Endotracheal Intubation Without Muscle Relaxants
Primary Purpose
Muscle Relaxation, Intubation Complication
Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Avoidance of rocuronium/cisatracurium
Sevoflurane 8% + Intravenous fentanyl
Sponsored by
About this trial
This is an interventional treatment trial for Muscle Relaxation focused on measuring Endotracheal intubation, muscle relaxants, inhalational anesthesia
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
Sites / Locations
- Hospital Universitario Puerta de Hierro
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Sevoflurane 8% + Intravenous fentanyl
Arm Description
Avoidance of rocuronium/cisatracurium
Outcomes
Primary Outcome Measures
Incidence of treatment-emergent adverse events during intubation
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.
Secondary Outcome Measures
Subject satisfaction following surgery
subjects opinion regarding surgery satisfaction was collected
Post operative nausea and vomiting
record of nausea and/or vomiting events
Full Information
NCT ID
NCT03112564
First Posted
March 29, 2017
Last Updated
April 7, 2017
Sponsor
Puerta de Hierro University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT03112564
Brief Title
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
2. Study Status
Record Verification Date
April 2017
Overall Recruitment Status
Completed
Study Start Date
March 1, 2013 (Actual)
Primary Completion Date
November 30, 2014 (Actual)
Study Completion Date
December 15, 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Puerta de Hierro University Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Muscle Relaxation, Intubation Complication
Keywords
Endotracheal intubation, muscle relaxants, inhalational anesthesia
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
91 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Sevoflurane 8% + Intravenous fentanyl
Arm Type
Other
Arm Description
Avoidance of rocuronium/cisatracurium
Intervention Type
Other
Intervention Name(s)
Avoidance of rocuronium/cisatracurium
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Sevoflurane 8% + Intravenous fentanyl
Intervention Description
Sevoflurane 8% + Intravenous fentanyl was the regimen used for induction and maintenance of anesthesia
Primary Outcome Measure Information:
Title
Incidence of treatment-emergent adverse events during intubation
Description
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 Frame
Time from anesthesia induction to 12 hours after the end of surgery
Secondary Outcome Measure Information:
Title
Subject satisfaction following surgery
Description
subjects opinion regarding surgery satisfaction was collected
Time Frame
from the end of surgery until the discharge day up to 7 days
Title
Post operative nausea and vomiting
Description
record of nausea and/or vomiting events
Time Frame
first 12 hours after surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Antonio Romero Berrocal, MD,PhD
Organizational Affiliation
Hospital Universitario Puerta de Hierro, Madrid, Spain
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital Universitario Puerta de Hierro
City
Majadahonda
State/Province
Madrid
ZIP/Postal Code
28222
Country
Spain
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
1416135
Citation
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Results Reference
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PubMed Identifier
9428849
Citation
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PubMed Identifier
10866915
Citation
Joo HS, Perks WJ. Sevoflurane versus propofol for anesthetic induction: a meta-analysis. Anesth Analg. 2000 Jul;91(1):213-9. doi: 10.1097/00000539-200007000-00040.
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PubMed Identifier
3289770
Citation
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PubMed Identifier
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Citation
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PubMed Identifier
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Citation
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PubMed Identifier
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Citation
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Citation
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PubMed Identifier
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Citation
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PubMed Identifier
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Citation
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Citation
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Endotracheal Intubation Without Muscle Relaxants
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