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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Melbourne Health
ClinicalTrials.gov Identifier:
NCT01866605
First received: May 28, 2013
Last updated: May 30, 2013
Last verified: February 2009
  Purpose

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
Anxiety
Drug: Midazolam
Drug: Normal Saline
Device: Bair Hugger
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Thermal comfort [ Time Frame: During immediate pre-operative phase ] [ Designated as safety issue: No ]
  • Recovery from anaesthesia [ Time Frame: During immediate post-operative phase ] [ Designated as safety issue: No ]
  • Satisfaction with care [ Time Frame: During immediate post-operative phase ] [ Designated as safety issue: No ]

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
Other Name: normal saline
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
Other Name: midazolam
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
Other Name: bair hugger

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.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01866605

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

No publications provided

Responsible Party: Melbourne Health
ClinicalTrials.gov Identifier: NCT01866605     History of Changes
Other Study ID Numbers: HREC 2008.074
Study First Received: May 28, 2013
Last Updated: May 30, 2013
Health Authority: Australia: Department of Health and Ageing Therapeutic Goods Administration

Keywords provided by Melbourne Health:
anxiety
midazolam
forced-air warming

Additional relevant MeSH terms:
Anxiety Disorders
Mental Disorders
Midazolam
Adjuvants, Anesthesia
Anesthetics
Anesthetics, General
Anesthetics, Intravenous
Anti-Anxiety Agents
Central Nervous System Agents
Central Nervous System Depressants
GABA Agents
GABA Modulators
Hypnotics and Sedatives
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Pharmacologic Actions
Physiological Effects of Drugs
Psychotropic Drugs
Therapeutic Uses
Tranquilizing Agents

ClinicalTrials.gov processed this record on November 24, 2014