Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12612000211864
Ethics application status
Approved
Date submitted
20/02/2012
Date registered
20/02/2012
Date last updated
13/03/2012
Type of registration
Prospectively registered

Titles & IDs
Public title
A comparison of propofol and dexmedetomidine for sedation during hip and knee arthoplasty.
Scientific title
A comparison of propofol and dexmedetomidine for sedation during hip and knee arthoplasty, in adults, assessing patient satisfaction and respiratory and cardiovascular stability.
Secondary ID [1] 279970 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Sedation during hip and knee arthroplasty, which is often associated with a need for airway support due to respiratory depression and reduced airway tone. 285888 0
Condition category
Condition code
Anaesthesiology 286078 286078 0 0
Anaesthetics
Musculoskeletal 286082 286082 0 0
Osteoarthritis

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention will be usage of dexmedetomidine for sedation in assocation with neuraxial block for hip and knee arthroplasty. Dosage will be at the clinicians' discretion using standard dosages. However typical dosages are a loading dose of 0.5micrograms per kilogram (40micrograms for an 80kg patient) and 0.7 mcg/kg/hr, 56micrograms per kilogram per hour (56 micrograms an hour for an 80kg patient). Dosages are typically reduced for elderly patients. This would be given via intravenous infusion, commencing once the patient is positioned and it would not be combined with other sedative agents.
Intervention code [1] 284308 0
Treatment: Drugs
Comparator / control treatment
Propofol for sedation. This is typically used via a "target-controlled-infusion" pump which calculates the patients' estimated plasma concentration of propofol using computerised models. A typical plasma "target" for sedation in combination with neuraxial block would be 3 micrograms/millilitre. This is titrated to effect. It would also be given via intravenous infusion commencing once the patient is positioned, and also not combined with other sedative agents.
Control group
Active

Outcomes
Primary outcome [1] 286555 0
Patient satisfaction with the sedation experience will be assessed postoperatively on an analogue scale. Mean patient satisfaction scores will be compared between groups.
Timepoint [1] 286555 0
Within one week.
Secondary outcome [1] 296153 0
The outcome will be assessed using clinical assessment. It will be determined by the treating clinician whether one or more of jaw support; laryngeal mask insertion; use of Guedel airway; or endotracheal tube insertion occurs. Lowest pulse and lowest systolic blood pressure will be recorded intraoperatively. This will be recorded on the worksheet.
Timepoint [1] 296153 0
Intraoperative (less than three hours)

Eligibility
Key inclusion criteria
Adults with neuraxial block undergoing hip and knee arthroplasty.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Any contraindication to sedation.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Enrolling - discussed with patient prior to surgery and formal consent obtained on or before day of surgery. Clinicians will contact the anaesthetic department who will hold the allocation sequence. Departmental staff will inform the clinicians of assignment.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computerised block registration.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 4
Type of endpoint/s
Safety
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
11/03/2012
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
40
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 284735 0
Self funded/Unfunded
Name [1] 284735 0
Dr Mark Suss
Country [1] 284735 0
Australia
Primary sponsor type
Individual
Name
Dr Mark Suss
Address
Department of Anaesthesia
Cabrini Hospital
183 Wattletree Rd
Malvern
Victoria 3144
Country
Australia
Secondary sponsor category [1] 283631 0
None
Name [1] 283631 0
Address [1] 283631 0
Country [1] 283631 0
Other collaborator category [1] 260555 0
Individual
Name [1] 260555 0
Dr Antonio Grossi
Address [1] 260555 0
Department of Anaesthesia
Cabrini Hospital
183 Wattletree Rd
Malvern
Victoria 3144
Country [1] 260555 0
Australia
Other collaborator category [2] 260610 0
Individual
Name [2] 260610 0
Dr Chantal McNally
Address [2] 260610 0
Department of Anaesthesia Cabrini Hospital 183 Wattletree Rd Malvern Victoria 3144
Country [2] 260610 0
Australia
Other collaborator category [3] 260611 0
Individual
Name [3] 260611 0
Dr Chantal McNally
Address [3] 260611 0
Department of Anaesthesia Cabrini Hospital 183 Wattletree Rd Malvern Victoria 3144
Country [3] 260611 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 286742 0
CHREC Cabrini Health
Ethics committee address [1] 286742 0
Cabrini Hospital
183 Wattletree Rd
Malvern
Victoria 3144
Ethics committee country [1] 286742 0
Australia
Date submitted for ethics approval [1] 286742 0
01/12/2011
Approval date [1] 286742 0
Ethics approval number [1] 286742 0

Summary
Brief summary
This trial will compare the sedative medicine propofol with the newer sedative dexmedetomidine. The comparison will take place in a group of patients having replacement of their hips or knees with mechanical joints. The study will look at patients undergoing this surgery under a spinal block, where the body is made numb from the waist downwards. Typically these patients have some sort of sedation to make them more comfortable and less aware of noise or movement in the operating theatre. The most commonly used infusion, propofol has some side effects including reduced breathing efforts, which sometimes requires the anaesthetist to intervene and support the airway or even convert the sedation to a full anaesthetic. A newer sedative medicine, dexmedetomidine appears to have fewer of these effects. It may be that it is a better option for this sort of sedation. Some mild side effects such as changes in pulse rate have been associated with dexmedetomidine but these do not appear to be severe enough to prevent its usefulness in this setting. Patients will be randomized to receive either propofol or dexmedetomidine. They will receive their normal regional (eg “spinal” ) anaesthetic. The researchers will be measuring:
Patient satisfaction with the sedation experience (within one week of surgery);
Need for airway support; and haemodynamic values intraoperatively.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 33800 0
Address 33800 0
Country 33800 0
Phone 33800 0
Fax 33800 0
Email 33800 0
Contact person for public queries
Name 17047 0
Dr Mark Suss
Address 17047 0
Department of Anaesthesia
Cabrini Hospital
183 Wattletree Rd
Malvern
Victoria 3144
Country 17047 0
Australia
Phone 17047 0
61395081219
Fax 17047 0
Email 17047 0
[email protected]
Contact person for scientific queries
Name 7975 0
Dr Mark Suss
Address 7975 0
Department of Anaesthesia
Cabrini Hospital
183 Wattletree Rd
Malvern
Victoria 3144
Country 7975 0
Australia
Phone 7975 0
61395081219
Fax 7975 0
Email 7975 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.