Remifentanil Versus Sufentanil for Intubation Condition Without Myorelaxant

NCT01910285 | Completed Phase 4

• 2 other identifiers: 12 522 03HAO
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

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.

Conditions

Anaesthetic Induction

Keywords

Anesthetic induction; Intubation conditions; Tooth extraction; Propofol; Sufentanil; Remifentanil

Outcome Measures

Primary Outcomes (1)

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

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

Secondary Outcomes (3)

• 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 Arms (2)

Remifentanyl- sufentanil placebo

EXPERIMENTAL

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

Drug: Remifentanyl - sufentanil placebo

Sufentanil - remifentanyl placebo

ACTIVE COMPARATOR

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

Drug: Sufentanil - remifentanyl placebo

Interventions

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.

Remifentanyl- sufentanil placebo

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.

Sufentanil - remifentanyl placebo

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Toulouse: lead

Study Sites (1)

University Hospital of Purpan

Toulouse, Midi-Pyrénées, 31059, France

Location

Related Publications (17)

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

  BACKGROUND

• 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.

  PMID: 9972359 BACKGROUND

• 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.

  PMID: 10486634 BACKGROUND

• 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.

  PMID: 17573390 BACKGROUND

• 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.

  PMID: 18383960 BACKGROUND

• 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.

  PMID: 20868965 BACKGROUND

• 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.

  PMID: 10540091 BACKGROUND

• 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.

  PMID: 19624626 BACKGROUND

• 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.

  PMID: 19922881 BACKGROUND

• 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.

  PMID: 14564237 BACKGROUND

• 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.

  PMID: 20101512 BACKGROUND

• 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.

  PMID: 17635389 BACKGROUND

• 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.

  PMID: 1952185 BACKGROUND

• 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.

  PMID: 3103664 BACKGROUND

• 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.

  PMID: 2870669 BACKGROUND

• 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.

  PMID: 10211042 BACKGROUND

• 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.

  PMID: 9416711 BACKGROUND

Study Officials

• Christine ROCHE-TISSOT, MD

  University Hospital of Toulouse

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 15, 2013
• First Posted: July 29, 2013
• Study Start: June 1, 2013
• Primary Completion: September 1, 2015
• Study Completion: September 1, 2015
• Last Updated: May 9, 2016

Record last verified: 2016-05

Locations

FR (1)