Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12608000272392
Ethics application status
Approved
Date submitted
27/05/2008
Date registered
29/05/2008
Date last updated
26/11/2015
Type of registration
Prospectively registered

Titles & IDs
Public title
A Study of Methods to Reduce Anxiety in Preoperative Elective Surgical Patients
Scientific title
Forced-air warming, midazolam or control prevention of anxiety as measured by a 100-mm visual analog scale in patients presenting for elective non-cardiac surgery.
Secondary ID [1] 288007 0
nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Preoperative anxiety 3196 0
Condition category
Condition code
Anaesthesiology 3358 3358 0 0
Anaesthetics

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Reassurance, cotton blanket, saline injection (2 ml at time 0); Reassurance, cotton blanket, midazolam injection (0.3 mg/kg i.v. at time 0); Reassurance, forced-air warming blanket, midazolam injection (0.3 mg/kg at time 0). Reassurance and cotton blanket or forced air warming blanket applied from time 0 to time 20. Study conducted in the 20 minutes prior to induction of anaesthesia.
Intervention code [1] 2941 0
Prevention
Comparator / control treatment
Reassurance, cotton blanket, saline injection (2 ml at time 0)
Control group
Active

Outcomes
Primary outcome [1] 4245 0
Visual analog score for anxiety on 100-mm scale
Timepoint [1] 4245 0
From admission to anaesthetic room to discharge from recovery room
Secondary outcome [1] 7173 0
Thermal comfort during preoperative treatment (100 mm visual analog scale)
Timepoint [1] 7173 0
During immediate preoperative phase
Secondary outcome [2] 7174 0
Times to eyes open after surgery
Timepoint [2] 7174 0
During stay in recovery room

Eligibility
Key inclusion criteria
Patients aged between 18 and 70 years, male and female
Presenting for elective surgery
Requiring general anaesthesia
American Society of Anesthesiologists' physical status score 1-3
Minimum age
18 Years
Maximum age
70 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Cardiothoracic and intracranial surgery
Day case surgery
Pre-existing anxiety disorder
Patients on psychotropic drugs preoperatively
Febrile patients T > 37.5 degrees Celsius
Allergy to midazolam
Obstructive Sleep Apnoea diagnosed on sleep study

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled 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
Parallel
Other design features
Phase
Phase 4
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/07/2008
Actual
7/08/2008
Date of last participant enrolment
Anticipated
20/03/2009
Actual
3/04/2009
Date of last data collection
Anticipated
Actual
Sample size
Target
90
Accrual to date
Final
120
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 3429 0
Self funded/Unfunded
Name [1] 3429 0
Melbourne Health
Country [1] 3429 0
Australia
Primary sponsor type
Hospital
Name
Melbourne Health
Address
Royal Melbourne Hospital
Parkville, VIC, 3050
Country
Australia
Secondary sponsor category [1] 3071 0
None
Name [1] 3071 0
Address [1] 3071 0
Country [1] 3071 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 5455 0
Ethics committee address [1] 5455 0
Ethics committee country [1] 5455 0
Date submitted for ethics approval [1] 5455 0
27/05/2008
Approval date [1] 5455 0
Ethics approval number [1] 5455 0
HREC 2008.074
Ethics committee name [2] 293927 0
Melbourne Health HREC
Ethics committee address [2] 293927 0
Royal Melbourne Hospital
Parkville VIC 3050
Ethics committee country [2] 293927 0
Australia
Date submitted for ethics approval [2] 293927 0
27/05/2008
Approval date [2] 293927 0
07/08/2008
Ethics approval number [2] 293927 0
Nil known

Summary
Brief summary
We tested the hypothesis that pre-operative forced-air warming is as effective for anxiolysis as
intravenous midazolam, using a blinded, placebo controlled factorial design. One hundred and
twenty patients were randomly assigned to cotton blanket and saline injection (n = 30), forced-air
warmer and saline injection (n = 30), midazolam 30 lg.kg)1 and cotton blanket (n = 30), and
forced-air warmer and midazolam 30 lg.kg)1 (n = 30). Patients completed visual analogue scales
for anxiety and thermal comfort, and the State-Trait Anxiety Inventory, at baseline and after
20 min. The estimated effect of midazolam on visual analogue scores for anxiety was )10 (95% CI
)3 to )18; p = 0.007) and on state anxiety was )5 (95% CI )7 to )4; p = 0.03). Warming had
no influence on visual analogue scores for anxiety (p = 0.50) or state anxiety (p = 0.33), but its
estimated effect on thermal comfort was +23 (95% CI 19–27; p < 0.0001). There was no interaction
between midazolam and warming. Pre-operative warming was not equivalent to midazolam
for anxiolysis and cannot be recommended solely for this purpose.
Trial website
Trial related presentations / publications
Wen R, LESLIE K, Rajendra P. Pre-operative forced-air warming as a method of anxiolysis. Anaesthesia 2009; 64: 1077-80
Public notes

Contacts
Principal investigator
Name 28622 0
Prof Kate Leslie
Address 28622 0
Department of Anaesthesia and Pain Management
Royal Melbourne Hospital
Parkville VIC 3050
Australia
Country 28622 0
Australia
Phone 28622 0
61-3-93427540
Fax 28622 0
Email 28622 0
kate.leslie@mh.org.au
Contact person for public queries
Name 11779 0
Prof Kate Leslie
Address 11779 0
Royal Melbourne Hospital
Parkville VIC 3050
Country 11779 0
Australia
Phone 11779 0
+61-3-93427000
Fax 11779 0
Email 11779 0
kate.leslie@mh.org.au
Contact person for scientific queries
Name 2707 0
Prof Kate Leslie
Address 2707 0
Royal Melbourne Hospital
Parkville VIC 3050
Country 2707 0
Australia
Phone 2707 0
+61-3-93427000
Fax 2707 0
Email 2707 0
kate.leslie@mh.org.au

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

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