Clinical TrialMajor Depressive Disorder (MDD)KetaminePlaceboWithdrawn

Preoperative Ketamine and Perioperative Depression

Randomised, double‑blind, parallel pilot study (n=40 planned) comparing a single preoperative IV ketamine infusion (0.5 mg/kg over 40 min) versus midazolam (0.045 mg/kg) to improve perioperative depressive symptoms in surgical patients with a history of MDD.

Target Enrollment
40 participants
Study Type
Phase IV interventional
Design
Randomized, double Blind

Detailed Description

This trial tests the feasibility and preliminary efficacy of a single preoperative sub‑anesthetic ketamine infusion (0.5 mg/kg IV over 40 minutes) compared with midazolam (0.045 mg/kg IV) given 1–3 days before surgery to reduce depressive symptoms in patients with a history of major depressive disorder.

Primary aims are feasibility of enrolment, estimate of variability in change in MADRS score at day 1 post‑surgery (≥2‑point improvement), and safety/tolerability including dysphoric reactions and need for hospitalization.

Population: adults with life history of MDD undergoing lumbar surgery; cognitive status screened with MMSE; outcomes include MADRS change, adverse events, and perioperative complications.

Study Protocol

Preparation

sessions

Dosing

1 sessions
40 min each

Integration

sessions

Study Arms & Interventions

Ketamine

experimental

Single intravenous sub‑anesthetic ketamine infusion given preoperatively.

Interventions

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

    Infusion over 40 minutes given 1–3 days before surgery.

Midazolam

active comparator

Intravenous midazolam active comparator given preoperatively.

Interventions

  • Placebo0.045 mg/kg
    via IV• single dose• 1 doses total

    Midazolam 0.045 mg/kg IV over 40 minutes (active comparator; compound recorded as placebo reference).

Participants

Ages
18 – 65
Sexes
Male & Female

Inclusion Criteria

  • Inclusion Criteria:
  • Male or female patients age ≥ 65 years
  • Planned lumbar surgery for degenerative disc disease or spinal stenosis involving 2 or more levels
  • A life history of MDD (DSM-5 criteria) and a MADRS score ≥20
  • Mini-Mental State Examination (MMSE) score ≥ 15
  • MMSE is between 15-26
  • Ability to understand English.

Exclusion Criteria

  • Exclusion Criteria:
  • MMSE < 15
  • History of psychosis
  • Poorly controlled hypertension
  • Pre-existing aneurysmal vascular disorders
  • Cocaine or other illicit drug use.

Study Details

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