Randomized Comparison Study of Single Dose Morphine and Fentanyl Added to Intrathecal Mixture on Orthopedics Patients With Undiagnosed Obstructive Sleep Apnea
试验速览
- 阶段
- 1 期
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Oxygen Desaturation Index (ODI)
研究概览
简要总结
Obstructive Sleep Apnea (OSA) is a common clinical problem with a reported prevalence of 2% to 4% in the general population. The incidence was double on patients who had a diagnosis of OSA going for orthopedics surgery.
Little literature composed mostly of case reports or small retrospective case-control studies exist examining the use of intrathecal opioids on outcomes in OSA patients is inconclusive. The primary objective of this study is to compare the post operative respiratory effect after single dose intrathecal morphine and intrathecal fentanyl on orthopedics patients who suspected or undiagnosed obstructive sleep apnea.
Hypotheses
Undiagnosed OSA patients who received intrathecal morphine are more likely to have respiratory events post-operatively.
详细描述
This is a prospective, randomized study to compare the post operative respiratory effect after single dose intrathecal morphine (0.1mg) and intrathecal fentanyl (40mcg) on orthopedics patients who suspected or undiagnosed obstructive sleep apnea.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Patients who admitted for orthopedic surgery and consented for regional anesthesia
- •STOP - BANG score ≥ 5
排除标准
- •Refused to give informed consent
- •Previous diagnosis and treatment of OSA or any sleep-related breathing disorder
- •Allergic to morphine / fentanyl / Local anesthetic
- •Contra-indicated for regional anesthesia
- •Pregnant woman
- •Contraindication to either of the oral analgesia as in protocol
研究组 & 干预措施
Morphine
Intrathecal Morphine 0.1mg
干预措施: Morphine (Drug)
Fentanyl
Intrathecal Fentanyl 40mcg
干预措施: Fentanyl (Drug)
结局指标
主要结局
Oxygen Desaturation Index (ODI)
时间窗: 72 hours post-operative
The end point of the study is to assess the Oxygen Desaturation Index (ODI) within 72 hours post-operatively in both arms of the patients.
Respiratory Rate (RR)
时间窗: 72 hours post operatively
The end point of the study is to assess the respiratory rate (RR) within 72 hours post-operatively in both arms of the patients.
Heart Rate (HR)
时间窗: 72 hours post-operative
The end point of the study is to assess the heart rate (HR) within 72 hours post-operatively in both arms of the patients.
次要结局
未报告次要终点