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

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.

Study Overview

• Status: Completed
• Conditions: Anxiety
• Intervention / Treatment: Drug: Normal Saline; Drug: Midazolam; Device: Bair Hugger

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 Type: Interventional
• Enrollment (Actual): 120
• Phase: Phase 4

Contacts and Locations

Study Locations

• Australia
  • Victoria
    • Parkville, Victoria, Australia, 3050
      • Royal Melbourne Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Melbourne Health
• Investigators: Principal Investigator: Kate Leslie, MD, Melbourne Health

Study record dates

Study Major Dates

• Study Start: July 1, 2008
• Primary Completion (Actual): May 1, 2009
• Study Completion (Actual): May 1, 2009

Study Registration Dates

• First Submitted: May 28, 2013
• First Submitted That Met QC Criteria: May 30, 2013
• First Posted (Estimate): May 31, 2013

Study Record Updates

• Last Update Posted (Estimate): May 31, 2013
• Last Update Submitted That Met QC Criteria: May 30, 2013
• Last Verified: February 1, 2009

More Information

Terms related to this study

• Keywords: midazolam; anxiety; forced-air warming
• Additional Relevant MeSH Terms: Mental Disorders; Anxiety Disorders; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Tranquilizing Agents; Psychotropic Drugs; Hypnotics and Sedatives; Adjuvants, Anesthesia; Anti-Anxiety Agents; GABA Modulators; GABA Agents; Midazolam
• Other Study ID Numbers: HREC 2008.074