Lidocaine Infusion for Propofol Dose Reduction in ERCP Procedure

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

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.

Study Overview

• Status: Recruiting
• Conditions: Sedation
• Intervention / Treatment: Drug: Placebo; Drug: Lidocaine

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 Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Caius Breazu, MD PHD; Phone Number: 0040743010012; Email: csbreazu@yahoo.com
• Study Contact Backup: Name: Alex Alexandru, MD; Email: alexandru_reziati@yahoo.com

Study Locations

• Romania
  • Cluj
    • Cluj-Napoca, Cluj, Romania, 400162
      • Recruiting
      • Regional Institute of Gastroenterology and Hepatology "Prof.dr.Octavian Fodor"

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years to 85 years (OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

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

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: TRIPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
PLACEBO_COMPARATOR: Group Placebo; the control group will be given the same volume of saline as the experimental group	Drug: Placebo; the control group will be given the same volume of saline.
ACTIVE_COMPARATOR: Group Lidocaine; the experimental group will be given l-1.5mg lidocaine and then 2mg/kg/h	Drug: Lidocaine; the experimental group will be given 1.5mg/kg lidocaine and then 2mg/kg/h

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Propofol consumption between the 2 groups	To evaluate propofol consumption by recording total dose of propofol(mg) during ERCP procedure between the 2 groups.	During ERCP procedure

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Iuliu Hatieganu University of Medicine and Pharmacy
• Investigators: Study Chair: Daniela Ionescu, MD PhD, UMF Iuliu Hatieganu Cluj-Napoca

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 3, 2022
• Primary Completion (ANTICIPATED): March 3, 2022
• Study Completion (ANTICIPATED): April 3, 2022

Study Registration Dates

• First Submitted: February 17, 2022
• First Submitted That Met QC Criteria: March 10, 2022
• First Posted (ACTUAL): March 11, 2022

Study Record Updates

• Last Update Posted (ACTUAL): March 11, 2022
• Last Update Submitted That Met QC Criteria: March 10, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Arrhythmia Agents; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Membrane Transport Modulators; Anesthetics, Local; Voltage-Gated Sodium Channel Blockers; Sodium Channel Blockers; Lidocaine
• Other Study ID Numbers: LIP

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No