Effects of Intravenous Lidocaine During Sedation for Colonoscopy.

December 29, 2017 updated by: Jean François Brichant, University of Liege

Investigation of the Effects of Intravenous Lidocaine Infusion During Sedation for Colonoscopy

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)

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Liege, Belgium, 4000
        • University Hospital of Liege

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • colonoscopy without gastroscopy

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Lidocaine
Lidocaine. Administration of lidocaine is started with 1.5 mg/kg bolus injection followed by a continuous infusion of 4mg/kg/h.
Drug: 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
Other Names:
  • XYLOCAINE ; (NDA) 006488
Placebo Comparator: Placebo
Placebo Administration of normal saline: same volume of saline as lidocaine.
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Consumption of propofol
Time Frame: intraoperative
Dose of propofol administered during sedation if measured at the end of it.
intraoperative

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Episodes of oxygen desaturation
Time Frame: intraoperative
Episodes of oxygen desaturation: SpO2 < 95 and 90%
intraoperative
Time for recovery
Time Frame: intraoperative
the patient is discharged when conscious and able to give his birth date
intraoperative
Quality of working conditions assessed by the gastroenterologist
Time Frame: intraoperative
intraoperative
Abdominal discomfort
Time Frame: intraoperative and 15 minutes later
Evaluation with VAS (visual analog scale) form 0 (no discomfort) to 10 (unbearable Abdominal discomfort assessed on a 0 to 10 visual analog scale
intraoperative and 15 minutes later
Postoperative fatigue
Time Frame: 15 min after sedation
Fatigue will be assessed on a visual analog scale
15 min after sedation
Cognitive condition
Time Frame: 15 minutes after sedation
Cognitive condition will be evaluated with the MMSE (Minimal Mental State Examination)
15 minutes after sedation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Liege

Investigators

  • Principal Investigator: Jean Joris, MD, University of Liège

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2016

Primary Completion (Actual)

September 1, 2016

Study Completion (Actual)

October 1, 2016

Study Registration Dates

First Submitted

May 2, 2016

First Submitted That Met QC Criteria

May 26, 2016

First Posted (Estimate)

May 27, 2016

Study Record Updates

Last Update Posted (Actual)

January 3, 2018

Last Update Submitted That Met QC Criteria

December 29, 2017

Last Verified

December 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LIDOCOLO2016JJCF

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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