Effects of Intravenous Lidocaine During Sedation for Colonoscopy.
NCT ID: NCT02784860
Last Updated: 2018-01-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
40 participants
INTERVENTIONAL
2016-03-31
2016-10-31
Brief Summary
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Sedation will consist of propofol infusion titrated to provide adequate working conditions to the gastroenterologist. Patients will be randomly allocated into two groups: lidocaine infusion (bolus of 1.5 mg/kg followed by a continuous infusion of 4 mg/kg/h) or the same volume of placebo (normal saline)
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Detailed Description
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* propofol consumption (primary outcome)
* intraoperative respiratory depression
* time for patient recovery
* postoperative fatigue
* postoperative pain
* postoperative cognitive dysfunction
Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
DOUBLE
Study Groups
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Lidocaine
Lidocaine. Administration of lidocaine is started with 1.5 mg/kg bolus injection followed by a continuous infusion of 4mg/kg/h.
Lidocaine
Propofol (0.5 mg/kg or more) is titrated to provide loss of consciousness. Then in the lidocaine group, lidocaine 2% is administered as a bolus followed by a continuous intravenous infusion after loss of consciousness
Placebo
Placebo Administration of normal saline: same volume of saline as lidocaine.
normal saline
Propofol (0.5 mg/kg or more) is titrated to provide loss of consciousness. Then in the placebo group, the same volume of normal saline is administered after loss of consciousness
Interventions
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Lidocaine
Propofol (0.5 mg/kg or more) is titrated to provide loss of consciousness. Then in the lidocaine group, lidocaine 2% is administered as a bolus followed by a continuous intravenous infusion after loss of consciousness
normal saline
Propofol (0.5 mg/kg or more) is titrated to provide loss of consciousness. Then in the placebo group, the same volume of normal saline is administered after loss of consciousness
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* epilepsy
* severe heart rhythm disorders
* renal failure with creatinine clearance lower than 30ml/minute
18 Years
70 Years
ALL
Yes
Sponsors
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University of Liege
OTHER
Responsible Party
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Jean François Brichant
Professor and Chair
Principal Investigators
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Jean Joris, MD
Role: PRINCIPAL_INVESTIGATOR
University of Liege
Locations
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University Hospital of Liege
Liège, , Belgium
Countries
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References
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Forster C, Vanhaudenhuyse A, Gast P, Louis E, Hick G, Brichant JF, Joris J. Intravenous infusion of lidocaine significantly reduces propofol dose for colonoscopy: a randomised placebo-controlled study. Br J Anaesth. 2018 Nov;121(5):1059-1064. doi: 10.1016/j.bja.2018.06.019. Epub 2018 Aug 1.
Other Identifiers
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LIDOCOLO2016JJCF
Identifier Type: -
Identifier Source: org_study_id
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