Ankara Bilkent City Hospital
Ankara, 06610, Turkey (Türkiye)
NCT Number: NCT07333859
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.
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Notify Me18 year–85 year
All sexes
Interventional
Phase 4
Ankara, 06610, Turkey (Türkiye)
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
ASA Physical Status I, II, or III.
Age between 18 and 85 years.
Provided written informed consent.
Exclusion criteria
Severe hepatic or renal failure.
History of AV block or severe cardiac arrhythmia.
Pregnancy or lactation.
Chronic opioid use.
Patient refusal.
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.
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..
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.
Time frame: From induction until the end of the procedure
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.
Time frame: From induction until the end of the procedure
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).
Time frame: From induction until the end of the procedure
The frequency of adverse events including hypotension (MAP drop >20% from baseline), bradycardia (Heart rate <50 bpm), and hypoxemia (SpO2 <90%).
Time frame: From induction until the end of the procedure
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.
Time frame: From the completion of the ERCP procedure until discharge criteria are met (approximately 30-120 minutes).
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).
Ankara City Hospital Bilkent
Other
Effect of Intravenous Lidocaine Infusion on Duodenal Peristalsis, Sedation Quality and Rescue Spasmolytic Requirement in ERCP Procedures: A Randomized, Double-Blind, Placebo-Controlled Study
Acronym: LIDO ERCP
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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