Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12608000304336
Ethics application status
Approved
Date submitted
12/06/2008
Date registered
20/06/2008
Date last updated
14/10/2013
Type of registration
Prospectively registered

Titles & IDs
Public title
Dexmedetomidine Sedation for Awake Fibreoptic Bronchoscopy
Scientific title
Feasibility and Safety of Dexmedetomidine Sedation for Patients presenting for Awake Fibreoptic Bronchoscopy
Secondary ID [1] 283401 0
nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Safety and Feasibility of Dexmedetomidine Sedation for Awake Fibreoptic Bronchoscopy 3261 0
Condition category
Condition code
Anaesthesiology 3426 3426 0 0
Anaesthetics

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Dexmedetomidine sedation as an intravenous infusion to obtain sedation. Initial bolus of 0.5mcg/kg over 10 minutes followed by an infusion of 0.2-0.7mcg/kg/h, titrating to a Ramsay Sedation Score of 4 during the procedure. This infusion would be ceased once bronchoscopy is completed. The estimated time for the bronchoscopy would be about 15-20 minutes.
Intervention code [1] 3004 0
Treatment: Drugs
Comparator / control treatment
No Control
Control group
Uncontrolled

Outcomes
Primary outcome [1] 4322 0
Hemodynamic changes from baseline
(observational), Heart rate, Non-invasive blood pressure - systolic, mean and diastolic blood pressure
Timepoint [1] 4322 0
Baseline, during the sedation and 30 minutes after sedation ceasing (or return to baseline hemodynamics)
Secondary outcome [1] 7284 0
Ramsay Sedation Score
Timepoint [1] 7284 0
Baseline, during the sedation and 30 mins after ceasing sedation
Secondary outcome [2] 7285 0
Adverse events monitoring
Bradycardia (Heart rate (HR) <40), Hypotension (Mean Arterial Pressure (MAP)<55mmHg), Nausea
Timepoint [2] 7285 0
During the sedation and 30 mins after ceasing sedation
Secondary outcome [3] 7286 0
Patient Satisfaction (interview, visual analogue scale)
Timepoint [3] 7286 0
1 hour post procedure
Secondary outcome [4] 7287 0
Proceduralist Satisfaction (visual analogue scale)
Timepoint [4] 7287 0
Immediately after the procedure

Eligibility
Key inclusion criteria
18 years and above, Presenting for awake fibreoptic bronchoscopy, and
Not pregnant at the start of the procedure/sedation
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Allergy to dexmedetomidine,2nd degree heart block and above,Hypovolaemia,Hypotensive at the start of the procedure/sedation

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 3
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Stopped early
Data analysis
Reason for early stopping/withdrawal
Date of first participant enrolment
Anticipated
28/07/2008
Actual
15/12/2008
Date of last participant enrolment
Anticipated
Actual
2/03/2009
Date of last data collection
Anticipated
Actual
Sample size
Target
100
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 3483 0
Hospital
Name [1] 3483 0
Royal Melbourne Hospital
Country [1] 3483 0
Australia
Primary sponsor type
Individual
Name
Keat Lee
Address
Department of Anaesthesia and Pain Management
Royal Melbourne Hospital
Grattan Street
Parkville 3050
VIC
Country
Australia
Secondary sponsor category [1] 3125 0
Individual
Name [1] 3125 0
Ruari Orme
Address [1] 3125 0
Department of Anaesthesia and Pain Management
Royal Melbourne Hospital
Grattan Street
Parkville 3050
VIC
Country [1] 3125 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 5514 0
Melbourne Health - Human Research Ethics Committee
Ethics committee address [1] 5514 0
Royal Melbourne Hospital
Parkville
VIC 3050
Ethics committee country [1] 5514 0
Australia
Date submitted for ethics approval [1] 5514 0
02/07/2008
Approval date [1] 5514 0
23/10/2008
Ethics approval number [1] 5514 0
2008.134

Summary
Brief summary
We aim to trial dexmedetomidine as a sedating agent for awake diagnostic fibreoptic bronchoscopy. It has a number of unique properties which we feel would be useful - sedating, reduces discomfort and stress during potentially uncomfortable procedures. We would be monitoring for any problems or adverse events during this trial.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 28668 0
Dr Keat Lee
Address 28668 0
Department of Anaesthesia and Pain Management
Royal Melbourne Hospital
Grattan Street
Parkville VIC 3050
Country 28668 0
Australia
Phone 28668 0
+61393427540
Fax 28668 0
Email 28668 0
[email protected]
Contact person for public queries
Name 11825 0
A/Prof Reny Segal
Address 11825 0
Department of Anaesthesia and Pain Management
Royal Melbourne Hospital
Grattan Street
Parkville 3050
VIC
Country 11825 0
Australia
Phone 11825 0
03-93427540
Fax 11825 0
Email 11825 0
[email protected]
Contact person for scientific queries
Name 2753 0
Dr Keat Lee
Address 2753 0
Department of Anaesthesia and Pain Management
Royal Melbourne Hospital
Grattan Street 3050
Parkville
VIC
Country 2753 0
Australia
Phone 2753 0
03-93427540
Fax 2753 0
Email 2753 0
[email protected]

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.