Back to resultsA Study of Methods to Reduce Anxiety in Preoperative Elective Surgical Patients
Primary Purpose
Anxiety
Status
Completed
Phase
Phase 4
Locations
Australia
Study Type
Interventional
Intervention
Midazolam
Normal Saline
Bair Hugger
Sponsored by
About this trial
This is an interventional treatment trial for Anxiety focused on measuring anxiety, midazolam, forced-air warming
Eligibility Criteria
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
Sites / Locations
- Royal Melbourne Hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Placebo Comparator
Active Comparator
Active Comparator
Arm Label
1
2
3
Arm Description
Single un-warmed cotton blanket over body and limbs, and reassurance, during preoperative period in anaesthetic room
Single un-warmed cotton blanket over body and limbs, reassurance and intravenous midazolam 30 µg/kg i.v, during preoperative period in anaesthetic room
Single un-warmed cotton blanket, reassurance and forced-air warming with a Bair Hugger, during preoperative period in anaesthetic room
Outcomes
Primary Outcome Measures
Visual analog scale score for anxiety
Secondary Outcome Measures
Thermal comfort
Recovery from anaesthesia
Satisfaction with care
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01866605
Brief Title
A Study of Methods to Reduce Anxiety in Preoperative Elective Surgical Patients
Official Title
A Study of Methods to Reduce Anxiety in Preoperative Elective Surgical Patients
Study Type
Interventional
2. Study Status
Record Verification Date
February 2009
Overall Recruitment Status
Completed
Study Start Date
July 2008 (undefined)
Primary Completion Date
May 2009 (Actual)
Study Completion Date
May 2009 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Melbourne Health
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anxiety
Keywords
anxiety, midazolam, forced-air warming
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
120 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Placebo Comparator
Arm Description
Single un-warmed cotton blanket over body and limbs, and reassurance, during preoperative period in anaesthetic room
Arm Title
2
Arm Type
Active Comparator
Arm 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
Arm Title
3
Arm Type
Active Comparator
Arm Description
Single un-warmed cotton blanket, reassurance and forced-air warming with a Bair Hugger, during preoperative period in anaesthetic room
Intervention Type
Drug
Intervention Name(s)
Midazolam
Intervention Description
Intravenous midazolam 0.3 mg/kg
Intervention Type
Drug
Intervention Name(s)
Normal Saline
Intervention Description
Normal saline injection will be given to groups not receiving midazolam
Intervention Type
Device
Intervention Name(s)
Bair Hugger
Intervention Description
Forced air warming
Primary Outcome Measure Information:
Title
Visual analog scale score for anxiety
Time Frame
During immediate pre-operative phase
Secondary Outcome Measure Information:
Title
Thermal comfort
Time Frame
During immediate pre-operative phase
Title
Recovery from anaesthesia
Time Frame
During immediate post-operative phase
Title
Satisfaction with care
Time Frame
During immediate post-operative phase
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kate Leslie, MD
Organizational Affiliation
Melbourne Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
Royal Melbourne Hospital
City
Parkville
State/Province
Victoria
ZIP/Postal Code
3050
Country
Australia
12. IPD Sharing Statement
Learn more about this trial
A Study of Methods to Reduce Anxiety in Preoperative Elective Surgical Patients
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