Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12605000231640
Ethics application status
Approved
Date submitted
11/08/2005
Date registered
26/08/2005
Date last updated
24/02/2009
Type of registration
Retrospectively registered

Titles & IDs
Public title
A clinical trial of dexmedetomidine or remifentanil sedation for awake fibreoptic intubation
Scientific title
A clinical trial of dexmedetomidine or remifentanil sedation for awake fibreoptic intubation
Universal Trial Number (UTN)
Trial acronym
STOPIT
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Anaesthesia 317 0
Condition category
Condition code
Anaesthesiology 362 362 0 0
Anaesthetics

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Dexmedetomidine 0.7 mcg/kg then 0.4 mcg/kg/h until completion of procedure
Intervention code [1] 170 0
None
Comparator / control treatment
IV remifentanil 0.05 mcg/kg/min from arrival in operating room until intubation
Control group
Active

Outcomes
Primary outcome [1] 422 0
Efficacy of sedation
Timepoint [1] 422 0
Assessed by patient response at time of intubation
Secondary outcome [1] 907 0
Patient satisfaction
Timepoint [1] 907 0
at 24 hours post-procedure
Secondary outcome [2] 908 0
Anaesthetist satisfaction
Timepoint [2] 908 0
at end of procedure
Secondary outcome [3] 909 0
Requirement for adjustment of infusion rate
Timepoint [3] 909 0
during procedure

Eligibility
Key inclusion criteria
Awake fibreoptic intubation, no contraindication to remifentanil or dexmedetomidine.
Minimum age
18 Years
Maximum age
Not stated
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Chronic alpha-2 agonist or opioid therapy, allergy or previous adverse reaction to study drugs, uncontrolled hypertension, heart <50, 2nd or 3rd degree heart block, severe ventricular, renal, hepatic or respiratory dysfuction, pregnancy or lactation.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Sealed envelope
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer generated
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Stopped early
Data analysis
Reason for early stopping/withdrawal
Date of first participant enrolment
Anticipated
30/11/2004
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
20
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 421 0
Commercial sector/Industry
Name [1] 421 0
Abbott Australasia
Country [1] 421 0
Australia
Primary sponsor type
Individual
Name
Dr Sarah Harper
Address
Department of Anaesthesia and Pain Medicine, Royal Perth Hospital, Wellington St Perth WA 6000
Country
Australia
Secondary sponsor category [1] 340 0
Hospital
Name [1] 340 0
Royal Perth Hospital
Address [1] 340 0
Wellington St, Perth WA 6000
Country [1] 340 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 1393 0
Royal Perth Hospital
Ethics committee address [1] 1393 0
Ethics committee country [1] 1393 0
Australia
Date submitted for ethics approval [1] 1393 0
Approval date [1] 1393 0
30/10/2004
Ethics approval number [1] 1393 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 35500 0
Address 35500 0
Country 35500 0
Phone 35500 0
Fax 35500 0
Email 35500 0
Contact person for public queries
Name 9359 0
Michael Paech
Address 9359 0
Department of Anaesthesia and Pain Medicine
Royal Perth Hospital
Wellington Street
Perth WA 6000
Country 9359 0
Australia
Phone 9359 0
+61 8 92241036
Fax 9359 0
Email 9359 0
michael.paech@health.wa.gov.au
Contact person for scientific queries
Name 287 0
Shauna Fatovich
Address 287 0
Department of Anaesthesia and Pain Medicine
Royal Perth Hospital
Wellington Street
Perth WA 6000
Country 287 0
Australia
Phone 287 0
+61 8 92241036
Fax 287 0
Email 287 0
shauna.fatovich@health.wa.gov.au

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.