Diagnostic Gastroscopy
Conditions
Brief summary
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.
Interventions
administration of a bolus of lidocaine 1.5 mg/kg
administration of a bolus of saline solution as a placebo
Sedation by total intravenous administration (TIVA) of propofol using target controlled infusion (TCI)
PROCEDUREgastroscopy
esogastroduodenoscopy
Sponsors
Erasme University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
computered randomisation, sealed enveloppes linisol versus placebo prepared by anesthesist not involved in the study or in patient care
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| ED50 of propofol | gastroscope introduction | ED50 of propofol for gastroscope introduction without movements |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| number of participants with hypotension | Procedure (during propofol sedation and gastroscopy | mean arterial pressure below 65 mmHg |
| number of participants presenting cough | Procedure (during propofol sedation and gastroscopy) | cough suggesting to light sedation |
| number of participants presenting laryngospasm | Procedure (during propofol sedation and gastroscopy) | laryngospasm suggesting to light sedation |
| number of participants presenting involuntary movements | Procedure (during propofol sedation and gastroscopy) | involuntary movements suggesting to light sedation |
| number of participants presenting side effects of lidocaine administration | Time Frame: during gastroscopy procedure | metallic taste, tinnitus, anaphylaxis |
| number of participants with moderate hypoxemia | Procedure (during propofol sedation and gastroscopy) | pulse saturation below 95% |
| 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 | at recovery room discharge, an average of 1 hour after completed procedure | analog digital scale from 1 to 10 |
| Time to anesthesia recover | completed procedure (before transfer to recovery room) | Time between stopping Propofol and recovering a MOAA/S score ≥ 4 |
| Time for post anesthesic care unit discharge | at recovery room discharge, an average of 1 hour after completed procedure | Time between arrival and discharge of the post anesthesic care unit (Aldrette score \>9) |
| score of Endoscopist satisfaction (1-5) | completed procedure (before transfer to recovery room) | Endoscopist satisfaction :1 = very bad; 2=bas; 3=good; 4=very good; 5= excellent |
Countries
Belgium
Contacts
Primary ContactCéline Boudart, PhD
Outcome results
None listed