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Endotracheal Intubation Without Muscle Relaxants

M

Majadahonda Iron Gate University

Status

Completed

Conditions

Intubation Complication
Muscle Relaxation

Treatments

Drug: Sevoflurane 8% + Intravenous fentanyl
Other: Avoidance of rocuronium/cisatracurium

Study type

Interventional

Funder types

Other

Identifiers

NCT03112564
HUPH:PI:13/15

Details and patient eligibility

About

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.

Full 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.

Enrollment

91 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

91 participants in 1 patient group

Sevoflurane 8% + Intravenous fentanyl
Other group
Description:
Avoidance of rocuronium/cisatracurium
Treatment:
Other: Avoidance of rocuronium/cisatracurium
Drug: Sevoflurane 8% + Intravenous fentanyl

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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