Clinical TrialPostpartum DepressionKetamineKetaminePlaceboUnknown status

Dose Low Dose Ketamine in Casesarian

Prospective case-control observational study (n=150) comparing single-dose IV ketamine (0.5 mg/kg), ketamine plus midazolam, and saline placebo in patients undergoing caesarean section to evaluate postpartum depression and postoperative outcomes.

Target Enrollment
150 participants
Study Type
Phase NA observational
Design
Non-randomized

Detailed Description

This prospective case-control study will allocate 150 patients undergoing caesarean section under spinal anaesthesia into three groups: ketamine 0.5 mg/kg IV, midazolam pre-dose followed by ketamine 0.5 mg/kg IV, or 5 ml IV saline placebo.

Postpartum depression will be assessed with the Edinburgh Postpartum Depression Scale (EPDS) preoperatively and at 1, 2 and 4 weeks post partum; secondary outcomes include analgesic requirement and adverse effects such as dizziness, hallucinations, nausea and vomiting.

Study Protocol

Preparation

sessions

Dosing

1 sessions

Integration

sessions

Study Arms & Interventions

Ketamine

experimental

Single IV bolus ketamine 0.5 mg/kg (diluted to 5 ml) given after cord clamping.

Interventions

  • Ketamine0.5 mg/kg
    via IV• single dose• 1 doses total

    Diluted to 5 ml; given within 5 minutes after cord clamping.

Ketamine + midazolam

experimental

Single IV midazolam pre-dose followed by ketamine 0.5 mg/kg (diluted to 5 ml) after cord clamping.

Interventions

  • Compound0.0125 mg/kg
    via IV• single dose

    Midazolam given prior to ketamine (arm text lists 0.0125 mg/kg; another section lists 0.03 mg/kg — see laterInfo).

  • Ketamine0.5 mg/kg
    via IV• single dose• 1 doses total

    Diluted to 5 ml; given after midazolam and after cord clamping.

Placebo

inactive

5 ml IV physiological saline single dose.

Interventions

  • Placebo
    via IV• single dose• 1 doses total

    5 ml normal saline (placebo) given after cord clamping.

Participants

Ages
18 – 45
Sexes
female

Inclusion Criteria

  • Inclusion Criteria:
  • American Society of Anesthesiologists II–III; 18–45 years; patients planned for cesarean section; patient requests cesarean with spinal anesthesia.

Exclusion Criteria

  • Exclusion Criteria:
  • Pathological obstetric complications; Hypertension; Contraindication for ketamine; Contraindication for spinal anaesthesia.

Study Details

Locations

Inonu universitesi — Malatya, Turkey (Türkiye)

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