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临床试验/NCT02713191
NCT02713191已完成2 期

Efficacy and Safety of Dexmedetomidine vs. Midazolam Sedation in Patients Undergoing Convex-probe Endobronchial Ultrasound: a Randomized Double Blind Trial

Post Graduate Institute of Medical Education and Research, Chandigarh1 个研究点 分布在 1 个国家目标入组 197 人开始时间: 2016年3月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
2 期
状态
已完成
发起方
入组人数
197
试验地点
1
主要终点
Number of midazolam boluses administered to achieve targeted Ramsay sedation score of two

研究概览

简要总结

The randomized controlled trial will compare efficacy and safety of dexmedetomidine to midazolam for sedation during endobronchial ultrasound

详细描述

Benzodiazepines, opioids, and propofol are currently used alone or in combination for achieving sedation during endobronchial ultrasound and other bronchoscopic procedures. However, all these agents carry a risk of respiratory depression. Dexmedetomidine, a highly selective adrenergic alpha-2 agonist, has sedative and analgesic properties but does not cause respiratory depression. This study aims to compare efficacy and safety of dexmedetomidine as a sedative to midazolam in patients with hilar/mediastinal lymphadenopathy undergoing convex-probe endobronchial ultrasonography on day care basis. Patients will be randomized to receive either dexmedetomidine plus fentanyl or midazolam plus fentanyl prior to procedure, followed by dexmedetomidine or saline infusion respectively during the procedure. Ramsay sedation score of two will be targeted, failing which patients in both groups will receive midazolam bolus on as-needed basis. Bronchoscopist will remain blinded to group allocation. Patients will be monitored for sedation, oxygenation and hemodynamic parameters throughout. Need for additional midazolam, sedative efficacy, frequency of adverse respiratory and hemodynamic events, and bronchoscopist and patient satisfaction with the procedure will be compared between the two groups.

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 99 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age 18 years or more
  • American Society of Anesthesiologists physical status I or II
  • Presence of hilar and/or mediastinal lymph nodes on thoracic CT scan

排除标准

  • Known allergy to dexmedetomidine or midazolam or fentanyl
  • Documented coagulopathy
  • Pregnancy
  • Hemodynamic instability (hypotension, arrhythmia, recent acute coronary event)
  • Neuropsychiatric illness
  • History of previous endobronchial ultrasound procedure
  • Refusal to provide consent

研究组 & 干预措施

Dexmedetomidine

Experimental

Dexmedetomidine + fentanyl before, and dexmedetomidine infusion during, procedure

干预措施: Dexmedetomidine (Drug)

Dexmedetomidine

Experimental

Dexmedetomidine + fentanyl before, and dexmedetomidine infusion during, procedure

干预措施: Rescue midazolam (Drug)

Dexmedetomidine

Experimental

Dexmedetomidine + fentanyl before, and dexmedetomidine infusion during, procedure

干预措施: Fentanyl (Drug)

Midazolam

Active Comparator

Midazolam + fentanyl before, and matching saline infusion during, procedure

干预措施: Midazolam bolus (Drug)

Midazolam

Active Comparator

Midazolam + fentanyl before, and matching saline infusion during, procedure

干预措施: Saline placebo (Other)

Midazolam

Active Comparator

Midazolam + fentanyl before, and matching saline infusion during, procedure

干预措施: Rescue midazolam (Drug)

Midazolam

Active Comparator

Midazolam + fentanyl before, and matching saline infusion during, procedure

干预措施: Fentanyl (Drug)

结局指标

主要结局

Number of midazolam boluses administered to achieve targeted Ramsay sedation score of two

时间窗: From start of endobronchial ultrasound procedure until finish of endobronchial ultrasound procedure, assessed up to two hours

次要结局

  • Mean difference in depth of sedation during procedure as assessed by Ramsay scale(From start of endobronchial ultrasound procedure until finish of endobronchial ultrasound procedure, assessed up to two hours)
  • Mean difference in time taken to discharge patient from post-procedure recovery room(From end of endobronchial ultrasound procedure until final patient discharge from recovery room, assessed up to twelve hours)
  • Frequency of adverse hemodynamic events - hypotension, hypertension, tachycardia, bradycardia(From start of endobronchial ultrasound procedure until finish of endobronchial ultrasound procedure, assessed up to two hours)
  • Frequency of respiratory events - hypoxia, need for air airway maneuvers to maintain oxygenation(From start of endobronchial ultrasound procedure until finish of endobronchial ultrasound procedure, assessed up to two hours)
  • Mean difference in patient and physician satisfaction related to procedure as assessed by visual analogue scale(Immediately after endobronchial ultrasound procedure)

研究者

发起方
Post Graduate Institute of Medical Education and Research, Chandigarh
申办方类型
Other
责任方
Principal Investigator
主要研究者

Ashutosh Nath Aggarwal

Professor of Pulmonary Medicine

Post Graduate Institute of Medical Education and Research, Chandigarh

研究点 (1)

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