Back to resultsIntravenous Dexmedetomidine for Cesarean Section
Primary Purpose
Breast Feeding, Analgesia Obstetrical, Postoperative Pain
Status
Completed
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Normal Saline
Dexmedetomidine 0.03ug/kg/h
Dexmedetomidine 0.05ug/kg/h
Dexmedetomidine 0.08ug/kg/h
Sponsored by
About this trial
This is an interventional treatment trial for Breast Feeding focused on measuring Dexmedetomidine, Butorphanol tartrate, Analgesia, Breastfeeding, Relative infant dose
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.
Sites / Locations
- The First Affiliated Hospital with Nanjing Medical University
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Placebo Comparator
Experimental
Experimental
Experimental
Arm Label
control group
Dexmedetomidine 0.03ug/kg/h group
Dexmedetomidine 0.05ug/kg/h group
Dexmedetomidine 0.08ug/kg/h group
Arm Description
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.
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.
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.
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.
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
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).
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
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).
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.
Number of Participants That Experienced Nausea or Vomiting
Total times during 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).
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).
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).
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
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
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.
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.
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.
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.
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
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
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
Full Information
NCT ID
NCT03065530
First Posted
February 18, 2017
Last Updated
January 10, 2020
Sponsor
The First Affiliated Hospital with Nanjing Medical University
1. Study Identification
Unique Protocol Identification Number
NCT03065530
Brief Title
Intravenous Dexmedetomidine for Cesarean Section
Official Title
Efficacy and Safety of Dexmedetomidine Combined With Butorphanol Tartrate for Postoperative Analgesia and Breastfeeding in Cesarean Section
Study Type
Interventional
2. Study Status
Record Verification Date
January 2020
Overall Recruitment Status
Completed
Study Start Date
February 7, 2017 (Actual)
Primary Completion Date
September 30, 2017 (Actual)
Study Completion Date
October 5, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The First Affiliated Hospital with Nanjing Medical University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Feeding, Analgesia Obstetrical, Postoperative Pain
Keywords
Dexmedetomidine, Butorphanol tartrate, Analgesia, Breastfeeding, Relative infant dose
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
120 (Actual)
8. Arms, Groups, and Interventions
Arm Title
control group
Arm Type
Placebo Comparator
Arm Description
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.
Arm Title
Dexmedetomidine 0.03ug/kg/h group
Arm Type
Experimental
Arm Description
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.
Arm Title
Dexmedetomidine 0.05ug/kg/h group
Arm Type
Experimental
Arm Description
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.
Arm Title
Dexmedetomidine 0.08ug/kg/h group
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Normal Saline
Intervention Description
Drug: Normal saline control group receive NS after delivery. Drug: butorphanol tartrate PCA: butorphanol tartrate after cesarean section.
Intervention Type
Drug
Intervention Name(s)
Dexmedetomidine 0.03ug/kg/h
Other Intervention Name(s)
dexmedetomidine Injection, Dexmedetomidine Hydrochloride
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Dexmedetomidine 0.05ug/kg/h
Other Intervention Name(s)
dexmedetomidine Injection, Dexmedetomidine Hydrochloride
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Dexmedetomidine 0.08ug/kg/h
Other Intervention Name(s)
dexmedetomidine Injection, Dexmedetomidine Hydrochloride
Intervention Description
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.
Primary Outcome Measure Information:
Title
Postoperative Pain Score (Visual Analogue Scale, VAS) at Rest
Description
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.
Secondary Outcome Measure Information:
Title
Relative Infant Dose (RID) of Dexmedetomidine
Description
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.
Title
Postoperative Pain Score (Visual Analogue Scale, VAS) at Rest
Description
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.
Title
Ramsay Sedation Score(RSS)
Description
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.
Title
The Degree of Satisfaction
Description
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.
Title
Number of Participants That Experienced Nausea or Vomiting
Description
Total times during 48h after cesarean section.
Time Frame
48h after cesarean section.
Title
Ramsay Sedation Score(RSS)
Description
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.
Title
Ramsay Sedation Score(RSS)
Description
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.
Title
Ramsay Sedation Score(RSS)
Description
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.
Title
Postoperative Pain Score (Visual Analogue Scale, VAS) at Rest
Description
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.
Title
Postoperative Pain Score (Visual Analogue Scale, VAS)
Description
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.
Title
Postoperative Pain Score (Visual Analogue Scale, VAS) on Movement
Description
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.
Title
Postoperative Pain Score (Visual Analogue Scale, VAS) on Movement
Description
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.
Title
Postoperative Pain Score (Visual Analogue Scale, VAS) on Movement
Description
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.
Title
Postoperative Pain Score (Visual Analogue Scale, VAS) on Movement
Description
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.
Title
Postoperative Pain Score (Visual Analogue Scale, VAS) on Uterine Cramping
Description
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.
Title
Postoperative Pain Score (Visual Analogue Scale, VAS) on Uterine Cramping
Description
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.
Title
Postoperative Pain Score (Visual Analogue Scale, VAS) on Uterine Cramping
Description
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.
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
24 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Facility Information:
Facility Name
The First Affiliated Hospital with Nanjing Medical University
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
210029
Country
China
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Intravenous Dexmedetomidine for Cesarean Section
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