Intravenous Dexmedetomidine for Cesarean Section

Study Overview
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Brief Summary
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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.

Official Title
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Efficacy and Safety of Dexmedetomidine Combined With Butorphanol Tartrate for Postoperative Analgesia and Breastfeeding in Cesarean Section

Conditions
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Breast Feeding, Analgesia Obstetrical, Postoperative Pain

Intervention / Treatment
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* Drug: Normal Saline
* Drug: Dexmedetomidine 0.03ug/kg/h
* Drug: Dexmedetomidine 0.05ug/kg/h
* Drug: Dexmedetomidine 0.08ug/kg/h


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 24 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: control group<br>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. | Drug: Normal Saline<br>* Drug: Normal saline control group receive NS after delivery. Drug: butorphanol tartrate PCA: butorphanol tartrate after cesarean section.<br>|
| Experimental: Dexmedetomidine 0.03ug/kg/h group<br>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. | Drug: Dexmedetomidine 0.03ug/kg/h<br>* 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.<br>* Other names: Dexmedetomidine Hydrochloride;|
| Experimental: Dexmedetomidine 0.05ug/kg/h group<br>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. | Drug: Dexmedetomidine 0.05ug/kg/h<br>* 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.<br>* Other names: Dexmedetomidine Hydrochloride;|
| Experimental: Dexmedetomidine 0.08ug/kg/h group<br>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. | Drug: Dexmedetomidine 0.08ug/kg/h<br>* 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.<br>* Other names: Dexmedetomidine Hydrochloride;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 6h after cesarean section. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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). | 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 | 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). | 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. | 48h after cesarean section. | 
| Number of Participants That Experienced Nausea or Vomiting | Total times during 48h after cesarean section. | 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). | 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). | 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). | 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 | 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 | 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. | 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. | 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. | 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. | 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 | 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 | 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 | 24h after cesarean section. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Dexmedetomidine, Butorphanol tartrate, Analgesia, Breastfeeding, Relative infant dose