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Prospective study conducted between March 2013 and November 2014 at Hospital Universitario Puerta de Hierro-Majadahonda, in Madrid, Spain to identify complications and evaluate the efficacy of pure inhalational anesthesia induction to achieve endotracheal intubation without the use of muscle relaxant and analgesic drugs.
This is a prospective study conducted between March 2013 and November 2014 at Hospital Universitario Puerta de Hierro-Majadahonda, in Madrid, Spain, with the previous approval by the institutional clinical research ethics committee. A total of 91 subjects who underwent general, gastrointestinal, orthopedic, urology and neurological surgery were randomly selected and provided written informed consent before any study-related procedures were performed.
The aim of this study was to identify complications and evaluate the efficacy of pure inhalational anesthesia induction to achieve endotracheal intubation without the use of muscle relaxant and analgesic drugs.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sevoflurane 8% + Intravenous fentanyl | Other | Avoidance of rocuronium/cisatracurium |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Avoidance of rocuronium/cisatracurium | Other | Anesthesia induction was performed at tidal volume, avoiding the use of analgesics and/or muscle relaxants with FGF of 6 L/min. Induction time was shortened as the FGF was increased. Once 5% sevoflurane end-tidal volume was reached, ventilation with facial mask was maintained for three more minutes. The time lapsed until the loss of blink reflex was achieved and orotracheal tube (OTT) was placed, difficulties in OTT placement, sevoflurane end-tidal volume after OTT placement, complications related to OTT insertion (movement, coughing, rigidity, apnea), mean arterial pressure (MAP) variations were measured. No muscle relaxants were given during surgery. |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of treatment-emergent adverse events during intubation | Measurement of time lapsed from the loss of blink reflex after anesthesia induction and endotracheal tube placement. Number of patients with difficulty for intubation and number of patients with mean arterial pressure variations. | Time from anesthesia induction to 12 hours after the end of surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Subject satisfaction following surgery | subjects opinion regarding surgery satisfaction was collected | from the end of surgery until the discharge day up to 7 days |
| Post operative nausea and vomiting |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Antonio Romero Berrocal, MD,PhD | Hospital Universitario Puerta de Hierro, Madrid, Spain | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Universitario Puerta de Hierro | Majadahonda | Madrid | 28222 | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 1416135 | Background | Scheller MS, Zornow MH, Saidman LJ. Tracheal intubation without the use of muscle relaxants: a technique using propofol and varying doses of alfentanil. Anesth Analg. 1992 Nov;75(5):788-93. doi: 10.1213/00000539-199211000-00024. | |
| Background | Savarese JJ, Caldwell JE, Lien CA, Miller RD. Pharmacology of muscle relaxants and their antagonists. Anesthesia. 2000;5:412-90. | ||
| 9428849 |
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| ID | Term |
|---|---|
| D009123 | Muscle Hypotonia |
| ID | Term |
|---|---|
| D020879 | Neuromuscular Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
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Not provided
| ID | Term |
|---|---|
| C101584 | cisatracurium |
| D000077149 | Sevoflurane |
| ID | Term |
|---|---|
| D008738 | Methyl Ethers |
| D004987 | Ethers |
| D009930 | Organic Chemicals |
| D006845 | Hydrocarbons, Fluorinated |
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|
| Sevoflurane 8% + Intravenous fentanyl | Drug | Sevoflurane 8% + Intravenous fentanyl was the regimen used for induction and maintenance of anesthesia |
|
record of nausea and/or vomiting events
| first 12 hours after surgery |
| Background |
| Stevens JB, Wheatley L. Tracheal intubation in ambulatory surgery patients: using remifentanil and propofol without muscle relaxants. Anesth Analg. 1998 Jan;86(1):45-9. doi: 10.1097/00000539-199801000-00009. |
| 10866915 | Background | Joo HS, Perks WJ. Sevoflurane versus propofol for anesthetic induction: a meta-analysis. Anesth Analg. 2000 Jul;91(1):213-9. doi: 10.1097/00000539-200007000-00040. |
| 3289770 | Background | Trepanier CA, Brousseau C, Lacerte L. Myalgia in outpatient surgery: comparison of atracurium and succinylcholine. Can J Anaesth. 1988 May;35(3 ( Pt 1)):255-8. doi: 10.1007/BF03010619. |
| 11682393 | Background | Kirkbride DA, Parker JL, Williams GD, Buggy DJ. Induction of anesthesia in the elderly ambulatory patient: a double-blinded comparison of propofol and sevoflurane. Anesth Analg. 2001 Nov;93(5):1185-7, table of contents. doi: 10.1097/00000539-200111000-00026. |
| 9135350 | Background | Thwaites A, Edmends S, Smith I. Inhalation induction with sevoflurane: a double-blind comparison with propofol. Br J Anaesth. 1997 Apr;78(4):356-61. doi: 10.1093/bja/78.4.356. |
| 15863438 | Background | Knaggs CL, Drummond GB. Randomized comparison of three methods of induction of anaesthesia with sevoflurane. Br J Anaesth. 2005 Aug;95(2):178-82. doi: 10.1093/bja/aei149. Epub 2005 Apr 29. |
| 20953528 | Background | Topuz D, Postaci A, Sacan O, Yildiz N, Dikmen B. A comparison of sevoflurane induction versus propofol induction for laryngeal mask airway insertion in elderly patients. Saudi Med J. 2010 Oct;31(10):1124-9. |
| 10325830 | Background | Walpole R, Logan M. Effect of sevoflurane concentration on inhalation induction of anaesthesia in the elderly. Br J Anaesth. 1999 Jan;82(1):20-4. doi: 10.1093/bja/82.1.20. |
| 17302078 | Background | Vidal MA, Calderon E, Martinez E, Pernia A, Torres LM. [Comparison of 2 techniques for inhaled anesthetic induction with sevoflurane in coronary artery revascularization]. Rev Esp Anestesiol Reanim. 2006 Dec;53(10):639-42. Spanish. |
| 15781547 | Background | Siddik-Sayyid SM, Aouad MT, Taha SK, Daaboul DG, Deeb PG, Massouh FM, Muallem MA, Baraka AS. A comparison of sevoflurane-propofol versus sevoflurane or propofol for laryngeal mask airway insertion in adults. Anesth Analg. 2005 Apr;100(4):1204-1209. doi: 10.1213/01.ANE.0000148166.29749.3B. |
| 16827070 | Background | Bel Marcoval I, Gambus Cerrillo P. [Risk assessment, prophylaxis and treatment for postoperative nausea and vomiting]. Rev Esp Anestesiol Reanim. 2006 May;53(5):301-11. Spanish. |
| 10475291 | Background | Philip BK, Lombard LL, Roaf ER, Drager LR, Calalang I, Philip JH. Comparison of vital capacity induction with sevoflurane to intravenous induction with propofol for adult ambulatory anesthesia. Anesth Analg. 1999 Sep;89(3):623-7. doi: 10.1097/00000539-199909000-00014. |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D006846 |
| Hydrocarbons, Halogenated |
| D006838 | Hydrocarbons |