Clinical Trial: Endotracheal Intubation Without Muscle Relaxants

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

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.

Detailed Summary:

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.


Sponsor: Puerta de Hierro University Hospital

Current Primary Outcome: 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.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • 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
  • Post operative nausea and vomiting [ Time Frame: first 12 hours after surgery ]
    record of nausea and/or vomiting events


Original Secondary Outcome: Same as current

Information By: Puerta de Hierro University Hospital

Dates:
Date Received: March 29, 2017
Date Started: March 1, 2013
Date Completion:
Last Updated: April 7, 2017
Last Verified: April 2017