Phase 4
N=120
Intravenous Dexmedetomidine for Cesarean Section
Breast Feeding · Analgesia Obstetrical · Postoperative Pain
Bottom Line
View on ClinicalTrials.gov: NCT03065530 ↗Enrolled (actual)
120
Serious AEs
0.0%
Results posted
Jan 2020
Primary outcome: Primary: Postoperative Pain Score (Visual Analogue Scale, VAS) at Rest — 3.143; 2.897; 1.665; 1.25 units on a scale — p=<0.05
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Normal Saline (Drug); Dexmedetomidine 0.03ug/kg/h (Drug); Dexmedetomidine 0.05ug/kg/h (Drug); Dexmedetomidine 0.08ug/kg/h (Drug)
- Age
- Adult · 24+ yrs
- Sex
- Female
- Sponsor
- The First Affiliated Hospital with Nanjing Medical University
- Primary completion
- Sep 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Postoperative Pain Score (Visual Analogue Scale, VAS) at Rest |
3.21; 2.93; 1.72; 1.57 | — |
| SECONDARY Relative Infant Dose (RID) of Dexmedetomidine |
0.1712; 0.1967; 0.3701 | — |
| SECONDARY Postoperative Pain Score (Visual Analogue Scale, VAS) at Rest |
3.21; 2.93; 1.72; 1.57 | — |
| SECONDARY Ramsay Sedation Score(RSS) |
2; 2; 2; 2 | — |
| SECONDARY The Degree of Satisfaction |
12; 16; 26; 25 | — |
| SECONDARY Number of Participants That Experienced Nausea or Vomiting |
1; 2; 1; 1 | — |
| SECONDARY Ramsay Sedation Score(RSS) |
2; 2; 2; 2 | — |
| SECONDARY Ramsay Sedation Score(RSS) |
2; 2; 2; 2 | — |
| SECONDARY Ramsay Sedation Score(RSS) |
2; 2; 2; 2 | — |
| SECONDARY Postoperative Pain Score (Visual Analogue Scale, VAS) at Rest |
3.21; 2.93; 1.72; 1.57 | — |
| SECONDARY Postoperative Pain Score (Visual Analogue Scale, VAS) |
2.11; 2; 1.72; 125 | — |
| SECONDARY Postoperative Pain Score (Visual Analogue Scale, VAS) on Movement |
3.43; 3.28; 2.24; 1.21 | — |
| SECONDARY Postoperative Pain Score (Visual Analogue Scale, VAS) on Movement |
3.43; 3.28; 2.24; 1.21 | — |
| SECONDARY Postoperative Pain Score (Visual Analogue Scale, VAS) on Movement |
3.43; 3.28; 2.24; 1.21 | — |
| SECONDARY Postoperative Pain Score (Visual Analogue Scale, VAS) on Movement |
3.43; 3.28; 2.24; 1.21 | — |
| SECONDARY Postoperative Pain Score (Visual Analogue Scale, VAS) on Uterine Cramping |
3.75; 3.55; 2.59; 1.79 | — |
| SECONDARY Postoperative Pain Score (Visual Analogue Scale, VAS) on Uterine Cramping |
3.75; 3.55; 2.59; 1.79 | — |
| SECONDARY Postoperative Pain Score (Visual Analogue Scale, VAS) on Uterine Cramping |
3.75; 3.55; 2.59; 1.79 | — |
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
- Parturients who had successfully breastfed a prior infant and planned to breastfeed after this delivery were screened for eligibility.
- Parturients undergoing elective caesarean delivery under epidural anaesthesia
- ASA I and II parturients aged 18-45 years, with singleton gestation.
- Parturients with verbal and written mandarin
- Parturients who want to use PCA intravenous analgesia and can use the pump correctly
- written informed consent.
Exclusion Criteria
- Multiple gestation.
- A history of allergy to dexmedetomidine or other study drugs
- Cardiovascular disease (basic HR<50bpm or SBP<100mmHg)
- Opioid drugs abuse.
- BMI more than 35 kg/m2
- Conditions that preclude spinal anesthesia.
- Preeclampsia or epilepsy.
- A history of neuromuscular disease.
- Epidural anaesthesia was unsuccessful.
- The parturients, whose surgery ended after 11 a.m.
Data sourced from ClinicalTrials.gov (NCT03065530). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.