Clinical TrialDepressive DisordersKetamineMidalozamCompleted

Intra-operative sedation with S-Ketamine to improve depression in patients with mental depression.

This randomised controlled parallel group Phase II trial (n=80) evaluated the safety and efficacy of ketamine for mental depression.

Target Enrollment
80 participants
Study Type
Phase II interventional
Design
Randomized

Detailed Description

OBJECTIVES: to determine whether S-ketamine, used as an intra-operative sedative, can alleviate depression, in the elderly, in the immediate postoperative period. To evaluate also if low doses of S-ketamine have no adverse side effects that can restrict its clinical use.

Study Arms & Interventions

Experimental Arm

experimental

Interventions

  • Ketamine
  • Midalozam

Participants

Inclusion Criteria

  • age>60, males and females;spinal or epidural anaesthesia; patients with depression criteria according to Diagnostic and Statistical Manual of Mental Disorders; patients without depression (control).

Exclusion Criteria

  • patients with depression, but that scored < 7 (Hamilton Scale) ;
  • arterial hypertension not correctly treated; -unstable angina; severe cardiovascular disease; anaemia (<10 g.dl ; hyper or hypothyroidism not correctly treated; morbid obesity; -convulsive episodes; - schizophrenia; -psychotic disorders; -drug addiction; -patients that used the last 15 days monoamine oxidase inhibitors and lithium

Study Details

Locations

Unknown facility — Australia

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