drugset / Trial / NCT02711904
Concentrations of Remifentanil for Extubation
Phase 4
Completed
110 enrolled
Seganest
Instituto Para Ninos Ciegos y Sordos del Valle del Cauca · collab
RandomizedParallel-groupQuadruple-blindPrevention
Summary
Condition of the State: (terminated, recruiting, etc.) Terminated Study Design: Main Objective: Compare the frequency and intensity of coughing at the time of extubation with two infusions of remifentanil that predict a plasma concentration (PC) of 3 - 4 and 2 - 3 ng/ml, through the technique of target controlled anesthesia
Timeline
- Start
- 2011-01
- Primary completion
- 2011-01
- Completion
- 2012-07
Publications
- Background Neelakanta G, Miller J. Minimum alveolar concentration of isoflurane for tracheal extubation in deeply anesthetized children. Anesthesiology. 1994 Apr;80(4):811-3. doi: 10.1097/00000542-199404000-00013.
- Background Guler G, Akin A, Tosun Z, Eskitascoglu E, Mizrak A, Boyaci A. Single-dose dexmedetomidine attenuates airway and circulatory reflexes during extubation. Acta Anaesthesiol Scand. 2005 Sep;49(8):1088-91. doi: 10.1111/j.1399-6576.2005.00780.x.
- Background Saghaei M, Reisinejad A, Soltani H. Prophylactic versus therapeutic administration of intravenous lidocaine for suppression of post-extubation cough following cataract surgery: a randomized double blind placebo controlled clinical trial. Acta Anaesthesiol Taiwan. 2005 Dec;43(4):205-9.
- Background Minogue SC, Ralph J, Lampa MJ. Laryngotracheal topicalization with lidocaine before intubation decreases the incidence of coughing on emergence from general anesthesia. Anesth Analg. 2004 Oct;99(4):1253-1257. doi: 10.1213/01.ANE.0000132779.27085.52.
- Background Fagan C, Frizelle HP, Laffey J, Hannon V, Carey M. The effects of intracuff lidocaine on endotracheal-tube-induced emergence phenomena after general anesthesia. Anesth Analg. 2000 Jul;91(1):201-5. doi: 10.1097/00000539-200007000-00038.
- Background Tagaito Y, Isono S, Nishino T. Upper airway reflexes during a combination of propofol and fentanyl anesthesia. Anesthesiology. 1998 Jun;88(6):1459-66. doi: 10.1097/00000542-199806000-00007.
- Background Nishina K, Mikawa K, Maekawa N, Obara H. Fentanyl attenuates cardiovascular responses to tracheal extubation. Acta Anaesthesiol Scand. 1995 Jan;39(1):85-9. doi: 10.1111/j.1399-6576.1995.tb05597.x.
- Background Mendel P, Fredman B, White PF. Alfentanil suppresses coughing and agitation during emergence from isoflurane anesthesia. J Clin Anesth. 1995 Mar;7(2):114-8. doi: 10.1016/0952-8180(94)00024-x.
- Background Sant'Ambrogio G, Widdicombe J. Reflexes from airway rapidly adapting receptors. Respir Physiol. 2001 Mar;125(1-2):33-45. doi: 10.1016/s0034-5687(00)00203-6.
- Background Lema FE, Tafur LA, Giraldo C, Delgado MA. [Incidence of cough after desflurane and sevoflurane administration through a laryngeal mask: a controlled clinical trial]. Rev Esp Anestesiol Reanim. 2010 Mar;57(3):141-6. doi: 10.1016/s0034-9356(10)70188-2. Spanish.
- Background Ramsay MA, Savege TM, Simpson BR, Goodwin R. Controlled sedation with alphaxalone-alphadolone. Br Med J. 1974 Jun 22;2(5920):656-9. doi: 10.1136/bmj.2.5920.656.
- Background Grahame-Smith DG. How will knowledge of the human genome affect drug therapy? Br J Clin Pharmacol. 1999 Jan;47(1):7-10. doi: 10.1046/j.1365-2125.1999.00909.x. No abstract available.
- Background Van Poucke GE, Bravo LJ, Shafer SL. Target controlled infusions: targeting the effect site while limiting peak plasma concentration. IEEE Trans Biomed Eng. 2004 Nov;51(11):1869-75. doi: 10.1109/TBME.2004.827935.
- Background Tafur LA, Gómez JM, Parra LE. Validación de nomogramas de remifentanil y propofol para la administración de anestesia total endovenosa. Rev. Col. Anest. 2009; 37:21-8.
- Background Mertens MJ, Olofsen E, Engbers FH, Burm AG, Bovill JG, Vuyk J. Propofol reduces perioperative remifentanil requirements in a synergistic manner: response surface modeling of perioperative remifentanil-propofol interactions. Anesthesiology. 2003 Aug;99(2):347-59. doi: 10.1097/00000542-200308000-00016.
- Background Eger EI 2nd. Age, minimum alveolar anesthetic concentration, and minimum alveolar anesthetic concentration-awake. Anesth Analg. 2001 Oct;93(4):947-53. doi: 10.1097/00000539-200110000-00029.
- Background Matsuura T, Oda Y, Tanaka K, Mori T, Nishikawa K, Asada A. Advance of age decreases the minimum alveolar concentrations of isoflurane and sevoflurane for maintaining bispectral index below 50. Br J Anaesth. 2009 Mar;102(3):331-5. doi: 10.1093/bja/aen382. Epub 2009 Jan 24.
