Endotracheal Intubation Without Muscle Relaxants

NCT03112564 | Completed

• 1 other identifier: HUPH:PI:13/15
• Study Type: interventional
• Target: 91
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Muscle Relaxation; Intubation Complication

Keywords

Endotracheal intubation; muscle relaxants; inhalational anesthesia

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (2)

• Subject satisfaction following surgery

  from the end of surgery until the discharge day up to 7 days

• Post operative nausea and vomiting

  first 12 hours after surgery

Study Arms (1)

Sevoflurane 8% + Intravenous fentanyl

OTHER

Avoidance of rocuronium/cisatracurium

Other: Avoidance of rocuronium/cisatracurium; Drug: Sevoflurane 8% + Intravenous fentanyl

Interventions

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.

Sevoflurane 8% + Intravenous fentanyl

Sevoflurane 8% + Intravenous fentanyl DRUG

Sevoflurane 8% + Intravenous fentanyl was the regimen used for induction and maintenance of anesthesia

Sevoflurane 8% + Intravenous fentanyl

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or Female patients
• Age ≥ 18 years
• ASA ≤ 3
• Able to provide informed consent

You may not qualify if:

• Subjects with left ventricle ejection fraction (LEVF) ≤ 35%
• History of ischemic heart disease in the last year
• History of malignant hyperthermia
• Presence of thoracic drain tubes
• Increased intracranial pressure (ICP) or brain tumors, undergoing neurophysiological monitoring
• Hemodynamic instability or likely to become unstable during induction of anesthesia

Sponsors & Collaborators

• Puerta de Hierro University Hospital: lead

Study Sites (1)

Hospital Universitario Puerta de Hierro

Majadahonda, Madrid, 28222, Spain

Location

Related Publications (14)

• 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.

  PMID: 1416135 BACKGROUND

• Savarese JJ, Caldwell JE, Lien CA, Miller RD. Pharmacology of muscle relaxants and their antagonists. Anesthesia. 2000;5:412-90.

  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.

  PMID: 9428849 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.

  PMID: 10866915 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.

  PMID: 3289770 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.

  PMID: 11682393 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.

  PMID: 9135350 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.

  PMID: 15863438 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.

  PMID: 20953528 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.

  PMID: 10325830 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.

  PMID: 17302078 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.

  PMID: 15781547 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.

  PMID: 16827070 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.

  PMID: 10475291 BACKGROUND

MeSH Terms

Conditions

Muscle Hypotonia

Interventions

cisatracurium; Sevoflurane

Condition Hierarchy (Ancestors)

Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Methyl Ethers; Ethers; Organic Chemicals; Hydrocarbons, Fluorinated; Hydrocarbons, Halogenated; Hydrocarbons

Study Officials

• Antonio Romero Berrocal, MD,PhD

  Hospital Universitario Puerta de Hierro, Madrid, Spain

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Anesthesiology and Critical Care

Study Record Dates

• First Submitted: March 29, 2017
• First Posted: April 13, 2017
• Study Start: March 1, 2013
• Primary Completion: November 30, 2014
• Study Completion: December 15, 2014
• Last Updated: April 13, 2017

Record last verified: 2017-04

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)