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| Name | Class |
|---|---|
| China Health Promotion Foundation | UNKNOWN |
| Beijing Haidian Maternal and Child Health Hospital | OTHER |
| Obstetrics & Gynecology Hospital of Fudan University | OTHER |
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During the past years, a large number of clinical trials have investigated the use of the non-competitive N-methyl-D-aspartate (NMDA) receptor antagonist racemic ketamine as an adjunct to local anaesthetics, opioids, or other analgesic agents for the management and prevention of postoperative pain. Actually racemic ketamine not only abolishes peripheral afferent noxious stimulation, but can also prevent the central nociceptor sensitization. S-ketamine, one of two enantiomers of racemic ketamine, has twice the analgesic potency of the racemate. Moreover, S-ketamine shows smaller nervous system and less psychotropic effects than racemic ketamine , which may make the drug more suitable for clinical use. Recently, S-ketamine has been approved to treat refractory depression (TRD) and major depressive disorder (MDD) by the FDA .S-ketamine may have greater clinical significance due to the high rate of maternal depression. Therefore, we plan to explore whether clinical use of S-ketamine can optimize anesthesia protocol and improve maternal prognosis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Saline group | Placebo Comparator | Parturients were subsequently placed in a supine position with a left lateral tilt (15 ̊). Combined spinal-epidural anesthesia method (CSE) was performed at the L2-L3 or L3-L4 lumbar vertebral interspace, with 10~13mg 0.5% ropivacaine by a needle-through-needle technique. When adequate anesthesia to the T6 dermatome was achieved (Sensory and motor assessments were performed at 1 min intervals using pinprick testing and the modified Bromage score). Parturients received 10ml intravenous normal saline before surgery, If the anesthesia is inadequate, another 5ml 0.5% ropivacaine was given. Morphine hydrochloride 1 mg in saline 10 mL was injected by several times into the epidural space at the end of the operation. After the surgery, their PCA protocol consisted of 150 ug sufentanil and 24ml atropisetron diluted into 150 ml (2ml of basal infusion, a bolus of 0.5ml on demand, "lock-out" interval of 10 min, last for 48 h postoperatively); |
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| K1 group | Experimental | Parturients were subsequently placed in a supine position with a left lateral tilt (15 ̊). Combined spinal-epidural anesthesia method (CSE) was performed at the L2-L3 or L3-L4 lumbar vertebral interspace, with 10~13mg 0.5% ropivacaine by a needle-through-needle technique. When adequate anesthesia to the T6 dermatome was achieved (Sensory and motor assessments were performed at 1 min intervals using pinprick testing and the modified Bromage score). Parturients received 10ml intravenous 0.2mg/kg before surgery, If the anesthesia is inadequate, another 5ml 0.5% ropivacaine was given. Morphine hydrochloride 1 mg in saline 10 mL was injected by several times into the epidural space at the end of the operation. After the surgery, their PCA protocol consisted of 150 ug sufentanil and 24ml atropisetron diluted into 150 ml (2ml of basal infusion, a bolus of 0.5ml on demand, "lock-out" interval of 10 min, last for 48 h postoperatively); |
|
| K2 group |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| S-ketamine | Drug | K1 group: pregnant women received 0.2mg/kg S-ketamine, intravenous drip; |
|
| Measure | Description | Time Frame |
|---|---|---|
| Intraoperative anesthesia effect | Anesthesia effect is graded I-IV. Level I means that it is very satisfactory, while Level IV means other anesthesia methods are needed to complete the operation. We expect to reach level I. | Day 1 |
| Ramsay Sedation Scale score | The Ramsay Sedation Scale (RSS) was the first scale to be defined for sedated patients and was designed as a test of rousability. The RSS scores sedation at six different levels, according to how rousable the patient is. | Day 1 |
| Clock-in-the-Box(CIB) | The Clock-in-the-Box (CIB) is a rapidly administered cognitive screening measure which has been previously validated with cognitive screening and neuropsychological assessments. The CIB is scored on a 0-8 point scale and the total score includes two separate subscale scores. The higher scores reflect better performance. | Day 0 & Day 2 |
| Measure | Description | Time Frame |
|---|---|---|
| PHQ-9 | PHQ-9 is the major depressive disorder(MDD) module of the full PHQ. Used to provisionally diagnose depression and grade severity of symptoms in general medical and mental health settings. Scores each of the 9 DSM criteria of MDD as "0" (not at all) to "3" (nearly every day), providing a 0-27 severity score. Higher PHQ-9 scores are associated with decreased functional status and increased symptom-related difficulties, sick days, and healthcare utilization. |
