A Prospective, Observational, Double-blind (Black-Box) Study Evaluating Incidence, Severity and Predictive Factors of Respiratory Depression During Postoperative Neuraxial Opioid Analgesia in Obstetric Patients After Cesarean Delivery Using Current Standard Intermittent Postoperative Monitoring Compared to Continuous Pulse Oximetry / Capnography
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- RESPIRATORY DEPRESSION
研究概览
简要总结
This study is designed to determine the incidence and severity of respiratory depression in elective cesarean section patients who have received a spinal or epidural narcotic called duramorph for management of postoperative pain. A monitoring device called a capnograph as well as a device called a pulse oximeter is placed on the patient once in the recovery room after delivery. The capnograph monitors the carbon dioxide level that the patient breathes out as well as their respiratory rate. The pulse oximeter is a device that is taped on the patient's finger and measures their oxygen saturation level. The monitoring is maintained for 18-24 hours after surgery.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 55 Years(Adult)
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Are female >= 18 years of age and <=55 years of age with ASA class I-III
- •Schedule for cesarean surgery
- •Are willing and able to sign informed consent form for this study
- •Are willing and able to follow the instruction in this study protocol
排除标准
- •Have known contraindication/allergy to neuraxial anesthesia or morphine.
- •Have an ASA class > III
- •Age > 55 years
结局指标
主要结局
RESPIRATORY DEPRESSION
时间窗: 24 HOURS
RESPIRATORY DEPRESSION OBSERVATION ONLY OF CURRENT PRACTICES, DOES NOT INVOLVE TREATMENT
次要结局
未报告次要终点
