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Trial registered on ANZCTR


Registration number
ACTRN12607000413426
Ethics application status
Not yet submitted
Date submitted
5/08/2007
Date registered
13/08/2007
Date last updated
13/08/2007
Type of registration
Prospectively registered

Titles & IDs
Public title
Blood pressure – during general anaesthesia versus sleep
Scientific title
In healthy adults undergoing surgery, how does general anaesthesia compared to sleep affect blood pressure.
Universal Trial Number (UTN)
Trial acronym
BGAS
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hypotension 2219 0
Condition category
Condition code
Anaesthesiology 2310 2310 0 0
Other anaesthesiology

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Hypotension/changes in blood pressure that occur during general anaesthesia (for duration of anaesthetic) compared to normal everyday life for a 24 hour period (including sleep)
Intervention code [1] 1930 0
Treatment: Other
Comparator / control treatment
Normal everyday life
Control group

Outcomes
Primary outcome [1] 3207 0
Mean arterial pressure
Timepoint [1] 3207 0
Timepoints:
-at baseline (during sleep)
-at 5 minutely intervals during general anaesthesia
Secondary outcome [1] 5346 0
Systolic and diastolic blood pressure
Timepoint [1] 5346 0
Timepoints:
- at baseline
- at 5 minutely intervals during anaesthesia

Eligibility
Key inclusion criteria
Patients undergoing peripheral surgery (ie. not cardiothoracic or intra-abdominal) of ASA (American Society of Anaesthesiologists) score 1 or 2 (ie. ASA 1 = a normal healthy patient or ASA 2 = a patient with mild systemic disease).
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients who are unsuitable for wearing an automated blood pressure device or unable to give informed consent due to cognitive reasons or language barriers. Patients with physical factors not permitting the wearing of an automated blood pressure monitor.

Study design
Purpose
Natural history
Duration
Cross-sectional
Selection
Convenience sample
Timing
Prospective
Statistical methods / analysis

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

Funding & Sponsors
Funding source category [1] 2476 0
Hospital
Name [1] 2476 0
St Vincent's Hospital
Country [1] 2476 0
Australia
Primary sponsor type
Individual
Name
Dr Jaclyn Soo
Address
Country
Secondary sponsor category [1] 2249 0
Individual
Name [1] 2249 0
Dr Sally Lacey
Address [1] 2249 0
Country [1] 2249 0
Secondary sponsor category [2] 2250 0
Individual
Name [2] 2250 0
Dr Brendan Silbert
Address [2] 2250 0
Country [2] 2250 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 4380 0
St Vincent's Health HREC
Ethics committee address [1] 4380 0
Ethics committee country [1] 4380 0
Date submitted for ethics approval [1] 4380 0
Approval date [1] 4380 0
Ethics approval number [1] 4380 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 27744 0
Address 27744 0
Country 27744 0
Phone 27744 0
Fax 27744 0
Email 27744 0
Contact person for public queries
Name 11119 0
Jaclyn Soo
Address 11119 0
Department of Anaesthesia
St Vincent's Hospital
55 Victoria Parade
PO Box 2900
Fitzroy VIC 3065
Country 11119 0
Australia
Phone 11119 0
(03) 9288 2211
Fax 11119 0
Email 11119 0
Contact person for scientific queries
Name 2047 0
Jaclyn Soo
Address 2047 0
Department of Anaesthesia
St Vincent's Hospital
PO Box 2900
55 Victoria Parade
Fitzroy VIC 3065
Country 2047 0
Australia
Phone 2047 0
(03) 9288 2211
Fax 2047 0
Email 2047 0

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.