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Our aim, in this study, is to elucidate the optimal dosing range (ED50 and ED95) of bolus remifentanil in order to counter the painful stimuli resulting from direct laryngoscopy and tracheal intubation by using the NOL index. In order to maximize the clinical relevance of our findings, induction of general anesthesia will be done with standard medications and doses and laryngoscopy will be done with the Macintosh laryngoscope, the most common tool used for intubation in the operating room
Background: There are no study so far that determined the ED50 and ED95 of remifentanil to perform tracheal intubation by using the NOL index as the criterion measured to determine the failure (painful intubation) or the success (pain free intubation) of the assessed procedure.
Objectives: To determine the ED50 and ED95 of remifentanil bolus to perform tracheal intubation without NOL index variating over threshold for nociceptive response (determined as a NOL index going over 20 - peak value of maximum 20) using the Macintosh blade when obtaining good conditions of intubation in anesthetized patients. Good conditions of intubation will be determined as obtaining a Cormack-Lehane grade I and II.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Remifentanil dose 0.5 ug/kg | Experimental | Remifentanil will be given (dosage of 0.5 µg/kg of adjusted body weight bolus) from an infusion pump over 30 seconds. The bolus of remifentanil will be programmed on an electronic pump which gives an auditory signal when each bolus is completed. When the pump will ring at the end of the remifentanil bolus, the chronometer on the Dräger Monitor (anesthesia machine, Dräger Perseus A500, Draeger Medical Canada Inc., Ontario, Canada) will be turned on. |
|
| Remifentnil dose 1 ug/kg | Experimental | Remifentanil will be given (dosage of 1.0 µg/kg of adjusted body weight bolus according to randomization) from an infusion pump over 30 seconds. The bolus of remifentanil will be programmed on an electronic pump which gives an auditory signal when each bolus is completed. When the pump will ring at the end of the remifentanil bolus, the chronometer on the Dräger Monitor (anesthesia machine, Dräger Perseus A500, Draeger Medical Canada Inc., Ontario, Canada) will be turned on. |
|
| Remifentanil dose 1.5 ug/kg | Experimental | Remifentanil will be given (dosage of 1.5 µg/kg of adjusted body weight bolus according to randomization) from an infusion pump over 30 seconds. The bolus of remifentanil will be programmed on an electronic pump which gives an auditory signal when each bolus is completed. When the pump will ring at the end of the remifentanil bolus, the chronometer on the Dräger Monitor (anesthesia machine, Dräger Perseus A500, Draeger Medical Canada Inc., Ontario, Canada) will be turned on. |
|
| Remifentanil dose 2 ug/kg |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Remifentanil dose 0.5 ug/kg | Drug | Remifentanil will be given (dosage of 0.5 µg/kg of adjusted body weight bolus) from an infusion pump over 30 seconds |
|
| Measure | Description | Time Frame |
|---|---|---|
| determine ED95 of remifentanil bolus in mcg/kg for tracheal intubation | The primary goal of this study is to determine the ED95 of remifentanil bolus to perform tracheal intubation without NOL index varying over 20 (peak maximal value of 20) using the Macintosh blade when obtaining a Cormack-Lehane grade I or II of intubation in anesthetized patients (the size of the blade will be chosen according to patient characteristics described in the user's manual for each blade and published in previous literature). This primary outcome will be expressed in mcg/kg of remifentanil. | in the surgery |
| Measure | Description | Time Frame |
|---|---|---|
| NOL maximal value after intubation (NOL is an index without unit going from 0 to 100) | After tracheal intubation NOL index maximal value will be evaluated and compared between the 4 doses of remifentanil in mcg/kg received in this study. | in the surgery |
| Variation of NOL index after tracheal intubation; DELTA NOL (no unit) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Philippe Richebe, MD PhD | CIUSSS de l'Est de Montreal, Hopital Maisonneuve Rosemont | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hopital Maisonneuve Rosemont | Montreal East | Quebec | H1T2M4 | Canada |
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| ID | Term |
|---|---|
| D010146 | Pain |
| D000377 | Agnosia |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010468 | Perceptual Disorders |
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Four groups of patients. Randomization into the dose of remifentanil given according to a randomization list for a total number of patients of 80.
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remifentanil will be given by a dosage of 0.5-1.0-1.5-2.0 µg/kg of adjusted body weight bolus according to randomization, by an infusion pump over 30 seconds
| Experimental |
Remifentanil will be given (dosage of 2 µg/kg of adjusted body weight bolus according to randomization) from an infusion pump over 30 seconds. The bolus of remifentanil will be programmed on an electronic pump which gives an auditory signal when each bolus is completed. When the pump will ring at the end of the remifentanil bolus, the chronometer on the Dräger Monitor (anesthesia machine, Dräger Perseus A500, Draeger Medical Canada Inc., Ontario, Canada) will be turned on. |
|
| Remifentanil dose 1 ug/kg | Drug | Remifentanil will be given (dosage of 1 µg/kg of adjusted body weight bolus) from an infusion pump over 30 seconds |
|
| Remifentanil dose 1.5 ug/kg | Drug | Remifentanil will be given (dosage of 1.5 µg/kg of adjusted body weight bolus) from an infusion pump over 30 seconds |
|
| Remifentanil dose 2 ug/kg | Drug | Remifentanil will be given (dosage of 2 µg/kg of adjusted body weight bolus) from an infusion pump over 30 seconds |
|
After tracheal intubation DELTA NOL index will be evaluated and compared between the 4 doses of remifentanil in mcg/kg received in this study. |
| in the surgery |
| Time in seconds NOL spends above 25 after tracheal intubation (in seconds) | Time in seconds spent above 25 of NOL index and comparison between the 4 doses of remifentanil used in this study | in the surgery |
| Area under the curve for NOL index after tracheal intubation (no unit) | Compare the AUC of NOL after tracheal intubation between the 4 doses of remifentanil used in this study. | in the surgery |
| Heart Rate Maximal value after tracheal intubation (in beat per minutes) | To compare maximal heart rate values reached after tracheal intubation between the 4 doses of remifentanil used in this study | in the surgery |
| Heart Rate variation (DELTA Heart Rate) after tracheal intubation (in beats per minute) | To compare the DELTA Heart Rate after tracheal intubation between the 4 doses of remifentanil used in this study | in the surgery |
| Time in seconds that Heart Rate spends above threshold of 10%; in seconds | To compare the time in seconds between the 4 doses of remifentanil that Heart Rate spends above teh threshold of 10% of variation above normal prestimulus values. | in the surgery |
| Area under the curve of Heart Rate after tracheal intubation (no unit) | To compare AUC of Heart Rate values after tracheal intubation between teh 4 different doses of remifentanil used in this study. | in the surgery |
| D019954 | Neurobehavioral Manifestations |
| D009422 | Nervous System Diseases |