Clinical TrialDepressive DisordersKetamineTerminated

Effects of Low Dose Ketamine Given at Induction of Anesthesia on Postoperative Mood in Patients With Depressive Symptoms

Randomised, double-blind, parallel study (n=12) testing a single 0.5 mg/kg IV ketamine dose at induction of anaesthesia versus no ketamine in female surgical patients with depressive symptoms.

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Target Enrollment
12 participants
Study Type
Phase NA interventional
Design
Randomized, double Blind

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Compound research: KetamineTopic research: Depressive DisordersResearch in United States

Detailed Description

This parallel, randomised trial enrolled female patients undergoing gynaecological surgery who scored ≥5 on the Goldberg Depression Screen to assess whether a single low dose of ketamine at induction (0.5 mg/kg IV) reduces depressive symptoms after surgery.

All participants received routine premedication (midazolam and fentanyl); outcomes included Goldberg Depression Screen at baseline and at one week, and monitoring for adverse events including suicidal ideation, nausea and vomiting.

Study Protocol

Preparation

sessions

Dosing

1 sessions

Integration

sessions

Study Arms & Interventions

Ketamine 35 mg/70 kg

experimental

Ketamine 0.5 mg/kg IV at induction of general anesthesia.

Interventions

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

    Given at induction alongside midazolam and fentanyl per anaesthetic care.

No ketamine

waitlist

Standard induction without ketamine.

Participants

Ages
18 – 65
Sexes
female

Inclusion Criteria

  • Inclusion Criteria:
  • History of or current depression scoring five or above on Goldberg Depression Screen
  • Non-pregnant females aged 18–65 admitted for gynaecological surgery
  • Able and willing to consent

Exclusion Criteria

  • Exclusion Criteria:
  • Uncontrolled hypertension
  • Allergy to ketamine
  • Pregnancy

Study Protocol, Arms & Participants

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Study Details

  • Status
    Terminated
  • Phase
    Phase NA
  • Type
    interventional
  • Design
    Randomizeddouble Blind
  • Target Enrollment12 participants
  • Timeline
    Start: 2015-12-01
    End: 2016-09-01
  • Compound
    Ketamine
  • Topic
    Depressive Disorders

Locations

University Hospital — San Antonio, Texas, United States

Recent activity

  • TerminatedEffects of Low Dose Ketamine Given at Induction of Anesthesia on Postoperative Mood in Patients With Depr… (NCT02422303, ketamine)
  • StartedEffects of Low Dose Ketamine Given at Induction of Anesthesia on Postoperative Mood in Patients With Depr… (NCT02422303, ketamine)

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