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Completed

NCT Number: NCT01910285

Remifentanil Versus Sufentanil for Intubation Condition Without Myorelaxant

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.

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Key information

Conditions

Anaesthetic Induction

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

University Hospital of Purpan

Toulouse, Midi-Pyrénées, 31059, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Remifentanyl - sufentanil placebo

Drug

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.

Sufentanil - remifentanyl placebo

Drug

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.

Primary outcomes

  1. 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

  1. percentage of patient with a decrease of over 20% in Mean Arterial Pressure (MAP) or Heart Rate (HR)

    Time frame: This outcome measure is assessed at day 1 during the per-anesthesic period and the monitoring period in PACU.

  2. breath - hold time - time to extubation, time to Aldrete score of 10 in PostAnesthesia Care Unit (PACU)

    Time frame: This outcome measure is assessed at day 1 during the per-anesthesic period and the monitoring period in PACU.

  3. difficult intubating scale (Adnet et al. Anesthesiology. 99)

    Time frame: This outcome measure is assessed at day 1 during the per-anesthesic period and the monitoring period in PACU.

Sponsors and collaborators

Lead sponsor

University Hospital, Toulouse

Other

Registry information

Official study title

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

Acronym: REMIDENT

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
Jul 29, 2013
Registry last updated
May 9, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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