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This randomized controlled trial is designed to investigate the effect of low-dose of S-ketamine combined with sufentanil for postoperative patient-controlled intravenous analgesia in patients following cesarean section.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| S-ketamine group | Experimental | The pump is established with S-ketamine 1mg/kg, sufentanil 2microgram/kg, andondansetron16mg, diluted with normal saline to 100 ml. |
|
| Control group | Placebo Comparator | The pump is established with sufentanil 2microgram/kg, andondansetron16mg, diluted with normal saline to 100 ml. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| S-ketamine | Drug | After surgery, patient-controlled analgesia is provided. The pump is established with S-ketamine 1mg/kg, sufentanil 2microgram/kg, andondansetron16mg, diluted with normal saline to 100 ml. The pump is programmed to deliver 2 ml boluses with a background infusion rate at 2 ml /h and a 30 min lockout interval. |
| Measure | Description | Time Frame |
|---|---|---|
| The percentage of patients with moderate-to-severe pain | Moderate-to-severe pain is defined as a numeric rating scale (NRS; an 11-point scale where 0=no pain and 10=the worst pain) pain score ≥4. | Up to 48 hours after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| NRS pain score at rest and with movement | Pain is assessed with a numeric rating scale (NRS; an 11-point scale where 0=no pain and 10=the worst pain) | Hour 12 & Hour 24 & Hour 48 after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| The total number of presses of Patient-controlled Analgesia (PCA) | The total number of presses of PCA | Up to 48 hours after surgery |
| The percentage of using rescue analgesics | The percentage of using rescue analgesics |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ling Dong, Ph.D | Contact | 18866862815 | dongling1668@163.com | |
| Ling Dong, MD | Contact | 18866862815 | dongling1668@163.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Qianfoshan Hospital, The First Hospital affiliated of Shandong First Medical University | Recruiting | Jinan | Shandong | 250000 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30570761 | Background | Brinck EC, Tiippana E, Heesen M, Bell RF, Straube S, Moore RA, Kontinen V. Perioperative intravenous ketamine for acute postoperative pain in adults. Cochrane Database Syst Rev. 2018 Dec 20;12(12):CD012033. doi: 10.1002/14651858.CD012033.pub4. | |
| 29870457 | Background | Schwenk ES, Viscusi ER, Buvanendran A, Hurley RW, Wasan AD, Narouze S, Bhatia A, Davis FN, Hooten WM, Cohen SP. Consensus Guidelines on the Use of Intravenous Ketamine Infusions for Acute Pain Management From the American Society of Regional Anesthesia and Pain Medicine, the American Academy of Pain Medicine, and the American Society of Anesthesiologists. Reg Anesth Pain Med. 2018 Jul;43(5):456-466. doi: 10.1097/AAP.0000000000000806. |
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| ID | Term |
|---|---|
| D000377 | Agnosia |
| ID | Term |
|---|---|
| D010468 | Perceptual Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| C000629870 | Esketamine |
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|
| Placebo | Drug | After surgery, patient-controlled analgesia is provided. The pump is established with sufentanil 2microgram/kg, andondansetron16mg, diluted with normal saline to 100 ml. The pump is programmed to deliver 2 ml boluses with a background infusion rate at 2 ml /h and a 30 min lockout interval. |
|
| Up to 48 hours after surgery |
| The Richmond Agitation-Sedation Scale(RASS) | Sedation is assessed with a numeric rating scale(RASS;an 10-point scale with -5 to +4) | Hour 12 & Hour 24 & Hour 48 after surgery |
| The incidence of postoperative adverse event | postoperative adverse event with nausea,vomiting,dizziness,nightmares, hallucination and etc | Up to 48 hours after surgery |
| 27418219 | Background | Isik Y, Dag ZO, Tulmac OB, Pek E. Early postpartum lactation effects of cesarean and vaginal birth. Ginekol Pol. 2016;87(6):426-30. doi: 10.5603/GP.2016.0020. |
| 27118118 | Background | Hobbs AJ, Mannion CA, McDonald SW, Brockway M, Tough SC. The impact of caesarean section on breastfeeding initiation, duration and difficulties in the first four months postpartum. BMC Pregnancy Childbirth. 2016 Apr 26;16:90. doi: 10.1186/s12884-016-0876-1. |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |