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临床试验/NCT02129426
NCT02129426终止不适用

Comparison of Outcomes During MRI Sedation With Midazolam-dexmedetomidine Versus Ketamine-dexmedetomidine

University of Louisville1 个研究点 分布在 1 个国家目标入组 21 人开始时间: 2014年8月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
终止
入组人数
21
试验地点
1
主要终点
The Number of Participants With Hypotension and/or Bradycardia During Sedation and Recovery (Generally 2-3 Hours)

研究概览

简要总结

This study will compare 2 different sedation drugs (Ketamine and Midazolam) when they are used with another sedating medicine called Dexmedetomidine for MRI sedation. This study hopes to measure the impact each drug has on what happens during and after MRI sedation with Dexmedetomidine

详细描述

The will be a randomized, double-blind, prospective study. All patients referred to UCSS for brain MRI and for whom dexmedetomidine would otherwise be the sedation regimen of choice will be eligible for enrollment. The investigators propose to limit the study to patients undergoing only brain MRI as these studies are of a predictable length (25-30 minutes); therefore the sedation regimen can be more easily standardized. Parents of eligible patients would be approached prior to or during the pre-sedation assessment and told about the study and, if they agree to enroll, informed consent would be obtained. Assent will be obtained from children 7 years of age and greater, if they are otherwise developmentally capable of giving assent. The goal is to enroll 50 subjects (25 per treatment group) which would be sufficient to detect a 25% or greater difference in the mean maximal heart rate or blood pressure decrease from baseline between the 2 groups.

Following consent, subjects would be randomized to be sedated with either midazolam-dexmedetomidine or ketamine-dexmedetomidine and, upon achieving an appropriate depth of sedation, undergo their MRI. Monitoring during the MRI and subsequent recovery would occur in compliance with the current Norton Children's Hospital Sedation policy. Recovery-related behavior would be assessed using the Pediatric Anesthesia Emergence Delirium Scale.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Health Services Research
盲法
Triple (Participant, Care Provider, Investigator)

入排标准

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

入选标准

  • Inpatient at Kosair Children's Hospital.
  • Order placed by treating team for MRI of the brain with sedation.
  • Age less than or equal to 18 years.
  • Plan to sedate with dexmedetomidine, regardless of study participation.

排除标准

  • Previous adverse reaction to dexmedetomidine or clonidine
  • Current use of clonidine as a routine medication
  • Concurrent use of a heart-rate decreasing medication (digoxin, propranolol)
  • Contraindication to ketamine use
  • Intracranial hypertension or traumatic brain injury
  • Intraocular hypertension of eye trauma
  • Pulmonary hypertension requiring medical management
  • Planned additional procedure during the sedation encounter (non-brain MRI, lumbar puncture, EEG etc)

研究组 & 干预措施

Dexmedetomidine and Ketamine

Experimental

Subjects will already be getting Dexmedetomidine and Ketamine for their routine care.

干预措施: Ketamine (Drug)

Dexmedetomidine and Ketamine

Experimental

Subjects will already be getting Dexmedetomidine and Ketamine for their routine care.

干预措施: Dexmedetomidine (Drug)

Dexmedetomidine and Midazolam

Active Comparator

Subjects will already be getting Dexmedetomidine and Midazolam for their routine care.

干预措施: Midazolam (Drug)

Dexmedetomidine and Midazolam

Active Comparator

Subjects will already be getting Dexmedetomidine and Midazolam for their routine care.

干预措施: Dexmedetomidine (Drug)

结局指标

主要结局

The Number of Participants With Hypotension and/or Bradycardia During Sedation and Recovery (Generally 2-3 Hours)

时间窗: a total of 2-3 hours during sedation and recovery.

number of participants developing hypotension and or bradycardia

次要结局

  • Percent Change in Heart Rate From Baseline(during sedation and recovery (generally 2-3 hours))
  • The Number of Participants With Adverse Recovery-related Behaviors During Sedation Recovery(Recovery-related behaviors will be specifically measured using the "Pediatric Anesthesia Emergence Delirium (PAED)" scale every 5 minutes from procedure completion until sedation recovery is complete (usually less than 2 hrs))
  • Percent Change in Blood Pressure From Baseline(during sedation and recovery (generally 2-3 hours))

研究者

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

John W Berkenbosch

Professor

University of Louisville

研究点 (1)

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