Analgesia Obstetrical, Breast Feeding, Postoperative Pain
Conditions
Keywords
Dexmedetomidine, Butorphanol tartrate, Analgesia, Breastfeeding, Relative infant dose
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.
Interventions
DRUGDexmedetomidine 0.08ug/kg/h
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.
DRUGNormal Saline
Drug: Normal saline control group receive NS after delivery. Drug: butorphanol tartrate PCA: butorphanol tartrate after cesarean section.
DRUGDexmedetomidine 0.03ug/kg/h
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.
DRUGDexmedetomidine 0.05ug/kg/h
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.
Sponsors
The First Affiliated Hospital with Nanjing Medical University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
24 Years to 45 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Postoperative Pain Score (Visual Analogue Scale, VAS) at Rest | 12h 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) | 6h 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. |
| 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) | 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 | 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 on movement was assessed when patients changed from supine to lateral position. |
| Postoperative Pain Score (Visual Analogue Scale, VAS) on Uterine Cramping | 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-C was assessed when the patient required oxytocin after surgery in supine position |
| Number of Participants That Experienced Nausea or Vomiting | 48h after cesarean section. | Total times during 48h after cesarean section. |
Countries
China
Participant flow
Recruitment details
Parturients (\>18 and \<45 years old) with a singleton pregnancy admitted to our institute who underwent elective caesarean delivery under epidural anaesthesia were recruited in this study between February 2017 and October 2017.
Pre-assignment details
not meeting inclusion criteria (n=39) declined to participate , n=14 other reasons, n=3
Participants by arm
| Arm | Count |
|---|---|
| Placebo The placebo group will pumped in the same volume of saline 0.9% as calculated by parturients' weight in 30 min.
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.
Normal Saline: Drug: Normal saline control group receive NS after delivery. Drug: butorphanol tartrate PCA: butorphanol tartrate after cesarean section. | 28 |
| Dexmedetomidine 0.03ug/kg/h This group will receive 0.5ug/kg intravenous dexmedetomidine diluted to 4ug/ml in 30 min.
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 0.03ug/kg/h: 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. | 29 |
| Dexmedetomidine 0.05ug/kg/h This group will receive 0.5ug/kg intravenous dexmedetomidine diluted to 4ug/ml in 30 min.
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.
Dexmedetomidine 0.05ug/kg/h: 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. | 29 |
| Dexmedetomidine 0.08ug/kg/h This group will receive 0.5ug/kg intravenous dexmedetomidine diluted to 4ug/ml in 30 min.
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 0.08ug/kg/h: 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. | 28 |
| Total | 114 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | Lack of Efficacy | 1 | 1 | 0 | 1 |
| Overall Study | Protocol Violation | 1 | 0 | 1 | 1 |
Baseline characteristics
| Characteristic | Total | Dexmedetomidine 0.03ug/kg/h | Dexmedetomidine 0.05ug/kg/h | Placebo | Dexmedetomidine 0.08ug/kg/h |
|---|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 114 Participants | 29 Participants | 29 Participants | 28 Participants | 28 Participants |
| Age, Continuous | 31.59 years STANDARD_DEVIATION 3.67 | 31.41 years STANDARD_DEVIATION 3.69 | 32.07 years STANDARD_DEVIATION 4.2 | 31.75 years STANDARD_DEVIATION 3.46 | 31.11 years STANDARD_DEVIATION 3.37 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 114 Participants | 29 Participants | 29 Participants | 28 Participants | 28 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Region of Enrollment China | 114 Participants | 29 Participants | 29 Participants | 28 Participants | 28 Participants |
| Sex: Female, Male Female | 114 Participants | 29 Participants | 29 Participants | 28 Participants | 28 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 28 | 0 / 29 | 0 / 29 | 0 / 28 |
| other Total, other adverse events | 1 / 28 | 2 / 29 | 1 / 29 | 1 / 28 |
| serious Total, serious adverse events | 0 / 28 | 0 / 29 | 0 / 29 | 0 / 28 |
Outcome results
Primary
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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Group C | Postoperative Pain Score (Visual Analogue Scale, VAS) at Rest | 3.143 units on a scale | Standard Deviation 1.38 |
| Group D1 | Postoperative Pain Score (Visual Analogue Scale, VAS) at Rest | 2.897 units on a scale | Standard Deviation 1.012 |
| Group D2 | Postoperative Pain Score (Visual Analogue Scale, VAS) at Rest | 1.665 units on a scale | Standard Deviation 1.045 |
| Group D3 | Postoperative Pain Score (Visual Analogue Scale, VAS) at Rest | 1.25 units on a scale | Standard Deviation 0.7515 |
Comparison: The sample size was calculated on the basis of an our initial pilot study, and the SD was 1.4 between the four groups. We hypothesized that the differences in VAS between the four groups and the SDs would be 15%. A power analysis suggested that there will be 80% power to detect differences at an α=0.05 significance level (two-tailed), including 24 individuals per treatment group. Considering the exclusion of 25% of patients, 30 parturients were eventually recruited in each group.p-value: <0.05Kruskal-Wallis
Secondary
Number of Participants That Experienced Nausea or Vomiting
Total times during 48h after cesarean section.
