Effect of intra-operative sedation with low-doses of S-Ketamine on depression in the elderly: randomized double-blind controlled trial

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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12610001090000

Enrollment

Registered

2010-12-13

Start date

2006-05-20

Completion date

Unknown

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

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.

Interventions

70 elderly patients (62 men), from two Brazilian hospitals (Brasilia), classified as depressed (D) and not depressed (ND), according to the Diagnostic and Statistical Manual of Mental Disorders criteria, where divided randomly into four groups. Group D1 and ND1 used for sedation 10 mg of S- Ketamine, plus 1 mg of midazolam and groups D2 and ND2 only 1mg of Midazolam, in intravenous bolus, until 3-4 grade in Ramsay Scale was reached. Primary efficacy measure was quantitatively estimated by the 2

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Treatment

Masking

Blinded (masking used)

Eligibility

Sex/Gender

All

Age

60 Years to 100 Years

Healthy volunteers

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

Outcome results