Clinical trial NCT01910285: Remifentanil Versus Sufentanil for Intubation Condition Without Myorelaxant
Official title: Comparison of Intubation Conditions After Induction With Propofol Associated With a Dose of Remifentanil or Sufentanil in Surgical Tooth Extraction.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Anaesthetic Induction
Keywords: Anesthetic induction
Intubation conditions
Tooth extraction
Propofol
Sufentanil
Remifentanil
Lead sponsor: University Hospital, Toulouse
Sponsor class: OTHER
First posted: 2013-07-29
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Scandinavian Scale of Intubation Conditions (from Viby-Mogensen). The comparison will be made on the percentage of obtaining excellent intubation conditions.
timeFrame: This outcome measure is assessed at day 1 during the per-anesthetic period.
Secondary outcomes:
measure: percentage of patient with a decrease of over 20% in Mean Arterial Pressure (MAP) or Heart Rate (HR)
timeFrame: This outcome measure is assessed at day 1 during the per-anesthesic period and the monitoring period in PACU.
measure: breath - hold time - time to extubation, time to Aldrete score of 10 in PostAnesthesia Care Unit (PACU)
timeFrame: This outcome measure is assessed at day 1 during the per-anesthesic period and the monitoring period in PACU.
measure: difficult intubating scale (Adnet et al. Anesthesiology. 99)
timeFrame: This outcome measure is assessed at day 1 during the per-anesthesic period and the monitoring period in PACU.
Other outcomes:
Locations:
city: Toulouse
country: France
facility: University Hospital of Purpan
state: Midi-Pyrénées
Study officials:
affiliation: University Hospital of Toulouse
name: Christine ROCHE-TISSOT, MD
role: PRINCIPAL_INVESTIGATOR
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