Electroencephalogram Studies of Induction and Recovery From Ketamine-Induced General Anesthesia
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 16
- 试验地点
- 1
- 主要终点
- Average Pain Intensity Pre- and Post-Ketamine Induction
研究概览
简要总结
We are doing this research study to find out how and where ketamine acts in the brain. Ketamine is an anesthetic (a drug or agent used to decrease or eliminate the feeling of pain by putting you in an unconscious state). We will look at the brain using a machine that records the brain's electrical activity, called an electroencephalogram (EEG). We will assess how it impacts patient's pain responses.
详细描述
In this trial, participants will be given ketamine at a high enough dosage to induce general anesthesia. EEG recording will be conducted during this time. Cognitive assessments and pain monitoring will be administered at various points before and after ketamine induction.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Between the ages of 18 to 45
- •Normal body weight and habitus, BMI less than or equal to 30
- •Non-smoker
- •American Society of Anesthesiologists (ASA) physical status classification P1
排除标准
- •Cardiovascular: myocardial infarction, coronary artery disease, peripheral vascular disease, arrhythmia, congestive heart failure, valvular disease, hypertension
- •Respiratory: bronchitis, chronic obstructive pulmonary disease, smoking, shortness of breath
- •Hepatic: hepatitis, jaundice, ascites
- •Neurologic: seizure, stroke, positive neurologic findings on neurologic examination, multiple sclerosis, Meniere's disease, Parkinson's disease, neuropathy, peripheral stenosis
- •Gastrointestinal: esophageal reflux, hiatal hernia, ulcer
- •Endocrine: diabetes, thyroid disease
- •Renal: acute or chronic severe renal insufficiency
- •Hematologic: blood dyscrasias, anemia, coagulopathies, on anticoagulant therapy
- •Musculoskeletal: prior surgery or trauma to head neck or face, arthritis, personal or family history of malignant hyperthermia
- •Psychiatric: history or treatment for an active psychiatric problem, depression
- •Reproductive: pregnancy, breast-feeding
- •Medications: regular use of prescription and non-prescription medications expected to affect CNS function, St. John's Wort
- •Allergies: labetalol, ondansetron, glycopyrrolate, ketamine, midazolam
研究组 & 干预措施
Ketamine
15 subjects undergoing ketamine general anesthesia.
干预措施: Ketamine (Drug)
结局指标
主要结局
Average Pain Intensity Pre- and Post-Ketamine Induction
时间窗: Approximately 125 minutes
Average Pain Intensity prior to ketamine induction, 30 minutes post ketamine, 60 minutes post ketamine, 75 minutes post ketamine, and 120 minutes post ketamine. PROMIS Pain Intensity 1a was used to assess pain delivered by a pre-calibrated pain cuff. Scale of 0 (no pain) to 10 (worst imaginable pain).
次要结局
- Average Dissociation States Score Pre- and Post-Ketamine Induction(About 125 minutes)
- Difference of the Mean Clinician Administered Dissociative States Scale Before and After Midazolam Administration(About 60 minutes)
研究者
Oluwaseun Johnson-Akeju, MD, MMSc
Associate Professor of Anaesthesia
Massachusetts General Hospital