Effects of Dexmedetomidine on Mood and Breastfeeding in Parturient Undergoing Elective Cesarean Section.
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 160
- 试验地点
- 1
- 主要终点
- Self-reported exclusive breastfeeding at sixth week after caesarean section
研究概览
简要总结
The purpose of this study was to investigate whether dexmedetomidine used in the perioperative period of elective cesarean section can improve maternal mood, improve analgesic effect, improve maternal recovery quality, and then make the breastfeeding better.At the same time, this experiment attempts to explore the optimal dose of dexmedetomidine to produce the above effect.
详细描述
After obtaining the informed consent, parturients were randomly divided into two groups according to the computer-generated random number table, namely, dexmedetomidine group and the control group.Spinal anesthesia is administered to all maternal women undergoing elective cesarean delivery. Immediately after the umbilicus is cut, the infusion of the experimental drug was started until the end of the operation, and the PCIA pump with the study medication is used during 2 days postoperatively.Continuous follow-up for three days after surgery.Follow-up personnel recorded LATCH score, VAS score, quality-of-recovery score and other indicators.In the 6th week after caesarean section, the outcome indicators were collected by electronic questionnaire and telephone follow-up.This randomized controlled trial is aims to prove that dexmedetomidine, used in parturient with elective cesarean section, can improve maternal mood and prolong the duration of breastfeeding.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •ASA class I or II
- •BMI≦35kg/m2
- •Greater than 37 weeks gestation
- •Expressed a desire to breastfeed for a least 3 months postpartum
- •Elective cesarean section
排除标准
- •Intraspinal anesthesia contraindication
- •Twin or fetal Intrauterine distress
- •Preoperative history of application of analgesia or sedative drug
- •Severe cardiac and pulmonary dysfunction
- •History of neurological and psychiatric diseases
研究组 & 干预措施
dexmedetomidine group
After umbilical cord was cut, a loading dose of dexmedetomidine was pumped at 0.5ug/kg within 10min, followed by a further infusion of dexmedetomidine at 0.5ug /kg/h until the end of the surgery.Then connected with patient-controlled intravenous analgesia pump (dexmedetomidine 2ug/kg + sufentanil 1.5ug/kg + dolasetron 25mg/100ml saline).
干预措施: dexmedetomidine group (Drug)
control group
Continuous infusion of saline after the umbilical cord was cut until the end of the operation.Then connected with patient-controlled intravenous analgesia pump (sufentanil 1.5ug/kg + dolasetron 25mg/100ml saline).
干预措施: control group (Drug)
结局指标
主要结局
Self-reported exclusive breastfeeding at sixth week after caesarean section
时间窗: 6th week postpartum
Self-reported exclusive breastfeeding at sixth week postpartum by telephone follow-up.If exclusive breastfeeding is discontinued, obtain the point of discontinuation.
Postpartum depression at sixth week after caesarean section
时间窗: 6th week postpartum
The Edinburgh Postnatal Depression Scale(EPDS) was used to determine the presence of postpartum depression through an electronic questionnaire in the sixth week after delivery. The Edinburgh Postnatal Depression Scale(EPDS) consists of 10 items. According to the severity of the symptoms, each item is scored in 4 levels (0, 1, 2, 3 points) with a cumulative maximum score of 30 points.In order to reduce the rate of missed diagnosis, we refer to the previous literature and use 10 points as the diagnostic threshold for postpartum depression. A score of 10 or more is considered as postpartum depression.
次要结局
- VAS score after cesarean section(6,12,24 and 48 hours after cesarean section)
- Quality-of-recovery score(Preoperative, 1st day and 2nd day postpartum)
- Hospital Anxiety and Depression Scale(HADS) score(Preoperative, 1st day and 2nd day postpartum)
- LATCH breastfeeding assessments(1st day postpartum)