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Inclusion Criteria:
Exclusion Criteria:
Parturients undergoing elective cesarean section
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Mingjun Xu | Contact | 86-13701038959 | snake650222@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Lei Wang | Beijing Haidian Maternal and Child Health Hospital | Principal Investigator |
| Shaoqiang Huang | Obstetrics & Gynecology Hospital of Fudan University | Principal Investigator |
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| ID | Term |
|---|---|
| D000377 | Agnosia |
| D003863 | Depression |
| D019052 | Depression, Postpartum |
| ID | Term |
|---|---|
| D010468 | Perceptual Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| C000629870 | Esketamine |
| D000077330 | Saline Solution |
| ID | Term |
|---|---|
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |
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| The Fourth Hospital of Shijiazhuang |
| OTHER |
| Changzhi Maternal and Child Health Hospital | UNKNOWN |
| Linfen Maternity&Child Healthcare Hospital | UNKNOWN |
| Maternal and Child Health Hospital, Jiading District | OTHER |
| Tongzhou Maternal and Child Healthcare Hospital of Beijing | UNKNOWN |
| Beijing Chaoyang District Maternal and Child Health Care Hospital | UNKNOWN |
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Parturients were subsequently placed in a supine position with a left lateral tilt (15 ̊). Combined spinal-epidural anesthesia method (CSE) was performed at the L2-L3 or L3-L4 lumbar vertebral interspace, with 10~13mg 0.5% ropivacaine by a needle-through-needle technique. When adequate anesthesia to the T6 dermatome was achieved (Sensory and motor assessments were performed at 1 min intervals using pinprick testing and the modified Bromage score). Parturients received 10ml intravenous 0.3mg/kg before surgery, If the anesthesia is inadequate, another 5ml 0.5% ropivacaine was given. Morphine hydrochloride 1 mg in saline 10 mL was injected by several times into the epidural space at the end of the operation. After the surgery, their PCA protocol consisted of 150 ug sufentanil and 24ml atropisetron diluted into 150 ml (2ml of basal infusion, a bolus of 0.5ml on demand, "lock-out" interval of 10 min, last for 48 h postoperatively); |
|
| normal saline | Other | Saline group: pregnant women received saline, intravenous drip |
|
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| S-ketamine | Drug | K2 group: pregnant women received 0.3mg/kg S-ketamine, intravenous drip; |
|
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| Day 0 & Day 3 & Day 8 & Day 43 |
| Edinburgh Postnatal Depression Scale(EPDS) | EPDS is a valuable and efficient way of identifying patients at risk for "perinatal" depression. Mothers who score above 13 are likely to be suffering from a depressive illness of varying severity depression. | Day 3 & Day 8 & Day 43 |
| Apgar score | The Apgar score is a test given to newborns soon after birth. This test checks a baby's heart rate, muscle tone, and other signs to see if extra medical care or emergency care is needed. The test is usually given twice: once at 1 minute after birth, and again at 5 minutes after birth. | Day 0 |
| placental transfer of S-ketamine | Placental transfer was evaluated based on the whole blood concentrations of S-ketamine in the maternal and cord blood | Day 0 |
| blood gas | Blood gases are a group of tests that are performed together to measure the pH and the amount of oxygen (O2) and carbon dioxide (CO2) present in a sample of blood | Day 0 |
| umbilical arterial (UA)/umbilical venous (UV) ratio | UA/UV ratio was evaluated based on the blood concentrations of S-ketamine in the umbilical arterial and umbilical venous blood | Day 0 |
| Jin Zhang |
| The Fourth Hospital of Shijiazhuang |
| Principal Investigator |
| Yingbin Ren | Changzhi Maternal and Child Health Hospital | Principal Investigator |
| Yong Qin | Linfen Maternity&Child Healthcare Hospital | Principal Investigator |
| Shenghua Li | Maternal and Child Health Hospital, Jiading District | Principal Investigator |
| Zhenhuan Hou | Tongzhou Maternal and Child Healthcare Hospital of Beijing | Principal Investigator |
| Shuyi Miao | Beijing Chaoyang District Maternal and Child Health Care Hospital | Principal Investigator |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
| D011644 | Puerperal Disorders |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D003866 | Depressive Disorder |
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |