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临床试验/NCT02643979
NCT02643979终止4 期

Ketamine and Propofol Combination Versus Propofol for Upper Gastrointestinal Endoscopy

Icahn School of Medicine at Mount Sinai1 个研究点 分布在 1 个国家目标入组 22 人开始时间: 2016年1月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
终止
入组人数
22
试验地点
1
主要终点
Number of Participants With Gagging Reaction

研究概览

简要总结

Propofol is one of the most popular anesthetic drugs used for sedation during upper gastrointestinal endoscopies due to its quick onset and quick resolution of symptoms allowing patients to leave the hospital sooner. However, when administered it can also slow the breathing of patients and cause others to have upper airway obstruction (such as snoring) which can impede proper spontaneous breathing. Ketamine is an agent that is capable of providing both pain control and sedation while having either minimal effect on breathing or promoting spontaneous breathing. Combining Ketamine with Propofol has the potential to reduce the total amount of Propofol used resulting in a procedure being performed under the same level of sedation but without the downside of reduced spontaneous breathing. Patients who are obese (defined as body mass index greater than 35) tend to be even more susceptible to this effect of Propofol. The researchers are investigating whether the addition of Ketamine will indeed allow for this continued comfortable level of sedation while promoting continued spontaneous breathing in obese patients undergoing upper gastrointestinal endoscopies.

详细描述

Upon patient arrival to endoscopy suite heart rate (HR), pre-procedure baseline blood pressure (BP), and pre-procedure oxygen saturation (SPO2) via pulse oximeter are recorded in endoscopy holding area, patient alertness and orientation assessed (respond to name, know the state, know the hospital, know the year, know the season).

Once the subject enters the endoscopy suite monitors are placed to record starting BP, HR, SPO2 recorded, nasal cannula with end tidal carbon dioxide (CO2) monitor attached, and 5-lead ECG.

Following time out patient given 100mg Lidocaine IV bolus, 1-minute delay, then study-provided syringe administered. Once patient assessed to produce an RSS score >5 (Asleep with sluggish response to glabellar tap or NO response) endoscopy proceeds.

Recorder (blinded) notes if initially provided syringe alone was enough to produce an RSS >5, notes subject's response to endoscopy insertion (presence or absence of gagging), notes amount of additional propofol required to maintain adequate conditions to continue endoscopy, records non-invasive blood pressure (NIBP) at 3-minute intervals, notes for level of airway obstruction (obstruction with continued air movement, obstruction requiring chin lift or jaw thrust for relief, obstruction requiring progression to assisted ventilation or intubation), notes for desaturation events (SPO2 <90% with a coherent waveform).

At the end of the procedure the total anesthesia time is recorded, total procedure start-to-finish time recorded, total dose of propofol recorded, and any incidence of patient agitation noted.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Double (Participant, Care Provider)

入排标准

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

入选标准

  • BMI > 30
  • Undergoing an upper gastrointestinal endoscopy

排除标准

  • History of schizophrenia/schizoaffective disorder
  • History of bipolar disorder
  • History of dementia
  • Non-English Speaking
  • History of Glaucoma
  • Craniofacial Abnormalities
  • Allergy to Propofol
  • Allergy to Ketamine
  • Current known intracranial mass/lesion

研究组 & 干预措施

Ketofol and Propofol

Experimental

This arm receives a 50mg dose of Ketamine mixed with 100mg of Propofol at the start of their upper endoscopy.

干预措施: Ketofol (Drug)

Ketofol and Propofol

Experimental

This arm receives a 50mg dose of Ketamine mixed with 100mg of Propofol at the start of their upper endoscopy.

干预措施: Propofol (Drug)

Propofol only

Active Comparator

This arm receives 100mg of Propofol mixed with 1mL of saline at the start of the upper gastrointestinal endoscopy.

干预措施: Propofol (Drug)

Propofol only

Active Comparator

This arm receives 100mg of Propofol mixed with 1mL of saline at the start of the upper gastrointestinal endoscopy.

干预措施: Saline (Drug)

结局指标

主要结局

Number of Participants With Gagging Reaction

时间窗: Day 1

Number of participants with gagging or "vomit-like" reaction on endoscopic insertion

次要结局

  • Number of Participants With Any Type of Airway Obstruction(Day 1)
  • Number of Participants With Post-operative Nausea and/or Vomiting(up to 6 months)
  • Time to Recovery(Day 1)
  • Number of Participants With Emergence Delirium(Day 1)
  • Total Dose of Propofol Used During the Procedure(Day 1)
  • Total Sedation Required to Allow Initiation of Procedure(Day 1)

研究者

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

Daniel Katz

Assistant Professor

Icahn School of Medicine at Mount Sinai

研究点 (1)

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