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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Linisol | Active Comparator | Patients will receive 1.5 mg/kg of intravenous linisol before propofol sedatation and gastroscope introduction |
|
| Control | Placebo Comparator | Patients will receive intravenous placebo (saline solution),before propofol sedation and gastroscope introduction |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lidocaine 2% Injectable Solution | Drug | administration of a bolus of lidocaine 1.5 mg/kg |
| |
| Measure | Description | Time Frame |
|---|---|---|
| ED50 of propofol | ED50 of propofol for gastroscope introduction without movements | gastroscope introduction |
| Measure | Description | Time Frame |
|---|---|---|
| number of participants with moderate hypoxemia | pulse saturation below 95% | Procedure (during propofol sedation and gastroscopy) |
| number of participants with hypotension | mean arterial pressure below 65 mmHg |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Céline Boudart, PhD | Contact | +322555391+9 | celine.boudart@hubruxelles.be |
| Name | Affiliation | Role |
|---|---|---|
| Céline Boudart, PhD | Erasme University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Boudart Céline | Recruiting | Brussels | 1070 | Belgium |
all IPD that underlie results in a publication
Data will be available after publication
data will be provided anonymously upon request by email from the corresponding author
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computered randomisation, sealed enveloppes linisol versus placebo prepared by anesthesist not involved in the study or in patient care
| Saline administration as placebo |
| Drug |
administration of a bolus of saline solution as a placebo |
|
|
| Propofol injection | Drug | Sedation by total intravenous administration (TIVA) of propofol using target controlled infusion (TCI) |
|
| gastroscopy | Procedure | esogastroduodenoscopy |
|
| Procedure (during propofol sedation and gastroscopy |
| number of participants presenting cough | cough suggesting to light sedation | Procedure (during propofol sedation and gastroscopy) |
| number of participants presenting laryngospasm | laryngospasm suggesting to light sedation | Procedure (during propofol sedation and gastroscopy) |
| number of participants presenting involuntary movements | involuntary movements suggesting to light sedation | Procedure (during propofol sedation and gastroscopy) |
| number of participants presenting side effects of lidocaine administration | metallic taste, tinnitus, anaphylaxis | Time Frame: during gastroscopy procedure |
| score of Endoscopist satisfaction (1-5) | Endoscopist satisfaction :1 = very bad; 2=bas; 3=good; 4=very good; 5= excellent | completed procedure (before transfer to recovery room) |
| score of Patient satisfaction (1-5) | Patient satisfaction :1 = very bad; 2=bas; 3=good; 4=very good; 5= excellent | at recovery room discharge, an average of 1 hour after completed procedure |
| 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 | completed procedure (before transfer to recovery room) |
| Time for post anesthesic care unit discharge | Time between arrival and discharge of the post anesthesic care unit (Aldrette score >9) | at recovery room discharge, an average of 1 hour after completed procedure |
| ID | Term |
|---|---|
| D008012 | Lidocaine |
| D015742 | Propofol |
| D005773 | Gastroscopy |
| ID | Term |
|---|---|
| D000083 | Acetanilides |
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
| D000588 | Amines |
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D016099 | Endoscopy, Gastrointestinal |
| D016145 | Endoscopy, Digestive System |
| D003938 | Diagnostic Techniques, Digestive System |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D004724 | Endoscopy |
| D003949 | Diagnostic Techniques, Surgical |
| D013505 | Digestive System Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
| D019060 | Minimally Invasive Surgical Procedures |
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