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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
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.
Scientific title
Testing the efficacy of Lidocaine and dexmedetomidine as an alternative to propofol for sedation in colonoscopy according to the patient satisfaction.
Secondary ID [1] 299442 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Sedation for colonoscopy 314640 0
Condition category
Condition code
Anaesthesiology 312981 312981 0 0
Anaesthetics
Oral and Gastrointestinal 313731 313731 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure
Study type
Interventional
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
Intervention code [1] 315711 0
Treatment: Drugs
Comparator / control treatment
The control group will include patients who will receive propofol intravenous infusion for sedation for colonoscopy
Control group
Active

Outcomes
Primary outcome [1] 321572 0
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
Timepoint [1] 321572 0
immediately after recovery
Secondary outcome [1] 375405 0
Heart rate
monitored by ECG monitors
Timepoint [1] 375405 0
during the procedure
Secondary outcome [2] 375406 0
Apnic attacks .
assessed by clinical observation and monitoring.
apnic attacks means ( number of times where the patient stops breathing
Timepoint [2] 375406 0
during the procedure
Secondary outcome [3] 375407 0
Pain score , assessed by the numerical pain score
Timepoint [3] 375407 0
Immediately after recovery
Secondary outcome [4] 375408 0
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.
Timepoint [4] 375408 0
time of discharge
Secondary outcome [5] 377490 0
Blood pressure
continuously monitored by non-invasive bench-top sphygmomanometer
Timepoint [5] 377490 0
throughout the procedure
Secondary outcome [6] 377491 0
oxygen saturation by the pulse-oximetry
Timepoint [6] 377491 0
throughout the procedure

Eligibility
Key inclusion criteria
All adult ASA I and II patients admitted for elective colonoscopy
Minimum age
19 Years
Maximum age
70 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients with bradycardia (heart rate < 55/min).
Patients with known allergy to. lidocaine or dexemedotimidine

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
central randomization by computer
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
28/02/2020
Actual
1/03/2020
Date of last participant enrolment
Anticipated
Actual
28/11/2020
Date of last data collection
Anticipated
Actual
15/12/2020
Sample size
Target
60
Accrual to date
Final
62
Recruitment outside Australia
Country [1] 21898 0
United Arab Emirates
State/province [1] 21898 0

Funding & Sponsors
Funding source category [1] 303991 0
Hospital
Name [1] 303991 0
NMC royal Hospital
Country [1] 303991 0
United Arab Emirates
Primary sponsor type
Hospital
Name
NMC Royal Hospital
Address
Dubai
Dubai Investment park
P.O Box: 7832
Country
United Arab Emirates
Secondary sponsor category [1] 304165 0
None
Name [1] 304165 0
Address [1] 304165 0
Country [1] 304165 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 304449 0
NMC Hospital
Ethics committee address [1] 304449 0
Ethics committee country [1] 304449 0
United Arab Emirates
Date submitted for ethics approval [1] 304449 0
15/02/2020
Approval date [1] 304449 0
25/02/2020
Ethics approval number [1] 304449 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 96982 0
Dr Tamer Hamed Ibrahim
Address 96982 0
NMC Royal Hospital
Dubai Investment Park
Dubai
P.O Box: 7832
Country 96982 0
United Arab Emirates
Phone 96982 0
+971505740809
Fax 96982 0
Email 96982 0
[email protected]
Contact person for public queries
Name 96983 0
Tamer Hamed Ibrahim
Address 96983 0
NMC Royal Hospital
Dubai Investment Park
Dubai
PO Box: 7832
Country 96983 0
United Arab Emirates
Phone 96983 0
+971505740809
Fax 96983 0
Email 96983 0
[email protected]
Contact person for scientific queries
Name 96984 0
Tamer Hamed Ibrahim
Address 96984 0
NMC Royal Hospital
Dubai Investment Park
Dubai
P.O Box: 7832
Country 96984 0
United Arab Emirates
Phone 96984 0
+971505740809
Fax 96984 0
Email 96984 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
patient data, primary and secondary outcome results
When will data be available (start and end dates)?
data will be available from 30 March 2020 till December 2020
Available to whom?
after publication results will be available to every body.
patient data will not be shared
Available for what types of analyses?
any
How or where can data be obtained?
by the primary author ([email protected])


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
5252Study protocol  [email protected]
5253Statistical 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.