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.

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

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

experimental

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

Interventions

  • Ketamine0.5 mg/kg
    via IVsingle dose1 doses total

    Given at induction alongside midazolam and fentanyl per anaesthetic care.

No ketamine

waitlist

Standard induction without ketamine.

Participants

Ages
1865
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 Details

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

Locations

University HospitalSan Antonio, Texas, United States

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