Effect of Dexmedetomidine of Gastrointestinal Motility
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 22
- 试验地点
- 1
- 主要终点
- Intra-anal Sphincter Pressure (IASP) 1 Minute After Dexmedetomidine Administration
研究概览
简要总结
Anorectal manometry requires that the patient be able to respond to command and not receive any medications which could alter muscle tone or motility. In the pediatric population, anorectal manometry can be psychologically challenging to parents and their child, as it is traditionally performed without adjuvant sedation or anesthesia. Sedatives and anesthesia can alter motility and smooth muscle activity, as well as render it difficult or impossible for the child to follow commands required of the study. Patient or parent non-compliance, inability to follow commands or to tolerate the procedure often renders the study invalid or impossible to complete. Dexmedetomidine is a sedative who's effect on anorectal musculature has not been studied nor determined. It would be important to determine whether it spares smooth muscle function, as it would provide a viable option to provide sedation to children while still preserving their ability to respond to command. The primary objective of this study is to examine the effects of dexmedetomidine on gastrointestinal smooth muscle by observing changes in anorectal manometry before and after dexmedetomdine administration.
详细描述
Primary objective:
To examine the effects of dexmedetomidine on intra-anal pressure and the dose response curve to balloon distention by comparing the baseline measurements with those after dexmedetomidine administration.
Dexmedetomidine is an alpha-2 agonist that is considered to be a smooth muscle relaxant. It's a potential use as a sedative for endoscopies has been considered. It is important to know whether or not it has effect on smooth muscle tone and would affect manometry studies in those patients who could receive it. The investigator hypothesizes that dexmedetomidine will have minimal effects in the dosing that is being administered.
Background:
Anorectal manometry requires that the patient be able to respond to command and not receive any medications which could alter muscle tone or motility. These patients typically have the manometry performed without any adjuvant sedatives, anesthetics or medications. In the pediatric population, anorectal manometry can be psychologically challenging to parents and their child, particularly without adjuvant sedation or anesthesia. There are some exceptional circumstances which require sedation/anesthesia administration for these procedures, either because the children are young (< 5 years), they have behavioral issues (like autism) or because they have severe anxiety. In those patients with severe issues even general anesthesia may be needed. The risk of administering any medication to these patients is that they can alter motility and smooth muscle activity, consequently artificially altering the results of the anal manometry. It is important to know which medications can be administered without affecting anal muscle tone. Dexmedetomidine is a newer sedative and anxiolytic. It could be valuable for anxiolysis for anal manometry. It's effect on anal smooth muscle, however, has never been studied. It would be important to determine whether it spares smooth muscle function, as it would provide a viable option to provide sedation to children while still preserving their ability to respond to command.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 3 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Ages 3-18 years who are scheduled to have an anorectal manometry followed by an upper or lower endoscopic procedures at Boston Children's Hospital
- •Patients are cooperative to do the anorectal manometry without sedation (besides pre-med midazolam)
- •Anticipates to receive standard sedation with dexmedetomidine and propofol for a gastrointestinal procedure in the Gastroenterology Procedure Unit (GPU)
- •Provides written consent to participate in the research study
- •In females of reproductive age, pregnancy testing
排除标准
- •Do not meet established sedation criteria
- •Patients who require sedation prior to their anal manometry testing
- •History of allergy, intolerance, or reaction to dexmedetomidine
- •Current, repaired or risk of Moya-Moya disease
- •Recent stroke (cerebrovascular accident) within past 6 months
- •Uncontrolled hypertension
- •Concomitant use of opioids, beta antagonist, alpha 2 agonist or calcium channel blocker
- •BMI greater than 30 or weight above 110th percentile
- •Refuses insertion of intravenous catheter while awake
- •Currently receiving pharmacologic agents for hypertension or cardiac disease
- •Currently receiving or has received digoxin within the past 3 months
- •Active, uncontrolled gastroesophageal reflux (an aspiration risk), requiring endotracheal intubation.
- •Current (or within past 3 months) history of apnea requiring an apnea monitor
- •Unstable cardiac status (life threatening arrhythmias, abnormal cardiac anatomy, significant cardiac dysfunction)
- •Craniofacial anomaly, which could make it difficult to effectively establish a mask airway for positive pressure ventilation if needed
- •Active, current respiratory issues that are different from the baseline status (pneumonia, exacerbation of asthma, bronchiolitis, respiratory syncytial virus).
研究组 & 干预措施
Dexmedetomidine
This is a single arm, open label, interventional study examining the effects of dexmedetomidine on anal manometry. All subjects will be administered dexmedetomidine following their baseline manometry measurements. Following dexmedetomidine administration, anal manometry measurements will be observed for 15 minutes.
干预措施: Dexmedetomidine (Drug)
结局指标
主要结局
Intra-anal Sphincter Pressure (IASP) 1 Minute After Dexmedetomidine Administration
时间窗: 1 minute
Intra-anal Sphincter Pressure (IASP) 5 Minutes After Dexmedetomidine Administration
时间窗: 5 minutes
Intra-anal Sphincter Pressure (IASP) Baseline Measurement
时间窗: 30 seconds
IASP recorded prior to administration of dexmedetomidine
次要结局
未报告次要终点
研究者
Keira Mason
Associate Professor of Anaesthesia, Harvard Medical School Boston Children's Hospital
Boston Children's Hospital