Efficacy and Safety of Dexmedetomidine Combined With Butorphanol Tartrate for Postoperative Analgesia and Breastfeeding in Cesarean Section
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Postoperative Pain Score (Visual Analogue Scale, VAS) at Rest
研究概览
简要总结
Nervous, anxiety, fear and other psychological reactions always appears in parturients during cesarean section. This study intends to investigate the effectiveness and safety of dexmedetomidine combined with butorphanol tartrate for postoperative analgesia and breastfeeding 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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 24 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Parturients who had successfully breastfed a prior infant and planned to breastfeed after this delivery were screened for eligibility.
- •Parturients undergoing elective caesarean delivery under epidural anaesthesia
- •ASA I and II parturients aged 18-45 years, with singleton gestation.
- •Parturients with verbal and written mandarin
- •Parturients who want to use PCA intravenous analgesia and can use the pump correctly
- •written informed consent.
- •Exclusion Criteria
- •Multiple gestation.
- •A history of allergy to dexmedetomidine or other study drugs
- •Cardiovascular disease (basic HR<50bpm or SBP<100mmHg)
- •Opioid drugs abuse.
- •BMI more than 35 kg/m2
- •Conditions that preclude spinal anesthesia.
- •Preeclampsia or epilepsy.
- •A history of neuromuscular disease.
- •Epidural anaesthesia was unsuccessful.
- •The parturients, whose surgery ended after 11 a.m.
排除标准
- 未提供
研究组 & 干预措施
control group
The placebo group will pumped in the same volume of saline 0.9% as calculated by parturients' weight in 30 min and receive 1mg butorphanol after delivery.
Postoperative analgesic formula: 3ug/kg/h butorphanol tartrate, diluted with normal saline to 100ml. Background dose: 2ml/h, PCA: 0.5ml, locking time: 15 min.
干预措施: Normal Saline (Drug)
Dexmedetomidine 0.03ug/kg/h group
This group will receive 0.5ug/kg intravenous dexmedetomidine diluted to 4ug/ml in 30 min and 1mg butorphanol tartrate after delivery.
Postoperative analgesic formula: 3ug/kg/h butorphanol tartrate with 0.03ug/kg/h dexmedetomidine, diluted with normal saline to 100ml. Background dose: 2ml/h, PCA: 0.5ml, locking time: 15 min.
干预措施: Dexmedetomidine 0.03ug/kg/h (Drug)
Dexmedetomidine 0.05ug/kg/h group
This group will receive 0.5ug/kg intravenous dexmedetomidine diluted to 4ug/ml in 30 min and 1mg butorphanol tartrate after delivery.
Postoperative analgesic formula: 3ug/kg/h butorphanol tartrate with 0.05ug/kg/h dexmedetomidine, diluted with normal saline to 100ml. Background dose: 2ml/h, PCA: 0.5ml, locking time: 15 min.
干预措施: Dexmedetomidine 0.05ug/kg/h (Drug)
Dexmedetomidine 0.08ug/kg/h group
This group will receive 0.5ug/kg intravenous dexmedetomidine diluted to 4ug/ml in 30 min and 1mg butorphanol tartrate after delivery.
Postoperative analgesic formula: 3ug/kg/h butorphanol tartrate with 0.08ug/kg/h dexmedetomidine, diluted with normal saline to 100ml. Background dose: 2ml/h, PCA: 0.5ml, locking time: 15 min.
干预措施: Dexmedetomidine 0.08ug/kg/h (Drug)
结局指标
主要结局
Postoperative Pain Score (Visual Analogue Scale, VAS) at Rest
时间窗: 6h after cesarean section.
visual analogue scale (VAS; with 0, no pain; to 10, the worst imaginable pain) is a validated assessing scale for pain intensity. VAS at rest was assessed when the patient was in supine position
次要结局
- Postoperative Pain Score (Visual Analogue Scale, VAS) on Uterine Cramping(24h after cesarean section.)
- Relative Infant Dose (RID) of Dexmedetomidine(48h after cesarean section.)
- Postoperative Pain Score (Visual Analogue Scale, VAS) at Rest(24h after cesarean section.)
- Ramsay Sedation Score(RSS)(48h after cesarean section.)
- The Degree of Satisfaction(48h after cesarean section.)
- Number of Participants That Experienced Nausea or Vomiting(48h after cesarean section.)
- Postoperative Pain Score (Visual Analogue Scale, VAS)(48h after cesarean section.)
- Postoperative Pain Score (Visual Analogue Scale, VAS) on Movement(48h after cesarean section.)
研究者
Shijiang Liu
Attending
The First Affiliated Hospital with Nanjing Medical University