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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT01866605




Registration number
NCT01866605
Ethics application status
Date submitted
28/05/2013
Date registered
31/05/2013
Date last updated
31/05/2013

Titles & IDs
Public title
A Study of Methods to Reduce Anxiety in Preoperative Elective Surgical Patients
Scientific title
A Study of Methods to Reduce Anxiety in Preoperative Elective Surgical Patients
Secondary ID [1] 0 0
HREC 2008.074
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Anxiety 0 0
Condition category
Condition code
Mental Health 0 0 0 0
Anxiety

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Midazolam
Treatment: Drugs - Normal Saline
Treatment: Devices - Bair Hugger

Placebo Comparator: 1 - Single un-warmed cotton blanket over body and limbs, and reassurance, during preoperative period in anaesthetic room

Active Comparator: 2 - Single un-warmed cotton blanket over body and limbs, reassurance and intravenous midazolam 30 µg/kg i.v, during preoperative period in anaesthetic room

Active Comparator: 3 - Single un-warmed cotton blanket, reassurance and forced-air warming with a Bair Hugger, during preoperative period in anaesthetic room


Treatment: Drugs: Midazolam
Intravenous midazolam 0.3 mg/kg

Treatment: Drugs: Normal Saline
Normal saline injection will be given to groups not receiving midazolam

Treatment: Devices: Bair Hugger
Forced air warming
Intervention code [1] 0 0
Treatment: Drugs
Intervention code [2] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Visual analog scale score for anxiety
Timepoint [1] 0 0
During immediate pre-operative phase
Secondary outcome [1] 0 0
Thermal comfort
Timepoint [1] 0 0
During immediate pre-operative phase
Secondary outcome [2] 0 0
Recovery from anaesthesia
Timepoint [2] 0 0
During immediate post-operative phase
Secondary outcome [3] 0 0
Satisfaction with care
Timepoint [3] 0 0
During immediate post-operative phase

Eligibility
Key inclusion criteria
- Patients aged between 18 and 70 years

- male and female

- presenting for elective surgery

- requiring general anaesthesia

- ASA 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
Treatment
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?
The people receiving the treatment/s

The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Phase 4
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/07/2008
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/05/2009
Sample size
Target
Accrual to date
Final
120
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Royal Melbourne Hospital - Parkville
Recruitment postcode(s) [1] 0 0
3050 - Parkville

Funding & Sponsors
Primary sponsor type
Other
Name
Melbourne Health
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Patients are often anxious immediately before surgery. The investigators hypothesis is that a
warming blanket is as effective as the sedative midazolam in allaying anxiety before surgery.
Trial website
https://clinicaltrials.gov/ct2/show/NCT01866605
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Kate Leslie, MD
Address 0 0
Melbourne Health
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries