Effect of IV Lidocaine on Duodenal Peristalsis and Sedation in ERCP (LIDO ERCP)

Ankara City Hospital

Status and phase: Not yet enrolling; Phase 4

Conditions: ERCP; Sedation; Duodenal Spasm

Treatments: Drug: Lidocaine Hydrochloride 2%; Other: 0.9 % Normal Saline

Study type: Interventional

Funder types: Other

Identifiers

NCT07333859

MEHMET SAHAP (Other Identifier)

ERCP-LIDO-2026-01

Details and patient eligibility

About

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.

Full description

Duodenal peristalsis can hinder successful cannulation during ERCP. Traditionally, antispasmodics like hyoscine-N-butylbromide are used but have side effects. This randomized, double-blind, placebo-controlled trial includes 100 patients (ASA I-III) undergoing elective ERCP.

Patients will be randomized 1:1 into two groups:

Group L (Lidocaine): IV bolus 1.0 mg/kg before induction + 2.0 mg/kg/h continuous infusion during the procedure.

Group C (Control): Equal volume of 0.9% Saline. Primary outcome is the "Rescue Spasmolytic Requirement" based on endoscopist's evaluation. Secondary outcomes include duodenal peristalsis score (Suzuki Scale) assessed via video review by a blinded endoscopist, total propofol consumption, and recovery times.

Enrollment: 100 estimated patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients scheduled for elective ERCP.

ASA Physical Status I, II, or III.

Age between 18 and 85 years.

Provided written informed consent.

Exclusion criteria

• 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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100 participants in 2 patient groups, including a placebo group

Lidocaine Group

Experimental group

Description:

1.0 mg/kg IV bolus followed by 2.0 mg/kg/h IV infusion during the procedure.

Treatment:

Other: 0.9 % Normal Saline

Drug: Lidocaine Hydrochloride 2%

Placebo Group

Placebo Comparator group

Description:

IV bolus and infusion of 0.9% NaCl matched in volume and rate to the study drug.

Treatment:

Other: 0.9 % Normal Saline

Drug: Lidocaine Hydrochloride 2%