Intraoperative Low-dose Ketamine Infusion for Patients With Obstructive Sleep Apnea: A Prospective, Randomized, Controlled, Double-Blind Study
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 9
- 试验地点
- 1
- 主要终点
- Pain Scores
研究概览
简要总结
The aim of this study is to substantially reduce overall postoperative morbidity and mortality associated with obstructive sleep apnea.
详细描述
Obstructive sleep apnea (OSA) affects millions of people in the U.S., and currently, there is not a well-established, general anesthetic technique that clearly decreases the risk of postoperative respiratory complications in these patients. If OSA patients have significantly decreased postoperative opioid requirements and improved recovery profiles in the PACU, the protocol could have significant implications in defining future standardized general anesthesia recommendations for patients with this disease. Ultimately, the aim of this study is to substantially reduce overall postoperative morbidity and mortality associated with obstructive sleep apnea. The objective of this study is to compare the postoperative recovery profile of OSA patients receiving standard Sevoflurane inhaled anesthesia with normal saline infusion versus Sevoflurane combined with a low-dose ketamine infusion.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 19 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •aged 19-100
- •scheduled to undergo general ENT or Orthopedic Surgery
- •diagnosis of obstructive sleep apnea as confirmed by sleep study or deemed high risked for obstructive sleep apnea by clinical predictors (greater than 4 clinical predictors of obstructive sleep apnea as described by STOP BANG ).
排除标准
- •positive pregnancy test
- •ASA > III
- •history of alcohol or narcotic abuse in last 90 days
- •significant cardiovascular or respiratory disease (baseline oxygen saturation below 92%)
- •significant psychiatric or neurologic disease
- •history of significant hepatic or renal disease (baseline creatinine>1.5)
- •history of allergy or contraindication to anesthetic agents or ketamine including patients with increased ICP
- •increased IOP
- •severe arrhythmias
- •history of delirium
- •history of hallucinations
- •history of psychosis
- •history of uncontrolled seizures
- •potential risk for malignant hyperthermia (family history)
- •history of difficult intubation that would preclude standard induction of anesthesia
- •prisoners
- •persons who are mentally impaired
- •non-English speakers
研究组 & 干预措施
Control Group
OSA patients will receive standard inhaled anesthesia with normal saline infusion
干预措施: Control (Procedure)
Ketamine Group
OSA patients receiving standard inhaled anesthesia combined with a low-dose ketamine infusion.
干预措施: Ketamine (Drug)
结局指标
主要结局
Pain Scores
时间窗: up to 24 hours postoperatively
Visual Analog Scale pain rating
次要结局
- Patient Satisfaction Score(At 24 hrs post-op)
研究者
Peter A. Nagi
Associate Professor
University of Alabama at Birmingham