Endotracheal Intubation Without Muscle Relaxants

April 7, 2017 updated by: Antonio Romero Berrocal, Puerta de Hierro University Hospital

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

91

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
    • Madrid
      • Majadahonda, Madrid, Spain, 28222
        • Hospital Universitario Puerta de Hierro

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Sevoflurane 8% + Intravenous fentanyl
Avoidance of rocuronium/cisatracurium
Other: Avoidance of rocuronium/cisatracurium
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.
Drug: Sevoflurane 8% + Intravenous fentanyl
Sevoflurane 8% + Intravenous fentanyl was the regimen used for induction and maintenance of anesthesia

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Time from anesthesia induction to 12 hours after the end of surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
from the end of surgery until the discharge day up to 7 days
Post operative nausea and vomiting
Time Frame: first 12 hours after surgery
record of nausea and/or vomiting events
first 12 hours after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Puerta de Hierro University Hospital

Investigators

  • Principal Investigator: Antonio Romero Berrocal, MD,PhD, Hospital Universitario Puerta de Hierro, Madrid, Spain

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2013

Primary Completion (Actual)

November 30, 2014

Study Completion (Actual)

December 15, 2014

Study Registration Dates

First Submitted

March 29, 2017

First Submitted That Met QC Criteria

April 7, 2017

First Posted (Actual)

April 13, 2017

Study Record Updates

Last Update Posted (Actual)

April 13, 2017

Last Update Submitted That Met QC Criteria

April 7, 2017

Last Verified

April 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HUPH:PI:13/15

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Intubation Complication

Clinical Trials on Avoidance of rocuronium/cisatracurium

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in South Africa

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe