Effects of Intravenous Lidocaine During Sedation for Colonoscopy.

NCT ID: NCT02784860

Last Updated: 2018-01-03

Study Results

Results pending

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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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-03-31

Study Completion Date

2016-10-31

Brief Summary

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This study assesses the benefits of continuous intravenous lidocaine administration during sedation for colonoscopy.

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)

Detailed Description

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The potential benefits of lidocaine infusion will be tested on:

* propofol consumption (primary outcome)
* intraoperative respiratory depression
* time for patient recovery
* postoperative fatigue
* postoperative pain
* postoperative cognitive dysfunction

Conditions

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Colonoscopy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

DOUBLE

Participants Caregivers

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.

Group Type ACTIVE_COMPARATOR

Lidocaine

Intervention Type DRUG

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.

Group Type PLACEBO_COMPARATOR

normal saline

Intervention Type DRUG

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

Intervention Type DRUG

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

Intervention Type DRUG

Other Intervention Names

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XYLOCAINE ; (NDA) 006488

Eligibility Criteria

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Inclusion Criteria

* colonoscopy without gastroscopy

Exclusion Criteria

* lidocaine allergy
* epilepsy
* severe heart rhythm disorders
* renal failure with creatinine clearance lower than 30ml/minute
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Liege

OTHER

Sponsor Role lead

Responsible Party

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Jean François Brichant

Professor and Chair

Responsibility Role PRINCIPAL_INVESTIGATOR

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

Site Status

Countries

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Belgium

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.

Reference Type DERIVED
PMID: 30336850 (View on PubMed)

Other Identifiers

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LIDOCOLO2016JJCF

Identifier Type: -

Identifier Source: org_study_id

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