Lidocaine Infusion for Propofol Dose Reduction in ERCP Procedure

Iuliu Hatieganu University of Medicine and Pharmacy

Status and phase: Unknown; Phase 1

Conditions: Sedation

Treatments: Drug: Placebo; Drug: Lidocaine

Study type: Interventional

Funder types: Other

Identifiers

NCT05274984

LIP

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 estimated patients

Sex: All

Ages: 65 to 85 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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100 participants in 2 patient groups, including a placebo group

Group Placebo

Placebo Comparator group

Description:

the control group will be given the same volume of saline as the experimental group

Treatment:

Drug: Placebo

Group Lidocaine

Active Comparator group

Description:

the experimental group will be given l-1.5mg lidocaine and then 2mg/kg/h

Treatment:

Drug: Lidocaine