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Completed

NCT Number: NCT03112564

Endotracheal Intubation Without Muscle Relaxants

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.

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Key information

Conditions

Muscle Relaxation Intubation Complication Muscle Hypotonia Nervous System Diseases Neurologic Manifestations Neuromuscular Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital Universitario Puerta de Hierro

Majadahonda, Madrid, 28222, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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

Treatment and study plan

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

Drug

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

Primary outcomes

  1. Incidence of treatment-emergent adverse events during intubation

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

    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.

Secondary outcomes

  1. Subject satisfaction following surgery

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

    subjects opinion regarding surgery satisfaction was collected

  2. Post operative nausea and vomiting

    Time frame: first 12 hours after surgery

    record of nausea and/or vomiting events

Sponsors and collaborators

Lead sponsor

Puerta de Hierro University Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Apr 13, 2017
Registry last updated
Apr 13, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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