A Study of Methods to Reduce Anxiety in Preoperative Elec... | NCT01866605

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

NCT01866605

Sponsor

Melbourne Health

Status

Completed

Last Update Posted

May 31, 2013Estimated

Enrollment

120Actual

Phase

Phase 4

Conditions

Anxiety

Interventions

Midazolam
Normal Saline
Bair Hugger

Countries

Australia

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2009

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 2008

Primary Completion Date

May 2009Actual

Completion Date

May 2009Actual

First Submitted Date

May 28, 2013

First Submission Date that Met QC Criteria

May 30, 2013

First Posted Date

May 31, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 30, 2013

Last Update Posted Date

May 31, 2013Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

120Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Placebo Comparator	Single un-warmed cotton blanket over body and limbs, and reassurance, during preoperative period in anaesthetic room	Drug: Normal Saline
2	Active Comparator	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
3	Active Comparator	Single un-warmed cotton blanket, reassurance and forced-air warming with a Bair Hugger, during preoperative period in anaesthetic room	Device: Bair Hugger

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Midazolam	Drug	Intravenous midazolam 0.3 mg/kg	2
Normal Saline

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Kate Leslie, MD	Melbourne Health	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Royal Melbourne Hospital		Parkville	Victoria	3050	Australia

ID	Term
D001008	Anxiety Disorders

ID	Term
D001523	Mental Disorders

Intervention Browse Module

MeSH Terms

ID	Term
D008874	Midazolam
D000077330	Saline Solution

Ancestor Terms

ID	Term
D001569	Benzodiazepines
D001552	Benzazepines
D006574	Heterocyclic Compounds, 2-Ring
D000072471	Heterocyclic Compounds, Fused-Ring

Browse Leaves

Not provided

Browse Branches

Not provided