NCT01866605

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for phase_4 anxiety

Timeline
Completed

Started Jul 2008

Shorter than P25 for phase_4 anxiety

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2008

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2009

Completed
4.1 years until next milestone

First Submitted

Initial submission to the registry

May 28, 2013

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 31, 2013

Completed
Last Updated

May 31, 2013

Status Verified

February 1, 2009

Enrollment Period

10 months

First QC Date

May 28, 2013

Last Update Submit

May 30, 2013

Conditions

Anxiety

Keywords

anxietymidazolamforced-air warming

Outcome Measures

Primary Outcomes (1)

  • Visual analog scale score for anxiety

    During immediate pre-operative phase

Secondary Outcomes (3)

  • Thermal comfort

    During immediate pre-operative phase

  • Recovery from anaesthesia

    During immediate post-operative phase

  • Satisfaction with care

    During immediate post-operative phase

Study Arms (3)

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

MidazolamDRUG

Intravenous midazolam 0.3 mg/kg

2
Normal SalineDRUG

Normal saline injection will be given to groups not receiving midazolam

1
Bair HuggerDEVICE

Forced air warming

3

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients aged between 18 and 70 years
  • male and female
  • presenting for elective surgery
  • requiring general anaesthesia
  • ASA 1-3

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Royal Melbourne Hospital

Parkville, Victoria, 3050, Australia

Location

MeSH Terms

Conditions

Anxiety Disorders

Interventions

MidazolamSaline Solution

Condition Hierarchy (Ancestors)

Mental Disorders

Intervention Hierarchy (Ancestors)

BenzodiazepinesBenzazepinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsCrystalloid SolutionsIsotonic SolutionsSolutionsPharmaceutical Preparations

Study Officials

  • Kate Leslie, MD

    Melbourne Health

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 28, 2013

First Posted

May 31, 2013

Study Start

July 1, 2008

Primary Completion

May 1, 2009

Study Completion

May 1, 2009

Last Updated

May 31, 2013

Record last verified: 2009-02

Locations

AU(1)