Farmacocinética y farmacodinamia de la ketamina para la depresión y el dolor posparto después de una cesárea (PREPARE-2)
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.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
A lack of data on new pain treatments in pregnancy puts 1.2 million US women having cesarean delivery (CD) every year at risk for poor pain control, depressed mood, and poor recovery. Evidence of successful post-surgical pain management and rapid reduction of depressive symptoms render ketamine a great candidate for post-CD pain management and potential reduction of postpartum depression (PPD) symptomology. Knowledge gaps in ketamine pharmacokinetics (PK) in the postpartum period limit an informed approach to its use for postpartum analgesia and PPD mitigation strategies. Similarly, knowledge gaps about sex differences in ketamine PK limit understandings about potential heterogeneity of treatment effects. This study aims to better understand the pharmacokinetics and pharmacodynamics of ketamine in postpartum women. Secondarily, it will assess key differences in postpartum ketamine PK compared to non-pregnant female controls. Secondarily it will assess key sex differences in ketamine metabolism between male and female subjects.
Peripartum females undergoing cesarean delivery will receive a ketamine infusion for 12 hours after cord clamping. Samples will be taken to characterize ketamine PK (primary objective). Healthy volunteer control females and males will receive the same ketamine infusion dosing schematic. Comparisons will be made between peripartum females and non-pregnant female controls, and between female and male controls (secondary objectives).
Tipo de estudio
Inscripción (Estimado)
Fase
- Fase 1
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Natalie Bennion, MPH
- Número de teléfono: 385-209-1185
- Correo electrónico: natalie.bennion@utah.edu
Copia de seguridad de contactos de estudio
- Nombre: Amy Monroe, MPH, MBA
- Número de teléfono: 412-609-6161
- Correo electrónico: a.monroe@utah.edu
Ubicaciones de estudio
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Pennsylvania
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Pittsburgh, Pennsylvania, Estados Unidos, 15213
- Terminado
- Magee Womens Hospital of UPMC
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Utah
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Salt Lake City, Utah, Estados Unidos, 84132
- Reclutamiento
- University of Utah
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Investigador principal:
- Grace Lim, MD, MSc
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Contacto:
- Amy Monroe, MPH, MBA
- Número de teléfono: 412-609-6161
- Correo electrónico: a.monroe@utah.edu
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Contacto:
- Natalie R Bennion, MPH
- Número de teléfono: 385-209-1185
- Correo electrónico: natalie.bennion@utah.edu
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
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)
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Otro
- Asignación: No aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: Ketamine Infusion: Cesarean Delivery Population
Loading dose infusion for 1 hour followed immediately by maintenance dose infusion for 11 hours. |
Loading Dose: 0.18 mg/kg/hr x 1 hour; Maintenance Dose 0.05 mg/kg/hr x 11 hours
Otros nombres:
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Experimental: Ketamine Infusion: Healthy Control Population
Loading dose infusion for 1 hour followed immediately by maintenance dose infusion for 11 hours. |
Loading Dose: 0.18 mg/kg/hr x 1 hour; Maintenance Dose 0.05 mg/kg/hr x 11 hours
Otros nombres:
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Maternal ketamine area under the curve (AUC)
Periodo de tiempo: 0 to 24 hours from initiation of ketamine infusion
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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. |
0 to 24 hours from initiation of ketamine infusion
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Patient reported acceptability of any reported side effects
Periodo de tiempo: 0 to 24 hours after initiation of ketamine infusion
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Proportion (%) of patient cohort reporting acceptability of ketamine infusion |
0 to 24 hours after initiation of ketamine infusion
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|
Pain area under the curve (AUC)
Periodo de tiempo: 0 to 24 hours after initiation of ketamine infusion
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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. |
0 to 24 hours after initiation of ketamine infusion
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Depression scores (Peripartum)
Periodo de tiempo: Baseline to week 12 post-infusion
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Depression scores as defined by the Edinburgh Postnatal Depression Scale (Peripartum Group), scale 0-30, measured among the peripartum cohort. |
Baseline to week 12 post-infusion
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Depression Scores (control)
Periodo de tiempo: Baseline to week 12 post-infusion
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Depression scores as defined by the Patient Health Questionnaire (PHQ-9) (Control Group), scale 0-27, measured among the control nonperipartum cohort. |
Baseline to week 12 post-infusion
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Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Grace Lim, MD, MSc, University of Utah
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
- Enfermedades urogenitales
- Manifestaciones neurológicas
- Desordenes mentales
- Enfermedades urogenitales femeninas y complicaciones del embarazo
- Complicaciones del embarazo
- Trastornos del estado de ánimo
- Trastornos Puerperales
- Desorden depresivo
- Condiciones Patológicas, Signos y Síntomas
- Signos y síntomas
- Dolor
- Depresión, Posparto
- Químicos orgánicos
- Hidrocarburos
- Ciclohexanos
- Cicloparafinas
- Hidrocarburos, alicíclicos
- Hidrocarburos, cíclico
- Ketamina
Otros números de identificación del estudio
- STUDY22100019
- R01MH134538 (Subvención/contrato del NIH de EE. UU.)
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Descripción del plan IPD
Deidentified data will be available for public benefit and knowledge. Items for uploading will include clinical measures, patient reported outcomes, psychometric testing data, sensory testing data, and all PK data. Technical protocols and any other data collected under this project will be shared upon request to allow others to perform secondary analyses.
Marco de tiempo para compartir IPD
Beginning with 3 months and ending at 5 years following article publication.
Criterios de acceso compartido de IPD
Researchers who propose a methodologically sound proposal may submit said proposals to limkg2@upmc.edu. To gain access to data, requestors will need to sign a data access agreement.
Tipo de información de apoyo para compartir IPD
- PROTOCOLO DE ESTUDIO
- RSC
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .