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

NCT ID: NCT01866605

Last Updated: 2013-05-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-07-31

Study Completion Date

2009-05-31

Brief Summary

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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

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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.

Conditions

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Anxiety

Keywords

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anxiety midazolam forced-air warming

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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1

Single un-warmed cotton blanket over body and limbs, and reassurance, during preoperative period in anaesthetic room

Group Type PLACEBO_COMPARATOR

Normal Saline

Intervention Type DRUG

Normal saline injection will be given to groups not receiving midazolam

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

Group Type ACTIVE_COMPARATOR

Midazolam

Intervention Type DRUG

Intravenous midazolam 0.3 mg/kg

3

Single un-warmed cotton blanket, reassurance and forced-air warming with a Bair Hugger, during preoperative period in anaesthetic room

Group Type ACTIVE_COMPARATOR

Bair Hugger

Intervention Type DEVICE

Forced air warming

Interventions

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Midazolam

Intravenous midazolam 0.3 mg/kg

Intervention Type DRUG

Normal Saline

Normal saline injection will be given to groups not receiving midazolam

Intervention Type DRUG

Bair Hugger

Forced air warming

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Melbourne Health

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Kate Leslie, MD

Role: PRINCIPAL_INVESTIGATOR

Melbourne Health

Locations

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Royal Melbourne Hospital

Parkville, Victoria, Australia

Site Status

Countries

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Australia

Other Identifiers

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HREC 2008.074

Identifier Type: -

Identifier Source: org_study_id