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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Anxiety

Intervention / Treatment
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* Drug: Midazolam
* Drug: Normal Saline
* Device: Bair Hugger


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: 1<br>Single un-warmed cotton blanket over body and limbs, and reassurance, during preoperative period in anaesthetic room | Drug: Normal Saline<br>* Normal saline injection will be given to groups not receiving midazolam<br>|
| Active Comparator: 2<br>Single un-warmed cotton blanket over body and limbs, reassurance and intravenous midazolam 30 µg/kg i.v, during preoperative period in anaesthetic room | Drug: Midazolam<br>* Intravenous midazolam 0.3 mg/kg<br>|
| Active Comparator: 3<br>Single un-warmed cotton blanket, reassurance and forced-air warming with a Bair Hugger, during preoperative period in anaesthetic room | Device: Bair Hugger<br>* Forced air warming<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual analog scale score for anxiety |  | During immediate pre-operative phase | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Thermal comfort |  | During immediate pre-operative phase | 
| Recovery from anaesthesia |  | During immediate post-operative phase | 
| Satisfaction with care |  | During immediate post-operative phase | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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anxiety, midazolam, forced-air warming