A Study of Methods to Reduce Anxiety in Preoperative Elective Surgical Patients
Overview
- Phase
- Phase 4
- Intervention
- Normal Saline
- Conditions
- Anxiety
- Sponsor
- Melbourne Health
- Enrollment
- 120
- Locations
- 1
- Primary Endpoint
- Visual analog scale score for anxiety
- Status
- Completed
- Last Updated
- 12 years ago
Overview
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Patients aged between 18 and 70 years
- •male and female
- •presenting for elective surgery
- •requiring general anaesthesia
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
Arms & Interventions
1
Single un-warmed cotton blanket over body and limbs, and reassurance, during preoperative period in anaesthetic room
Intervention: Normal Saline
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
Intervention: Midazolam
3
Single un-warmed cotton blanket, reassurance and forced-air warming with a Bair Hugger, during preoperative period in anaesthetic room
Intervention: Bair Hugger
Outcomes
Primary Outcomes
Visual analog scale score for anxiety
Time Frame: During immediate pre-operative phase
Secondary Outcomes
- Thermal comfort(During immediate pre-operative phase)
- Recovery from anaesthesia(During immediate post-operative phase)
- Satisfaction with care(During immediate post-operative phase)