Lidocaine Infusion for Propofol Dose Reduction in ERCP Procedure

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Sedation

Intervention / Treatment
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* Drug: Placebo
* Drug: Lidocaine


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 65 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Participants are randomly assigned to controll group or lidocaine group. Participants of control group are given placebo while participants of lidocaine group are given lidocaine.
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Group Placebo<br>the control group will be given the same volume of saline as the experimental group | Drug: Placebo<br>* the control group will be given the same volume of saline.<br>|
| Active Comparator: Group Lidocaine<br>the experimental group will be given l-1.5mg lidocaine and then 2mg/kg/h | Drug: Lidocaine<br>* the experimental group will be given 1.5mg/kg lidocaine and then 2mg/kg/h<br>|

What is the study measuring?
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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 |