Remifentanil Versus Sufentanil for Intubation Condition Without Myorelaxant
NCT ID: NCT01910285
Last Updated: 2016-05-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
70 participants
INTERVENTIONAL
2013-06-30
2015-09-30
Brief Summary
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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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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Remifentanyl- sufentanil placebo
3 mg/kg of propofol combined with 3 µg/kg of remifentanil
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.
Sufentanil - remifentanyl placebo
3 mg/kg of propofol combined with 0.3 mg/kg of sufentanil
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.
Interventions
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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.
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.
Eligibility Criteria
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Inclusion Criteria
* American Society of Anesthesiology (ASA) 1 or 2
* scheduled for surgical tooth extraction under general anesthesia with intubation
* signed consent form
Exclusion Criteria
* chronic alcoholism or opiate use
* beta-blockers or calcium channel blockers treatment
* allergy to paracetamol or ketoprofen
* patient under protection of justice
18 Years
60 Years
ALL
No
Sponsors
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University Hospital, Toulouse
OTHER
Responsible Party
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Principal Investigators
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Christine ROCHE-TISSOT, MD
Role: PRINCIPAL_INVESTIGATOR
University Hospital of Toulouse
Locations
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University Hospital of Purpan
Toulouse, Midi-Pyrénées, France
Countries
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References
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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.
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.
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.
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.
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.
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.
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.
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.
Other Identifiers
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HAO
Identifier Type: OTHER
Identifier Source: secondary_id
12 522 03
Identifier Type: -
Identifier Source: org_study_id
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