A Randomized, Double-Blinded, Placebo-Controlled Study to Determine if Caffeine Citrate Accelerates Emergence From Anesthesia
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 8
- 试验地点
- 1
- 主要终点
- Waking Time - Time Between Terminating Anesthesia and Subject Opening Eyes.
研究概览
简要总结
At present clinicians have no way to reverse anesthesia. Patients wake when their bodies clear the anesthetic. Most people wake quickly, but some do not. All patients have memory and other cognitive problems after waking from anesthesia. In studies on animals, the investigators observed that caffeine caused rats to wake much more rapidly from propofol anesthesia. This was true for all the animals tested. The investigators would like to see if this holds true in humans. Will caffeine accelerate waking from anesthesia? Will it reverse the cognitive deficits associated with anesthesia, after waking?
The propose investigators carrying out a modest trial with 8 test subjects. Each volunteer will be anesthetized twice. Each volunteer will be anesthetized one time and receive an infusion of saline (placebo control), without the aid of any other drugs and the other time the volunteer will receive an infusion of a relatively low dose of caffeine. The order of saline versus caffeine will be randomized and the study will be done in a double blind manner. We will determine whether emergence from propofol anesthesia will be significantly accelerated by the caffeine infusion. And whether any adverse events are observed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 25 Years 至 40 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Normal healthy subject without systematic diseases or conditions.
- •Metabolic Equivalents of Functional Capacity >=
- •Low risk for Obstructive Sleep Apnea (OSA) based on the screening test (STOP-bang score established by American Society of Sleep Apnea): Yes to > 3 items- high risk of OSA
- •No History of Arrhythmia (Baseline EKG will be obtained during the history and physical session), seizure, liver and kidney diseases.
- •BMI < 30 kg/m
- •No history of prior difficulty with anesthesia.
- •No personal or family history of malignant hyperthermia.
- •No history of any mental illness.
- •No history of drugs or alcohol abuse (urine drug screens required).
- •Subjects capable of giving consent.
- •Living less than 30 miles away from University of Chicago.
- •No history of seizure disorders.
- •No history of head trauma.
排除标准
- •Age <25 or >
- •ASA physical status > 1 (normal healthy subject without systematic diseases or conditions)
- •Metabolic Equivalents of Functional Capacity (METs) <
- •High risks for Obstructive Sleep Apnea (OSA) based on the screening test (STOP-bang score established by American Society of Sleep Apnea): Yes to > 3 items- high risk of OSA
- •History Arrhythmia (Baseline EKG will be obtained during the history and physical session), seizure, liver and kidney diseases
- •BMI>30 kg/m
- •Prior difficulty with anesthesia.
- •Personal or family history of malignant hyperthermia.
- •History of any mental illness.
- •History of drugs or alcohol abuse (urine drug screens required)
- •Subjects not capable of giving consent
- •Living more than 30 miles away from University of Chicago.
- •History of seizure disorders.
- •History of head trauma.
研究组 & 干预措施
Placebo then Caffeine
Anesthetized volunteers will be allowed to wake after injection of saline (placebo control) followed by a washout period and then anesthetized again and allowed to wake after injection of caffeine (15 mg/ kg).
干预措施: Placebo (Drug)
Caffeine then Placebo
Anesthetized volunteers will be allowed to wake after injection of caffeine (15 mg/ kg) followed by a washout period and then anesthetized again and allowed to wake after injection of saline (placebo control).
干预措施: Placebo (Drug)
Placebo then Caffeine
Anesthetized volunteers will be allowed to wake after injection of saline (placebo control) followed by a washout period and then anesthetized again and allowed to wake after injection of caffeine (15 mg/ kg).
干预措施: Caffeine (Drug)
Caffeine then Placebo
Anesthetized volunteers will be allowed to wake after injection of caffeine (15 mg/ kg) followed by a washout period and then anesthetized again and allowed to wake after injection of saline (placebo control).
干预措施: Caffeine (Drug)
结局指标
主要结局
Waking Time - Time Between Terminating Anesthesia and Subject Opening Eyes.
时间窗: 15 minutes
The goal of the study is to determine whether caffeine speeds emergence from anesthesia. The time between terminating delivery of anesthetic and the subject opening their eyes will be measured. The time to "emerge" from anesthesia will be defined as the time between terminating the anesthesia and the test subject opening their eyes.
次要结局
- Cognitive Test1 - Visual Analog Scale(Up to 120 minutes after terminating anesthesia.)
- Cognitive Test2 - Sternberg Test of Memory(Up to 120 minutes after terminating anesthesia.)
- Cognitive Test3 - Divided Attention Task(Up to 120 minutes after terminating anesthesia.)
- Bispectral Index(Up to 120 minutes after terminating anesthesia.)
- Mean Arterial Blood Pressure(Up to 120 minutes after terminating anesthesia.)
- Heart Rate(Up to 120 minutes after terminating anesthesia.)