Clinical Trials Directory

Trials / Completed

CompletedNCT03112564

Endotracheal Intubation Without Muscle Relaxants

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

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
91 (actual)
Sponsor
Puerta de Hierro University Hospital · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

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 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.

Conditions

Interventions

TypeNameDescription
OTHERAvoidance of rocuronium/cisatracuriumAnesthesia 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.
DRUGSevoflurane 8% + Intravenous fentanylSevoflurane 8% + Intravenous fentanyl was the regimen used for induction and maintenance of anesthesia

Timeline

Start date
2013-03-01
Primary completion
2014-11-30
Completion
2014-12-15
First posted
2017-04-13
Last updated
2017-04-13

Locations

1 site across 1 country: Spain

Source: ClinicalTrials.gov record NCT03112564. Inclusion in this directory is not an endorsement.