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Trial registered on ANZCTR
Registration number
ACTRN12616001648415
Ethics application status
Approved
Date submitted
13/05/2016
Date registered
29/11/2016
Date last updated
26/03/2019
Date data sharing statement initially provided
26/03/2019
Type of registration
Prospectively registered
Titles & IDs
Public title
Does the addition of intravenous lignocaine to midazolam and fentanyl sedation for gastrointestinal endoscopy improve the quality and safety of sedation?
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Scientific title
Does the addition of intravenous lignocaine to standard sedation protocol for gastrointestinal endoscopy reduce requirements for midazolam and fentanyl, and improve the quality and safety of sedation? A randomised, double blind controlled trial.
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Secondary ID [1]
289213
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None
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Universal Trial Number (UTN)
U1111-1182-9108
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Trial acronym
InLiGIE
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
GI endoscopy
298771
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Condition category
Condition code
Anaesthesiology
298826
298826
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0
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Anaesthetics
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Patients will be randomised to an intravenous lignocaine (2%) or placebo (0.9% NaCl). Study drug will be administered as a bolus of 0.1ml/kg (2mg/kg lignocaine) by the anaesthetic researcher following initial dose of midazolam and fentanyl. Further boluses of 0.025ml/kg (0.5mg/kg lignocaine) will be given every 15mins for the duration of the procedure (approx 20 - 60 mins). The anaesthetic researcher will not be otherwise involved with the care of the patient. Midazolam and fentanyl will be titrated to effect by the gastroenterologist (blinded to study drug) throughout the procedure according to their normal practice. They will be instructed to reduce their initial dose to 50% of what they would normally give to allow for potential reduced requirements, and titrate further sedation as needed.
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Intervention code [1]
294751
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Treatment: Drugs
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Comparator / control treatment
Comparative treatment will be placebo (0.9% NaCl)
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Control group
Placebo
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Outcomes
Primary outcome [1]
298292
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Midazolam dose required. The dosage of midazolam administered will be recorded at the end of the case by the anaesthetic researcher.
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Assessment method [1]
298292
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Timepoint [1]
298292
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End of procedure
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Primary outcome [2]
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Fentanyl dose required. The dosage of fentanyl administered will be recorded at the end of the case by the anaesthetic researcher.
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Assessment method [2]
298293
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Timepoint [2]
298293
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End of procedure
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Secondary outcome [1]
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Proceduralist rated quality of sedation. At the end of the procedure the gastroenterologist will be asked to rate the quality of sedation which will then be recorded by the anaesthetic researcher. Sedation will be rated according to the following scale
1 – inadequate sedation to allow completion of procedure
2 – completion of procedure, but with significant disruption/difficulty due to patient discomfort/movement of adverse events requiring intervention
3 – completion of procedure with mild disruption/difficulty due to BOTH patient discomfort/movement and adverse events requiring intervention
4 - completion of procedure with mild disruption/difficulty due to EITHER patient discomfort/movement OR adverse events requiring intervention
5 - excellent sedation, allows completion of procedure without negative impacts from either patient discomfort/movement or adverse events requiring intervention
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Assessment method [1]
323802
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Timepoint [1]
323802
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End of procedure
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Secondary outcome [2]
323803
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Incidence of failed sedation. This will be the incidence of rating 1 on the proceduralist rated quality of sedation (inadequate sedation to allow completion of procedure).
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Assessment method [2]
323803
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Timepoint [2]
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End of procedure
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Secondary outcome [3]
323804
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Patient rated satisfaction with sedation. Patients will be asked to rate their satisfaction with the sedation prior to discharge from the unit. They will record this on a scale of 1 to 5 on a form with the explanation of the scale, 1 representing complete dissatisfaction and 5 representing complete satisfaction. No further explanation or instructions will be given. The form will later be collected by the anaesthetic researcher.
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Assessment method [3]
323804
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Timepoint [3]
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Prior to discharge
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Secondary outcome [4]
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Incidence of desaturation <92%. All patients will have oxygen administered at a rate of 4 litres per minute via nasal prongs during the procedure. The anaesthetic researcher will record whether oxygen saturations (as measured by finger probe SpO2) drop below 92% at any point during the procedure.
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Assessment method [4]
323805
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Timepoint [4]
323805
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End of procedure
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Secondary outcome [5]
323806
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Incidence of airway obstruction requiring airway support. The anaesthetic researcher will record whether intervention to relieve upper airway obstruction (jaw thrust, chin lift) by any of the treating team (nurse, gastroenterologist) was required at any point during the procedure.
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Assessment method [5]
323806
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Timepoint [5]
323806
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End of procedure
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Secondary outcome [6]
323807
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Incidence of hypotension (SBP <90mmHg, or pharmacological intervention). The anaesthetic researcher will record whether the systolic blood pressure (as measured by intermittent, automated, non invasive cuff) drops below 90mmHg, or pharmacological intervention for reduced blood pressure (metaraminol, ephedrine) was administered during the procedure.
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Assessment method [6]
323807
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Timepoint [6]
323807
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End of procedure
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Secondary outcome [7]
323808
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Incidence of bradycardia (<50bpm or pharmacological intervention). The anaesthetic researcher will record whether the heart rate (as measured by either ECG or SpO2) drops below 50bpm, or pharmacological intervention for bradycardia (atropine, ephedrine) was administered during the procedure.
