- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01910285
Remifentanil Versus Sufentanil for Intubation Condition Without Myorelaxant (REMIDENT)
Comparison of Intubation Conditions After Induction With Propofol Associated With a Dose of Remifentanil or Sufentanil in Surgical Tooth Extraction.
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Phase 4
Contacts and Locations
Study Locations
-
-
Midi-Pyrénées
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Toulouse, Midi-Pyrénées, France, 31059
- University Hospital of Purpan
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Remifentanyl- sufentanil placebo
3 mg/kg of propofol combined with 3 µg/kg of remifentanil
|
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
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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.
|
This outcome measure is assessed at day 1 during the per-anesthetic period.
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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.
|
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)
Time Frame: This outcome measure is assessed at day 1 during the per-anesthesic period and the monitoring period in 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)
Time Frame: This outcome measure is assessed at day 1 during the per-anesthesic period and the monitoring period in PACU.
|
This outcome measure is assessed at day 1 during the per-anesthesic period and the monitoring period in PACU.
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Christine ROCHE-TISSOT, MD, University Hospital of Toulouse
Publications and helpful links
General Publications
- Fuchs-Buder T, Claudius C, Skovgaard LT, Eriksson LI, Mirakhur RK, Viby-Mogensen J; 8th International Neuromuscular Meeting. Good clinical research practice in pharmacodynamic studies of neuromuscular blocking agents II: the Stockholm revision. Acta Anaesthesiol Scand. 2007 Aug;51(7):789-808. doi: 10.1111/j.1399-6576.2007.01352.x.
- Adnet F, Borron SW, Racine SX, Clemessy JL, Fournier JL, Plaisance P, Lapandry C. The intubation difficulty scale (IDS): proposal and evaluation of a new score characterizing the complexity of endotracheal intubation. Anesthesiology. 1997 Dec;87(6):1290-7. doi: 10.1097/00000542-199712000-00005.
- Combes X, Andriamifidy L, Dufresne E, Suen P, Sauvat S, Scherrer E, Feiss P, Marty J, Duvaldestin P. Comparison of two induction regimens using or not using muscle relaxant: impact on postoperative upper airway discomfort. Br J Anaesth. 2007 Aug;99(2):276-81. doi: 10.1093/bja/aem147. Epub 2007 Jun 15.
- Fujii Y, Itakura M. A comparison of pretreatment with fentanyl and lidocaine preceded by venous occlusion for reducing pain on injection of propofol: a prospective, randomized, double-blind, placebo-controlled study in adult Japanese surgical patients. Clin Ther. 2009 Oct;31(10):2107-12. doi: 10.1016/j.clinthera.2009.10.012.
- Indications de la curarisation en anesthésie : conférence de consensus (texte court). Ann Fr Anesth Reanim 1999;19:34-7.
- Laxenaire MC, Auroy Y, Clergue F, Pequignot F, Jougla E, Lienhart A. [Organization and techniques of anesthesia]. Ann Fr Anesth Reanim. 1998;17(11):1317-23. doi: 10.1016/s0750-7658(99)80044-6. No abstract available. French.
- Laxenaire MC. [Epidemiology of anesthetic anaphylactoid reactions. Fourth multicenter survey (July 1994-December 1996)]. Ann Fr Anesth Reanim. 1999 Aug;18(7):796-809. doi: 10.1016/s0750-7658(00)88460-9. French.
- Adamus M, Koutna J, Gabrhelik T, Zapletalova J. [Tracheal intubation without muscle relaxant--the impact of different sufentanil doses on the quality of intubating conditions: a prospective study]. Cas Lek Cesk. 2008;147(2):96-101. Czech.
- Hanna SF, Ahmad F, Pappas AL, Mikat-Stevens M, Jellish WS, Kleinman B, Avramov MN. The effect of propofol/remifentanil rapid-induction technique without muscle relaxants on intraocular pressure. J Clin Anesth. 2010 Sep;22(6):437-42. doi: 10.1016/j.jclinane.2009.12.004.
- Alexander R, Olufolabi AJ, Booth J, El-Moalem HE, Glass PS. Dosing study of remifentanil and propofol for tracheal intubation without the use of muscle relaxants. Anaesthesia. 1999 Nov;54(11):1037-40. doi: 10.1046/j.1365-2044.1999.00904.x.
- Bouvet L, Stoian A, Rimmele T, Allaouchiche B, Chassard D, Boselli E. Optimal remifentanil dosage for providing excellent intubating conditions when co-administered with a single standard dose of propofol. Anaesthesia. 2009 Jul;64(7):719-26. doi: 10.1111/j.1365-2044.2009.05916.x.
- Fattorini F, Romano R, Ciccaglioni A, Pascarella MA, Rocco A, Mariani V, Pietropaoli P. Effects of remifentanil on human heart electrical system. A transesophageal pacing electrophysiological study. Minerva Anestesiol. 2003 Sep;69(9):673-7, 677-9. English, Italian.
- Maruyama K, Nishikawa Y, Nakagawa H, Ariyama J, Kitamura A, Hayashida M. Can intravenous atropine prevent bradycardia and hypotension during induction of total intravenous anesthesia with propofol and remifentanil? J Anesth. 2010 Apr;24(2):293-6. doi: 10.1007/s00540-009-0860-2. Epub 2010 Jan 26.
- Egan TD, Brock-Utne JG. Asystole after anesthesia induction with a fentanyl, propofol, and succinylcholine sequence. Anesth Analg. 1991 Dec;73(6):818-20. doi: 10.1213/00000539-199112000-00025. No abstract available.
- Maryniak JK, Bishop VA. Sinus arrest after alfentanil. Br J Anaesth. 1987 Mar;59(3):390-1. doi: 10.1093/bja/59.3.390. No abstract available.
- Starr NJ, Sethna DH, Estafanous FG. Bradycardia and asystole following the rapid administration of sufentanil with vecuronium. Anesthesiology. 1986 Apr;64(4):521-3. doi: 10.1097/00000542-198604000-00023. No abstract available.
- Wang J, Winship S, Russell G. Induction of anaesthesia with sevoflurane and low-dose remifentanil: asystole following laryngoscopy. Br J Anaesth. 1998 Dec;81(6):994-5. doi: 10.1093/bja/81.6.994-a. No abstract available.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Pathologic Processes
- Disease
- Physiological Effects of Drugs
- Central Nervous System Depressants
- Peripheral Nervous System Agents
- Analgesics
- Sensory System Agents
- Anesthetics, Intravenous
- Anesthetics, General
- Anesthetics
- Analgesics, Opioid
- Narcotics
- Adjuvants, Anesthesia
- Remifentanil
- Sufentanil
- Dsuvia
Other Study ID Numbers
- 12 522 03
- HAO (Other Identifier: University Hospital of Toulouse)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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