Muscle RelaxationNCT03112564

Endotracheal Intubation Without Muscle Relaxants

A study testing Avoidance of rocuronium/cisatracurium and Sevoflurane 8% + Intravenous fentanyl in people with Muscle Relaxation and Intubation Complication, run by Puerta de Hierro University Hospital at 1 site in Spain.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial 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… Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Muscle Relaxation, Intubation Complication
What is being tested?: Avoidance of rocuronium/cisatracurium and Sevoflurane 8% + Intravenous fentanyl
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 91 participants
Where: 1 siteSpain
Study dates: 1 Mar 2013to 15 Dec 2014
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Male or Female patients
Age ≥ 18 years
ASA ≤ 3
Able to provide informed consent

Who cannot join

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 locations and contacts

1 site in 1 country.

Spain1 site

Hospital Universitario Puerta de Hierro
Majadahonda, Madrid, 28222

Other trials in Spain

About this study

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

Read the 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.

Conditions: Muscle Relaxation, Intubation Complication
Being tested: Avoidance of rocuronium/cisatracurium, Sevoflurane 8% + Intravenous fentanyl
Keywords: Endotracheal intubation, muscle relaxants, inhalational anesthesia
Medical subject headings: Muscle Hypotonia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Avoidance of rocuronium/cisatracuriumOther
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.
Sevoflurane 8% + Intravenous fentanylDrug
Sevoflurane 8% + Intravenous fentanyl was the regimen used for induction and maintenance of anesthesia

Study groups in NCT03112564
Study group	Role	What they receive
Sevoflurane 8% + Intravenous fentanyl	Other	Avoidance of rocuronium/cisatracurium Receives: Other: Avoidance of rocuronium/cisatracurium; Drug: Sevoflurane 8% + Intravenous fentanyl

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: Time from anesthesia induction to 12 hours after the end of surgery

Secondary outcomes (2)

Subject satisfaction following surgery
subjects opinion regarding surgery satisfaction was collected
Measured: from the end of surgery until the discharge day up to 7 days
Post operative nausea and vomiting
record of nausea and/or vomiting events
Measured: first 12 hours after surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Mar 201315 Dec 2014

First posted13 Apr 2017
Study start1 Mar 2013
Primary completion30 Nov 2014
Study completion15 Dec 2014

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (14)Papers the sponsor has linked to this study.
Other trials for Muscle RelaxationStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 91 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03112564
Sponsor's protocol ID: HUPH:PI:13/15
Status last verified: Apr 2017
First submitted: 29 Mar 2017
Last updated: 13 Apr 2017
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

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.
PubMed 1416135
Savarese JJ, Caldwell JE, Lien CA, Miller RD. Pharmacology of muscle relaxants and their antagonists. Anesthesia. 2000;5:412-90.
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.
PubMed 9428849
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.
PubMed 10866915
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.
PubMed 3289770
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.
PubMed 11682393
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.
PubMed 9135350
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.
PubMed 15863438
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.
PubMed 20953528
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.
PubMed 10325830
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.
PubMed 17302078
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.
PubMed 15781547
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.
PubMed 16827070
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.
PubMed 10475291

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Recruiting
Inspiratory Muscle Training and Diaphragmatic Breathing in GAD
Generalized Anxiety Disorder (GAD)
Not yet recruitingObservational study
Diaphragm Ultrasound and Neuromuscular Monitoring for Predicting Early Respiratory Events After Extubation
Residual Neuromuscular Blockade, Diaphragm Dysfunction
Not yet recruiting
Comparative Effects Of Exercises Targeting Upper Trapezius In Patients With Non Specific Neck Pain
Non Specific Neck Pain
Not yet recruitingObservational study
Sugammadex Timing and Recovery Profile in Pediatric Adenotonsillectomy
Neuromuscular Blockade, Delayed Emergence From Anesthesia
Not yet recruitingPhase 4
Effect of Neuromuscular Blocking Agent Use on Video Laryngeal Mask Airway Insertion
Airway Management, Supraglottic Airway Device Insertion

All Muscle Relaxation trials

Study at a glance

From the registry record, last updated by the sponsor on 13 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Evaluation of the Effectiveness and Safety of Endotracheal Intubation for Inhalational Anesthesia Without the Use of Muscle Relaxants or Analgesics
ClinicalTrials.gov ID: NCT03112564
Acronym / sponsor ID: HUPH:PI:13/15
Conditions: Muscle Relaxation, Intubation Complication
Keywords: Endotracheal intubation, muscle relaxants, inhalational anesthesia
Study type: Interventional
Recruitment status: Completed
Enrolment: 91 participants (actual)
Lead sponsor: Puerta de Hierro University HospitalUniversity, hospital or other
Study start: 1 Mar 2013 (actual)
Primary completion: 30 Nov 2014 (actual)
Study completion: 15 Dec 2014 (actual)
First posted: 13 Apr 2017 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Sevoflurane 8% + Intravenous fentanyl	Other	Other: Avoidance of rocuronium/cisatracurium, Drug: Sevoflurane 8% + Intravenous fentanylAvoidance of rocuronium/cisatracurium

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

Male or Female patients
Age ≥ 18 years
ASA ≤ 3
Able to provide informed consent

Key exclusion criteria (6 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Avoidance of rocuronium/cisatracuriumAnesthesia 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.	Other	Sevoflurane 8% + Intravenous fentanyl
Sevoflurane 8% + Intravenous fentanylSevoflurane 8% + Intravenous fentanyl was the regimen used for induction and maintenance of anesthesia	Drug	Sevoflurane 8% + Intravenous fentanyl

Primary outcome

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.

2 secondary outcomes

Subject satisfaction following surgery
Time frame: 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

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2017.
Background: PubMed 1416135Scheller 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.
BackgroundSavarese JJ, Caldwell JE, Lien CA, Miller RD. Pharmacology of muscle relaxants and their antagonists. Anesthesia. 2000;5:412-90.
Background: PubMed 9428849Stevens 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.
Background: PubMed 10866915Joo 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.
Background: PubMed 3289770Trepanier 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.
Background: PubMed 11682393Kirkbride 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.
Background: PubMed 9135350Thwaites 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.
Background: PubMed 15863438Knaggs 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.
Background: PubMed 20953528Topuz 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.
Background: PubMed 10325830Walpole 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.
Background: PubMed 17302078Vidal 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.
Background: PubMed 15781547Siddik-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.
Individual participant dataSharing planned: No

Related trials for Muscle Relaxation

Recruiting
Inspiratory Muscle Training and Diaphragmatic Breathing in GAD
Generalized Anxiety Disorder (GAD)
Not yet recruitingObservational study
Diaphragm Ultrasound and Neuromuscular Monitoring for Predicting Early Respiratory Events After Extubation
Residual Neuromuscular Blockade, Diaphragm Dysfunction
Not yet recruiting
Comparative Effects Of Exercises Targeting Upper Trapezius In Patients With Non Specific Neck Pain
Non Specific Neck Pain
Not yet recruitingObservational study
Sugammadex Timing and Recovery Profile in Pediatric Adenotonsillectomy
Neuromuscular Blockade, Delayed Emergence From Anesthesia
Not yet recruitingPhase 4
Effect of Neuromuscular Blocking Agent Use on Video Laryngeal Mask Airway Insertion
Airway Management, Supraglottic Airway Device Insertion

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Antonio Romero Berrocal, MD,PhD principal investigator

Hospital Universitario Puerta de Hierro, Madrid, Spain

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 13 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of treatment-emergent adverse events during intubation (time frame: Time from anesthesia induction to 12 hours after the end of surgery). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03112564, which also lists 14 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2017.