Remifentanil Versus Sufentanil for Intubation Condition Without Myorelaxant

Study Overview
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Brief Summary
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The main objective is the comparison of intubation conditions after anesthetic induction bolus of propofol-sufentanil when compared to injection of propofol-remifentanil in patients undergoing surgery for tooth extraction. Intubation without myorelaxant with propofol and sufentanil is classic but less efficient than induction with curare on achieving perfect intubation conditions. The use of a protocol without curare is sometimes justified for short gestures or when you want to avoid allergia. Remifentanil often provides excellent intubation conditions without myorelaxant. However, remifentanil was never compared to sufentanil in terms of intubating conditions without muscle relaxant.

Official Title
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Comparison of Intubation Conditions After Induction With Propofol Associated With a Dose of Remifentanil or Sufentanil in Surgical Tooth Extraction.

Conditions
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Anaesthetic Induction

Intervention / Treatment
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* Drug: Remifentanyl - sufentanil placebo
* Drug: Sufentanil - remifentanyl placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: patients 18 to 60 years American Society of Anesthesiology (ASA) 1 or 2 scheduled for surgical tooth extraction under general anesthesia with intubation signed consent form Exclusion Criteria: criterion of difficult ventilation or intubation chronic alcoholism or opiate use beta-blockers or calcium channel blockers treatment allergy to paracetamol or ketoprofen patient under protection of justice

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Remifentanyl- sufentanil placebo<br>3 mg/kg of propofol combined with 3 µg/kg of remifentanil | Drug: Remifentanyl - sufentanil placebo<br>* Induction of general anesthesia with 3 mg/kg of propofol combined with 3 µg/kg of remifentanil and 10 ml of isotonic sodium chloride for the double blind. The trachea is then intubated after waiting the time of action of each product.<br>|
| Active Comparator: Sufentanil - remifentanyl placebo<br>3 mg/kg of propofol combined with 0.3 mg/kg of sufentanil | Drug: Sufentanil - remifentanyl placebo<br>* Induction of general anesthesia with 3 mg/kg of propofol combined with 0.3 mg/kg of sufentanil and 25 ml of isotonic sodium chloride for the double blind. The trachea is then intubated after waiting the time of action of each product.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Scandinavian Scale of Intubation Conditions (from Viby-Mogensen). The comparison will be made on the percentage of obtaining excellent intubation conditions. |  | This outcome measure is assessed at day 1 during the per-anesthetic period. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| percentage of patient with a decrease of over 20% in Mean Arterial Pressure (MAP) or Heart Rate (HR) |  | This outcome measure is assessed at day 1 during the per-anesthesic period and the monitoring period in PACU. | 
| breath - hold time - time to extubation, time to Aldrete score of 10 in PostAnesthesia Care Unit (PACU) |  | This outcome measure is assessed at day 1 during the per-anesthesic period and the monitoring period in PACU. | 
| difficult intubating scale (Adnet et al. Anesthesiology. 99) |  | This outcome measure is assessed at day 1 during the per-anesthesic period and the monitoring period in PACU. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Anesthetic induction, Intubation conditions, Tooth extraction, Propofol, Sufentanil, Remifentanil