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OpenTrials
Completed

NCT Number: NCT01866605

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.

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Key information

Conditions

Anxiety Anxiety Disorders Mental Disorders

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Royal Melbourne Hospital

Parkville, Victoria, 3050, Australia

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

midazolam

Drug

Intravenous midazolam 0.3 mg/kg

normal saline

Drug

Normal saline injection will be given to groups not receiving midazolam

Bair Hugger

Device

Forced air warming

Primary outcomes

  1. Visual analog scale score for anxiety

    Time frame: During immediate pre-operative phase

Secondary outcomes

  1. Thermal comfort

    Time frame: During immediate pre-operative phase

  2. Recovery from anaesthesia

    Time frame: During immediate post-operative phase

  3. Satisfaction with care

    Time frame: During immediate post-operative phase

Sponsors and collaborators

Lead sponsor

Melbourne Health

Other

Registry information

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
May 31, 2013
Registry last updated
May 31, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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