跳至主要内容
临床试验/NCT01126957
NCT01126957终止不适用

Combined Ketamine/Propofol for Emergency Department Procedural Sedation

University of Missouri-Columbia1 个研究点 分布在 1 个国家目标入组 107 人开始时间: 2007年5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
107
试验地点
1
主要终点
Respiratory Depression

研究概览

简要总结

Introduction

Numerous drugs and combinations of drugs are used for procedural sedation and analgesia (PSA) in Emergency Departments, including propofol, ketamine, benzodiazepines, narcotics, barbiturates, and others, but propofol has gained popularity despite its potential to cause cardiac and respiratory depression. Obviously the optimal agent or combination of agents has not been identified. There are reasons to believe that a combination of ketamine and propofol may have advantages over other agents/combinations. These include better hemodynamic stability at equal depth of anesthesia with a combination of ketamine/propofol than with propofol alone, less respiratory depression with the combination in comparison to propofol alone, and preservation of respiratory drive with the combination. There is one study of ketamine/propofol in Emergency Department (ED) procedural sedation which demonstrated the safety and effectiveness of the combination, but did not compare it to any other agents or combinations. The investigators designed a randomized, placebo controlled study to compare propofol to propofol and ketamine for adequacy of sedation and respiratory depression in Emergency Department procedural sedation and analgesia. The investigators hypothesis was that the combination of propofol/ketamine would produce better sedation and/or less respiratory depression than propofol alone.

Methods

Study design

The investigators conducted a randomized, prospective, double-blinded study of all patients receiving procedural sedation. From April 2007 until July 2009 in the ED of a 274 bed university teaching hospital. The study was approved by the University of Missouri's Institutional Review Board and informed consent was obtained from all participants.

详细描述

Introduction

Numerous drugs and combinations of drugs are used for procedural sedation and analgesia (PSA) in Emergency Departments, including propofol, ketamine, benzodiazepines, narcotics, barbiturates, and others, but propofol has gained popularity despite its potential to cause cardiac and respiratory depression. Obviously the optimal agent or combination of agents has not been identified. There are reasons to believe that a combination of ketamine and propofol may have advantages over other agents/combinations. These include better hemodynamic stability at equal depth of anesthesia with a combination of ketamine/propofol than with propofol alone, less respiratory depression with the combination in comparison to propofol alone, and preservation of respiratory drive with the combination. There is one study of ketamine/propofol in Emergency Department (ED) procedural sedation which demonstrated the safety and effectiveness of the combination, but did not compare it to any other agents or combinations. We designed a randomized, placebo controlled study to compare propofol to propofol and ketamine for adequacy of sedation and respiratory depression in Emergency Department procedural sedation and analgesia. Our hypothesis was that the combination of propofol/ketamine would produce better sedation and/or less respiratory depression than propofol alone.

Methods

Study design

We conducted a randomized, prospective, double-blinded study of all patients receiving procedural sedation. From May 2007 until March 2009 in the ED of a 274 bed university teaching hospital. The study was approved by the University of Missouri's Institutional Review Board and informed consent was obtained from all participants.

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
Double (Participant, Investigator)

入排标准

年龄范围
1 Year 至 —(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Healthy individuals from 1 year of age and up without the below exclusion criteria

排除标准

  • Subjects: All patients who require ED conscious sedation and do not meet any of the following exclusion criteria are eligible for study participation:
  • Age < 1yr
  • History of prior adverse reaction to anesthesia
  • History of cardiac disease
  • History of pulmonary disease
  • Hepatic dysfunction
  • Thyroid disease
  • Pregnancy
  • Porphyria
  • Psychiatric Illness
  • Allergy to eggs, soybeans, or sulfites
  • Increased intracranial or intraocular pressure
  • Active upper respiratory infection in children
  • Abnormal airway
  • ASA score of III or greater

研究组 & 干预措施

Ketamine

Experimental

Participants received 0.5-1.5 micrograms/kg Fentanyl, followed 0.5 mg/kg Ketamine infusion, followed by propofol to maintain sedation.

干预措施: Ketamine (Drug)

Ketamine

Experimental

Participants received 0.5-1.5 micrograms/kg Fentanyl, followed 0.5 mg/kg Ketamine infusion, followed by propofol to maintain sedation.

干预措施: Fentanyl (Drug)

Ketamine

Experimental

Participants received 0.5-1.5 micrograms/kg Fentanyl, followed 0.5 mg/kg Ketamine infusion, followed by propofol to maintain sedation.

干预措施: Propofol (Drug)

Placebo

Placebo Comparator

Participants received 0.5-1.5 micrograms/kg Fentanyl, followed by placebo infusion, followed by propofol to maintain sedation.

干预措施: Placebo (Drug)

Placebo

Placebo Comparator

Participants received 0.5-1.5 micrograms/kg Fentanyl, followed by placebo infusion, followed by propofol to maintain sedation.

干预措施: Fentanyl (Drug)

Placebo

Placebo Comparator

Participants received 0.5-1.5 micrograms/kg Fentanyl, followed by placebo infusion, followed by propofol to maintain sedation.

干预措施: Propofol (Drug)

结局指标

主要结局

Respiratory Depression

时间窗: Baseline and throughout procedure

1. Endotracheal carbon dioxide (ETCO2) rise \> 5mm/hg 2. Arterial oxygen saturation (SaO2) \<90% 3. Respiratory rate (RR) \< 8 br/min 4. Apnea \> 15 sec 5. airway manipulation

次要结局

  • Satisfaction With Procedural Sedation(20 minutes)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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