search
Back to results

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
Puerta de Hierro University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Muscle Relaxation focused on measuring Endotracheal intubation, muscle relaxants, inhalational anesthesia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

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

First Posted
March 29, 2017
Last Updated
April 7, 2017
Sponsor
Puerta de Hierro University Hospital
search

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
Scheller MS, Zornow MH, Saidman LJ. Tracheal intubation without the use of muscle relaxants: a technique using propofol and varying doses of alfentanil. Anesth Analg. 1992 Nov;75(5):788-93. doi: 10.1213/00000539-199211000-00024.
Results Reference
background
Citation
Savarese JJ, Caldwell JE, Lien CA, Miller RD. Pharmacology of muscle relaxants and their antagonists. Anesthesia. 2000;5:412-90.
Results Reference
background
PubMed Identifier
9428849
Citation
Stevens JB, Wheatley L. Tracheal intubation in ambulatory surgery patients: using remifentanil and propofol without muscle relaxants. Anesth Analg. 1998 Jan;86(1):45-9. doi: 10.1097/00000539-199801000-00009.
Results Reference
background
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.
Results Reference
background
PubMed Identifier
3289770
Citation
Trepanier CA, Brousseau C, Lacerte L. Myalgia in outpatient surgery: comparison of atracurium and succinylcholine. Can J Anaesth. 1988 May;35(3 ( Pt 1)):255-8. doi: 10.1007/BF03010619.
Results Reference
background
PubMed Identifier
11682393
Citation
Kirkbride DA, Parker JL, Williams GD, Buggy DJ. Induction of anesthesia in the elderly ambulatory patient: a double-blinded comparison of propofol and sevoflurane. Anesth Analg. 2001 Nov;93(5):1185-7, table of contents. doi: 10.1097/00000539-200111000-00026.
Results Reference
background
PubMed Identifier
9135350
Citation
Thwaites A, Edmends S, Smith I. Inhalation induction with sevoflurane: a double-blind comparison with propofol. Br J Anaesth. 1997 Apr;78(4):356-61. doi: 10.1093/bja/78.4.356.
Results Reference
background
PubMed Identifier
15863438
Citation
Knaggs CL, Drummond GB. Randomized comparison of three methods of induction of anaesthesia with sevoflurane. Br J Anaesth. 2005 Aug;95(2):178-82. doi: 10.1093/bja/aei149. Epub 2005 Apr 29.
Results Reference
background
PubMed Identifier
20953528
Citation
Topuz D, Postaci A, Sacan O, Yildiz N, Dikmen B. A comparison of sevoflurane induction versus propofol induction for laryngeal mask airway insertion in elderly patients. Saudi Med J. 2010 Oct;31(10):1124-9.
Results Reference
background
PubMed Identifier
10325830
Citation
Walpole R, Logan M. Effect of sevoflurane concentration on inhalation induction of anaesthesia in the elderly. Br J Anaesth. 1999 Jan;82(1):20-4. doi: 10.1093/bja/82.1.20.
Results Reference
background
PubMed Identifier
17302078
Citation
Vidal MA, Calderon E, Martinez E, Pernia A, Torres LM. [Comparison of 2 techniques for inhaled anesthetic induction with sevoflurane in coronary artery revascularization]. Rev Esp Anestesiol Reanim. 2006 Dec;53(10):639-42. Spanish.
Results Reference
background
PubMed Identifier
15781547
Citation
Siddik-Sayyid SM, Aouad MT, Taha SK, Daaboul DG, Deeb PG, Massouh FM, Muallem MA, Baraka AS. A comparison of sevoflurane-propofol versus sevoflurane or propofol for laryngeal mask airway insertion in adults. Anesth Analg. 2005 Apr;100(4):1204-1209. doi: 10.1213/01.ANE.0000148166.29749.3B.
Results Reference
background
PubMed Identifier
16827070
Citation
Bel Marcoval I, Gambus Cerrillo P. [Risk assessment, prophylaxis and treatment for postoperative nausea and vomiting]. Rev Esp Anestesiol Reanim. 2006 May;53(5):301-11. Spanish.
Results Reference
background
PubMed Identifier
10475291
Citation
Philip BK, Lombard LL, Roaf ER, Drager LR, Calalang I, Philip JH. Comparison of vital capacity induction with sevoflurane to intravenous induction with propofol for adult ambulatory anesthesia. Anesth Analg. 1999 Sep;89(3):623-7. doi: 10.1097/00000539-199909000-00014.
Results Reference
background

Learn more about this trial

Endotracheal Intubation Without Muscle Relaxants

We'll reach out to this number within 24 hrs