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Assessment method [7]
323808
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Timepoint [7]
323808
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End of procedure
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Eligibility
Key inclusion criteria
Elective (Outpatient) GI endoscopy (diagnostic or therapeutic) under proceduralist sedation (midazolam/fentanyl)
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Minimum age
18
Years
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Maximum age
80
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
- Pregnancy
- History of significant cardiac arrhythmia or conduction delay or pacemaker
- Pre-procedure bradycardia (HR<50)
- Cardiac failure equivalent to NYHA III/IV
- COPD requiring home O2, or saturations <94% on room air
- Chronic Liver Disease/Cirrhosis
- Chronic Renal Failure
- History of epilepsy or seizure disorder
- Recent administration of fluvoxamine, verapamil or ciprofloxacin
- Cognitive impairment significant enough to preclude informed consent
- Insufficient English to enable informed consent
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 4
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Type of endpoint/s
Safety/efficacy
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Statistical methods / analysis
Student T test for normally distributed data, Mann-Whitney U test for non-parametric data. Given that data will be analysed as all cases, Upper GI and Colonoscopies sample sizes have been calculated to allow for meaningful analysis of subgroups. Data from pilot study suggests that 103 upper GI procedures and 58 colonoscopies will give 80% power to detect a 25% reduction in midazolam dose with an alpha of 0.017 (Bonferroni correction for 3 measures to 0.05). Given that the upper GI and combined to colonoscopy only case ratio was roughly 2:1 in the pilot study, the total number of cases will be 120 upper GI endoscopies (upper GI endoscopy and combined procedures) and 60 colonoscopies.
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Recruitment
Recruitment status
Withdrawn
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Reason for early stopping/withdrawal
Lack of funding/staff/facilities
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Date of first participant enrolment
Anticipated
3/07/2017
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Actual
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Date of last participant enrolment
Anticipated
1/01/2018
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Actual
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Date of last data collection
Anticipated
1/01/2018
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Actual
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Sample size
Target
180
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
WA
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Recruitment hospital [1]
5797
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Sir Charles Gairdner Hospital - Nedlands
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Recruitment postcode(s) [1]
13240
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6009 - Nedlands
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Funding & Sponsors
Funding source category [1]
293595
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Hospital
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Name [1]
293595
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Sir Charles Gairdner Hospital
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Address [1]
293595
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Sir Charles Gairdner Hospital, Hospital Ave, Nedlands, WA 6009
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Country [1]
293595
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Australia
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Primary sponsor type
Individual
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Name
Daniel Ellyard
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Address
Sir Charles Gairdner Hospital, Hospital Ave, Nedlands WA 6009
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Country
Australia
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Secondary sponsor category [1]
292410
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None
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Name [1]
292410
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Address [1]
292410
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Country [1]
292410
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
295035
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Sir Charles Gairdner Hospital HREC
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Ethics committee address [1]
295035
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Sir Charles Gairdner Hospital, Hospital Ave, Nedlands 6009
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Ethics committee country [1]
295035
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Australia
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Date submitted for ethics approval [1]
295035
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20/05/2016
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Approval date [1]
295035
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27/07/2016
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Ethics approval number [1]
295035
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Summary
Brief summary
Sedation and analgesia during GI endoscopy under proceduralist guided sedation is limited by the dose dependent adverse effect profile of midazolam and fentanyl. Quality of sedation and patient comfort must be balanced against adverse effects such as respiratory depression, airway obstruction, and loss of verbal response. Intravenous lignocaine possesses a different side effect profile, with less sedative and respiratory effects. The airway reflex suppressive and analgesic properties of intravenous lignocaine may allow a reduction in the required dose of fentanyl and/or midazolam, limiting the incidence of clinically relevant adverse events (multimodal sedation) and allowing an improved quality of sedation. Intravenous lignocaine has shown to provide significant postoperative analgesia in open and laparoscopic abdominal surgery, with improved pain, reduced opioid requirements and improved quality of recovery. It has also been shown to improve tolerability of instrumentation of the upper airway, with improved haemodynamic following laryngoscopy and intubation, as well as decreased rates of coughing, gagging and laryngospasm with LMA insertion. The objective of this trial is to assess whether the addition of intravenous lignocaine as to standard sedation protocol reduces midazolam/fentanyl requirements, improves the quality of sedation and decreases adverse events in patients undergoing GI endoscopy. The trial will be a randomised, double-blind, placebo controlled trial. Patients will be stratified into those undergoing upper GI endoscopy, colonoscopy or both. Patients will be randomised to a loading bolus of 2mg/kg lignocaine or saline, at commencement of sedation, with further 0.5mg/kg lignocaine or saline boluses ever 15 mins for the duration of the procedure. Primary outcome will be midazolam/fentanyl dose. Secondary outcomes will be proceduralist rated quality of sedation, patient satisfaction with sedation, incidence of bradycardia, hypotension, desaturations, airway support and sedation failure.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Dr Daniel Ellyard
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Address
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Department of Anaesthesia, Sir Charles Gairdner Hospital, Hospital Ave, Nedlands WA 6009
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Country
65854
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Australia
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Phone
65854
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+61 8 9346 3333
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Fax
65854
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Email
65854
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[email protected]
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Contact person for public queries
Name
65855
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Daniel Ellyard
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Address
65855
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Department of Anaesthesia, Sir Charles Gairdner Hospital, Hospital Ave, Nedlands WA 6009
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Country
65855
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Australia
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Phone
65855
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+61 8 9346 3333
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Fax
65855
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Email
65855
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[email protected]
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Contact person for scientific queries
Name
65856
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Daniel Ellyard
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Address
65856
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Department of Anaesthesia, Sir Charles Gairdner Hospital, Hospital Ave, Nedlands WA 6009
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Country
65856
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Australia
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Phone
65856
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+61 8 9346 3333
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Fax
65856
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Email
65856
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[email protected]
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Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
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No/undecided IPD sharing reason/comment
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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.
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