Fetal or Neonatal Effect of Damage to Placenta From Caesarean Section Clinical Trial
Official title:
A Multicenter Study of the Efficacy and Safety of Esketamine for Analgesia During
| Verified date | June 2024 |
| Source | Women's Hospital School Of Medicine Zhejiang University |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
This study proposed applying intravenous Esketamine to cesarean section in parturient, detecting the plasma concentration of Esketamine in maternal blood, neonatal umbilical venous blood and umbilical arterial blood when the baby is delivered ketamine blood drug concentration, observing vital signs, adverse visual analog pain score (VAS), and sedation score (Ramsay) in parturient, neonatal Apgar score 1, 5 to 10 minutes after birth, the umbilical arterial blood gas and neurobehavioral scores (NBNA) 2, 24 hours after the birth. This study aims to address placental transfer, metabolism and analgesic and sedative effects in neonates and parturients of Esketamine so as to explore the feasibility, efficacy and safety of Esketamine as adjuvant medication for cesarean section.
| Status | Recruiting |
| Enrollment | 600 |
| Est. completion date | September 30, 2024 |
| Est. primary completion date | September 30, 2024 |
| Accepts healthy volunteers | No |
| Gender | Female |
| Age group | 20 Years to 40 Years |
| Eligibility | Inclusion Criteria: - 18 years or older - full-term single pregnancy - had regular prenatal examination - scheduled for elective cesarean delivery with epidural anesthesia Exclusion Criteria: - body mass index (calculated as weight in kilograms divided by height in meters squared) of 27 or greater - previous mental illness, central nervous system disease, liver disease, abnormal kidney function, abnormal heart and lung function, diabetes, or American Society of Anesthesiologists (ASA) classification III or above - severe obstetric complications, such as preeclampsia and eclampsia, pregnancy-induced hypertension, placenta previa, or placental abruption - stillbirth or neonatal malformation - contraindications to epidural anesthesia, including abnormal coagulation function, anticoagulant therapy, severe hypovolemia, or hemodynamic instability |
| Country | Name | City | State |
|---|---|---|---|
| China | Women's Hospital School of Medicine Zhejiang University | Hangzhou | Zhejiang |
| Lead Sponsor | Collaborator |
|---|---|
| Women's Hospital School Of Medicine Zhejiang University |
China,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Other | Adverse events including hypotension, hypertension, bradycardia, tachycardia and desaturation | hypotension was defined as a systolic blood pressure decrease less than 20% of baseline, hypertension was defined as a systolic blood pressure increase greater than 20% of baseline, bradycardia was defined as a heart rate less than 60 beats per minute, tachycardia was defined as a heart rate greater than 100 beats per minute, and desaturation was defined as oxygen saturation less than 90%. | Adverse events were recorded as Frequency of occurrence between the time the patient entered the operating room and the end of surgery | |
| Other | offspring's neurodevelopment | Neurodevelopment was measured by the Ages and Stages Questionnaire, third edition (ASQ-3).The ASQ-3 assesses 5 developmental domains: gross motor skills, fine motor skills, problem-solving ability, communication, and personal and social skills. Each domain is assessed by 6 questions ascertaining achievement of relevant skills and answered as yes (10 points), sometimes (5 points), or not yet (0 points). Scores for individual items are summed to give an overall continuous score for each of the 5 domains (possible range, 0-60). | 2 years after birth | |
| Other | Mothers' memories of childbirth | Mothers' memories of childbirth was assessed by The Birth Memories and Recall Questionnaire (BirthMARQ),which focused on parents' positive, negative or mixed emotions at the birth/in recalling the event. Each item (e.g. 'my emotions at the time were extremely negative') was rated on a scale ranging from 1 (strongly disagree) to 7 (strongly agree). | at 2 years after birth | |
| Primary | Maternal pain intensity | Pain intensity was assessed with the numeric rating scale (NRS; an 11-point scale, with 0 indicating no pain and 10 indicating the worst pain) | immediately after fetal delivery | |
| Primary | Maternal sedation level | Maternal sedation level was assessed with Ramsay Sedation Scale (with 1 indicating restless; 2, completely awake, quiet, and cooperative; 3, drowsy but responding to verbal commands; 4, lightly asleep but responding to touch or pain; 5, asleep but slowly responding to touch or pain; and 6, deeply asleep and does not respond) | immediately after fetal delivery | |
| Secondary | Maternal pain intensity at other timepoints | Maternal pain intensity at other timepoints were assessed with the numeric rating scale (NRS; an 11-point scale, with 0 indicating no pain and 10 indicating the worst pain) | before anesthesia, immediately after anesthesia, surgical incision, 5 minutes after study, end of surgery, 6 hours after surgery, and 12 hours after surgery. drug administration, | |
| Secondary | Maternal sedation level at other timepoints | Maternal sedation level at other timepoints were assessed with Ramsay Sedation Scale (with 1 indicating restless; 2, completely awake, quiet, and cooperative; 3, drowsy but responding to verbal commands; 4, lightly asleep but responding to touch or pain; 5, asleep but slowly responding to touch or pain; and 6, deeply asleep and does not respond) | before anesthesia, immediately after anesthesia, surgical incision, 5 minutes after study, end of surgery, 6 hours after surgery, and 12 hours after surgery. drug administration, | |
| Secondary | systolic blood pressure, diastolic blood pressure, and mean blood pressure | systolic and diastolic blood pressure were assessed by non-invasive blood pressure cuff,mean blood pressure was measured by the Calculation formula: Mean arterial pressure =(systolic pressure +2× diastolic pressure)/3 | before anesthesia, immediately after anesthesia, at surgical incision, 5 minutes after study drug administration, immediately after fetal delivery, at end of surgery, and 1 hour after surgery | |
| Secondary | maternal heart rate | maternal heart rate | before anesthesia, immediately after anesthesia, at surgical incision, 5 minutes after study drug administration, immediately after fetal delivery, at end of surgery, and 1 hour after surgery | |
| Secondary | pulse oxygen saturation | pulse oxygen saturation | before anesthesia, immediately after anesthesia, at surgical incision, 5 minutes after study drug administration, immediately after fetal delivery, at end of surgery, and 1 hour after surgery | |
| Secondary | Apgar score of newborn | Apgar was assessed by appearance, pulse, grimace, activity, respiration. Each item was measured on a scale of 0, 1, and 2, respectively, with a maximum total score of 10. | at 1 minute and 5 minute after birth | |
| Secondary | postnatal umbilical vein blood gas pH value | postnatal umbilical vein blood gas pH value | Results of umbilical arterial blood gas analysis after birth | |
| Secondary | Esketamine concentrations in maternal arterial blood and neonatal umbilical arterial | Esketamine concentrations was assessed by reverse-phase high-performance liquid chromatography | Immediately after fetal delivery |