Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12609000523202
Ethics application status
Not yet submitted
Date submitted
23/06/2009
Date registered
1/07/2009
Date last updated
1/07/2009
Type of registration
Prospectively registered

Titles & IDs
Public title
Modification of Anaesthetic Technique to Improve Seizure Duration and Quality in Patients Undergoing Electroconvulsive Therapy (ECT)
Scientific title
Does Alfentanil - Propofol Combination Improve Seizure Duration and Quality In Patients Undergoing Electroconvulsive Therapy(ECT)
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Mental illness 237084 0
Depression 237092 0
Condition category
Condition code
Mental Health 237406 237406 0 0
Depression
Anaesthesiology 237407 237407 0 0
Anaesthetics

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Combination of alfenatnil and propofol in different dose combinations given to patients and studied in cross-over design to determine influence on ECT duartion and quality.

Most patients undergoing electroconvulsive therapy (ECT) have six treatments on alternate days during a course. Every patient recruited into the study will have four treatments during the study period. Each of these patients will receive four treatments as part of a ECT course on alternate days. All patients will receive either drug A, B, C or D for induction on a particular day.

Group A 30 patients will receive intravenous (iv) propofol (PPF) 0.5 mg/kg along with iv alfentanil 10 mcg/kg

Group B 30 patients will receive iv PPF 0.75 mg/kg along with iv alfentanil 10 mcg/kg

Group C 30 patients will receive iv PPF 1.0 mg/kg

Group D 30 patients will receive iv Thiopentone 3.0 mg/kg

Wash-out period for these treatments would be approximately 48 hours.
Intervention code [1] 236804 0
Treatment: Drugs
Comparator / control treatment
Group D
Control group
Dose comparison

Outcomes
Primary outcome [1] 238208 0
reduction in propofol dose when combined with alfentanil
Timepoint [1] 238208 0
end of induction using bispectral index (BIS) monitor - patient deemed to be asleep once BIS reading less than 50
Primary outcome [2] 238209 0
seizure duration and quality using post ictal supression index analysis
Timepoint [2] 238209 0
after administration of ECT i.e., 25 - 50 seconds approximately
Secondary outcome [1] 244521 0
recovery profile

using haemodynamic variable such as heart rate, blood pressure,

oxygenation using saturation

time to return to conscious state

time to be able to ambulate
Timepoint [1] 244521 0
discharge from recovery suite

Eligibility
Key inclusion criteria
ASA I or II
Minimum age
17 Years
Maximum age
70 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Involuntary patients
Patients with heart disease or neuroendocrine disorders
Patients on alpha or beta blockers

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Phase
Phase 4
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/09/2009
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
120
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 237196 0
Self funded/Unfunded
Name [1] 237196 0
Country [1] 237196 0
Australia
Primary sponsor type
Individual
Name
Sanjay Sharma
Address
PO Box 577
Ballarat
VIC 3353
Country
Australia
Secondary sponsor category [1] 4692 0
Hospital
Name [1] 4692 0
Ballarat Health Services
Address [1] 4692 0
PO Box 577
Ballarat
VIC 3353
Country [1] 4692 0
Australia

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 239292 0
Ballarat Health Services and St John of God Human Research and Ethics Committee
Ethics committee address [1] 239292 0
PO Box 577
Ballarat
VIC 3353
Ethics committee country [1] 239292 0
Australia
Date submitted for ethics approval [1] 239292 0
01/07/2009
Approval date [1] 239292 0
Ethics approval number [1] 239292 0

Summary
Brief summary
This is a project being jointly conducted by departments of Anesthesia and Psychiatry at Ballarat Health Services.

Anaesthetic agents such as hypnotics tend to increase the seizure threshold in patients undergoing electroconvulsive therapy (ECT). Consequently, higher current strength may be required to induce seizure activity.

This study aims to reduce the dose of such anaesthetic agents. However, this does not imply that patients will be awake or partially awake at the time of ECT. Agents that do not increase seizure threshold such as opioids would be used in combination with hypnotics. In fact, a monitor to record depth of anaesthesia, will be employed during this study to ensure patients are asleep before ECT is administered.

This study will be approved by Ballarat Health Services and St John of God Human Research and Ethics Committee.

The main aim of the study is to determine optimal dose of anesthetic agents used with or without opioid to induce good quality seizure.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 29790 0
Address 29790 0
Country 29790 0
Phone 29790 0
Fax 29790 0
Email 29790 0
Contact person for public queries
Name 13037 0
Sanjay Sharma
Address 13037 0
PO Box 577
Ballarat
VIC 3353
Country 13037 0
Australia
Phone 13037 0
+61353204590
Fax 13037 0
+61353204591
Email 13037 0
[email protected]
Contact person for scientific queries
Name 3965 0
Sanjay Sharma
Address 3965 0
PO Box 577
Ballarat
VIC 3353
Country 3965 0
Australia
Phone 3965 0
+61353204590
Fax 3965 0
+61353204591
Email 3965 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
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.