A Multicenter Study: Dexmedetomidine Combined With Sufentanil for Patient Controlled Intravenous Analgesia After Caesarean Section
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 225
- 试验地点
- 1
- 主要终点
- Changes in pain score
研究概览
简要总结
The purpose of this multicenter study is to evaluate the effectiveness and safety of dexmedetomidine combined with sufentanil for patient-controlled analgesia after caesarean section
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
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Parturients undergoing elective caesarean delivery under spinal anaesthesia
- •American Society of Anesthesiologists class I and II parturients aged 18-45 years, with term singleton pregnancies
- •Parturients with the ability to understand verbal and written mandarin
- •Parturients who want to use PCA intravenous analgesia and can use the pump correctly
- •Parturients whose written informed consent have been obtained
排除标准
- •A history of allergy to dexmedetomidine or other study drugs
- •A long use history of opioid analgesic, NSAIDs, tranquilliser use
- •Psychiatric disorders
- •A history of neuromuscular and endocrine disease or allergic disease
- •A history of lower abdominal surgery
- •Preoperative heart rate (HR) less than 50 bpm, SBP less than 100 mmHg or cardiac conduction or rhythm abnormalities
- •spinal anaesthesia was unsuccessful or an epidural catheter had to be used to achieve adequate anaesthesia
- •A second operation is required during the study.
- •Participating other study during the latest three months
- •Body mass index more than 30 kg/m2
- •Difficult airway ( Mallampati score more than 3 and anatomic deformity )
- •Not suitable for participation estimated by investigation
研究组 & 干预措施
Control Group
Parturients in this group receive 20ml intravenous normal saline immediately after delivery. Their patient controlled analgesia (PCA) protocol after surgery consists of 100 mcg sufentanil diluted into 100ml and administer at a background infusion of 1ml/h,and a bolus of 2ml, with a lock-out of 8min.
干预措施: Normal saline (Drug)
Control Group
Parturients in this group receive 20ml intravenous normal saline immediately after delivery. Their patient controlled analgesia (PCA) protocol after surgery consists of 100 mcg sufentanil diluted into 100ml and administer at a background infusion of 1ml/h,and a bolus of 2ml, with a lock-out of 8min.
干预措施: Sufentanil (Drug)
Dex Group
Parturients in this group receive 0.5mcg/kg intravenous dexmedetomidine diluted to 20ml with normal saline. Their PCA protocol after surgery is 100mcg sufentanil and 300mcg dexmedetomidine diluted to 100ml in saline, with the continuous infusion of 1ml/h, and a bolus of 2 ml, with a lock-out of 8min.
干预措施: Dexmedetomidine (Drug)
Dex Group
Parturients in this group receive 0.5mcg/kg intravenous dexmedetomidine diluted to 20ml with normal saline. Their PCA protocol after surgery is 100mcg sufentanil and 300mcg dexmedetomidine diluted to 100ml in saline, with the continuous infusion of 1ml/h, and a bolus of 2 ml, with a lock-out of 8min.
干预措施: Sufentanil and dexmedetomidine (Drug)
结局指标
主要结局
Changes in pain score
时间窗: At 0, 4, 8 and 24 h after surgery
Pain scores at rest and movement are evaluated with a visual analogue scale (VAS).
Sufentanil consumption
时间窗: During 24h after surgery
The total consumption of sufentanil during 24h after surgery are recorded.
次要结局
- Changes in heart rate (HR)(At 0 min, 5 min, 10 min, 30 min after intervention during surgery and at 8h,24 h after surgery)
- Changes in systolic blood pressure(At 0 min, 5 min, 10 min, 30 min after intervention during surgery and at 8h,24 h after surgery.)
- Changes in Ramsay sedation score (RSS)(At 4, 8 and 24 h after surgery)
- Press times of analgesic pump(During 24h after surgery)
- Changes in saturation of blood oxygen (SpO2)(At 0 min, 5 min, 10 min, 30 min after intervention during surgery and at 8h,24 h after surgery)
- Changes in diastolic blood pressure(At 0 min, 5 min, 10 min, 30 min after intervention during surgery and at 8h,24 h after surgery)
- Changes in mean arterial blood(At 0 min, 5 min, 10 min, 30 min after intervention during surgery and at 8h,24 h after surgery)
研究者
Nie Yuyan
Associate Professor
Obstetrics & Gynecology Hospital of Fudan University