Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 4:43 PM
Ignite Modification Date:
2025-12-24 @ 4:43 PM
NCT ID:
NCT06767566
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)
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT06767566
Study Brief:
Protocol Section:
NCT06767566