A Multicenter Study: Dexmedetomidine Combined With Sufentanil for Patient Controlled Intravenous Analgesia After Caesarean Section
NCT ID: NCT02741219
Last Updated: 2021-05-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
225 participants
INTERVENTIONAL
2015-11-30
2016-01-31
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
TRIPLE
Study Groups
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Control Group
Parturients in this group receive 20ml intravenous normal saline immediately after delivery. Their patient controlled analgesia (PCA) protocol after surgery consists of 100 mcg sufentanil diluted into 100ml and administer at a background infusion of 1ml/h,and a bolus of 2ml, with a lock-out of 8min.
Normal saline
Control Group receives normal saline bolus after delivery
Sufentanil
sufentanil PCA after surgery
Dex Group
Parturients in this group receive 0.5mcg/kg intravenous dexmedetomidine diluted to 20ml with normal saline. Their PCA protocol after surgery is 100mcg sufentanil and 300mcg dexmedetomidine diluted to 100ml in saline, with the continuous infusion of 1ml/h, and a bolus of 2 ml, with a lock-out of 8min.
Dexmedetomidine
Dex Group receives dexmedetomidine bolus 0.5mcg/kg after delivery
Sufentanil and dexmedetomidine
sufentanil combined with dexmedetomidine PCA after surgery
Interventions
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Normal saline
Control Group receives normal saline bolus after delivery
Dexmedetomidine
Dex Group receives dexmedetomidine bolus 0.5mcg/kg after delivery
Sufentanil
sufentanil PCA after surgery
Sufentanil and dexmedetomidine
sufentanil combined with dexmedetomidine PCA after surgery
Eligibility Criteria
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Inclusion Criteria
2. American Society of Anesthesiologists class I and II parturients aged 18-45 years, with term singleton pregnancies
3. Parturients with the ability to understand verbal and written mandarin
4. Parturients who want to use PCA intravenous analgesia and can use the pump correctly
5. Parturients whose written informed consent have been obtained
Exclusion Criteria
2. A long use history of opioid analgesic, NSAIDs, tranquilliser use
3. Psychiatric disorders
4. A history of neuromuscular and endocrine disease or allergic disease
5. A history of lower abdominal surgery
6. Preoperative heart rate (HR) less than 50 bpm, SBP less than 100 mmHg or cardiac conduction or rhythm abnormalities
7. spinal anaesthesia was unsuccessful or an epidural catheter had to be used to achieve adequate anaesthesia
8. A second operation is required during the study.
9. Participating other study during the latest three months
10. Body mass index more than 30 kg/m2
11. Difficult airway ( Mallampati score more than 3 and anatomic deformity )
12. Not suitable for participation estimated by investigation
18 Years
45 Years
FEMALE
No
Sponsors
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Obstetrics & Gynecology Hospital of Fudan University
OTHER
Responsible Party
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Nie Yuyan
Associate Professor
Locations
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Obstetrics & Gynecology Hospital of Fudan University
Shanghai, Shanghai Municipality, China
Countries
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Other Identifiers
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OBGynFudanU
Identifier Type: -
Identifier Source: org_study_id
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