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Completed

NCT Number: NCT02784860

Effects of Intravenous Lidocaine 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)

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Key information

Conditions

Colonoscopy

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

University Hospital of Liege

Liège, 4000, Belgium

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • colonoscopy without gastroscopy

Exclusion criteria

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

Treatment and study plan

Lidocaine

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

Other names: XYLOCAINE ; (NDA) 006488

normal saline

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

Primary outcomes

  1. Consumption of propofol

    Time frame: intraoperative

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

Secondary outcomes

  1. Episodes of oxygen desaturation

    Time frame: intraoperative

    Episodes of oxygen desaturation: SpO2 < 95 and 90%

  2. Time for recovery

    Time frame: intraoperative

    the patient is discharged when conscious and able to give his birth date

  3. Quality of working conditions assessed by the gastroenterologist

    Time frame: intraoperative

  4. 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

  5. Postoperative fatigue

    Time frame: 15 min after sedation

    Fatigue will be assessed on a visual analog scale

  6. Cognitive condition

    Time frame: 15 minutes after sedation

    Cognitive condition will be evaluated with the MMSE (Minimal Mental State Examination)

Sponsors and collaborators

Lead sponsor

University of Liege

Other

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
May 27, 2016
Registry last updated
Jan 3, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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