NCT02784860

Brief Summary

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)

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Mar 2016

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2016

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

May 2, 2016

Completed
25 days until next milestone

First Posted

Study publicly available on registry

May 27, 2016

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2016

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2016

Completed
Last Updated

January 3, 2018

Status Verified

December 1, 2017

Enrollment Period

6 months

First QC Date

May 2, 2016

Last Update Submit

December 29, 2017

Conditions

Colonoscopy

Keywords

colonoscopylidocainepropofolsedation

Outcome Measures

Primary Outcomes (1)

  • Consumption of propofol

    Dose of propofol administered during sedation if measured at the end of it.

    intraoperative

Secondary Outcomes (6)

  • Episodes of oxygen desaturation

    intraoperative

  • Time for recovery

    intraoperative

  • Quality of working conditions assessed by the gastroenterologist

    intraoperative

  • Abdominal discomfort

    intraoperative and 15 minutes later

  • Postoperative fatigue

    15 min after sedation

  • +1 more secondary outcomes

Study Arms (2)

Lidocaine

ACTIVE COMPARATOR

Lidocaine. Administration of lidocaine is started with 1.5 mg/kg bolus injection followed by a continuous infusion of 4mg/kg/h.

Drug: Lidocaine

Placebo

PLACEBO COMPARATOR

Placebo Administration of normal saline: same volume of saline as lidocaine.

Drug: normal saline

Interventions

LidocaineDRUG

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

Also known as: XYLOCAINE ; (NDA) 006488
Lidocaine
normal salineDRUG

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

Placebo

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • colonoscopy without gastroscopy

You may not qualify if:

  • lidocaine allergy
  • epilepsy
  • severe heart rhythm disorders
  • renal failure with creatinine clearance lower than 30ml/minute

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital of Liege

Liège, 4000, Belgium

Location

Related Publications (1)

  • 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.

    PMID: 30336850DERIVED

MeSH Terms

Interventions

LidocaineSaline Solution

Intervention Hierarchy (Ancestors)

AcetanilidesAnilidesAmidesOrganic ChemicalsAniline CompoundsAminesCrystalloid SolutionsIsotonic SolutionsSolutionsPharmaceutical Preparations

Study Officials

  • Jean Joris, MD

    University of Liege

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor and Chair

Study Record Dates

First Submitted

May 2, 2016

First Posted

May 27, 2016

Study Start

March 1, 2016

Primary Completion

September 1, 2016

Study Completion

October 1, 2016

Last Updated

January 3, 2018

Record last verified: 2017-12

Data Sharing

IPD Sharing
Will not share

Locations

BE(1)