Time frame: 48h after cesarean section.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Group C | Number of Participants That Experienced Nausea or Vomiting | 1 participants |
| Group D1 | Number of Participants That Experienced Nausea or Vomiting | 2 participants |
| Group D2 | Number of Participants That Experienced Nausea or Vomiting | 1 participants |
| Group D3 | Number of Participants That Experienced Nausea or Vomiting | 1 participants |
Secondary
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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Group C | Postoperative Pain Score (Visual Analogue Scale, VAS) | 2.11 score on a scale | Standard Deviation 0.96 |
| Group D1 | Postoperative Pain Score (Visual Analogue Scale, VAS) | 2 score on a scale | Standard Deviation 0.8 |
| Group D2 | Postoperative Pain Score (Visual Analogue Scale, VAS) | 1.72 score on a scale | Standard Deviation 0.84 |
| Group D3 | Postoperative Pain Score (Visual Analogue Scale, VAS) | 125 score on a scale | Standard Deviation 0.75 |
Secondary
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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Group C | Postoperative Pain Score (Visual Analogue Scale, VAS) at Rest | 3.21 score on a scale | Standard Deviation 0.92 |
| Group D1 | Postoperative Pain Score (Visual Analogue Scale, VAS) at Rest | 2.93 score on a scale | Standard Deviation 1.03 |
| Group D2 | Postoperative Pain Score (Visual Analogue Scale, VAS) at Rest | 1.72 score on a scale | Standard Deviation 0.84 |
| Group D3 | Postoperative Pain Score (Visual Analogue Scale, VAS) at Rest | 1.57 score on a scale | Standard Deviation 1.17 |
Secondary
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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Group C | Postoperative Pain Score (Visual Analogue Scale, VAS) at Rest | 3.29 score on a scale | Standard Deviation 1.01 |
| Group D1 | Postoperative Pain Score (Visual Analogue Scale, VAS) at Rest | 2.86 score on a scale | Standard Deviation 0.99 |
| Group D2 | Postoperative Pain Score (Visual Analogue Scale, VAS) at Rest | 1.62 score on a scale | Standard Deviation 0.78 |
| Group D3 | Postoperative Pain Score (Visual Analogue Scale, VAS) at Rest | 0.93 score on a scale | Standard Deviation 0.94 |
Secondary
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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Group C | Postoperative Pain Score (Visual Analogue Scale, VAS) on Movement | 3.43 score on a scale | Standard Deviation 1.26 |
| Group D1 | Postoperative Pain Score (Visual Analogue Scale, VAS) on Movement | 3.28 score on a scale | Standard Deviation 1.1 |
| Group D2 | Postoperative Pain Score (Visual Analogue Scale, VAS) on Movement | 2.24 score on a scale | Standard Deviation 1.19 |
| Group D3 | Postoperative Pain Score (Visual Analogue Scale, VAS) on Movement | 1.21 score on a scale | Standard Deviation 0.92 |
Secondary
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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Group C | Postoperative Pain Score (Visual Analogue Scale, VAS) on Movement | 3.82 score on a scale | Standard Deviation 0.86 |
| Group D1 | Postoperative Pain Score (Visual Analogue Scale, VAS) on Movement | 3.79 score on a scale | Standard Deviation 0.82 |
| Group D2 | Postoperative Pain Score (Visual Analogue Scale, VAS) on Movement | 2.35 score on a scale | Standard Deviation 1.2 |
| Group D3 | Postoperative Pain Score (Visual Analogue Scale, VAS) on Movement | 1.93 score on a scale | Standard Deviation 1.02 |
Secondary
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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Group C | Postoperative Pain Score (Visual Analogue Scale, VAS) on Movement | 3.71 score on a scale | Standard Deviation 0.81 |
| Group D1 | Postoperative Pain Score (Visual Analogue Scale, VAS) on Movement | 3.52 score on a scale | Standard Deviation 0.87 |
| Group D2 | Postoperative Pain Score (Visual Analogue Scale, VAS) on Movement | 2.69 score on a scale | Standard Deviation 1.07 |
| Group D3 | Postoperative Pain Score (Visual Analogue Scale, VAS) on Movement | 1.18 score on a scale | Standard Deviation 0.86 |
Secondary
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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Group C | Postoperative Pain Score (Visual Analogue Scale, VAS) on Movement | 4.39 score on a scale | Standard Deviation 0.74 |
| Group D1 | Postoperative Pain Score (Visual Analogue Scale, VAS) on Movement | 4.31 score on a scale | Standard Deviation 1.14 |
| Group D2 | Postoperative Pain Score (Visual Analogue Scale, VAS) on Movement | 2.86 score on a scale | Standard Deviation 1.48 |
| Group D3 | Postoperative Pain Score (Visual Analogue Scale, VAS) on Movement | 2.2 score on a scale | Standard Deviation 0.65 |
