Ignite Creation Date:
2026-03-26 @ 3:14 PM
Ignite Modification Date:
2026-03-30 @ 3:08 AM
Study NCT ID:
NCT07333859
Status:
RECRUITING
Last Update Posted:
2026-03-06
First Post:
2025-12-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of IV Lidocaine on Duodenal Peristalsis and Sedation in ERCP
Sponsor:
Ankara City Hospital Bilkent
Organization:
Study Overview
Official Title:
Effect of Intravenous Lidocaine Infusion on Duodenal Peristalsis, Sedation Quality and Rescue Spasmolytic Requirement in ERCP Procedures: A Randomized, Double-Blind, Placebo-Controlled Study
Status:
RECRUITING
Status Verified Date:
2026-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
LIDO ERCP
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.
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.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| MEHMET SAHAP | OTHER | ANKARA BILKENT CITY HOSPİTAL | View |