Effect of Dexmedetomidine on Parturient Undergoing Elective Cesarean Section.

Xuzhou Medical University

Status and phase: Completed; Phase 4

Conditions: Cesarean Section

Treatments: Drug: control group; Drug: dexmedetomidine group

Study type: Interventional

Funder types: Other

Identifiers

NCT03805945

XYFY2019-KL054-02

Details and patient eligibility

About

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.

Full 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.

Enrollment: 160 patients

Sex: Female

Ages: 20 to 40 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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160 participants in 2 patient groups, including a placebo group

dexmedetomidine group

Experimental group

Description:

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).

Treatment:

Drug: dexmedetomidine group

control group

Placebo Comparator group

Description:

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).

Treatment:

Drug: control group