Effect of Intravenous Lidocaine Infusion on Duodenal Peristalsis, Sedation Quality and Rescue Spasmolytic Requirement in ERCP Procedures: A Randomized, Double-Blind, Placebo-Controlled Study
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Rescue Spasmolytic Requirement Rate
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 85 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients scheduled for elective ERCP.
- •ASA Physical Status I, II, or III.
- •Age between 18 and 85 years.
- •Provided written informed consent.
排除标准
- •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.
研究组 & 干预措施
Lidocaine Group
1.0 mg/kg IV bolus followed by 2.0 mg/kg/h IV infusion during the procedure.
干预措施: Lidocaine Hydrochloride 2% (Drug)
Placebo Group
IV bolus and infusion of 0.9% NaCl matched in volume and rate to the study drug.
干预措施: 0.9 % Normal Saline (Other)
结局指标
主要结局
Rescue Spasmolytic Requirement Rate
时间窗: 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.
次要结局
- Total Propofol Consumption(From induction until the end of the procedure)
研究者
Mehmet sahap
Asist Prof Dr
Ankara City Hospital Bilkent
