Does the Use of a Videolaryngoscope Modifies Anesthetic Induction ?

NCT ID: NCT02245789

Last Updated: 2016-10-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-09-30

Study Completion Date

2015-02-28

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Videolaryngoscopes become widely used. The aim of this study is to compare anesthetic induction when patients are tracheally intubated using a MacGraph Mac videolaryngoscope or a conventional MacIntosh laryngoscope.

Tracheal intubation induces a nociceptive stimulation. Hypothesis is that the use of a videolaryngoscope induces a less pronounced nociceptive stimulation and, consequently, that it modifies the anesthetic drugs requirement. .

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

All patients will received a standardized anesthetic procedure : combined closed-loop anesthesia system using bispectral index as control variable and two proportional-differential control algorithms, a propofol and a remifentanil target-controlled infusion system. The effectiveness of such a closed-loop anesthesia system has been demonstrated in a prospective, randomized study.

Patients will be randomized in two groups : intubation using a conventional MacIntosh laryngoscope or intubation using a videolaryngoscope.

If our hypothesis is confirmed, the required concentration of remifentanil, an opioid agent, will be reduced in the group using a videolaryngoscope.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Tracheal Intubation

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Macintosh laryngoscope

Tracheal intubation will be performed using a Macintosh laryngoscope. All patients will received propofol and remifentanil anesthesia.

Group Type ACTIVE_COMPARATOR

Tracheal intubation

Intervention Type PROCEDURE

Tracheal intubation will be performed using a Macintosh laryngoscope or a McGrath Mac videolaryngoscope

Propofol and remifentanil anesthesia

Intervention Type DRUG

The standardized anesthetic procedure used a closed-loop anesthesia system with bispectral index as control variable and with two proportional-differential control algorithms, one for propofol target-controlled infusion system and one for remifentanil target-controlled infusion system.

McGrath Mac videolaryngoscope

Tracheal intubation will be performed using a McGrath Mac videolaryngoscope. All patients will received propofol and remifentanil anesthesia.

Group Type EXPERIMENTAL

Tracheal intubation

Intervention Type PROCEDURE

Tracheal intubation will be performed using a Macintosh laryngoscope or a McGrath Mac videolaryngoscope

Propofol and remifentanil anesthesia

Intervention Type DRUG

The standardized anesthetic procedure used a closed-loop anesthesia system with bispectral index as control variable and with two proportional-differential control algorithms, one for propofol target-controlled infusion system and one for remifentanil target-controlled infusion system.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Tracheal intubation

Tracheal intubation will be performed using a Macintosh laryngoscope or a McGrath Mac videolaryngoscope

Intervention Type PROCEDURE

Propofol and remifentanil anesthesia

The standardized anesthetic procedure used a closed-loop anesthesia system with bispectral index as control variable and with two proportional-differential control algorithms, one for propofol target-controlled infusion system and one for remifentanil target-controlled infusion system.

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* patient scheduled for a general anesthesia with orotracheal intubation

Exclusion Criteria

* predictable risk of difficult mask ventilation or of difficult tracheal intubation
* necessity of a rapid sequence induction
* contra-indication to the use of the automated administration of propofol and of remifentanil
* contra-indication to the use of atracurium
* Otolaryngology, thoracic surgery, or intracranial surgery
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Hopital Foch

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Michel Chandon, MD

Role: PRINCIPAL_INVESTIGATOR

Hopital Foch

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Institut Hospitalier Franco-Britannique

Levallois-Perret, Hauts de Seine, France

Site Status

Hopital Foch

Suresnes, Hauts de Seine, France

Site Status

Countries

Review the countries where the study has at least one active or historical site.

France

References

Explore related publications, articles, or registry entries linked to this study.

Liu N, Chazot T, Hamada S, Landais A, Boichut N, Dussaussoy C, Trillat B, Beydon L, Samain E, Sessler DI, Fischler M. Closed-loop coadministration of propofol and remifentanil guided by bispectral index: a randomized multicenter study. Anesth Analg. 2011 Mar;112(3):546-57. doi: 10.1213/ANE.0b013e318205680b. Epub 2011 Jan 13.

Reference Type BACKGROUND
PMID: 21233500 (View on PubMed)

Ing R, Liu N, Chazot T, Fessler J, Dreyfus JF, Fischler M, Le Guen M. Nociceptive stimulation during Macintosh direct laryngoscopy compared with McGrath Mac videolaryngoscopy: A randomized trial using indirect evaluation using an automated administration of propofol and remifentanil. Medicine (Baltimore). 2017 Sep;96(38):e8087. doi: 10.1097/MD.0000000000008087.

Reference Type DERIVED
PMID: 28930848 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2013-A01308-37

Identifier Type: OTHER

Identifier Source: secondary_id

2013/43

Identifier Type: -

Identifier Source: org_study_id