Lidocaine Infusion for Propofol Dose Reduction in ERCP Procedure

Phase 1

• Conditions: Sedation
• Interventions: Drug: Placebo; Drug: Lidocaine

• Registration Number: NCT05274984
• Lead Sponsor: Iuliu Hatieganu University of Medicine and Pharmacy

Brief 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.

Study Timeline

• Study Start: 2022-01-03
• Study First Submitted: 2022-02-17
• Status Verified: 2022-03
• Primary Completion: 2022-03-03
• Study First Submitted QC: 2022-03-10
• Last Update Submitted: 2022-03-10
• Study First Posted: 2022-03-11
• Last Update Posted: 2022-03-11
• Study Completion: 2022-04-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• 65-85 years old
• physical status ASA I, II, III,
• ERCP scheduled

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Exclusion Criteria

• ASA IV or higher
• severe renal, cardiac or liver failure,
• allergy to lidocaine,
• patients weighing less than 40 kg,
• inability to give informed consent

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group Placebo	Placebo	the control group will be given the same volume of saline as the experimental group
Group Lidocaine	Lidocaine	the experimental group will be given l-1.5mg lidocaine and then 2mg/kg/h

Primary Outcome Measures

Name	Time	Method
Propofol consumption between the 2 groups	During ERCP procedure	To evaluate propofol consumption by recording total dose of propofol(mg) during ERCP procedure between the 2 groups.

Secondary Outcome Measures

Name	Time	Method
Safety assessed by the rate of hypoxia during the procedure	During ERCP procedure	Recording the number of hypoxia episodes, defined as peripheral oxygen saturation \<94% for \>30 seconds during ERCP procedure between the 2 groups.
Safety assessed by the rate of involuntary movement during the procedure	During ERCP procedure	Number of involuntary movements, defined as unconscious movements requiring restraint of patients during ERCP procedure between the 2 groups
Lidocaine	During ERCP procedure	Asses the total dose of lidocaine (mg) used in GROUP Lidocaine during ERCP procedure
Endoscopist satisfaction between 2 groups	After ERCP procedure	The endoscopists satisfaction score to be assessed on a 1-4 VAS after the procedure ( 1-poor, 2-moderate, 3-good, 4-excellent)

Trial Locations

Locations (1)

Regional Institute of Gastroenterology and Hepatology "Prof.dr.Octavian Fodor"; 🇷🇴 Cluj-Napoca, Cluj, Romania