NCT02483221已完成4 期
Phase 4 Study of Postoperative Pain Therapy With Hydromorphone Using Patient-Controlled Target-Controlled Infusion (TCI-PCA) vs. Patient-Controlled Analgesia (PCA) With Morphine After Elective Cardiac Surgery
University of Erlangen-Nürnberg Medical School1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2015年4月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Numerical Rating Score
研究概览
简要总结
Treatment of postoperative pain with hydromorphone (a strong analgesic) using patient-controlled analgesia with target-controlled infusion compared to conventional patient-controlled analgesia with morphine after elective cardiac surgery
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
- Single (Participant)
入排标准
- 年龄范围
- 40 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Written informed consent
- •Scheduled for elective cardiac surgery involving thoracotomy and subsequent ICU stay
排除标准
- •Administration of other analgesics or sedatives, if not administered in stable dosages for at least 14 days or if not used for premedication and surgery
- •Administration of hydromorphone or morphine in the period between screening and surgery
- •Severe hepatic or renal impairment in medical history
- •BMI>= 35 ASA>= 4
研究组 & 干预措施
TCI-PCA
Active Comparator
干预措施: Hydromorphone (Drug)
PCA
Active Comparator
干预措施: Morphine (Drug)
结局指标
主要结局
Numerical Rating Score
时间窗: up to 17 hours after extubation
Comparison of pain analgetic efficacy between hydromorphone TCI-PCA and conventional morphine PCA during the early postoperative stage
次要结局
- Respiratory Frequency(up to 17 hours after extubation)
- Modified Observer's Assessment of Alertness/Sedation Scale(up to 17 hours after extubation)
- Postoperative Nausea and Vomiting(day of surgery)
研究者
研究点 (1)
Loading locations...
相似试验
已完成
4 期
Postoperative Pain Therapy With Hydromorphone Using TCI-PCAPostoperative PainNCT02035709University of Erlangen-Nürnberg Medical School50
已完成
3 期
Protocolized vs Nonprotocolized Treatment of Adult ED Patients With Acute Severe PainAcute PainNCT00627367Montefiore Medical Center224
招募中
不适用
Effectiveness of postoperative pain control with intravenous acetaminophen (Acelio) following esophageal cancer surgery: A prospective randomize controlled trialEsophageal cancerJPRN-UMIN000026381Tokushima university and graduated school60
已完成
4 期
A Comparison Between Continuous and Intermittent Intraabdominal Analgesia Using Local AnaestheticsAbdominal HysterectomyNCT01492075Örebro University, Sweden40
已完成
4 期
Postoperative Analgesic Effect of Hydromorphone on Partial Pulmonary Resection Under Video-assisted ThoracoscopyPain, PostoperativeThoracic Surgery, Video-AssistedNCT03648008Second Affiliated Hospital, School of Medicine, Zhejiang University171