Ketamine Pharmacokinetics and Pharmacodynamics for Postpartum Depression and Pain After Cesarean Delivery
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Utah
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Cesarean delivery
Adults 18 years and older
Term delivery ≥ 37 weeks gestation anticipated at time of delivery
ASA PS 2 or 3
Disqualifiers
Patient going under general anesthesia for cesarean delivery
Allergy to study medication (ketamine)
ASA PS 4 +
Contraindications to neuraxial anesthesia
Trial design
Design model
Parallel
Treatments tested in this trial
Ketamine (Ketalar)
DrugLoading Dose: 0.18 mg/kg/hr x 1 hour; Maintenance Dose 0.05 mg/kg/hr x 11 hours
Treatment groups
50 Participants
are divided into 2 treatment groupsGroup A: Ketamine Infusion: Cesarean Delivery PopulationExperimental treatment 1 intervention
Group B: Ketamine Infusion: Healthy Control PopulationExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Maternal ketamine area under the curve (AUC)
Ketamine area under the plasma concentration-time curve (AUC 0-∞) (AUC, mcg\*min/mL), which reflects the actual body exposure to ketamine after administration of ketamine.
Time frame
0 to 24 hours from initiation of ketamine infusionSecondary outcomes
1
Patient reported acceptability of any reported side effects
Proportion (%) of patient cohort reporting acceptability of ketamine infusion
Time frame
0 to 24 hours after initiation of ketamine infusion2
Pain area under the curve (AUC)
Pain score area under the curve (AUC) where pain scores are measured from 0 (no pain) to 10 (worst imaginable pain), for the duration of epidural analgesia.
Time frame
0 to 24 hours after initiation of ketamine infusion3
Depression scores (Peripartum)
Depression scores as defined by the Edinburgh Postnatal Depression Scale (Peripartum Group), scale 0-30, measured among the peripartum cohort.
Time frame
Baseline to week 12 post-infusion4
Depression Scores (control)
Depression scores as defined by the Patient Health Questionnaire (PHQ-9) (Control Group), scale 0-27, measured among the control nonperipartum cohort.
Time frame
Baseline to week 12 post-infusionSponsors and contacts
Click on the lead sponsor to view all of their trials.
University of Utah
Lead sponsor
National Institute of Mental Health (NIMH)
Collaborator
Source ClinicalTrials.gov