Clinical trial NCT03805945: Effect of Dexmedetomidine on Parturient Undergoing Elective Cesarean Section.
Official title: Effects of Dexmedetomidine on Mood and Breastfeeding in Parturient Undergoing Elective Cesarean Section.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Cesarean Section
Keywords: Cesarean Section
Dexmedetomidine
Breast Feeding
Recovery quality
Lead sponsor: The Affiliated Hospital of Xuzhou Medical University
Sponsor class: OTHER
First posted: 2019-01-16
Enrollment: 160
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

1. ASA class I or II
2. BMI≦35kg/m2
3. Greater than 37 weeks gestation
4. Expressed a desire to breastfeed for a least 3 months postpartum
5. Elective cesarean section

Exclusion Criteria:

1. Intraspinal anesthesia contraindication
2. Twin or fetal Intrauterine distress
3. Preoperative history of application of analgesia or sedative drug
4. Severe cardiac and pulmonary dysfunction
5. History of neurological and psychiatric diseases

Primary outcomes:
measure: Postpartum depression at sixth week after caesarean section
timeFrame: 6th week postpartum
measure: Self-reported exclusive breastfeeding at sixth week after caesarean section
timeFrame: 6th week postpartum
Secondary outcomes:
measure: Hospital Anxiety and Depression Scale(HADS) score
timeFrame: Preoperative, 1st day and 2nd day postpartum
measure: LATCH breastfeeding assessments
timeFrame: 1st day postpartum
measure: VAS score after cesarean section
timeFrame: 6,12,24 and 48 hours after cesarean section
measure: Quality-of-recovery score
timeFrame: Preoperative, 1st day and 2nd day postpartum
Other outcomes:
Locations:
city: Xuzhou
country: China
facility: The Affiliated Hospital of Xuzhou Medical University
state: Jiangsu
Study officials:
affiliation: The Affiliated Hospital of Xuzhou Medical University
name: Ming Yan, M.D/Ph.D
role: STUDY_DIRECTOR
References:
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citation: Wang Y, Fang X, Liu C, Ma X, Song Y, Yan M. Impact of Intraoperative Infusion and Postoperative PCIA of Dexmedetomidine on Early Breastfeeding After Elective Cesarean Section: A Randomized Double-Blind Controlled Trial. Drug Des Devel Ther. 2020 Mar 11;14:1083-1093. doi: 10.2147/DDDT.S241153. eCollection 2020.