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Trial registered on ANZCTR


Registration number
ACTRN12610001090000
Ethics application status
Approved
Date submitted
4/02/2008
Date registered
13/12/2010
Date last updated
6/01/2011
Type of registration
Retrospectively registered

Titles & IDs
Public title
Effect of intra-operative sedation with low-doses of S-Ketamine on depression in the elderly: randomized double-blind controlled trial
Scientific title
Intra-operative sedation with S-Ketamine to improve depression in patients with mental depression.
Secondary ID [1] 253280 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Mental Depression 258806 0
Condition category
Condition code
Anaesthesiology 258956 258956 0 0
Anaesthetics

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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 21-item Hamilton Depression Rating Scale, one day before and one day after surgery.
Intervention code [1] 2538 0
Treatment: Drugs
Comparator / control treatment
Groups D2 and ND2 receive 1mg of midazolam, in intravenous bolus, until 3-4 grade in Ramsay Scale was reached.
Control group
Active

Outcomes
Primary outcome [1] 259809 0
To access improvement of mental depression after treatment with S-ketamine, by using the 21 items Hamilton Depression Rating Scale.
Timepoint [1] 259809 0
-the day before the surgery (after randomization)
-On the second day of the postoperative period
Secondary outcome [1] 268611 0
To evaluate side effects of S-ketamine: nausea and vomits, allucinations, postoperative pain, cardiovascular effects, respiratory depression, sedation and amnesia.
To mesure them:a intraoperative non invasive blood pressure monitoring and ECG (cardiovascular effects), SpO2 (respiratory depression), Ramsay Scale (sedation), Visual analogic scale (pain) and by questioning the patient (nausea and vomits, psychedelic effects, amnesia)
Timepoint [1] 268611 0
-the day before the surgery (after randomization)
-On the second day of the postoperative period

Eligibility
Key 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).
Minimum age
60 Years
Maximum age
100 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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 design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
All patients scheduled for surgery with epidural or spinal anaesthesia were separated into depressed (D) and not depressed (ND) according to the Diagnostic and Statistical Manual of Mental Disorders criteria. Then they were randomized into D1 (depressed with S-ketamine + midazolam), D2 (depressed with midazolam), ND1 (not depressed with S-ketamine + midazolam), ND2 (not depressed with midazolam).
We used for randomization sets of 10 sealed, opaque carbonate envelopes, at the time.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Permuted block randomisation: for randomization sealed, opaque envelopes were used. In the inside we could find the numbers 1 or 2 and the therapy was prepared accordingly. After that, the name of the patient was written in the envelope, the protocol used was included inside and the envelope was sealed again. It was not open until final results were evaluated.
All depressed patients that met the inclusion criteria were randomized in D1 and D2 groups.
In a sequence of 4 patients not depressed, one of them was elected and then randomized in ND1 and ND2 groups (the other 3 were excluded)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
20/05/2006
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
80
Accrual to date
Final
Recruitment outside Australia
Country [1] 778 0
Brazil
State/province [1] 778 0
Distrito Federal

Funding & Sponsors
Funding source category [1] 258200 0
Hospital
Name [1] 258200 0
Hospital das Forcas Armadas
Country [1] 258200 0
Brazil
Primary sponsor type
Individual
Name
Margarida Castanheira Rodrigues Bretas Bastos, MD
Address
3 Temple Road
Dartry
Dublin 6
Ireland
Country
Brazil
Secondary sponsor category [1] 257373 0
University
Name [1] 257373 0
Universidade Catolica de Brasilia
Address [1] 257373 0
Campus Universitario
QS 07 Lote 01 EPTC
Aguas Claras
Taguatinga
CEP 72030-170
Brasilia, DF.
Country [1] 257373 0
Brazil
Other collaborator category [1] 194 0
Individual
Name [1] 194 0
Edisio Pereira, MD, PhD
Address [1] 194 0
SQN 311, Bloco F Apt. 504
CEP 70757-060
BRASiLIA
Country [1] 194 0
Brazil
Other collaborator category [2] 195 0
Individual
Name [2] 195 0
Mauricio Gomes Pereira, MD PhD
Address [2] 195 0
QI 17 conjunto 5 casa 21.
Lago Sul
CEP: 71635250
Brasilia
Country [2] 195 0
Brazil

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 5002 0
Ethics Committee: Universidade Catolica de Brasilia (UCB).
Ethics committee address [1] 5002 0
Campus Universitario, QS 07 Lote 01 EPTC Aguas Claras Taguatinga, Cep 72030-170; Brasilia, DF.
Ethics committee country [1] 5002 0
Brazil
Date submitted for ethics approval [1] 5002 0
14/01/2006
Approval date [1] 5002 0
20/05/2006
Ethics approval number [1] 5002 0
number CEP/UCB 47/2006.

Summary
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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 28350 0
Address 28350 0
Country 28350 0
Phone 28350 0
Fax 28350 0
Email 28350 0
Contact person for public queries
Name 11507 0
Margarida Castanheira Rodrigues Bretas Bastos, MD
Address 11507 0
3 Temple Road
Dartry
Dublin 6
Ireland
Country 11507 0
Ireland
Phone 11507 0
353 872809987
Fax 11507 0
Email 11507 0
[email protected]
Contact person for scientific queries
Name 2435 0
Margarida Castanheira Rodrigues Bretas Bastos, MD
Address 2435 0
3 Temple Road
Dartry
Dublin 6
Ireland
Country 2435 0
Ireland
Phone 2435 0
353 872809987
Fax 2435 0
Email 2435 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
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Documents added automatically
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