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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
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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 |
|
| Sham | 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 |
|---|---|---|
| total propofol dose in milligramme | total propofol dose consumed | procedure (from the beginning of propofol infusion until arrival of the gastroscope in the stomach) |
| total propofol dose in milligramme | total propofol dose consumed | Procedure (from the beginning of propofol infusion until endoscope removal) |
| propofol in site effet concentration in microgram per milliliter | AIVOC : Effect concentration of propofol | procedure (from the beginning of propofol infusion until arrival of the gastroscope in the stomach) |
| propofol in site effet concentration in microgram per milliliter | AIVOC : Effect concentration of propofol | Procedure (from the beginning of propofol infusion until endoscope removal) |
| 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 | Affiliation | Role |
|---|---|---|
| celine Boudart, MD PhD | Erasme University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Erasme Hospital | Brussels | 1070 | Belgium |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36153625 | Background | 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. | |
| 36253717 | Background |
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| ID | Term |
|---|---|
| D008012 | Lidocaine |
| D015742 | Propofol |
| D005773 | Gastroscopy |
| ID | Term |
|---|---|
| D000083 | Acetanilides |
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 |
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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 |
|
| gastroscopy | Procedure | esogastroduodenoscopy |
|
| Procedure (during propofol sedation and gastroscopy) |
| number of participants with severe hypoxemia | pulse saturation below 90% | 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 | 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 |
| 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. |
| 35983429 | Background | 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. |
| 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 |