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Trial registered on ANZCTR
Registration number
ACTRN12620000249954
Ethics application status
Approved
Date submitted
8/10/2019
Date registered
26/02/2020
Date last updated
1/07/2021
Date data sharing statement initially provided
26/02/2020
Date results information initially provided
1/07/2021
Type of registration
Prospectively registered
Titles & IDs
Public title
Studying the efficacy of using lidocaine and dexmedetomidine as an alternative to propofol to provide sedation for patients undergoing colonoscopy.
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Scientific title
Testing the efficacy of Lidocaine and dexmedetomidine as an alternative to propofol for sedation in colonoscopy according to the patient satisfaction.
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Secondary ID [1]
299442
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None
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Sedation for colonoscopy
314640
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Condition category
Condition code
Anaesthesiology
312981
312981
0
0
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Anaesthetics
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Oral and Gastrointestinal
313731
313731
0
0
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Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Patients scheduled for colonoscopy will be devided into two groups to receive either sedation by propofol infusion or by combined dexmedetomidine and lidocaine.
(A) propofol infusion at dose 25-75 ug/kg/min, Lidocaine infusion 1-2 mg/kg/hour and Dexmedetomidine infusion 0.2-0.5 ug/kg/min, all the infusions will start just before the beginning of the procedure.
(B) Drugs will be administered all-through the duration of the procedure
(C) Drugs will be administered by intravenous infusion
(D) The primary anesthesiologist ( the anesthesiologist who planned the methodology ) will be responsible for administration.
(E) The group who will receive lidocaine and Dexmedetomidine will be the intervention group
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Intervention code [1]
315711
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Treatment: Drugs
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Comparator / control treatment
The control group will include patients who will receive propofol intravenous infusion for sedation for colonoscopy
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Control group
Active
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Outcomes
Primary outcome [1]
321572
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patient satisfaction by the procedure and sedation.
It will be assessed by a scale from 0 to 10 where 0 means not at all satisfied and 10 means maximally satisfied.
patient will be asked to give the scale score once he/she is fully awake.
Patient satisfaction is a composite primary outcome
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Assessment method [1]
321572
0
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Timepoint [1]
321572
0
immediately after recovery
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Secondary outcome [1]
375405
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Heart rate
monitored by ECG monitors
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Assessment method [1]
375405
0
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Timepoint [1]
375405
0
during the procedure
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Secondary outcome [2]
375406
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Apnic attacks .
assessed by clinical observation and monitoring.
apnic attacks means ( number of times where the patient stops breathing
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Assessment method [2]
375406
0
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Timepoint [2]
375406
0
during the procedure
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Secondary outcome [3]
375407
0
Pain score , assessed by the numerical pain score
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Assessment method [3]
375407
0
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Timepoint [3]
375407
0
Immediately after recovery
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Secondary outcome [4]
375408
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time to discharge to home which will be known from the doctor order for discharge and the data will be collected from the medical records.
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Assessment method [4]
375408
0
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Timepoint [4]
375408
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time of discharge
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Secondary outcome [5]
377490
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Blood pressure
continuously monitored by non-invasive bench-top sphygmomanometer
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Assessment method [5]
377490
0
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Timepoint [5]
377490
0
throughout the procedure
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Secondary outcome [6]
377491
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oxygen saturation by the pulse-oximetry
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Assessment method [6]
377491
0
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Timepoint [6]
377491
0
throughout the procedure
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Eligibility
Key inclusion criteria
All adult ASA I and II patients admitted for elective colonoscopy
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Minimum age
19
Years
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Maximum age
70
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
Patients with bradycardia (heart rate < 55/min).
Patients with known allergy to. lidocaine or dexemedotimidine
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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)
central randomization by computer
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software
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Masking / blinding
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Who is / are masked / blinded?
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Intervention assignment
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Date of first participant enrolment
Anticipated
28/02/2020
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Actual
1/03/2020
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Date of last participant enrolment
Anticipated
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Actual
28/11/2020
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Date of last data collection
Anticipated
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Actual
15/12/2020
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Sample size
Target
60
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Accrual to date
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Final
62
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Recruitment outside Australia
Country [1]
21898
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United Arab Emirates
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State/province [1]
21898
0
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Funding & Sponsors
Funding source category [1]
303991
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Hospital
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Name [1]
303991
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NMC royal Hospital
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Address [1]
303991
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NMC Royal Hospital
Dubai Investment park
P.O Box: 7832- Dubai
United Arab Of emirates
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Country [1]
303991
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United Arab Emirates
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Primary sponsor type
Hospital
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Name
NMC Royal Hospital
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Address
Dubai
Dubai Investment park
P.O Box: 7832
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Country
United Arab Emirates
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Secondary sponsor category [1]
304165
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None
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Name [1]
304165
0
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Address [1]
304165
0
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Country [1]
304165
0
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
304449
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NMC Hospital
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Ethics committee address [1]
304449
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Dubai
Dubai Investment park
P.O Box: 7832
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Ethics committee country [1]
304449
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United Arab Emirates
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Date submitted for ethics approval [1]
304449
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15/02/2020
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Approval date [1]
304449
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25/02/2020
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Ethics approval number [1]
304449
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Summary
Brief summary
Colonoscopy is one of the most common day case procedures allover the world. Propofol has been the gold standard drug used for sedation and anesthesia for such cases.
In our trial we will examine the efficacy of using dexmedetomidine and lidocaine infusion as an alternative to propofol infusion in such cases
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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
96982
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Dr Tamer Hamed Ibrahim
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Address
96982
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NMC Royal Hospital
Dubai Investment Park
Dubai
P.O Box: 7832
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Country
96982
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United Arab Emirates
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Phone
96982
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+971505740809
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Fax
96982
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Email
96982
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[email protected]
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Contact person for public queries
Name
96983
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Dr Tamer Hamed Ibrahim
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Address
96983
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NMC Royal Hospital
Dubai Investment Park
Dubai
PO Box: 7832
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Country
96983
0
United Arab Emirates
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Phone
96983
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+971505740809
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Fax
96983
0
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Email
96983
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[email protected]
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Contact person for scientific queries
Name
96984
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Dr Tamer Hamed Ibrahim
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Address
96984
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NMC Royal Hospital
Dubai Investment Park
Dubai
P.O Box: 7832
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Country
96984
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United Arab Emirates
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Phone
96984
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+971505740809
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Fax
96984
0
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Email
96984
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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)?
Yes
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What data in particular will be shared?
patient data, primary and secondary outcome results
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When will data be available (start and end dates)?
data will be available from 30 March 2020 till December 2020
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Available to whom?
after publication results will be available to every body.
patient data will not be shared
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Available for what types of analyses?
any
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How or where can data be obtained?
by the primary author (
[email protected]
)
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What supporting documents are/will be available?
No Supporting Document Provided
Doc. No.
Type
Citation
Link
Email
Other Details
Attachment
5252
Study protocol
[email protected]
5253
Statistical analysis plan
[email protected]
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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