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The purpose of this multicenter study is to evaluate the effectiveness and safety of dexmedetomidine combined with sufentanil for patient-controlled analgesia after caesarean section
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control Group | Placebo Comparator | 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. |
|
| Dex Group | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Normal saline | Drug | Control Group receives normal saline bolus after delivery |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Sufentanil consumption | The total consumption of sufentanil during 24h after surgery are recorded. | During 24h after surgery |
| Changes in pain score | Pain scores at rest and movement are evaluated with a visual analogue scale (VAS). | At 0, 4, 8 and 24 h after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in Ramsay sedation score (RSS) | Sedation intensity measured with RSS is recorded at the 4, 8 and 24 h after surgery. | At 4, 8 and 24 h after surgery |
| Changes in systolic blood pressure |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Obstetrics & Gynecology Hospital of Fudan University | Shanghai | Shanghai Municipality | 200090 | China |
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| Dexmedetomidine |
| Drug |
Dex Group receives dexmedetomidine bolus 0.5mcg/kg after delivery |
|
| Sufentanil | Drug | sufentanil PCA after surgery |
|
| Sufentanil and dexmedetomidine | Drug | sufentanil combined with dexmedetomidine PCA after surgery |
|
Systolic blood pressure is recorded at 0 min, 5 min, 10 min, 30 min after intervention during surgery and at 8h,24 h after surgery.
| At 0 min, 5 min, 10 min, 30 min after intervention during surgery and at 8h,24 h after surgery. |
| Press times of analgesic pump | The total press times and invalid press times are recorded during 24h after surgery. | During 24h after surgery |
| Changes in heart rate (HR) | HR is recorded at 0 min, 5 min, 10 min, 30 min after intervention during surgery and at 8h,24 h after surgery. | At 0 min, 5 min, 10 min, 30 min after intervention during surgery and at 8h,24 h after surgery |
| Changes in saturation of blood oxygen (SpO2) | SpO2 is recorded at 0 min, 5 min, 10 min, 30 min after intervention during surgery | At 0 min, 5 min, 10 min, 30 min after intervention during surgery and at 8h,24 h after surgery |
| Changes in diastolic blood pressure | Diastolic blood pressure is recorded at 0 min, 5 min, 10 min, 30 min after intervention during surgery and at 8h,24 h after surgery. | At 0 min, 5 min, 10 min, 30 min after intervention during surgery and at 8h,24 h after surgery |
| Changes in mean arterial blood | Mean arterial blood pressure is recorded at 0 min, 5 min, 10 min, 30 min after intervention during surgery and at 8h,24 h after surgery. | At 0 min, 5 min, 10 min, 30 min after intervention during surgery and at 8h,24 h after surgery |
| ID | Term |
|---|---|
| D010149 | Pain, Postoperative |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
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| ID | Term |
|---|---|
| D000077330 | Saline Solution |
| D020927 | Dexmedetomidine |
| D017409 | Sufentanil |
| ID | Term |
|---|---|
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D005283 | Fentanyl |
| D010880 | Piperidines |
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