Clinical TrialPeripartumKetamineKetamineKetamineKetamineRecruiting

Ketamine Pharmacokinetics and Pharmacodynamics for Postpartum Depression and Pain After Cesarean Delivery (PREPARE-2)

Phase I interventional study (n=50) comparing ketamine pharmacokinetics and pharmacodynamics in postpartum cesarean patients versus healthy controls using a 12-hour infusion (0.18 mg/kg/hr x1 h loading then 0.05 mg/kg/hr x11 h maintenance).

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Target Enrollment
50 participants
Study Type
Phase I interventional
Design
Non-randomized

Detailed Description

This study characterises ketamine pharmacokinetics and pharmacodynamics in postpartum women after cesarean delivery and compares kinetics to non-pregnant female and male controls receiving the same 12-hour infusion.

Primary objective is to define ketamine PK in the post‑delivery physiologic state; secondary objectives include comparison with reproductive age matched controls and assessment of sex differences in metabolism.

Peripartum participants receive a loading infusion for 1 hour followed by an 11‑hour maintenance infusion beginning after cord clamping; blood sampling will define PK parameters and PD measures.

Study Protocol

Preparation

sessions

Dosing

1 sessions
720 min each

Integration

sessions

Study Arms & Interventions

Postpartum CD

experimental

Cesarean delivery population receiving a 12-hour ketamine infusion after cord clamping (loading then maintenance).

Interventions

  • Ketamine0.18 mg/kg/hr
    via IV• single infusion

    Loading infusion 0.18 mg/kg/hr for 1 hour starting after cord clamping.

  • Ketamine0.05 mg/kg/hr
    via IV• single infusion

    Maintenance infusion 0.05 mg/kg/hr for 11 hours following loading dose.

Healthy controls

experimental

Non-pregnant female and male healthy controls receiving identical 12-hour ketamine infusion.

Interventions

  • Ketamine0.18 mg/kg/hr
    via IV• single infusion

    Loading infusion 0.18 mg/kg/hr for 1 hour.

  • Ketamine0.05 mg/kg/hr
    via IV• single infusion

    Maintenance infusion 0.05 mg/kg/hr for 11 hours.

Participants

Ages
18 – 99
Sexes
Male & Female

Inclusion 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.
  • 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

  • Peripartum Participants
  • 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
  • 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 Protocol, Arms & Participants

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Study Details

Locations

Magee Womens Hospital of UPMC — Pittsburgh, Pennsylvania, United States
UPMC Montefiore Clinical and Translational Research Center — Pittsburgh, Pennsylvania, United States

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