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

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.

Study Overview

• Status: Completed
• Conditions: Sedation; ERCP; Duodenal Spasm
• Intervention / Treatment: Drug: Lidocaine Hydrochloride 2%; Other: 0.9 % Normal Saline

Detailed 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 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
• Enrollment (Actual): 120
• Phase: Phase 4

Contacts and Locations

Study Locations

• Turkey (Türkiye)
  • Ankara, Turkey (Türkiye), 06610
    • Ankara Bilkent City Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Lidocaine Group; 1.0 mg/kg IV bolus followed by 2.0 mg/kg/h IV infusion during the procedure.	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.
Placebo Comparator: Placebo Group; IV bolus and infusion of 0.9% NaCl matched in volume and rate to the study drug.	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..

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rescue Spasmolytic Requirement Rate	The proportion of patients requiring rescue medication (Hyoscine-N-butylbromide or Glucagon) due to severe duodenal spasm preventing cannulation.	Intraoperative (During the ERCP procedure, approx. 30 minutes)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	From induction until the end of the procedure

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Endoscopist Satisfaction Score	An 11-point Numerical Rating Scale (NRS) used by the endoscopist to evaluate the ease of the procedure regarding patient movements and visceral reflexes (such as gagging, coughing, or hiccups). The scale ranges from 0 to 10, where: 0 = Poor conditions (Severe interference, procedure nearly impossible to perform); 10 = Excellent conditions (No interference/perfect conditions).	From induction until the end of the procedure
Incidence of Sedation-Related Adverse Events	The frequency of adverse events including hypotension (MAP drop >20% from baseline), bradycardia (Heart rate <50 bpm), and hypoxemia (SpO2 <90%).	From induction until the end of the procedure
Incidence of Significant Procedural Interference	The number of participants who experienced one or more visceral reflexes (gagging, coughing, or hiccups) or body movements that required a temporary halt or adjustment of the endoscopic intervention.	From induction until the end of the procedure
Recovery Time to Discharge Readiness	The time interval (in minutes) from the end of the ERCP procedure until the patient achieves a Modified Aldrete Score of ≥9, indicating readiness for discharge from the post-anesthesia care unit (PACU).	From the completion of the ERCP procedure until discharge criteria are met (approximately 30-120 minutes).

Collaborators and Investigators

• Sponsor: Ankara City Hospital Bilkent

Publications and helpful links

General Publications

• Suzuki M, Sekino Y, Hosono K, Kurita Y, Uechi H, Kuzuu K, Uchiyama S, Kawana K, Nagase H, Kubota K, Yoneda M, Nakajima A. Inhibitory Effect of Lidocaine on Duodenal Peristalsis During Endoscopic Retrograde Cholangiopancreatography: A Multicenter, Randomized Controlled Trial (With Video). DEN Open. 2025 Nov 27;6(1):e70252. doi: 10.1002/deo2.70252. eCollection 2026 Apr.
• Abrahams M, Derby R, Horn JL. Update on Ultrasound for Truncal Blocks: A Review of the Evidence. Reg Anesth Pain Med. 2016 Mar-Apr;41(2):275-88. doi: 10.1097/AAP.0000000000000372.
• Busch R, Murti K, Liu J, Patra AK, Muhammad K, Knobeloch KP, Lichtinger M, Bonifer C, Wortge S, Waisman A, Reifenberg K, Ellenrieder V, Serfling E, Avots A. NFATc1 releases BCL6-dependent repression of CCR2 agonist expression in peritoneal macrophages from Saccharomyces cerevisiae infected mice. Eur J Immunol. 2016 Mar;46(3):634-46. doi: 10.1002/eji.201545925. Epub 2016 Jan 8.

Study record dates

Study Major Dates

• Study Start (Actual): February 11, 2026
• Primary Completion (Actual): February 11, 2026
• Study Completion (Actual): March 15, 2026

Study Registration Dates

• First Submitted: December 30, 2025
• First Submitted That Met QC Criteria: December 30, 2025
• First Posted (Actual): January 12, 2026

Study Record Updates

• Last Update Posted (Actual): April 8, 2026
• Last Update Submitted That Met QC Criteria: April 7, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: lidocaine; deep sedation; Duodenoscopy; Intravenous Anesthesia; Peristalsis
• Additional Relevant MeSH Terms: Organic Chemicals; Pharmaceutical Preparations; Anilides; Amides; Aniline Compounds; Amines; Acetanilides; Crystalloid Solutions; Isotonic Solutions; Solutions; Lidocaine; Saline Solution
• Other Study ID Numbers: ERCP-LIDO-2026-01; MEHMET SAHAP (Other Identifier: ANKARA BILKENT CITY HOSPİTAL)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: "Individual participant data will not be shared due to privacy concerns and the lack of a dedicated data management infrastructure to ensure secure anonymization.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No