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Clinical trial

Does Intravenous Lidocaine Reduce ED 50 for Propofol Administered Using Target Controlled Infusion (TCI) During Gastroscopy in ASA 1 and 2 Patients.

ID
Name
SRB2023309
Description
The goal of this prospective, interventionnal clinical trial is to assess if intravenous administration of linisol reduce the ED50 of propofol when administered using Target Controlled Infusion (TCI) 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.
Trial arms
Trial start
2024-04-08
Estimated PCD
2024-08-31
Trial end
2024-08-31
Status
Recruiting
Treatment
Lidocaine 2% Injectable Solution
administration of a bolus of lidocaine 1.5 mg/kg
Arms:
Linisol
Saline administration as placebo
administration of a bolus of saline solution as a placebo
Arms:
Control
Other names:
administration of a bolus of saline solution as a placebo
Propofol injection
Sedation by total intravenous administration (TIVA) of propofol using target controlled infusion (TCI)
Arms:
Control, Linisol
gastroscopy
esogastroduodenoscopy
Arms:
Control, Linisol
Size
50
Primary endpoint
ED50 of propofol
gastroscope introduction
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
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'SUPPORTIVE_CARE', 'maskingInfo': {'masking': 'QUADRUPLE', 'maskingDescription': 'computered randomisation, sealed enveloppes linisol versus placebo prepared by anesthesist not involved in the study or in patient care', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 50, 'type': 'ESTIMATED'}}
Updated at
2024-04-24

1 organization

3 products

1 indication

Organization
Erasme University Hospital
Product
Lidocaine 2% Injectable Solution
Indication
Diagnostic Gastroscopy
Product
Saline
Product
Propofol