Clinical trial NCT03065530: Intravenous Dexmedetomidine for Cesarean Section
Official title: Efficacy and Safety of Dexmedetomidine Combined With Butorphanol Tartrate for Postoperative Analgesia and Breastfeeding in Cesarean Section
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Breast Feeding
Analgesia Obstetrical
Postoperative Pain
Keywords: Dexmedetomidine
Butorphanol tartrate
Analgesia
Breastfeeding
Relative infant dose
Lead sponsor: The First Affiliated Hospital with Nanjing Medical University
Sponsor class: OTHER
First posted: 2017-02-28
Enrollment: 120
Sex: FEMALE
Minimum age (years): 24
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

1. Parturients who had successfully breastfed a prior infant and planned to breastfeed after this delivery were screened for eligibility.
2. Parturients undergoing elective caesarean delivery under epidural anaesthesia
3. ASA I and II parturients aged 18-45 years, with singleton gestation.
4. Parturients with verbal and written mandarin
5. Parturients who want to use PCA intravenous analgesia and can use the pump correctly
6. written informed consent.

Exclusion Criteria

1. Multiple gestation.
2. A history of allergy to dexmedetomidine or other study drugs
3. Cardiovascular disease (basic HR\<50bpm or SBP\<100mmHg)
4. Opioid drugs abuse.
5. BMI more than 35 kg/m2
6. Conditions that preclude spinal anesthesia.
7. Preeclampsia or epilepsy.
8. A history of neuromuscular disease.
9. Epidural anaesthesia was unsuccessful.
10. The parturients, whose surgery ended after 11 a.m.

Primary outcomes:
measure: Postoperative Pain Score (Visual Analogue Scale, VAS) at Rest
timeFrame: 6h after cesarean section.
Secondary outcomes:
measure: Relative Infant Dose (RID) of Dexmedetomidine
timeFrame: 48h after cesarean section.
measure: Postoperative Pain Score (Visual Analogue Scale, VAS) at Rest
timeFrame: 12h after cesarean section.
measure: Ramsay Sedation Score(RSS)
timeFrame: 6h after cesarean section.
measure: The Degree of Satisfaction
timeFrame: 48h after cesarean section.
measure: Number of Participants That Experienced Nausea or Vomiting
timeFrame: 48h after cesarean section.
measure: Ramsay Sedation Score(RSS)
timeFrame: 12h after cesarean section.
measure: Ramsay Sedation Score(RSS)
timeFrame: 24h after cesarean section.
measure: Ramsay Sedation Score(RSS)
timeFrame: 48h after cesarean section.
measure: Postoperative Pain Score (Visual Analogue Scale, VAS) at Rest
timeFrame: 24h after cesarean section.
measure: Postoperative Pain Score (Visual Analogue Scale, VAS)
timeFrame: 48h after cesarean section.
measure: Postoperative Pain Score (Visual Analogue Scale, VAS) on Movement
timeFrame: 6h after cesarean section.
measure: Postoperative Pain Score (Visual Analogue Scale, VAS) on Movement
timeFrame: 12h after cesarean section.
measure: Postoperative Pain Score (Visual Analogue Scale, VAS) on Movement
timeFrame: 24h after cesarean section.
measure: Postoperative Pain Score (Visual Analogue Scale, VAS) on Movement
timeFrame: 48h after cesarean section.
measure: Postoperative Pain Score (Visual Analogue Scale, VAS) on Uterine Cramping
timeFrame: 6h after cesarean section.
measure: Postoperative Pain Score (Visual Analogue Scale, VAS) on Uterine Cramping
timeFrame: 12h after cesarean section.
measure: Postoperative Pain Score (Visual Analogue Scale, VAS) on Uterine Cramping
timeFrame: 24h after cesarean section.
Other outcomes:
Locations:
city: Nanjing
country: China
facility: The First Affiliated Hospital with Nanjing Medical University
state: Jiangsu
Study officials:
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