Effect of IV Lidocaine on Duodenal Peristalsis and Sedation in ERCP

NCT07333859 | Completed Phase 4

• 2 other identifiers: ERCP-LIDO-2026-01MEHMET SAHAP
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

lidocaine; Peristalsis; Intravenous Anesthesia; deep sedation; Duodenoscopy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Total Propofol Consumption

  From induction until the end of the procedure

Other Outcomes (4)

• Endoscopist Satisfaction Score

  From induction until the end of the procedure

• Incidence of Sedation-Related Adverse Events

  From induction until the end of the procedure

• Incidence of Significant Procedural Interference

  From induction until the end of the procedure

Study Arms (2)

Lidocaine Group

EXPERIMENTAL

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

Drug: Lidocaine Hydrochloride 2%

Placebo Group

PLACEBO COMPARATOR

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

Other: 0.9 % Normal Saline

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.

Lidocaine Group

0.9 % Normal Saline OTHER

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..

Placebo Group

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ankara City Hospital Bilkent: lead

Study Sites (1)

Ankara Bilkent City Hospital

Ankara, 06610, Turkey (Türkiye)

Location

Related Publications (3)

• 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.

  PMID: 41321955 BACKGROUND

• 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.

  PMID: 26866299 BACKGROUND

• 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.

  PMID: 26631626 BACKGROUND

MeSH Terms

Interventions

Lidocaine; Saline Solution

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Asist Prof Dr

Study Record Dates

• First Submitted: December 30, 2025
• First Posted: January 12, 2026
• Study Start: February 11, 2026
• Primary Completion: February 11, 2026
• Study Completion: March 15, 2026
• Last Updated: April 8, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)