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A Study of Methods to Reduce Anxiety in Preoperative Elective Surgical Patients

A Study of Methods to Reduce Anxiety in Preoperative Elective Surgical Patients

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01866605
Enrollment
120
Registered
2013-05-31
Start date
2008-07-31
Completion date
2009-05-31
Last updated
2013-05-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anxiety

Keywords

anxiety, midazolam, forced-air warming

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.

Detailed description

The investigators are randomising patients aged 18-70 having elective surgery to 1) a cotton blanket and reassurance as required; 2) midazolam, a cotton blanket and reassurance as required; and 3) forced-air warming, a cotton blanket and reassurance as required. The primary endpoint is a visual analog scale of anxiety.

Interventions

DRUGMidazolam

Intravenous midazolam 0.3 mg/kg

DRUGNormal Saline

Normal saline injection will be given to groups not receiving midazolam

Forced air warming

Sponsors

Melbourne Health
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No

Inclusion criteria

* Patients aged between 18 and 70 years * male and female * presenting for elective surgery * requiring general anaesthesia * ASA 1-3

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

Design outcomes

Primary

MeasureTime frame
Visual analog scale score for anxietyDuring immediate pre-operative phase

Secondary

MeasureTime frame
Thermal comfortDuring immediate pre-operative phase
Recovery from anaesthesiaDuring immediate post-operative phase
Satisfaction with careDuring immediate post-operative phase

Countries

Australia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026