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Trial registered on ANZCTR


Registration number
ACTRN12614001280695
Ethics application status
Approved
Date submitted
20/11/2014
Date registered
5/12/2014
Date last updated
5/12/2014
Type of registration
Prospectively registered

Titles & IDs
Public title
A pilot study assessing the effectiveness and safety of patient-controlled sedation during the insertion of a central venous line.
Scientific title
A pilot study assessing the use of intra-operative, patient-controlled sedation with midazolam and fentanyl for patients undergoing insertion of a central venous line.
Secondary ID [1] 285693 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Radiologically-guided insertion of a central venous line for patients undergoing chemotherapy, dialysis, or other conditions requiring high flow long term central line access (eg treatment of cystic fibrosis or other chronic disease) 293550 0
Condition category
Condition code
Anaesthesiology 293829 293829 0 0
Other anaesthesiology

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
To conduct a pilot study to assess intra-operative, patient–controlled sedation with midazolam and fentanyl for patients undergoing insertion of a central venous line.

This practice will allow the patient to self-administer a controlled dose of sedation/analgesia which then has a lock-out period. This will be done using a standard hospital patient controlled analgesia (PCA) pump which are in wide use in postoperative patients.

The intervention will allow patient's access to the PCA device from the beginning of the procedure (after 'time out' has been done) until the procedure finishes and the drapes are removed. Each button press will deliver a dose of 1 mg midazolam and 25 micrograms fentanyl. This will have a 3 minute lockout interval. Patient's will be instructed as to the way to use the device.

This practice will help to allow better control of sedation and potentially reduce the risk of underdosing and overdosing.

This pilot study will allow us to prove that the theory works (as has been shown in the literature) and to optimise the equipment and dosing in preparation for a larger RCT.
Intervention code [1] 290633 0
Treatment: Drugs
Intervention code [2] 290634 0
Treatment: Devices
Comparator / control treatment
This is a pilot study and will be in preparation for a larger randomised controlled trial where we will compare patient controlled sedation to radiologist controlled sedation.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 293613 0
Patient satisfaction with procedure and quality of recovery measured with the postoperative Alfred Quality of Recovery Tool and the 10 point VAS Patient Satisfaction Survey
Timepoint [1] 293613 0
Measured at 2 hours post the procedure
Primary outcome [2] 293614 0
Patient duration of amnesia for specified stimuli during the procedure, measured by questioning patients about the stimuli 1 hour after the procedure
Timepoint [2] 293614 0
1 hour after the procedure
Primary outcome [3] 293615 0
Success of sedation and analgesia measured by the Victorian Standard Sedation Score and Ramsay Sedation Score
Timepoint [3] 293615 0
Measured at selected time points during the procedure and immediately after the procedure:
Time 1 - Pre-procedure
Time 2 - After time out the procedure begins and the PCA is active
Time 3 - Prep and drape
Time 4 - Local anaesthetic
Time 5 - During the 'tunneling' process of the ventral line procedure
Time 6 - End of procedure - drapes removed, PCA removed
Secondary outcome [1] 311471 0
Safety assessed by the composite number of procedural, pre-discharge and 24 hour adverse events measured by Common Terminology Criteria for Adverse Events v4
Possible adverse effects include:
1 - undersedation (this is common but less likely to occur with this patient-controlled technique)
2 - overdosing (also unlikely to occur as patient will be sedation and unable to activate PCA button)
3 - paradoxical effects of sedation - transient disinhibition sometimes seen during light sedation
4 - hypotension - uncommon response to midzazolam and usually asymptomatic given the patient will be supine for the procedure
Timepoint [1] 311471 0
Recorded at discharge (2 hrs after procedure)
Secondary outcome [2] 311472 0
Level of intra-operative pain measured every 10 minutes and level of pain at the end of the procedure measured with the Victorian Acute Pain Management Measurement Toolkit
Timepoint [2] 311472 0
Every 10 minutes during procedure and after
Secondary outcome [3] 311473 0
Time to suitability for discharge at 2 hours post procedure, measured by the Modified Post Anaesthesia Discharge Scoring System (MPADSS)
Timepoint [3] 311473 0
2 hours post procedure
Secondary outcome [4] 311474 0
Numbers and timing of PCS button requests that are not successful, ie during the administration of a prior successful request: these unsuccessful requests are a measure of patient demand for sedation and therefore underdosing
Timepoint [4] 311474 0
After the procedure
Secondary outcome [5] 311475 0
Cumulative dose of midazolam and fentanyl measured by reference to the PCA system
Timepoint [5] 311475 0
Immediately after

Eligibility
Key inclusion criteria
Patients referred to the Radiology Department for elective central venous line insertion (for example, but not limited to: Hickman line for chemotherapy or antibiotics, Portacath for commencement urgent dailysis)
Males and females aged 18 to 75
No allergy to fentanyl and/or midazolam
ASA score 1 to 3
Signed study participant information and Consent form.
Minimum age
18 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Pregnancy
Coagulopathy (INR > 2, platelets < 50)
Abnormal renal function with a calculated e-GFR <40;
Allergy to contrast;
ASA score 4 to 6
Therapeutic heparinisation or current thrombolysis
Sepsis
Cellulitis or dermatitis at planned insertion site
On protease inhibitor antiretroviral drugs
Altered conscious state
Head injury
Significant hepatic dysfunction
Head or neck tumours
Not fasted for at least 4 hours
Contraindication to administration of inspired oxygen
Unable to sign participant information and Consent form
Lacks capacity to provide study consent for self

