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The Efficacy and Safety of S-ketamine in Elective Cesarean Section (ES-CS)

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ClinicalTrials.gov Identifier: NCT04657107
Recruitment Status : Not yet recruiting
First Posted : December 8, 2020
Last Update Posted : December 8, 2020
Sponsor:
Collaborators:
China Health Promotion Foundation
Beijing Haidian Maternal and Child Health Hospital
Obstetrics & Gynecology Hospital of Fudan University
Fourth Hospital of Shijiazhuang City
Changzhi Maternal and Child Health Hospital
Linfen Maternity&Child Healthcare Hospital
Maternal and Child Health Hospital, Jiading District
Tongzhou Maternal and Child Healthcare Hospital of Beijing
Beijing Chaoyang District Maternal and Child Health Care Hospital
Information provided by (Responsible Party):
Mingjun Xu, Beijing Obstetrics and Gynecology Hospital

Tracking Information
First Submitted Date  ICMJE December 1, 2020
First Posted Date  ICMJE December 8, 2020
Last Update Posted Date December 8, 2020
Estimated Study Start Date  ICMJE December 1, 2020
Estimated Primary Completion Date December 15, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 1, 2020)
  • Intraoperative anesthesia effect [ Time Frame: Day 1 ]
    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.
  • Ramsay Sedation Scale score [ Time Frame: Day 1 ]
    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.
  • Clock-in-the-Box(CIB) [ Time Frame: Day 0 & Day 2 ]
    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.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: December 1, 2020)
  • PHQ-9 [ Time Frame: Day 0 & Day 3 & Day 8 & Day 43 ]
    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.
  • Edinburgh Postnatal Depression Scale(EPDS) [ Time Frame: Day 3 & Day 8 & Day 43 ]
    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.
  • Apgar score [ Time Frame: Day 0 ]
    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.
  • placental transfer of S-ketamine [ Time Frame: Day 0 ]
    Placental transfer was evaluated based on the whole blood concentrations of S-ketamine in the maternal and cord blood
  • blood gas [ Time Frame: Day 0 ]
    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
  • umbilical arterial (UA)/umbilical venous (UV) ratio [ Time Frame: Day 0 ]
    UA/UV ratio was evaluated based on the blood concentrations of S-ketamine in the umbilical arterial and umbilical venous blood
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Efficacy and Safety of S-ketamine in Elective Cesarean Section
Official Title  ICMJE The Efficacy and Safety of S-ketamine in Elective Cesarean Section: a Multi-center, Randomized, Double-blind, Placebo-controlled Clinical Study
Brief Summary 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE
  • Anesthesia
  • Analgesia
  • Depression
  • Cesarean Section
  • Parturition
Intervention  ICMJE
  • Drug: S-ketamine
    K1 group: pregnant women received 0.2mg/kg S-ketamine, intravenous drip;
    Other Name: esketamine
  • Other: normal saline
    Saline group: pregnant women received saline, intravenous drip
    Other Name: physiological saline
  • Drug: S-ketamine
    K2 group: pregnant women received 0.3mg/kg S-ketamine, intravenous drip;
    Other Name: esketamine
Study Arms  ICMJE
  • Placebo Comparator: Saline group
    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);
    Intervention: Other: normal saline
  • Experimental: K1 group
    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);
    Intervention: Drug: S-ketamine
  • Experimental: K2 group
    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);
    Intervention: Drug: S-ketamine
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: December 1, 2020)
402
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE July 1, 2022
Estimated Primary Completion Date December 15, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. ASA II;
  2. Parturients voluntarily sign an informed consent form, fully understands the purpose and significance of the study, and voluntarily abides by the clinical study procedure;
  3. Subjects who plan to be elected to undergo cesarean section under continuous combined spinal-epidural anesthesia;
  4. Age 18 to 40 years;
  5. The expected duration of surgery was less than 2h;
  6. Prenatal body mass index (BMI) was less than 35kg/m2。

Exclusion Criteria:

  1. Parturients with contraindications to continuous combined spinal-epidural anesthesia (such as history of central nervous system infection, spinal cord or spinal canal disease or surgery history, systemic infection, skin or soft tissue infection at the puncture site, coagulation dysfunction);
  2. Those who have a history of stroke, cognitive dysfunction, and epilepsy;
  3. Patients with a history of myocardial infarction, angina pectoris, or a serious arrhythmia such as second-degree and above-degree atrioventricular block within 6 months before screening;
  4. Pregnancy with other diseases (malignant tumors, hypertension during pregnancy, abnormal thyroid function, etc.);
  5. In the non-oxygen state, the peripheral blood oxygen saturation (SpO2) <92%;
  6. Subjects whose prolactin is greater than the upper limit of normal during the screening period;
  7. Alanine aminotransferase (ALT), aspartate aminotransferase (AST), glutamine transferase (GGT)> 1.5 times than the normal value, and total bilirubin is higher than the upper limit of normal value, and blood creatinine (Cr)>1.2 times than the upper limit of normal value;
  8. The effect of combined spinal-epidural anesthesia is not good, and other anesthetics are needed;
  9. People with a history of allergies to various foods and drugs;
  10. Continuous taking for any reason within 3 months before the screening, including but not limited to: ketamine, non-steroidal anti-inflammatory drugs (aspirin, acetaminophen, indomethacin, diclofenac, ibuprofen, parecoxib) Sodium, etc.), alpha adrenergic receptor agonists (dexmedetomidine hydrochloride, clonidine, etc.), glucocorticoids (dexamethasone hydrochloride, hydrocortisone, methylprednisolone, etc.), antiepileptic ( Carbamazepine, sodium valproate, etc.), sedation (diazepam, estazolam, midazolam, alprazolam, barbital, phenobarbital and chloral hydrate, etc.), Chinese herbal medicine or Chinese patent medicine with pain and sedative effect;
  11. There is a history of drug abuse and/or alcohol abuse within 1 year before the screening;
  12. Participated in other drug or device trials within 3 months before the screening;
  13. Subjects judged by the investigator to be unsuitable to participate in this clinical study.
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Gender Based Eligibility: Yes
Gender Eligibility Description: Parturients undergoing elective cesarean section
Ages  ICMJE 18 Years to 40 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Mingjun Xu 86-13701038959 snake650222@163.com
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04657107
Other Study ID Numbers  ICMJE BeijingOGH
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Mingjun Xu, Beijing Obstetrics and Gynecology Hospital
Study Sponsor  ICMJE Beijing Obstetrics and Gynecology Hospital
Collaborators  ICMJE
  • China Health Promotion Foundation
  • Beijing Haidian Maternal and Child Health Hospital
  • Obstetrics & Gynecology Hospital of Fudan University
  • Fourth Hospital of Shijiazhuang City
  • Changzhi Maternal and Child Health Hospital
  • Linfen Maternity&Child Healthcare Hospital
  • Maternal and Child Health Hospital, Jiading District
  • Tongzhou Maternal and Child Healthcare Hospital of Beijing
  • Beijing Chaoyang District Maternal and Child Health Care Hospital
Investigators  ICMJE
Principal Investigator: Lei Wang Beijing Haidian Maternal and Child Health Hospital
Principal Investigator: Shaoqiang Huang Obstetrics & Gynecology Hospital of Fudan University
Principal Investigator: Jin Zhang Fourth Hospital of Shijiazhuang City
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
PRS Account Beijing Obstetrics and Gynecology Hospital
Verification Date December 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP