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Muscle RelaxationNCT03112564

Endotracheal Intubation Without Muscle Relaxants

A study testing Avoidance of rocuronium/cisatracurium and Sevoflurane 8% + Intravenous fentanyl in people with Muscle Relaxation and Intubation Complication, run by Puerta de Hierro University Hospital at 1 site in Spain.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Muscle Relaxation, Intubation Complication
What is being tested?
Avoidance of rocuronium/cisatracurium and Sevoflurane 8% + Intravenous fentanyl
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
91 participants
Where
1 siteSpain
Study dates
1 Mar 2013to 15 Dec 2014
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Spain1 site

  • Hospital Universitario Puerta de Hierro

    Majadahonda, Madrid, 28222

Other trials in Spain

About this study

Official title: Evaluation of the Effectiveness and Safety of Endotracheal Intubation for Inhalational Anesthesia Without the Use of Muscle Relaxants or Analgesics

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.

Read the detailed description

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.

Being tested
Avoidance of rocuronium/cisatracurium, Sevoflurane 8% + Intravenous fentanyl
Keywords
Endotracheal intubation, muscle relaxants, inhalational anesthesia
Medical subject headings
Muscle Hypotonia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Avoidance of rocuronium/cisatracuriumOther

    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 fentanylDrug

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

Study groups in NCT03112564
Study groupRoleWhat they receive
Sevoflurane 8% + Intravenous fentanylOtherAvoidance of rocuronium/cisatracurium
Receives: Other: Avoidance of rocuronium/cisatracurium; Drug: Sevoflurane 8% + Intravenous fentanyl

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Time from anesthesia induction to 12 hours after the end of surgery

Secondary outcomes (2)

  1. Subject satisfaction following surgery

    subjects opinion regarding surgery satisfaction was collected

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

  2. Post operative nausea and vomiting

    record of nausea and/or vomiting events

    Measured: first 12 hours after surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Apr 2017
  2. Study start1 Mar 2013
  3. Primary completion30 Nov 2014
  4. Study completion15 Dec 2014

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
91 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03112564
Sponsor's protocol ID
HUPH:PI:13/15
Status last verified
Apr 2017
First submitted
29 Mar 2017
Last updated
13 Apr 2017
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 1416135

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

  • 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.

    PubMed 9428849

  • 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.

    PubMed 10866915

  • 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.

    PubMed 3289770

  • 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.

    PubMed 11682393

  • 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.

    PubMed 9135350

  • 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.

    PubMed 15863438

  • 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.

    PubMed 20953528

  • 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.

    PubMed 10325830

  • 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.

    PubMed 17302078

  • 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.

    PubMed 15781547

  • 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.

    PubMed 16827070

  • 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.

    PubMed 10475291

Questions about this trial

What is this clinical trial studying?

A study testing Avoidance of rocuronium/cisatracurium and Sevoflurane 8% + Intravenous fentanyl in people with Muscle Relaxation and Intubation Complication, run by Puerta de Hierro University Hospital at 1 site in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 13 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of treatment-emergent adverse events during intubation (time frame: Time from anesthesia induction to 12 hours after the end of surgery). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03112564, which also lists 14 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2017.

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