NCT05274984

Lidocaine Infusion for Propofol Dose Reduction in ERCP Procedure

Lidocaine Continuous Infusion for ERCP Procedures: a Prospective, Randomized, Double-blinded, Controlled Trial

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Iuliu Hatieganu University of Medicine and Pharmacy · Academic / Other
• Sex: All
• Age: 65 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

This study aims to investigate the dose reduction of propofol if associated with continuous infusion of lidocaine during ERCP procedures in patients over 65 years old.

Detailed description

The primary aim of this study was to evaluate the effect of continuous infusion of lidocaine on propofol consumption in older patients having ERCP sedation. Secondary outcomes were to evaluate patient adverse events, sedation quality and satisfaction of the patient and the endoscopist, postprocedural pain, and sedation-related time.For this the investigators randomised patients into 2 groups: Group Lidocaine received 1,5 mg/kg lidocaine 1% 10 min before procedure and then 2 mg/kg/h continuous infusion of lidocaine 1%, whereas the Group Control received an equal volume of saline solution, which could not be visually identified from lidocaine by the blinded anaesthesiologist. All patients received propofol bolus dose of 1mg/kg than 10-20 mg iv boluses during the procedure guided by capnograph monitoring and the patient's grimace, mobility, hemodynamic changes.

Conditions

• Sedation

Interventions

Type	Name	Description
DRUG	Placebo	the control group will be given the same volume of saline.
DRUG	Lidocaine	the experimental group will be given 1.5mg/kg lidocaine and then 2mg/kg/h

Timeline

• Start date: 2022-01-03
• Primary completion: 2022-03-03
• Completion: 2022-04-03
• First posted: 2022-03-11
• Last updated: 2022-03-11

Locations

1 site across 1 country: Romania