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Effect of IV Lidocaine on Duodenal Peristalsis and Sedation in ERCP

NCT07333859 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2026-04-08

No results posted yet for this study

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.

Conditions

  • Duodenal Spasm
  • ERCP
  • Sedation

Interventions

DRUG

Lidocaine 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.

OTHER

0.9 % 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..

Sponsors & Collaborators

  • Ankara City Hospital Bilkent

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-02-11
Primary Completion
2026-02-11
Completion
2026-03-15

Countries

  • Turkey (Türkiye)

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07333859 on ClinicalTrials.gov