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

Melbourne Health

Status and phase: Completed; Phase 4

Conditions: Anxiety

Treatments: Drug: Normal Saline; Device: Bair Hugger; Drug: Midazolam

Study type: Interventional

Funder types: Other

Identifiers

NCT01866605

HREC 2008.074

Details and patient eligibility

About

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.

Full 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.

Enrollment: 120 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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120 participants in 3 patient groups, including a placebo group

1

Placebo Comparator group

Description:

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

Treatment:

Drug: Normal Saline

2

Active Comparator group

Description:

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

Treatment:

Drug: Midazolam

3

Active Comparator group

Description:

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

Treatment:

Device: Bair Hugger