attempts	Total number of intubation attempts until the esophagus is reached	Peroperatively counted by the assisting nurse
Secondary	Number of gag reflexes	Total number of gag reflexes during the examination	Peroperatively counted by the assisting nurse
Secondary	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)	Immediately after the procedure
Secondary	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)	Immediately after the procedure
Secondary	Sedation 1	Number of milligrams midazolam administered during the procedure	Peroperatively
Secondary	Sedation 2	Number of milligrams alfentanil administered during the procedure	Peroperatively
Secondary	Perception of gag reflexes	The endoscopist's rating of the patient's degree of gag reflexes, numeric rating scale (NRS) from 0 (worst) to 10 (best)	Immediately after the procedure