Farmacocinetica e farmacodinamica della ketamina per la depressione postpartum e il dolore dopo il parto cesareo (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.
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
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 di studio
Iscrizione (Stimato)
Fase
- Fase 1
Contatti e Sedi
Contatto studio
- Nome: Natalie Bennion, MPH
- Numero di telefono: 385-209-1185
- Email: natalie.bennion@utah.edu
Backup dei contatti dello studio
- Nome: Amy Monroe, MPH, MBA
- Numero di telefono: 412-609-6161
- Email: a.monroe@utah.edu
Luoghi di studio
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Pennsylvania
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Pittsburgh, Pennsylvania, Stati Uniti, 15213
- Terminato
- Magee Womens Hospital of UPMC
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Utah
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Salt Lake City, Utah, Stati Uniti, 84132
- Reclutamento
- University of Utah
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Investigatore principale:
- Grace Lim, MD, MSc
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Contatto:
- Amy Monroe, MPH, MBA
- Numero di telefono: 412-609-6161
- Email: a.monroe@utah.edu
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Contatto:
- Natalie R Bennion, MPH
- Numero di telefono: 385-209-1185
- Email: natalie.bennion@utah.edu
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
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)
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Altro
- Assegnazione: Non randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
|
Sperimentale: 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
Altri nomi:
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Sperimentale: 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
Altri nomi:
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Maternal ketamine area under the curve (AUC)
Lasso di tempo: 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
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Patient reported acceptability of any reported side effects
Lasso di tempo: 0 to 24 hours after initiation of ketamine infusion
|
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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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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Collaboratori e investigatori
Sponsor
Collaboratori
Investigatori
- Investigatore principale: Grace Lim, MD, MSc, University of Utah
Studiare le date dei record
Studia le date principali
Inizio studio (Effettivo)
Completamento primario (Stimato)
Completamento dello studio (Stimato)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
- Malattie urogenitali
- Manifestazioni neurologiche
- Disordini mentali
- Malattie urogenitali femminili e complicanze della gravidanza
- Complicazioni della gravidanza
- Disturbi dell'umore
- Disturbi puerperali
- Disordine depressivo
- Condizioni patologiche, segni e sintomi
- Segni e sintomi
- Dolore
- Depressione, dopo il parto
- Prodotti chimici organici
- Idrocarburi
- Ciclohexanes
- Cicloparaffins
- Idrocarburi, aliciclici
- Idrocarburi, ciclici
- Ketamina
Altri numeri di identificazione dello studio
- STUDY22100019
- R01MH134538 (Sovvenzione/contratto NIH degli Stati Uniti)
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
Descrizione del piano 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.
Periodo di condivisione IPD
Beginning with 3 months and ending at 5 years following article publication.
Criteri di accesso alla condivisione 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 di informazioni di supporto alla condivisione IPD
- STUDIO_PROTOCOLLO
- RSI
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
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