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Clinical Trials/NCT01910285
NCT01910285
Completed
Phase 4

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

University Hospital, Toulouse1 site in 1 country70 target enrollmentJune 2013

Overview

Phase
Phase 4
Intervention
Remifentanyl - sufentanil placebo
Conditions
Anaesthetic Induction
Sponsor
University Hospital, Toulouse
Enrollment
70
Locations
1
Primary Endpoint
Scandinavian Scale of Intubation Conditions (from Viby-Mogensen). The comparison will be made on the percentage of obtaining excellent intubation conditions.
Status
Completed
Last Updated
9 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
June 2013
End Date
September 2015
Last Updated
9 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

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

Arms & Interventions

Remifentanyl- sufentanil placebo

3 mg/kg of propofol combined with 3 µg/kg of remifentanil

Intervention: Remifentanyl - sufentanil placebo

Sufentanil - remifentanyl placebo

3 mg/kg of propofol combined with 0.3 mg/kg of sufentanil

Intervention: Sufentanil - remifentanyl placebo

Outcomes

Primary Outcomes

Scandinavian Scale of Intubation Conditions (from Viby-Mogensen). The comparison will be made on the percentage of obtaining excellent intubation conditions.

Time Frame: This outcome measure is assessed at day 1 during the per-anesthetic period.

Secondary Outcomes

  • 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.)

Study Sites (1)

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