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CompletedNCT05944887Updated Sep 18, 2023

Intravenous Lidocaine to Reduce Propofol Consumption During Gastroscopy.

An interventional study of Lidocaine 2% Injectable Solution and Saline administration as placebo in Diagnostic Gastroscopy, sponsored by Erasme University Hospital. Completed at 1 site in Belgium. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2023-09-18.

Sponsored by Erasme University Hospital · Not applicable, Interventional, and Supportive care

Phase
Not applicable
Study type
Interventional
Enrollment
46
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study summary

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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Conditions studied

  • Diagnostic Gastroscopy
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In context

Lead sponsor

Erasme University Hospital is the lead sponsor of 180 studies on the registry; 34 are open to participants now.

Browse Erasme University Hospital studies →

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
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Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
46 participants (actual)

Study arms

  • Active comparator
    Linisol

    Patients will receive 1.5 mg/kg of intravenous linisol before propofol sedatation and gastroscope introduction

    Drug: Lidocaine 2% Injectable Solution · Drug: Propofol injection · Procedure: gastroscopy

  • Placebo comparator
    Sham

    Patients will receive intravenous placebo (saline solution),before propofol sedation and gastroscope introduction

    Drug: Saline administration as placebo · Drug: Propofol injection · Procedure: gastroscopy

Interventions

  • DrugLidocaine 2% Injectable Solution

    administration of a bolus of lidocaine 1.5 mg/kg

  • DrugSaline administration as placebo

    administration of a bolus of saline solution as a placebo

  • DrugPropofol injection

    Sedation by total intravenous administration (TIVA) of propofol

  • Proceduregastroscopy

    esogastroduodenoscopy

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What researchers measure

Primary outcomes

  1. total propofol dose in milligramme

    total propofol dose consumed

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

  2. total propofol dose in milligramme

    total propofol dose consumed

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

  3. propofol in site effet concentration in microgram per milliliter

    AIVOC : Effect concentration of propofol

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

  4. propofol in site effet concentration in microgram per milliliter

    AIVOC : Effect concentration of propofol

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

Secondary outcomes

  1. number of participants with moderate hypoxemia

    pulse saturation below 95%

    Time frame: Procedure (during propofol sedation and gastroscopy)

  2. number of participants with hypotension

    mean arterial pressure below 65 mmHg

    Time frame: Procedure (during propofol sedation and gastroscopy)

  3. number of participants with severe hypoxemia

    pulse saturation below 90%

    Time frame: Procedure (during propofol sedation and gastroscopy)

  4. number of participants presenting cough

    cough suggesting to light sedation

    Time frame: Procedure (during propofol sedation and gastroscopy)

  5. number of participants presenting laryngospasm

    laryngospasm suggesting to light sedation

    Time frame: Procedure (during propofol sedation and gastroscopy)

  6. number of participants presenting involuntary movements

    involuntary movements suggesting to light sedation

    Time frame: Procedure (during propofol sedation and gastroscopy)

  7. number of participants presenting side effects of lidocaine administration

    metallic taste, tinnitus, anaphylaxis

    Time frame: during gastroscopy procedure

  8. score of Endoscopist satisfaction (1-5)

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

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

  9. score of Patient satisfaction (1-5)

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

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

  10. throat pain

    analog digital scale from 1 to 10

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

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Study locations

1 site
  • Erasme Hospital
    Brussels, 1070, Belgium
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References and documents

Publications

  • Qi XR, Sun JY, An LX, Zhang K, Xue FS. Effects of intravenous lidocaine on hypoxemia induced by propofol-based sedation for gastrointestinal endoscopy procedures: study protocol for a prospective, randomized, controlled trial. Trials. 2022 Sep 24;23(1):800. doi: 10.1186/s13063-022-06719-6. PubMed 36153625 ↗
  • Qi XR, Sun JY, An LX, Zhang K. Effect of intravenous lidocaine on the ED50 of propofol for inserting gastroscope without body movement in adult patients: a randomized, controlled study. BMC Anesthesiol. 2022 Oct 17;22(1):319. doi: 10.1186/s12871-022-01861-9. PubMed 36253717 ↗
  • Hu S, Wang M, Li S, Zhou W, Zhang Y, Shi H, Ye P, Sun J, Liu F, Zhang W, Zheng L, Hou Q, Wang Y, Sun W, Chen Y, Lu Z, Ji Z, Liao L, Lv X, Wang Y, Wang X, Yang H. Intravenous Lidocaine Significantly Reduces the Propofol Dose in Elderly Patients Undergoing Gastroscopy: A Randomized Controlled Trial. Drug Des Devel Ther. 2022 Aug 12;16:2695-2705. doi: 10.2147/DDDT.S377237. eCollection 2022. PubMed 35983429 ↗

Individual participant data

Plan to share: Yes

Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Clinical study report, Analytic code

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 18, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05944887
Lead sponsor
Erasme University Hospital
Responsible party
Omar Assam (principal investigator, Erasme University Hospital) — Principal investigator
First posted
Jul 13, 2023
Start date
Jul 21, 2023
Primary completion
Aug 21, 2023
Completion
Aug 25, 2023
Last update
Sep 18, 2023

Study contacts

celine Boudart, MD PhD
principal investigator · Erasme University Hospital

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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Studies of the drug tested here: Lidocaine

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