Effect of IV Lidocaine on Duodenal Peristalsis and Sedation in ERCP

Ankara City Hospital Bilkent120 enrolled

Overview

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.

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 120 patients (ASA I-III) undergoing elective ERCP. "All patients will undergo a standardized sedation protocol managed by an anesthesiologist. Sedation induction will be performed with a loading dose of propofol (0.5-1 mg/kg). Maintenance of sedation will be achieved through a continuous infusion of propofol (40-60 µg/kg/min), supplemented by intermittent bolus doses of 20-30 mg as clinically required. The sedation level will be dynamically titrated by the physician to maintain a target Ramsay Sedation Scale (RSS) score of 3-4 and Bispectral Index (BIS) values between 60 and 80. This approach ensures patient comfort and procedural stability while minimizing respiratory depression 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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

120

Conditions

Duodenal Spasm ERCP Sedation

Interventions

Lidocaine Hydrochloride 2%DRUG

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.

0.9 % Normal SalineOTHER

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..

Eligibility

Sex: ALLMin age: 18 YearsMax age: 85 Years

Medical Language ↔ Plain English

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.

Locations (1)

Ankara Bilkent City Hospital

Ankara, Turkey (Türkiye)

Outcomes

Primary Outcomes

Rescue Spasmolytic Requirement Rate

The proportion of patients requiring rescue medication (Hyoscine-N-butylbromide or Glucagon) due to severe duodenal spasm preventing cannulation.

Time frame: Intraoperative (During the ERCP procedure, approx. 30 minutes)

Secondary Outcomes

Total Propofol Consumption

The total amount of intravenous propofol (measured in milligrams) required to maintain the target sedation depth (RSS 3-4 and BIS 60-80) from the start of induction until the completion of the ERCP procedure.

Time frame: From induction until the end of the procedure

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.