RightFit
RecruitingPhase 1

Ketamine Pharmacokinetics and Pharmacodynamics for Postpartum Depression and Pain After Cesarean Delivery

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Procedures mentioned: Infusions

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "The purpose of this study is to identify pharmacokinetics of postpartum ketamine infusion."
  • "The peripartum group of this study will receive ketamine after cesarean delivery, while the control group will consist of non-pregnant female subjects and male subjects receiving the same infusion protocol."
  • "Peripartum females undergoing cesarean delivery will receive a ketamine infusion for 12 hours after cord clamping."
  • "Healthy volunteer control females and males will receive the same ketamine infusion dosing schematic."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study looks at how the body breaks down ketamine and responds to it after a C-section (surgery to deliver a baby). It compares adults after a C-section with nonpregnant women and men who receive ketamine the same way, through a vein.

The purpose of this study is to identify pharmacokinetics of postpartum ketamine infusion. This study will assess ketamine kinetics and metabolism in this setting. Ketamine is expected to exert different kinetics during the physiologic state of post-pregnancy. The goal in conducting this study is to better understand the pharmacokinetics and pharmacodynamics of postpartum ketamine infusion. A secondary goal is to compare these kinetics to reproductive age matched controls and to assess sex differences in ketamine pharmacokinetics. The peripartum group of this study will receive ketamine after cesarean delivery, while the control group will consist of non-pregnant female subjects and male subjects receiving the same infusion protocol.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • All: Age 18 or older and able to understand and agree to join.
  • C-section group: Expected to deliver at 37 weeks of pregnancy or later.
  • C-section group: Anesthesia health rating of ASA 2 or 3, meaning mild or serious illness.
  • C-section group: Not planning to breastfeed, or ketamine is needed as part of the pain care plan.
  • Comparison group: Men or nonpregnant women.
  • Comparison group: Anesthesia health rating of ASA 1, 2, or 3, meaning healthy or having mild or serious illness.

Who can't join

  • All: Ketamine allergy, another reason ketamine is unsafe, an ASA health rating of 4 or higher (life-threatening illness), unstable blood pressure or blood flow, or inability to complete study steps.
  • All: Past ketamine or PCP misuse; schizophrenia or psychosis, which can affect what seems real; or poor liver or kidney function.
  • All: Uncontrolled high blood pressure, chest pain, abnormal heartbeat, head injury, high pressure inside the skull, or an uncontrolled overactive thyroid.
  • All: Taking part in another study testing pain or depression treatment, or receiving hormone or gender-affirming therapy.
  • All: Use of certain medicines or drugs, including ketamine, PCP, psilocybin or other psychedelics; lithium, valproate, carbamazepine or lamotrigine; or medicines used to treat psychosis.
  • C-section group: General anesthesia (being fully asleep), inability to safely have spinal or epidural anesthesia, delivery before 37 weeks, or a planned need for complex care for the baby.
  • C-section group: Severe pre-eclampsia (a serious pregnancy-related blood pressure condition), use of blood pressure pills, or magnesium given through a vein.
  • Comparison group: Pregnant now or within the past 6 weeks. Women must be willing to give a urine sample for a pregnancy test.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

Peripartum Participants: Inclusion Criteria * Cesarean delivery * Adults 18 years and older * Term delivery ≥ 37 weeks gestation anticipated at time of delivery * ASA PS 2 or 3 * Able to provide informed consent * One of the following must be met for inclusion: Not planning to breastfeed OR ketamine use indicated for pain management plan. Exclusion Criteria * Patient going under general anesthesia for cesarean delivery * Allergy to study medication (ketamine) * ASA PS 4 + * Contraindications to neuraxial anesthesia * Preterm delivery (\<37 weeks gestation) * Anticipated fetal-neonatal complex care plan as indicated in the patient's chart * Patient history of ketamine or PCP abuse * Patient history of schizophrenia or psychosis * Patient history of liver or renal insufficiency * Patient history of uncontrolled hypertension, chest pain, arrhythmia, head trauma, or intracranial hypertension, uncontrolled hyperthyroidism, or other contraindications to ketamine * Participating in another pain or depression intervention trial * Undergoing hormonal or gender affirming therapies * Pre-eclampsia with severe features * Hemodynamic instability * Inability to participate in study procedures for any reason * Contraindicated medications use: oral antihypertensive medications (exclusion: hypertensive disorders of pregnancy), intravenous magnesium (exclusion: pre-eclampsia with severe features), ketamine/phencyclidine/psilocybins/any other psychedelics (exclusion: ketamine or PCP abuse), lithium/valproate/carbamazepine/lamotrigine/haloperidol/chlorpromazine/fluphenazine/aripiprazole/clozapine/other typical or atypical antipsychotic medications (exclusion: schizophrenia or psychosis) Control Participants Inclusion Criteria * Age 18 years and older * Sex: Male or Female * Able to provide informed consent * ASA PS 1, 2, or 3 Exclusion Criteria * Allergy to study medication (ketamine) * ASA PS 4 + * Inability to participate in study procedures for any reason * Patient history of ketamine or PCP abuse * Patient history of schizophrenia or psychosis * Patient history of liver or renal insufficiency * Patient history of uncontrolled hypertension, chest pain, arrhythmia, head trauma, intracranial hypertension, uncontrolled hyperthyroidism, or other contraindications to ketamine * Participating in another pain or depression intervention trial * Hemodynamic instability * Pregnant or pregnant within the last 6 weeks * Unwilling to provide urine sample for pregnancy testing (female controls) * Undergoing hormonal or gender affirming therapies * Contraindicated medications use: ketamine, phencyclidine, psilocybins, or other psychedelics (exclusion: ketamine or PCP abuse), lithium/valproate/carbamazepine/lamotrigine/haloperidol/chlorpromazine/fluphenazine/aripiprazole/clozapine, or other typical or atypical antipsychotic medications (exclusion: schizophrenia or psychosis)

Study sites (2)

PA

UT