NCT03805945

Effect of Dexmedetomidine on Parturient Undergoing Elective Cesarean Section.

Effects of Dexmedetomidine on Mood and Breastfeeding in Parturient Undergoing Elective Cesarean Section.

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 160 (actual)
• Sponsor: The Affiliated Hospital of Xuzhou Medical University · Academic / Other
• Sex: Female
• Age: 20 Years – 40 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Cesarean Section

Interventions

Type	Name	Description
DRUG	dexmedetomidine group	After the fetus was delivered, low-dose dexmedetomidine intraoperative infusion, postoperative low-dose dexmedetomidine patient-controlled intravenous analgesia pump(the background infusion is 2 ml/h, the bolus dose is 0.5 ml, the lock time is 15 min).
DRUG	control group	After the fetus was delivered, saline intraoperative infusion, postoperative patient-controlled intravenous analgesia pump(the background infusion is 2 ml/h, the bolus dose is 0.5 ml, the lock time is 15 min) without dexmedetomidine.

Timeline

• Start date: 2019-06-01
• Primary completion: 2019-12-02
• Completion: 2019-12-02
• First posted: 2019-01-16
• Last updated: 2019-12-03

Locations

1 site across 1 country: China