AnesthesiaES-CSNCT04657107

The Efficacy and Safety of S-ketamine in Elective Cesarean Section

A study testing S-ketamine and normal saline in people with Anesthesia and Analgesia, run by Beijing Obstetrics and Gynecology Hospital.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record

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Trial summary

Who is it for?: Ages 18 to 40 years, women onlyHealthy volunteers can take part
Conditions the study is for: Anesthesia, Analgesia, Depression
What is being tested?: S-ketamine and normal saline
Type of treatment: Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 402 participants
Where: No sites listed yet
Study dates: 1 Dec 2020to 1 Jul 2022
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 40 years
Women only
Healthy volunteers accepted
Adult

Who may be able to join

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

Who cannot join

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);
Those who have a history of stroke, cognitive dysfunction, and epilepsy;
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;
Pregnancy with other diseases (malignant tumors, hypertension during pregnancy, abnormal thyroid function, etc.);
In the non-oxygen state, the peripheral blood oxygen saturation (SpO2) <92%;
Subjects whose prolactin is greater than the upper limit of normal during the screening period;

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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;
The effect of combined spinal-epidural anesthesia is not good, and other anesthetics are needed;
People with a history of allergies to various foods and drugs;
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;
There is a history of drug abuse and/or alcohol abuse within 1 year before the screening;
Participated in other drug or device trials within 3 months before the screening;
Subjects judged by the investigator to be unsuitable to participate in this clinical study.

Trial locations and contacts

No sites are listed yet.

Mingjun Xu contact

86-13701038959

snake650222@163.com

About this study

Official title: The Efficacy and Safety of S-ketamine in Elective Cesarean Section: a Multi-center, Randomized, Double-blind, Placebo-controlled Clinical Study

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.

Conditions: Anesthesia, Analgesia, Depression, Cesarean Section, Parturition
Being tested: S-ketamine, normal saline
Keywords: S-ketamine, efficacy, safety, Postpartum depression
Medical subject headings: Agnosia, Depression, Depression, Postpartum

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

S-ketamineDrug
Also called esketamine
K1 group: pregnant women received 0.2mg/kg S-ketamine, intravenous drip;
normal salineOther
Also called physiological saline
Saline group: pregnant women received saline, intravenous drip
S-ketamineDrug
Also called esketamine
K2 group: pregnant women received 0.3mg/kg S-ketamine, intravenous drip;

Study groups in NCT04657107
Study group	Role	What they receive
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); Receives: Other: normal saline
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); Receives: Drug: S-ketamine
K2 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 0.3mg/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); Receives: Drug: S-ketamine

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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.
Measured: 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.
Measured: Day 0 & Day 2

Secondary outcomes (6)

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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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
Measured: 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
Measured: Day 0

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Dec 20201 Jul 2022

First posted8 Dec 2020
Study start1 Dec 2020 (estimated)
Primary completion15 Dec 2021 (estimated)
Study completion1 Jul 2022 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for AnesthesiaStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 402 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04657107
Sponsor's protocol ID: BeijingOGH
Acronym: ES-CS
Status last verified: Dec 2020
First submitted: 1 Dec 2020
Last updated: 8 Dec 2020
Results posted: No
FDA-regulated drug: No
FDA-regulated device: No

Want to know more?

Mingjun Xu

86-13701038959

snake650222@163.com

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 8 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: The Efficacy and Safety of S-ketamine in Elective Cesarean Section: a Multi-center, Randomized, Double-blind, Placebo-controlled Clinical Study
ClinicalTrials.gov ID: NCT04657107
Acronym / sponsor ID: ES-CS / BeijingOGH
Conditions: Anesthesia, Analgesia, Depression, Cesarean Section, Parturition
Keywords: S-ketamine, efficacy, safety, Postpartum depression
Study type: Interventional
Recruitment status: Unknown status
Enrolment: 402 participants (estimated)
Lead sponsor: Beijing Obstetrics and Gynecology HospitalUniversity, hospital or other
Collaborators: China Health Promotion Foundation, Beijing Haidian Maternal and Child Health Hospital, Obstetrics & Gynecology Hospital of Fudan University, The Fourth Hospital of Shijiazhuang, 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
Study start: 1 Dec 2020 (estimated)
Primary completion: 15 Dec 2021 (estimated)
Study completion: 1 Jul 2022 (estimated)
First posted: 8 Dec 2020 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 3

Arm	Type	Receives
Saline group	Placebo comparator	Other: normal salineParturients 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);
K1 group	Experimental	Drug: S-ketamineParturients 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	Experimental	Drug: S-ketamineParturients 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);

Who may qualify

Ages: 18 to 40 years
Sex: Female only
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (6 listed)

ASA II;
Parturients voluntarily sign an informed consent form, fully understands the purpose and significance of the study, and voluntarily abides by the clinical study procedure;
Subjects who plan to be elected to undergo cesarean section under continuous combined spinal-epidural anesthesia;
Age 18 to 40 years;
The expected duration of surgery was less than 2h;

Key exclusion criteria (13 listed)

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);
Those who have a history of stroke, cognitive dysfunction, and epilepsy;
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;
Pregnancy with other diseases (malignant tumors, hypertension during pregnancy, abnormal thyroid function, etc.);
In the non-oxygen state, the peripheral blood oxygen saturation (SpO2) <92%;

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
S-ketamineAlso: esketamineK1 group: pregnant women received 0.2mg/kg S-ketamine, intravenous drip;	Drug	K1 group
normal salineAlso: physiological salineSaline group: pregnant women received saline, intravenous drip	Other	Saline group
S-ketamineAlso: esketamineK2 group: pregnant women received 0.3mg/kg S-ketamine, intravenous drip;	Drug	K2 group

Primary outcome

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.

6 secondary outcomes

PHQ-9
Time frame: Day 0 & Day 3 & Day 8 & Day 43
Edinburgh Postnatal Depression Scale(EPDS)
Time frame: Day 3 & Day 8 & Day 43
Apgar score
Time frame: Day 0
placental transfer of S-ketamine
Time frame: Day 0
blood gas
Time frame: Day 0
umbilical arterial (UA)/umbilical venous (UV) ratio
Time frame: Day 0

Results and safety

Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 8 Dec 2020.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Mingjun Xu contact

86-13701038959

snake650222@163.com

Lei Wang principal investigator

Beijing Haidian Maternal and Child Health Hospital

Shaoqiang Huang principal investigator

Obstetrics & Gynecology Hospital of Fudan University

Jin Zhang principal investigator

The Fourth Hospital of Shijiazhuang

Questions about this trial

What is this clinical trial studying?

A study testing S-ketamine and normal saline in people with Anesthesia and Analgesia, run by Beijing Obstetrics and Gynecology Hospital.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 8 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Mingjun Xu (86-13701038959, snake650222@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Intraoperative anesthesia effect (time frame: Day 1). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04657107.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Dec 2020.