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Effect of intravenous Lidocaine bolus on the median effective concentration (EC50) of Propofol during target controlled infusion (TCI : Schnider model) for gastroscopy in adult patients : a prospective, randomized, double-blinded study

Status
Not yet recruiting
Phases
Phase 4
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2023-509888-24-00
Enrollment
50
Registered
2024-03-25
Start date
Unknown
Completion date
Unknown
Last updated
2024-03-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gastroscopy

Brief summary

estimated EC50 of propofol for gastroscope introduction without movements

Detailed description

number of participants with moderate hypoxemia (pulse saturation below 95%) during propofol sedation and gastroscopy, number of participants with hypotension (mean arterial pressure below 65 mmHg) during propofol sedation and gastroscopy, number of participants presenting cough cough suggesting to light sedation during propofol sedation and gastroscopy, number of participants presenting laryngospasm laryngospasm suggesting to light sedation during propofol sedation and gastroscopy, number of participants presenting involuntary movements involuntary movements suggesting to light sedation during propofol sedation and gastroscopy, number of participants presenting side effects of lidocaine administration metallic taste, tinnitus, anaphylaxis, score of Endoscopist satisfaction (1-5) after completion of the procedure (Endoscopist satisfaction :1 = very bad; 2=bas; 3=good; 4=very good; 5= excellent), score of Patient satisfaction (1-5) 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) ], throat pain (analog digital scale from 1 to 10) at recovery room discharge, an average of 1 hour after completed procedure, Time to anesthesia recover : Time between stopping Propofol and recovering a MOAA/S score ≥ 4, Time for post anesthesic care unit discharge

Interventions

DRUGNaCl 0
DRUGsolution injectable
DRUGPropofol B. Braun 1 % (10 mg/ml)
DRUGLinisol 2 %

Sponsors

Hopital Erasme
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
18 Years to 64 Years

Design outcomes

Primary

MeasureTime frame
estimated EC50 of propofol for gastroscope introduction without movements

Secondary

MeasureTime frame
number of participants with moderate hypoxemia (pulse saturation below 95%) during propofol sedation and gastroscopy, number of participants with hypotension (mean arterial pressure below 65 mmHg) during propofol sedation and gastroscopy, number of participants presenting cough cough suggesting to light sedation during propofol sedation and gastroscopy, number of participants presenting laryngospasm laryngospasm suggesting to light sedation during propofol sedation and gastroscopy, number of participants presenting involuntary movements involuntary movements suggesting to light sedation during propofol sedation and gastroscopy, number of participants presenting side effects of lidocaine administration metallic taste, tinnitus, anaphylaxis, score of Endoscopist satisfaction (1-5) after completion of the procedure (Endoscopist satisfaction :1 = very bad; 2=bas; 3=good; 4=very good; 5= excellent), score of Patient satisfaction (1-5) at recovery room discharge, an average of 1 hour after c

Countries

Belgium

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026