Intravenous Dexmedetomidine for Cesarean Section
- Conditions
- Breast FeedingAnalgesia ObstetricalPostoperative Pain
- Interventions
- Registration Number
- NCT03065530
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 120
- 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.
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description control group Normal Saline The placebo group will pumped in the same volume of saline 0.9% as calculated by parturients' weight in 30 min and receive 1mg butorphanol after delivery. Postoperative analgesic formula: 3ug/kg/h butorphanol tartrate, diluted with normal saline to 100ml. Background dose: 2ml/h, PCA: 0.5ml, locking time: 15 min. Dexmedetomidine 0.03ug/kg/h group Dexmedetomidine 0.03ug/kg/h This group will receive 0.5ug/kg intravenous dexmedetomidine diluted to 4ug/ml in 30 min and 1mg butorphanol tartrate after delivery. Postoperative analgesic formula: 3ug/kg/h butorphanol tartrate with 0.03ug/kg/h dexmedetomidine, diluted with normal saline to 100ml. Background dose: 2ml/h, PCA: 0.5ml, locking time: 15 min. Dexmedetomidine 0.08ug/kg/h group Dexmedetomidine 0.08ug/kg/h This group will receive 0.5ug/kg intravenous dexmedetomidine diluted to 4ug/ml in 30 min and 1mg butorphanol tartrate after delivery. Postoperative analgesic formula: 3ug/kg/h butorphanol tartrate with 0.08ug/kg/h dexmedetomidine, diluted with normal saline to 100ml. Background dose: 2ml/h, PCA: 0.5ml, locking time: 15 min. Dexmedetomidine 0.05ug/kg/h group Dexmedetomidine 0.05ug/kg/h This group will receive 0.5ug/kg intravenous dexmedetomidine diluted to 4ug/ml in 30 min and 1mg butorphanol tartrate after delivery. Postoperative analgesic formula: 3ug/kg/h butorphanol tartrate with 0.05ug/kg/h dexmedetomidine, diluted with normal saline to 100ml. Background dose: 2ml/h, PCA: 0.5ml, locking time: 15 min.
- Primary Outcome Measures
Name Time Method Postoperative Pain Score (Visual Analogue Scale, VAS) at Rest 6h after cesarean section. visual analogue scale (VAS; with 0, no pain; to 10, the worst imaginable pain) is a validated assessing scale for pain intensity. VAS at rest was assessed when the patient was in supine position
- Secondary Outcome Measures
Name Time Method Postoperative Pain Score (Visual Analogue Scale, VAS) on Uterine Cramping 24h after cesarean section. visual analogue scale (VAS; with 0, no pain; to 10, the worst imaginable pain) is a validated assessing scale for pain intensity. VAS-C was assessed when the patient required oxytocin after surgery in supine position
Relative Infant Dose (RID) of Dexmedetomidine 48h after cesarean section. Relative infant dose (RID) =Dose (infant, mg•kg-1•day-1) /Dose (mother, mg•kg-1•day-1) μg·kg-1·h-1. The Dose (infant) in mg•kg-1 is calculated by multiplying the concentration of the drug in breast milk by the volume of breast milk consumed daily (about 150 mL•kg-1).
Postoperative Pain Score (Visual Analogue Scale, VAS) at Rest 24h after cesarean section. visual analogue scale (VAS; with 0, no pain; to 10, the worst imaginable pain) is a validated assessing scale for pain intensity. VAS at rest was assessed when the patient was in supine position
Ramsay Sedation Score(RSS) 48h after cesarean section. Sedation intensity measured with RSS is recorded at the 6, 12, 24, and 48 h after cesarean section. Sedation was assessed by the Ramsay Sedation Scores (RSS) (1, anxious patient; 2, cooperative and tranquil; 3, responding to command; 4, brisk response to stimulus; 5, sluggish response to stimulus; 6, no response to stimulus).
The Degree of Satisfaction 48h after cesarean section. The degree of satisfaction (0, very satisfied; 1, satisfied; 2, moderately satisfied; 3, not satisfied) was evaluated at 48 h after surgery. The number of overall satisfied patients (satisfied and very satisfied) is reported.
Number of Participants That Experienced Nausea or Vomiting 48h after cesarean section. Total times during 48h after cesarean section.
Postoperative Pain Score (Visual Analogue Scale, VAS) 48h after cesarean section. visual analogue scale (VAS; with 0, no pain; to 10, the worst imaginable pain) is a validated assessing scale for pain intensity. VAS at rest was assessed when the patient was in supine position
Postoperative Pain Score (Visual Analogue Scale, VAS) on Movement 48h after cesarean section. visual analogue scale (VAS; with 0, no pain; to 10, the worst imaginable pain) is a validated assessing scale for pain intensity. VAS on movement was assessed when patients changed from supine to lateral position.
Trial Locations
- Locations (1)
The First Affiliated Hospital with Nanjing Medical University
🇨🇳Nanjing, Jiangsu, China