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

This study has been completed.
Information provided by (Responsible Party):
Melbourne Health Identifier:
First received: May 28, 2013
Last updated: May 30, 2013
Last verified: February 2009
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.

Condition Intervention Phase
Drug: Midazolam
Drug: Normal Saline
Device: Bair Hugger
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Study of Methods to Reduce Anxiety in Preoperative Elective Surgical Patients

Resource links provided by NLM:

Further study details as provided by Melbourne Health:

Primary Outcome Measures:
  • Visual analog scale score for anxiety [ Time Frame: During immediate pre-operative phase ]

Secondary Outcome Measures:
  • Thermal comfort [ Time Frame: During immediate pre-operative phase ]
  • Recovery from anaesthesia [ Time Frame: During immediate post-operative phase ]
  • Satisfaction with care [ Time Frame: During immediate post-operative phase ]

Enrollment: 120
Study Start Date: July 2008
Study Completion Date: May 2009
Primary Completion Date: May 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
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Please refer to this study by its identifier: NCT01866605

Australia, Victoria
Royal Melbourne Hospital
Parkville, Victoria, Australia, 3050
Sponsors and Collaborators
Melbourne Health
Principal Investigator: Kate Leslie, MD Melbourne Health
  More Information

Responsible Party: Melbourne Health Identifier: NCT01866605     History of Changes
Other Study ID Numbers: HREC 2008.074
Study First Received: May 28, 2013
Last Updated: May 30, 2013

Keywords provided by Melbourne Health:
forced-air warming

Additional relevant MeSH terms:
Anxiety Disorders
Mental Disorders
Adjuvants, Anesthesia
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Anti-Anxiety Agents
Tranquilizing Agents
Psychotropic Drugs
Anesthetics, Intravenous
Anesthetics, General
GABA Modulators
GABA Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action processed this record on May 25, 2017