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临床试验/NCT07166614
NCT07166614已完成不适用

Comparison of Respiratory and Hemodynamic Effects of Dexmedetomidine vs. Propofol in High-Risk Patients Undergoing ERCP: A Prospective Randomized Controlled Study

Sisli Hamidiye Etfal Training and Research Hospital1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2025年9月3日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
100
试验地点
1
主要终点
heart rate

研究概览

简要总结

ERCP requires deep sedation due to pain and discomfort, but propofol-commonly used with opioids-often causes respiratory and cardiovascular complications, especially in elderly or high-risk patients. Dexmedetomidine offers sedation without respiratory depression but may lower blood pressure and heart rate. Current monitoring often relies only on SpO₂, while capnography and the Integrated Pulmonary Index (IPI) provide earlier detection of respiratory events but are underused in ERCP studies.

This study compares dexmedetomidine and propofol in high-risk ERCP patients, focusing on respiratory and hemodynamic effects, propofol consumption, recovery, and discharge times. The hypothesis is that dexmedetomidine will cause fewer adverse respiratory and hemodynamic effects.

详细描述

Endoscopic Retrograde Cholangiopancreatography (ERCP) is uncomfortable and painful for patients. Moreover, immobility is required for procedural success, which necessitates deep sedation. Recently, propofol combined with an opioid has been frequently used for this purpose . However, propofol is associated with respiratory depression, hypoxemia, and hypotension, leading to increased cardiopulmonary complications. These risks become more significant in elderly patients and those with high comorbidity. The use of alternative sedative agents or combinations aims to reduce propofol dosage and minimize cardiopulmonary complications.

Dexmedetomidine is a highly selective α2-adrenoceptor agonist that reduces noradrenergic neuronal activity and is widely used for its sedative and anxiolytic properties. Unlike propofol, dexmedetomidine provides sedation without causing respiratory depression, even at loading doses. Several studies have evaluated the effects of dexmedetomidine and propofol on sedation in gastrointestinal endoscopic procedures . However, dexmedetomidine infusion alone has been shown to be less effective than propofol in terms of sedation quality, and it is associated with significant decreases in blood pressure and heart rate. These adverse events raise concerns regarding the use of dexmedetomidine in high-comorbidity patients requiring stable hemodynamics . Therefore, further studies are needed to evaluate the efficacy and safety of dexmedetomidine versus propofol in high-risk patients undergoing ERCP.

During endoscopy, monitoring of heart rate (HR), arterial blood pressure (BP), and pulse oximetry (SpO₂) is commonly used. Capnography with end-tidal CO₂ (ETCO₂) monitoring enables early detection of hypoventilation and apnea. Accordingly, both national and international guidelines (US and Europe) recommend capnography for monitoring during endoscopic procedures . The Integrated Pulmonary Index (IPI) incorporates HR, respiratory rate, SpO₂, and ETCO₂ parameters into an algorithm (14). It is considered the earliest method for detecting respiratory events and has been shown to be effective during endoscopic sedation.

However, studies evaluating the respiratory effects of sedative agents used in ERCP have been limited to SpO₂ values and adverse events, without assessment of ETCO₂ or IPI parameters.

In the study, the investigator primarily aimed to compare the respiratory and hemodynamic effects of dexmedetomidine versus propofol in high-risk patients undergoing ERCP. Secondarily, we evaluated total propofol consumption, recovery time, and discharge time from the endoscopy unit. Our hypothesis was that dexmedetomidine sedation in high-risk ERCP patients would result in fewer respiratory and hemodynamic side effects compared to propofol.

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
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •patients over 18 years of age
  • •ASA physical status III-IV
  • •scheduled for ERCP in the Gastroenterology Endoscopy Unit of our hospital

排除标准

  • •pregnant women;
  • •patients with neuropsychiatric disease,
  • •substance abuse, or known allergy to the sedatives used;
  • •patients with baseline heart rate ≤50 bpm;
  • •those who did not provide consent.

研究组 & 干预措施

group d

Experimental

A loading dose of dexmedetomidine at 1 μg/kg was administered over 10 minutes prior to the procedure. During the procedure, an infusion at 0.5 μg/kg/h was maintained, which was discontinued at the end of the procedure

干预措施: dexmedetomidin (Drug)

group p

Active Comparator

In our ERCP unit, induction was performed according to the standard protocol using fentanyl 1 µg/kg and propofol 1 mg/kg.

干预措施: Propofol (Drug)

结局指标

主要结局

heart rate

时间窗: during the endoscopy (30-60 minute)

heart rate

oxygen saturation

时间窗: during the endoscopy (30-60 minute)

oxygen saturation

end-tidal CO₂

时间窗: during the endoscopy (30-60 minute)

end-tidal CO₂

arterial blood pressure

时间窗: during the endoscopy (30-60 minute)

arterial blood pressure

次要结局

未报告次要终点

研究者

发起方
Sisli Hamidiye Etfal Training and Research Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Hacer Sebnem Turk

associate professor

Sisli Hamidiye Etfal Training and Research Hospital

研究点 (1)

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