A Randomized Placebo-controlled Pilot Study of Single-dose Intraoperative Ketamine for the Prevention of Delirium in Otolaryngeal Cancer Surgery Patients
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 入组人数
- 71
- 试验地点
- 1
- 主要终点
- Change in Confusion Assessment Method fo Intensive Care Unit (CAM-ICU) Delirium Score
研究概览
简要总结
The goal of this prospective randomized double blinded placebo controlled study is to investigate if a single dose of ketamine in addition to standard anesthesia will reduce the risk of delirium in otolaryngeal cancer patients postoperatively. Ketamine's effect on post-operative pain and opioid use will be measured as well. Electroencephalogram (EEG) will be utilized during the surgical procedure to evaluate its potential as a possible predictive device for delirium.
详细描述
This is a single center prospective randomized double blinded placebo controlled study.
The primary aim of the study is to optimize the intraoperative treatment protocol for head and neck cancer patients to reduce the incidence of delirium and associated postoperative cognitive dysfunction. Secondary aims are to determine the dose response relationship for intraoperative ketamine and delirium reduction, determine if a single dose of ketamine will reduce post-operative pain and opioid requirements, determine if raw electroencephalogram (EEG) data can predict postoperative delirium during general anesthesia, and to evaluate length of intensive care unit (ICU) and length of hospital stay.
Participants will be randomized to one of three groups after administration of general anesthesia; one dose of .5 mg/kg intravenous (IV) Ketamine, 1.0 mg/kg of IV Ketamine, or IV placebo.
An EEG will be used during the surgical procedure to gather raw data for off line analysis among patients developing post-operative delirium.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Current diagnosis of otolaryngeal cancer and undergoing surgery with general anesthesia
- •Competent to provide informed consent
排除标准
- •Emergency surgery
- •Monitored Anesthesia Care (i.e., regional anesthesia alone without plans for general anesthesia)
- •Surgery involving the eye, eyebrow, forehead, or frontal scalp near the sensor placement
- •Poor health literacy
- •Allergy, or have experienced any drug reaction to ketamine
- •Pregnant or lactating
- •Currently in active alcohol withdrawal
- •Taking buprenorphine for chronic pain
研究组 & 干预措施
Ketamine 0.5 mg/kg
Participants undergoing surgery for otolaryngeal cancer will be randomized to receive one dose of IV ketamine at 0.5 mg/kg.
干预措施: Electroencephalogram (EEG) (Device)
Ketamine 0.5 mg/kg
Participants undergoing surgery for otolaryngeal cancer will be randomized to receive one dose of IV ketamine at 0.5 mg/kg.
干预措施: Ketamine (Drug)
Ketamine 1.0 mg/kg
Participants undergoing surgery for otolaryngeal cancer will be randomized to receive one dose of IV ketamine at 1.0 mg/kg.
干预措施: Ketamine (Drug)
Ketamine 1.0 mg/kg
Participants undergoing surgery for otolaryngeal cancer will be randomized to receive one dose of IV ketamine at 1.0 mg/kg.
干预措施: Electroencephalogram (EEG) (Device)
Placebo
Participants undergoing surgery for otolaryngeal cancer will be randomized to receive one dose of IV saline/placebo.
干预措施: Placebo (Drug)
Placebo
Participants undergoing surgery for otolaryngeal cancer will be randomized to receive one dose of IV saline/placebo.
干预措施: Electroencephalogram (EEG) (Device)
结局指标
主要结局
Change in Confusion Assessment Method fo Intensive Care Unit (CAM-ICU) Delirium Score
时间窗: Baseline (Up to 30 minutes after PACU arrival), Post Operative (PACU discharge up to 6 hours)
The CAM-ICU assesses four features: 1) acute change or fluctuation in mental status from baseline, 2) inattention, 3) altered level of consciousness, and 4) disorganized thinking. The measure reports whether a participant meets criteria for delirium by summing the number of features answered as "present". Feature 1 plus 2 and either 3 or 4 present = delirium positive. Results are expressed as number of participants with or without delirium at each time frame.
次要结局
- Change in Behavioral Pain Scale (Non-Intubated) Score(Post Operation (Up to 6 Hours), Post Operation Day 0)
- Change in Cognitive Failure Questionnaire (CFQ) Score(Baseline, Post Surgery (Up to 6 Weeks))
- Post Operative Narcotics Use(Post Intervention (Intraoperative), Post Intervention (POD 0), Post Intervention (POD 1),Post Intervention (POD 2),Post Intervention (POD 3), Post Intervention (Follow up visit-up to 6 weeks post intervention))
- Change in Mini-Mental Status Examination (MMSE) Score(Baseline, Post Surgery (Up to 6 Weeks))
- Associations of Intraoperative EEG Patterns With PACU Delirium(Intraoperative EEG and delirium during PACU stay)
- Change in Pain Level Assessed by the Visual Analog Scale (VAS) Score(Baseline, Post Surgery (PACU), Post surgery (POD 0), Post surgery (POD 1), Post surgery (POD 2), Post surgery (POD 3), Post surgery (follow up visit - Up to 6 weeks))
- Change in Mini Cog Score(Baseline, Post Surgery (Up to 6 Weeks))
研究者
Amit Prabhakar
Assistant Professor
Emory University