Study Results
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View full resultsBasic Information
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COMPLETED
PHASE4
120 participants
INTERVENTIONAL
2017-02-07
2017-10-05
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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control group
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.
Normal Saline
Drug: Normal saline control group receive NS after delivery. Drug: butorphanol tartrate PCA: butorphanol tartrate after cesarean section.
Dexmedetomidine 0.03ug/kg/h group
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 0.03ug/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.
Dexmedetomidine 0.05ug/kg/h group
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.
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.
Dexmedetomidine 0.08ug/kg/h group
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 0.08ug/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.
Interventions
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Normal Saline
Drug: Normal saline control group receive NS after delivery. Drug: butorphanol tartrate PCA: butorphanol tartrate after cesarean section.
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.
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.
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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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.
24 Years
45 Years
FEMALE
Yes
Sponsors
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The First Affiliated Hospital with Nanjing Medical University
OTHER
Responsible Party
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Shijiang Liu
Attending
Locations
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The First Affiliated Hospital with Nanjing Medical University
Nanjing, Jiangsu, China
Countries
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References
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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2015-SR-203
Identifier Type: -
Identifier Source: org_study_id
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