- Background Albertin A, Casati A, Bergonzi P, Fano G, Torri G. Effects of two target-controlled concentrations (1 and 3 ng/ml) of remifentanil on MAC(BAR) of sevoflurane. Anesthesiology. 2004 Feb;100(2):255-9. doi: 10.1097/00000542-200402000-00012.
- Background Olofsen E, Sleigh JW, Dahan A. The influence of remifentanil on the dynamic relationship between sevoflurane and surrogate anesthetic effect measures derived from the EEG. Anesthesiology. 2002 Mar;96(3):555-64. doi: 10.1097/00000542-200203000-00009.
- Background Manyam SC, Gupta DK, Johnson KB, White JL, Pace NL, Westenskow DR, Egan TD. Opioid-volatile anesthetic synergy: a response surface model with remifentanil and sevoflurane as prototypes. Anesthesiology. 2006 Aug;105(2):267-78. doi: 10.1097/00000542-200608000-00009.
- Background Dennis R. Cómo estimar el tamaño de la muestra en investigación con humanos. Acta Méd Colom. 1989;14: 92-99.
- Background Dobson AJ. Calculating simple size. Transactions of the Menzie Foundation. 1984; 7:75-79.
- Background Lerou JG. Nomogram to estimate age-related MAC. Br J Anaesth. 2004 Aug;93(2):288-91. doi: 10.1093/bja/aeh186. Epub 2004 Jun 25.
- Background Coleridge HM, Coleridge JCC. Reflexes evoked from the tracheobronchial tree and lungs. In: Handbook of Physiology, Section 3: the Respiratory System, Vol II: Control of Breathing, Part I (Cherniack NS, Widdicombe JG, eds). Washington, DC:American Physiological Society, 1986;395-429.
- Background Widdicombe JG. Vagal reflexes in the airways. In: Neural Regulation of the Airways in Health and Disease (Kaliner M, Barnes PJ, eds). New York:Marcel Dekker, 1988;187-202.
- Background Lee DH, Park SJ. Effects of 10% lidocaine spray on arterial pressure increase due to suspension laryngoscopy and cough during extubation. Korean J Anesthesiol. 2011 Jun;60(6):422-7. doi: 10.4097/kjae.2011.60.6.422. Epub 2011 Jun 17.
- Background Irwin RS. Complications of cough: ACCP evidence-based clinical practice guidelines. Chest. 2006 Jan;129(1 Suppl):54S-58S. doi: 10.1378/chest.129.1_suppl.54S.
- Background Leech P, Barker J, Fitch W. Proceedings: Changes in intracranial pressure and systemic arterial pressure during the termination of anaesthesia. Br J Anaesth. 1974 Apr;46(4):315-6. doi: 10.1093/bja/46.4.315-a. No abstract available.
- Background Lee B, Lee JR, Na S. Targeting smooth emergence: the effect site concentration of remifentanil for preventing cough during emergence during propofol-remifentanil anaesthesia for thyroid surgery. Br J Anaesth. 2009 Jun;102(6):775-8. doi: 10.1093/bja/aep090. Epub 2009 May 2.
- Background Hohlrieder M, Tiefenthaler W, Klaus H, Gabl M, Kavakebi P, Keller C, Benzer A. Effect of total intravenous anaesthesia and balanced anaesthesia on the frequency of coughing during emergence from the anaesthesia. Br J Anaesth. 2007 Oct;99(4):587-91. doi: 10.1093/bja/aem203. Epub 2007 Jul 27.
- Background Shajar MA, Thompson JP, Hall AP, Leslie NA, Fox AJ. Effect of a remifentanil bolus dose on the cardiovascular response to emergence from anaesthesia and tracheal extubation. Br J Anaesth. 1999 Oct;83(4):654-6. doi: 10.1093/bja/83.4.654.
- Background Wilhelm W, Schlaich N, Harrer J, Kleinschmidt S, Muller M, Larsen R. Recovery and neurological examination after remifentanil-desflurane or fentanyl-desflurane anaesthesia for carotid artery surgery. Br J Anaesth. 2001 Jan;86(1):44-9. doi: 10.1093/bja/86.1.44.
- Background Jun NH, Lee JW, Song JW, Koh JC, Park WS, Shim YH. Optimal effect-site concentration of remifentanil for preventing cough during emergence from sevoflurane-remifentanil anaesthesia. Anaesthesia. 2010 Sep;65(9):930-5. doi: 10.1111/j.1365-2044.2010.06450.x.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Extubation U | Unknown | 4 ug/kg | — |
| Comparator | Extubation U | Unknown | 4.3 ug/kg | — |
| Comparator | Extubation U | Unknown | 4.6 ug/kg | — |
| Comparator | Extubation U | Unknown | 5 ug/kg | — |
| Comparator | Extubation U | Unknown | 5.3 ug/kg | — |
| Comparator | Extubation U | Unknown | 5.7 ug/kg | — |
| Comparator | Extubation U | Unknown | 6 ug/kg | — |
| Comparator | Extubation U | Unknown | 6.5 ug/kg | — |
| Comparator | Extubation U | Unknown | 7 ug/kg | — |
| Comparator | Extubation U | Unknown | 7.5 ug/kg | — |
| Comparator | Extubation U | Unknown | 8 ug/kg | — |
| Comparator | Extubation U | Unknown | 8.5 ug/kg | — |
| Comparator | Extubation U | Unknown | 9 ug/kg | — |
Indications
No indication recorded.