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OpenTrials
Completed

NCT Number: NCT05944887

Intravenous Lidocaine to Reduce Propofol Consumption During Gastroscopy.

The goal of this clinical trial is to assess if intravenous administration of linisol reduce the propofol consumption and the sides effects of sedation during gastroscopy in healthy patients (ASA 1 and 2 patients).

Prior to propofol sedation, participants will receive either an intravenous bolus of linisol (1.5 mg/kg) = treated group or placebo = control group.

After the gastroscopy, patients will be asked to complete a satisfaction questionnaire

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Key information

Conditions

Diagnostic Gastroscopy

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Erasme Hospital

Brussels, 1070, Belgium

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients scheduled for gastroscopy under narcosis and who have signed the consent.
  • ASA score: 1 and 2
  • BMI between 18 and 30 kg/m2

Exclusion criteria

  • Lidocaine allergy
  • Anesthesia within the last 7 days
  • Use of local anesthesia in the last 24 hours
  • Rhythm disorder or HR <50
  • Pregnant women and breastfeeding
  • Participation in another clinical study in the last months
  • Cannot understand VAS score or French
  • Severe central nervous disease and mental illness.
  • obstructive sleep apnea (known or STOP BANG score >5)
  • Upper lung infection.
  • Liver or kidney function disorder

Treatment and study plan

Lidocaine 2% Injectable Solution

Drug

administration of a bolus of lidocaine 1.5 mg/kg

Saline administration as placebo

Drug

administration of a bolus of saline solution as a placebo

Propofol Injection

Drug

Sedation by total intravenous administration (TIVA) of propofol

gastroscopy

Procedure

esogastroduodenoscopy

Primary outcomes

  1. total propofol dose in milligramme

    Time frame: procedure (from the beginning of propofol infusion until arrival of the gastroscope in the stomach)

    total propofol dose consumed

  2. total propofol dose in milligramme

    Time frame: Procedure (from the beginning of propofol infusion until endoscope removal)

    total propofol dose consumed

  3. propofol in site effet concentration in microgram per milliliter

    Time frame: procedure (from the beginning of propofol infusion until arrival of the gastroscope in the stomach)

    AIVOC : Effect concentration of propofol

  4. propofol in site effet concentration in microgram per milliliter

    Time frame: Procedure (from the beginning of propofol infusion until endoscope removal)

    AIVOC : Effect concentration of propofol

Secondary outcomes

  1. number of participants with moderate hypoxemia

    Time frame: Procedure (during propofol sedation and gastroscopy)

    pulse saturation below 95%

  2. number of participants with hypotension

    Time frame: Procedure (during propofol sedation and gastroscopy)

    mean arterial pressure below 65 mmHg

  3. number of participants with severe hypoxemia

    Time frame: Procedure (during propofol sedation and gastroscopy)

    pulse saturation below 90%

  4. number of participants presenting cough

    Time frame: Procedure (during propofol sedation and gastroscopy)

    cough suggesting to light sedation

  5. number of participants presenting laryngospasm

    Time frame: Procedure (during propofol sedation and gastroscopy)

    laryngospasm suggesting to light sedation

  6. number of participants presenting involuntary movements

    Time frame: Procedure (during propofol sedation and gastroscopy)

    involuntary movements suggesting to light sedation

  7. number of participants presenting side effects of lidocaine administration

    Time frame: during gastroscopy procedure

    metallic taste, tinnitus, anaphylaxis

  8. score of Endoscopist satisfaction (1-5)

    Time frame: completed procedure (before transfer to recovery room)

    Endoscopist satisfaction :1 = very bad; 2=bas; 3=good; 4=very good; 5= excellent

  9. score of Patient satisfaction (1-5)

    Time frame: at recovery room discharge, an average of 1 hour after completed procedure

    Patient satisfaction :1 = very bad; 2=bas; 3=good; 4=very good; 5= excellent

  10. throat pain

    Time frame: at recovery room discharge, an average of 1 hour after completed procedure

    analog digital scale from 1 to 10

Sponsors and collaborators

Lead sponsor

Erasme University Hospital

Other

Registry information

Official study title

Does Intravenous Lidocaine Reduce Propofol Consumption and the Side Effects of Sedation During Gastroscopy in ASA 1 and 2 Patients.

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Jul 13, 2023
Registry last updated
Sep 18, 2023

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.