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Remifentanil Versus Sufentanil for Intubation Condition Without Myorelaxant (REMIDENT)

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ClinicalTrials.gov Identifier: NCT01910285
Recruitment Status : Completed
First Posted : July 29, 2013
Last Update Posted : May 9, 2016
Sponsor:
Information provided by (Responsible Party):
University Hospital, Toulouse

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.


Condition or disease Intervention/treatment Phase
Anaesthetic Induction Drug: Remifentanyl - sufentanil placebo Drug: Sufentanil - remifentanyl placebo Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 70 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Comparison of Intubation Conditions After Induction With Propofol Associated With a Dose of Remifentanil or Sufentanil in Surgical Tooth Extraction.
Study Start Date : June 2013
Actual Primary Completion Date : September 2015
Actual Study Completion Date : September 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Remifentanyl- sufentanil placebo
3 mg/kg of propofol combined with 3 µg/kg of remifentanil
Drug: Remifentanyl - sufentanil placebo
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.

Active Comparator: Sufentanil - remifentanyl placebo
3 mg/kg of propofol combined with 0.3 mg/kg of sufentanil
Drug: Sufentanil - remifentanyl placebo
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 Outcome Measures :
  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 Outcome Measures :
  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. ]


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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01910285


Locations
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France
University Hospital of Purpan
Toulouse, Midi-Pyrénées, France, 31059
Sponsors and Collaborators
University Hospital, Toulouse
Investigators
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Principal Investigator: Christine ROCHE-TISSOT, MD University Hospital of Toulouse

Publications:
Indications de la curarisation en anesthésie : conférence de consensus (texte court). Ann Fr Anesth Reanim 1999;19:34-7.

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Responsible Party: University Hospital, Toulouse
ClinicalTrials.gov Identifier: NCT01910285     History of Changes
Other Study ID Numbers: 12 522 03
HAO ( Other Identifier: University Hospital of Toulouse )
First Posted: July 29, 2013    Key Record Dates
Last Update Posted: May 9, 2016
Last Verified: May 2016
Keywords provided by University Hospital, Toulouse:
Anesthetic induction
Intubation conditions
Tooth extraction
Propofol
Sufentanil
Remifentanil
Additional relevant MeSH terms:
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Disease
Pathologic Processes
Sufentanil
Remifentanil
Propofol
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Analgesics, Opioid
Narcotics
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Adjuvants, Anesthesia