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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
120
Drug: Normal saline control group receive NS after delivery. Drug: butorphanol tartrate PCA: butorphanol tartrate after cesarean section.
Drug: Dexmedetomidine This group receive Dex 0.5ug/kg after delivery. Drug: butorphanol tartrate and Dexmedetomidine. PCA: butorphanol tartrate with 0.03ug/kg/h Dexmedetomidine after cesarean section.
Drug: Dexmedetomidine This group receive Dex 0.5ug/kg after delivery. Drug: butorphanol tartrate and Dexmedetomidine. PCA: butorphanol tartrate with 0.05ug/kg/h Dexmedetomidine after cesarean section.
The First Affiliated Hospital with Nanjing Medical University
Nanjing, Jiangsu, China
Postoperative Pain Score (Visual Analogue Scale, VAS) at Rest
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
Time frame: 6h after cesarean section.
Relative Infant Dose (RID) of Dexmedetomidine
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).
Time frame: 48h after cesarean section.
Postoperative Pain Score (Visual Analogue Scale, VAS) at Rest
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
Time frame: 12h after cesarean section.
Ramsay Sedation Score(RSS)
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).
Time frame: 6h after cesarean section.
The Degree of Satisfaction
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.
Time frame: 48h after cesarean section.
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Drug: Dexmedetomidine This group receive Dex 0.5ug/kg after delivery. Drug: butorphanol tartrate and Dexmedetomidine. PCA: butorphanol tartrate with 0.08ug/kg/h Dexmedetomidine after cesarean section.
Number of Participants That Experienced Nausea or Vomiting
Total times during 48h after cesarean section.
Time frame: 48h after cesarean section.
Ramsay Sedation Score(RSS)
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).
Time frame: 12h after cesarean section.
Ramsay Sedation Score(RSS)
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).
Time frame: 24h after cesarean section.
Ramsay Sedation Score(RSS)
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).
Time frame: 48h after cesarean section.
Postoperative Pain Score (Visual Analogue Scale, VAS) at Rest
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
Time frame: 24h after cesarean section.
Postoperative Pain Score (Visual Analogue Scale, VAS)
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
Time frame: 48h after cesarean section.
Postoperative Pain Score (Visual Analogue Scale, VAS) on Movement
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.
Time frame: 6h after cesarean section.
Postoperative Pain Score (Visual Analogue Scale, VAS) on Movement
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.
Time frame: 12h after cesarean section.
Postoperative Pain Score (Visual Analogue Scale, VAS) on Movement
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.
Time frame: 24h after cesarean section.
Postoperative Pain Score (Visual Analogue Scale, VAS) on Movement
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.
Time frame: 48h after cesarean section.
Postoperative Pain Score (Visual Analogue Scale, VAS) on Uterine Cramping
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
Time frame: 6h after cesarean section.
Postoperative Pain Score (Visual Analogue Scale, VAS) on Uterine Cramping
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
Time frame: 12h after cesarean section.
Postoperative Pain Score (Visual Analogue Scale, VAS) on Uterine Cramping
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
Time frame: 24h after cesarean section.