Clinical trial NCT05944887: Intravenous Lidocaine to Reduce Propofol Consumption During Gastroscopy.
Official title: Does Intravenous Lidocaine Reduce Propofol Consumption and the Side Effects of Sedation During Gastroscopy in ASA 1 and 2 Patients.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diagnostic Gastroscopy
Lead sponsor: Erasme University Hospital
Sponsor class: OTHER
First posted: 2023-07-13
Enrollment: 46
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief 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


Eligibility criteria: 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

Primary outcomes:
measure: total propofol dose in milligramme
timeFrame: procedure (from the beginning of propofol infusion until arrival of the gastroscope in the stomach)
measure: total propofol dose in milligramme
timeFrame: Procedure (from the beginning of propofol infusion until endoscope removal)
measure: propofol in site effet concentration in microgram per milliliter
timeFrame: procedure (from the beginning of propofol infusion until arrival of the gastroscope in the stomach)
measure: propofol in site effet concentration in microgram per milliliter
timeFrame: Procedure (from the beginning of propofol infusion until endoscope removal)
Secondary outcomes:
measure: number of participants with moderate hypoxemia
timeFrame: Procedure (during propofol sedation and gastroscopy)
measure: number of participants with hypotension
timeFrame: Procedure (during propofol sedation and gastroscopy)
measure: number of participants with severe hypoxemia
timeFrame: Procedure (during propofol sedation and gastroscopy)
measure: number of participants presenting cough
timeFrame: Procedure (during propofol sedation and gastroscopy)
measure: number of participants presenting laryngospasm
timeFrame: Procedure (during propofol sedation and gastroscopy)
measure: number of participants presenting involuntary movements
timeFrame: Procedure (during propofol sedation and gastroscopy)
measure: number of participants presenting side effects of lidocaine administration
timeFrame: during gastroscopy procedure
measure: score of Endoscopist satisfaction (1-5)
timeFrame: completed procedure (before transfer to recovery room)
measure: score of Patient satisfaction (1-5)
timeFrame: at recovery room discharge, an average of 1 hour after completed procedure
measure: throat pain
timeFrame: at recovery room discharge, an average of 1 hour after completed procedure
Other outcomes:
Locations:
city: Brussel
country: Belgium
facility: Erasme Hospital
Study officials:
affiliation: Erasme University Hospital
name: celine Boudart, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.