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The patient is seen upstream by an anaesthetists resuscitator (MAR) in order to carry out his anesthesia consultation. If the patient meets the eligibility criteria he will be informed of the study and his signed consent will be obtained.
Patients will be divided into 3 parallel groups :
Constants are taken at T0. A non-invasive continuous monitoring (Clearsight ©) will be used to collect data: blood pressure, heart rate, cardiac output.
To ensure double-blinding the nurse who prepares the syringes is not part of the anesthesia team. He/she numbers them in syringe n°1 and n°2 to indicate the order of injection to the MAR.
The MAR injects the drugs according to the standardized study plan (see below):
The laryngoscopy is performed by an experienced MAR or nurse (IADE). The end of the intubation is defined by the fixation of the intubation tube (T3). Hemodynamic parameters are measured every minute for ten minutes after intubation (T4 to T13).
Maintenance of anesthesia is standardized with halogen gas (SEVOFLURANE) and an opioid (SUFENTANIL). Ten minutes after the patient's intubation (T13), the blind is lifted, allowing the addition of sufentanil in groups A and C before any surgical procedure.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A (placebo + remifentanil) | Experimental |
| |
| Group B (sufentanil + placebo) | Experimental |
| |
| Group C (placebo + placebo) | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Remifentanil | Drug | REMIFENTANIL, 5 µg/cc, solution for injection, 0.5 µg/kg, parenteral (intravenous) route, injection delay of 30 seconds, once only |
|
| Measure | Description | Time Frame |
|---|---|---|
| heart rate beats per minute | Absolute variation of heart rate beats per minute between T0 (reference value at the entrance into the operating room) and T2 (end of induction and oro-tracheal intubation) | T2 : oro-tracheal induction |
| Measure | Description | Time Frame |
|---|---|---|
| Cormack score | Cormack score in each group | T2 : oro-tracheal induction |
| Laryngoscopy of Macintosh number | Laryngoscopy number for each group |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Marine FONTAINE, MD | Centre Hospitalier Sud Francilien | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre Hospitalier Sud Francilien | Corbeil-Essonnes | France | 91106 | France |
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| ID | Term |
|---|---|
| D000077208 | Remifentanil |
| D017409 | Sufentanil |
| ID | Term |
|---|---|
| D011422 | Propionates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
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Double-blind randomized controlled study
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| Sufentanil | Drug | SUFENTANIL, 5 µg/cc, solution for injection, 0.2 µg/kg, parenteral (intravenous) route, bolus over 5 seconds, once |
|
| Placebo | Drug | PLACEBO contains 0.9% NaCl, parenteral (intravenous), bolus, one-time |
|
| T2 : oro-tracheal induction |
| Use of a long bent mandrel | Use of a long bent mandrel for each group | T2 : oro-tracheal induction |
| assess side effects according to the opioids used | Percentage of patients with intraoperative vomiting at T2 for each group | T2 : oro-tracheal induction |
| assess side effects according to the opioids used | Percentage of patients requiring vasopressor before T2 | before T2 : oro-tracheal induction |
| assess side effects according to the opioids used | Percentage of patients with thoracic rigidity and/or bradycardia < 50/min at T2 for each group | T2 : oro-tracheal induction |
| assess significant variation in hemodynamic responses | Absolute and relative variations of +-20% in SAP/DAP and MAP between T0 and T2 | T2 : oro-tracheal induction |
| assess significant variation in hemodynamic responses | Absolute and relative variations of +/- 20% in SAP/DA and MAP between T0 and T13 | T13 (10 minutes after intubation) |
| assess significant variation in hemodynamic responses | Relative variation of +/- 20% of HR between T0 and T2 | T2 : oro-tracheal induction |
| assess significant variation in hemodynamic responses | Absolute and relative variations of +/- 20% of HR between T0 and T13. | T13 (10 minutes after intubation) |
| D010880 |
| Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D005283 | Fentanyl |