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

Phase 4

Completed

• Conditions: Anxiety
• Interventions: Drug: Normal Saline; Drug: Midazolam; Device: Bair Hugger

• Registration Number: NCT01866605
• Lead Sponsor: Melbourne Health

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.

Study Timeline

• Study Start: 2008-07
• Status Verified: 2009-02
• Primary Completion: 2009-05
• Study Completion: 2009-05
• Study First Submitted: 2013-05-28
• Study First Submitted QC: 2013-05-30
• Last Update Submitted: 2013-05-30
• Study First Posted: 2013-05-31
• Last Update Posted: 2013-05-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Normal Saline	Single un-warmed cotton blanket over body and limbs, and reassurance, during preoperative period in anaesthetic room
2	Midazolam	Single un-warmed cotton blanket over body and limbs, reassurance and intravenous midazolam 30 µg/kg i.v, during preoperative period in anaesthetic room
3	Bair Hugger	Single un-warmed cotton blanket, reassurance and forced-air warming with a Bair Hugger, during preoperative period in anaesthetic room

Primary Outcome Measures

Name	Time	Method
Visual analog scale score for anxiety	During immediate pre-operative phase

Secondary Outcome Measures

Name	Time	Method
Thermal comfort	During immediate pre-operative phase
Recovery from anaesthesia	During immediate post-operative phase
Satisfaction with care	During immediate post-operative phase

Trial Locations

Locations (1)

Royal Melbourne Hospital; 🇦🇺 Parkville, Victoria, Australia