Clinical TrialParallelPeripartumKetamineCompleted

Sub-Anaesthetic Ketamine at C-Section to Prevent Postpartum Depression: Double-Blind RCT (Alipoor / Sarkoohi, Rafsanjan Iran 2021)

This unregistered trial (n=134) was a double-blind, placebo-controlled randomised clinical trial of sub-anaesthetic ketamine for the prevention of postpartum depression in women undergoing elective caesarean sections, which found that ketamine significantly reduced depression scores at two and four weeks postpartum.

Target Enrollment
134 participants
Study Type
interventional
Design
Randomized, double Blind

Detailed Description

This synthetic trial has been added to our database because a psychedelic paper (about a clinical trial) references this trial, but no (live) registration can be found.

The study evaluated the efficacy of a single sub-anaesthetic dose of intravenous ketamine (0.5 mg/kg) administered during the induction of general anaesthesia for elective caesarean sections. Participants were randomised to receive either ketamine alongside a sedative or a higher dose of sedative alone as a control.

The primary outcome was measured using the Edinburgh Postnatal Depression Scale (EPDS) at two and four weeks following delivery. Results indicated that the ketamine intervention group exhibited significantly lower depression scores compared to the control group at both follow-up intervals, suggesting a potential preventative effect against postpartum depression.

Study Protocol

Preparation

sessions

Dosing

1 sessions

Integration

sessions

Study Arms & Interventions

Ketamine-Nesdonal group

experimental

Nesdonal 1-2 mg/kg plus ketamine 0.5 mg/kg IV during anesthesia induction for caesarian section.

Interventions

  • Ketamine0.5 mg/kg
    via IVsingle dose during anesthesia induction1 doses total

    Sub-anesthetic ketamine dose administered with Nesdonal during induction of general anesthesia.

Nesdonal group

active comparator

Nesdonal 3-5 mg/kg IV during anesthesia induction for caesarian section.

Study Details

  • Status
    Completed
  • Type
    interventional
  • Design
    Randomizeddouble Blind
  • Target Enrollment134 participants
  • Timeline
    Start: 2019-01-01
    End: 2021-01-01
  • Compound
  • Topic

Locations

Iran

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