Secondary
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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Group C | Postoperative Pain Score (Visual Analogue Scale, VAS) on Uterine Cramping | 3.75 score on a scale | Standard Deviation 1.35 |
| Group D1 | Postoperative Pain Score (Visual Analogue Scale, VAS) on Uterine Cramping | 3.55 score on a scale | Standard Deviation 0.99 |
| Group D2 | Postoperative Pain Score (Visual Analogue Scale, VAS) on Uterine Cramping | 2.59 score on a scale | Standard Deviation 1.21 |
| Group D3 | Postoperative Pain Score (Visual Analogue Scale, VAS) on Uterine Cramping | 1.79 score on a scale | Standard Deviation 1.1 |
Secondary
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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Group C | Postoperative Pain Score (Visual Analogue Scale, VAS) on Uterine Cramping | 3.86 score on a scale | Standard Deviation 0.85 |
| Group D1 | Postoperative Pain Score (Visual Analogue Scale, VAS) on Uterine Cramping | 3.66 score on a scale | Standard Deviation 0.94 |
| Group D2 | Postoperative Pain Score (Visual Analogue Scale, VAS) on Uterine Cramping | 2.79 score on a scale | Standard Deviation 0.98 |
| Group D3 | Postoperative Pain Score (Visual Analogue Scale, VAS) on Uterine Cramping | 2 score on a scale | Standard Deviation 1.22 |
Secondary
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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Group C | Postoperative Pain Score (Visual Analogue Scale, VAS) on Uterine Cramping | 3.46 score on a scale | Standard Deviation 1.2 |
| Group D1 | Postoperative Pain Score (Visual Analogue Scale, VAS) on Uterine Cramping | 3.41 score on a scale | Standard Deviation 0.95 |
| Group D2 | Postoperative Pain Score (Visual Analogue Scale, VAS) on Uterine Cramping | 2.17 score on a scale | Standard Deviation 1 |
| Group D3 | Postoperative Pain Score (Visual Analogue Scale, VAS) on Uterine Cramping | 1.07 score on a scale | Standard Deviation 1.15 |
Secondary
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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Group C | Ramsay Sedation Score(RSS) | 2 score on a scale | Standard Deviation 0 |
| Group D1 | Ramsay Sedation Score(RSS) | 2 score on a scale | Standard Deviation 0 |
| Group D2 | Ramsay Sedation Score(RSS) | 2 score on a scale | Standard Deviation 0 |
| Group D3 | Ramsay Sedation Score(RSS) | 2 score on a scale | Standard Deviation 0 |
Secondary
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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Group C | Ramsay Sedation Score(RSS) | 2 score on a scale | Standard Deviation 0 |
| Group D1 | Ramsay Sedation Score(RSS) | 2.07 score on a scale | Standard Deviation 0.26 |
| Group D2 | Ramsay Sedation Score(RSS) | 2.10 score on a scale | Standard Deviation 0.31 |
| Group D3 | Ramsay Sedation Score(RSS) | 2.25 score on a scale | Standard Deviation 0.44 |
Secondary
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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Group C | Ramsay Sedation Score(RSS) | 2 score on a scale | Standard Deviation 0 |
| Group D1 | Ramsay Sedation Score(RSS) | 2.21 score on a scale | Standard Deviation 0.41 |
| Group D2 | Ramsay Sedation Score(RSS) | 2.28 score on a scale | Standard Deviation 0.45 |
| Group D3 | Ramsay Sedation Score(RSS) | 3.21 score on a scale | Standard Deviation 0.74 |
Secondary
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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Group C | Ramsay Sedation Score(RSS) | 2 score on a scale | Standard Deviation 0 |
| Group D1 | Ramsay Sedation Score(RSS) | 2.17 score on a scale | Standard Deviation 0.38 |
| Group D2 | Ramsay Sedation Score(RSS) | 2.14 score on a scale | Standard Deviation 0.35 |
| Group D3 | Ramsay Sedation Score(RSS) | 3.14 score on a scale | Standard Deviation 0.71 |
Secondary
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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Group C | Relative Infant Dose (RID) of Dexmedetomidine | 0.1712 percentage of one hundred | Standard Deviation 0.1764 |
| Group D1 | Relative Infant Dose (RID) of Dexmedetomidine | 0.1967 percentage of one hundred | Standard Deviation 0.1141 |
| Group D2 | Relative Infant Dose (RID) of Dexmedetomidine | 0.3701 percentage of one hundred | Standard Deviation 0.2357 |
Secondary
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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Group C | The Degree of Satisfaction | 12 Participants |
| Group D1 | The Degree of Satisfaction | 16 Participants |
| Group D2 | The Degree of Satisfaction | 26 Participants |
| Group D3 | The Degree of Satisfaction | 25 Participants |