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临床试验/NCT07333859
NCT07333859已完成4 期

Effect of Intravenous Lidocaine Infusion on Duodenal Peristalsis, Sedation Quality and Rescue Spasmolytic Requirement in ERCP Procedures: A Randomized, Double-Blind, Placebo-Controlled Study

Ankara City Hospital Bilkent1 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2026年2月11日最近更新:
干预措施

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

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

Experimental

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

Placebo Comparator

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Mehmet sahap

Asist Prof Dr

Ankara City Hospital Bilkent

研究点 (1)

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