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)
The Alfred patient ‘opt-out of research register’ will be checked by the Radiology Research Unit.
In-patients and patients from Alfred out-patient clinics are referred to the Radiology Department for CVA line insertion and bookings are made 48 hrs to one month in advance of the procedure date. When a referral is obtained potential participants will be seen by the rostered interventional radiologist/fellow on the ward or admission clinic and told about the study. If they are interested in participating they will be given a participant information and consent form, some time to study it, and then some opportunity to ask questions of the investigators. Potential participants will be asked about their understanding of the study. Study participant consent will be obtained by the study coordinator or procedural radiologist. Procedural consent will be obtained by the radiologist.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
As this is a small pilot study (in preparation for a larger RCT), there will be no randomisation
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Small non-blinded non-randomised pilot study
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
10 patients will be enrolled in the study.
Primary and secondary endpoints will be assessed to prove safety and efficacy before a larger RCT is designed.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
15/12/2014
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
10
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 3154 0
The Alfred - Prahran
Recruitment postcode(s) [1] 8933 0
3181 - Prahran

Funding & Sponsors
Funding source category [1] 290265 0
Self funded/Unfunded
Name [1] 290265 0
N/A
Country [1] 290265 0
Primary sponsor type
Hospital
Name
Alfred Hospital
Address
Commercial Road,
Prahran 3181
Victoria
Country
Australia
Secondary sponsor category [1] 288971 0
None
Name [1] 288971 0
N/A
Address [1] 288971 0
N/A
Country [1] 288971 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 291961 0
Alfred Hospital Human Research and Ethics Committee
Ethics committee address [1] 291961 0
Commercial Road,
Prahran 3181
Victoria
Ethics committee country [1] 291961 0
Australia
Date submitted for ethics approval [1] 291961 0
29/09/2014
Approval date [1] 291961 0
06/11/2014
Ethics approval number [1] 291961 0
376/14

Summary
Brief summary
Diagnostic and therapeutic procedures performed in interventional radiology can provoke anxiety and may be painful. Mild sedation with analgesia is administered by the interventional radiologist to calm patient anxiety, reduce unwanted movements and alleviate patient discomfort.

Central line placements are common, (including Hickman line placement, tunnelled dialysis catheter placement, injectable port implantation) and intravenous sedation would typically be used for these procedures.

The most commonly used drug for sedation in radiology is midazolam, a benzodiazepine. Midazolam has a short half-life of 2-6 hrs, but very powerful anxiolytic (anti-anxiety), amnestic, hypnotic, anticonvulsant, skeletal muscle relaxant, and sedative actions. It is administered at 1 milligram per dose to the desired response, has a 2 minute onset time and duration of 45 to 60 minutes.

The most common analgesic used is fentanyl, a short acting opioid that is administered at an incremental dose of 25 micrograms and repeated every 5 minutes to a maximum dose of 100 micrograms. Its onset time is 2-3 minutes and it has a duration time of 30-60 minutes.

Midazolam and fentanyl are usually administered concurrently, with 1 milligram midazolam and 25 micrograms fentanyl being the standard single dose. Multiple doses are titrated carefully to achieve and maintain adequate sedation and alleviation of anxiety, while preserving cardio-respiratory function, protective reflexes and the ability to respond appropriately to verbal and/or tactile stimulation. Doses are given incrementally, often starting with a double dose with at least 5 minutes interval before the next dose to allow evaluation of drug effect. Oxygen saturation, blood pressure, heart rate, and respiratory rate are monitored continuously and documented every 10 minutes. Neurological response is also monitored continuously by observing the patients response to command or conversation. Reversal "antidote" agents for these medications are flumazenil and naloxone respectively.

The current practice is that the radiologist takes a history from the patient, looking for patient factors that may affect the safety and practice of sedation. These would include patient size, age, prior cardiac and respiratory disease, diabetes, renal failure, obesity, allergies, drug interactions, previous anaesthetic history, and airway issues. There will be assessment of the patient’s level of anxiety and expectation of procedural discomfort. The radiologist will then decide on the appropriateness of midazolam/fentanyl sedation, and choose an initial dose. As the procedure starts, the level of sedation is assessed, and if needed, further aliquots of midazolam/fentanyl are administered at the radiologists’ discretion.

Our hypothesis is that this practice has problems in that there is a fear of the effects of oversedation (eg low blood pressure or slower respiratory rate), and this results in many patients being undersedated. The patient may be apprehensive to ask for more sedation and thus their overall experience of the procedure is suboptimal. Based on prior evidence in the literature in other medical settings, we believe that by giving the control of sedation to the patient (within a safe dose and lockout period), that the patient is more likely to seek sedation when required and hence will be at less risk of undersedation. We expect that this will lead to an overall greater experience for the patient. The medical procedure being performed (ie insertion of a tunnelled central line) will not be affected by this study.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 52862 0
Dr Tom Snow
Address 52862 0
Alfred Hospital
Department of Radiology
Commercial Road
Prahran 3181
Victoria
Country 52862 0
Australia
Phone 52862 0
+61390762118
Fax 52862 0
Email 52862 0
t.snow@alfred.org.au
Contact person for public queries
Name 52863 0
Dr Helen Kavnoudias
Address 52863 0
Alfred Hospital
Department of Radiology
Commercial Road
Prahran 3181
Victoria
Country 52863 0
Australia
Phone 52863 0
+61390762118
Fax 52863 0
Email 52863 0
h.kavnoudias@alfred.org.au
Contact person for scientific queries
Name 52864 0
Dr Helen Kavnoudias
Address 52864 0
Alfred Hospital
Department of Radiology
Commercial Road
Prahran 3181
Victoria
Country 52864 0
Australia
Phone 52864 0
+61390762118
Fax 52864 0
Email 52864 0
h.kavnoudias@alfred.org.au

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