RecruitingPhase 4NCT07333859

Effect of IV Lidocaine on Duodenal Peristalsis and Sedation in ERCP

Effect of Intravenous Lidocaine Infusion on Duodenal Peristalsis, Sedation Quality and Rescue Spasmolytic Requirement in ERCP Procedures: A Randomized, Double-Blind, Placebo-Controlled Study

Sponsor

Ankara City Hospital Bilkent

Enrollment

120 participants

Start Date

Feb 11, 2026

Study Type

INTERVENTIONAL

Conditions

Sedation ERCP Duodenal Spasm

Summary

This study aims to evaluate the efficacy of intravenous lidocaine infusion on duodenal peristalsis during Endoscopic Retrograde Cholangiopancreatography (ERCP). The study compares lidocaine against a placebo to determine if lidocaine can reduce the need for rescue spasmolytics (hyoscine-N-butylbromide or glucagon), decrease propofol consumption, and improve hemodynamic stability.

Eligibility

Min Age: 18 YearsMax Age: 85 Years

Inclusion Criteria4

Patients scheduled for elective ERCP.
ASA Physical Status I, II, or III.
Age between 18 and 85 years.
Provided written informed consent.

Exclusion Criteria6

Allergy to amide-type local anesthetics.
Severe hepatic or renal failure.
History of AV block or severe cardiac arrhythmia.
Pregnancy or lactation.
Chronic opioid use.
Patient refusal.

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Interventions

DRUGLidocaine Hydrochloride 2%

1.0 mg/kg IV bolus followed by 2.0 mg/kg/h IV infusion during the procedure. Propofol Induction: 0.5-1 mg/kg loading dose, Maintenance: Continuous infusion of 40-60 µg/kg/min, supplemented by intermittent 20-30 mg boluses as clinically required.

OTHER0.9 % Normal Saline

IV bolus and infusion of 0.9% NaCl matched in volume and rate to the study drug. Propofol Induction: 0.5-1 mg/kg loading dose, Maintenance: Continuous infusion of 40-60 µg/kg/min, supplemented by intermittent 20-30 mg boluses as clinically required..