Effect of Intravenous Lidocaine Infusion on Duodenal Peristalsis, Sedation Quality and Rescue Spasmolytic Requirement in ERCP Procedures: A Randomized, Double-Blind, Placebo-Controlled Study
Overview
- Phase
- Phase 4
- Status
- Completed
- Sponsor
- Ankara City Hospital Bilkent
- Enrollment
- 120
- Locations
- 1
- Primary Endpoint
- Rescue Spasmolytic Requirement Rate
Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 85 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
Lidocaine Group
1.0 mg/kg IV bolus followed by 2.0 mg/kg/h IV infusion during the procedure.
Intervention: Lidocaine Hydrochloride 2% (Drug)
Placebo Group
IV bolus and infusion of 0.9% NaCl matched in volume and rate to the study drug.
Intervention: 0.9 % Normal Saline (Other)
Outcomes
Primary Outcomes
Rescue Spasmolytic Requirement Rate
Time Frame: Intraoperative (During the ERCP procedure, approx. 30 minutes)
The proportion of patients requiring rescue medication (Hyoscine-N-butylbromide or Glucagon) due to severe duodenal spasm preventing cannulation.
Secondary Outcomes
- Total Propofol Consumption(From induction until the end of the procedure)
Investigators
Mehmet sahap
Asist Prof Dr
Ankara City Hospital Bilkent