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

Anxiety Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01866605
• Other study ID #: HREC 2008.074
• Status: Completed
• Phase: Phase 4
• First received: May 28, 2013
• Last updated: May 30, 2013
• Start date: July 2008
• Est. completion date: May 2009

Study information

• Verified date: February 2009
• Source: Melbourne Health
• Contact: n/a
• Is FDA regulated: No
• Health authority: Australia: Department of Health and Ageing Therapeutic Goods Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: May 2009
• Est. primary completion date: May 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Anxiety
• Anxiety Disorders

Intervention

Drug:
• Midazolam
Intravenous midazolam 0.3 mg/kg
• Normal Saline
Normal saline injection will be given to groups not receiving midazolam

Device:
• Bair Hugger
Forced air warming

Locations

Country	Name	City	State
Australia	Royal Melbourne Hospital	Parkville	Victoria

Sponsors (1)

Lead Sponsor	Collaborator
Melbourne Health

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Visual analog scale score for anxiety		During immediate pre-operative phase	No
Secondary	Thermal comfort		During immediate pre-operative phase	No
Secondary	Recovery from anaesthesia		During immediate post-operative phase	No
Secondary	Satisfaction with care		During immediate post-operative phase	No