Clinical trial NCT03112564: Endotracheal Intubation Without Muscle Relaxants
Official title: Evaluation of the Effectiveness and Safety of Endotracheal Intubation for Inhalational Anesthesia Without the Use of Muscle Relaxants or Analgesics
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Muscle Relaxation
Intubation Complication
Keywords: Endotracheal intubation
muscle relaxants
inhalational anesthesia
Lead sponsor: Puerta de Hierro University Hospital
Sponsor class: OTHER
First posted: 2017-04-13
Enrollment: 91
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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 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.

Eligibility criteria: 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

Primary outcomes:
measure: Incidence of treatment-emergent adverse events during intubation
timeFrame: Time from anesthesia induction to 12 hours after the end of surgery
Secondary outcomes:
measure: Subject satisfaction following surgery
timeFrame: from the end of surgery until the discharge day up to 7 days
measure: Post operative nausea and vomiting
timeFrame: first 12 hours after surgery
Other outcomes:
Locations:
city: Majadahonda
country: Spain
facility: Hospital Universitario Puerta de Hierro
state: Madrid
Study officials:
affiliation: Hospital Universitario Puerta de Hierro, Madrid, Spain
name: Antonio Romero Berrocal, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References:
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