NCT02245789

Brief Summary

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. .

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2014

Shorter than P25 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2014

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

September 4, 2014

Completed
18 days until next milestone

First Posted

Study publicly available on registry

September 22, 2014

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2015

Completed
Last Updated

October 31, 2016

Status Verified

October 1, 2016

Enrollment Period

5 months

First QC Date

September 4, 2014

Last Update Submit

October 28, 2016

Conditions

Tracheal Intubation

Outcome Measures

Primary Outcomes (1)

  • Required dose of opioid to counteract nociceptive stimulation

    Tracheal intubation induces a nociceptive stimulation. Hypothesis is that the use of a videolaryngoscope induces a less pronounced nociceptive stimulation and, consequently, that the required maximal concentration of remifentanil is lower than when a standard laryngoscope is used.

    1 hour

Secondary Outcomes (11)

  • Characteristics of anesthesia

    one hour

  • Characteristics of anesthesia

    one hour

  • Characteristics of anesthesia

    one hour

  • Characteristics of tracheal intubation

    one hour

  • Characteristics of tracheal intubation

    one hour

  • +6 more secondary outcomes

Study Arms (2)

Macintosh laryngoscope

ACTIVE COMPARATOR

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

Procedure: Tracheal intubationDrug: Propofol and remifentanil anesthesia

McGrath Mac videolaryngoscope

EXPERIMENTAL

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

Procedure: Tracheal intubationDrug: Propofol and remifentanil anesthesia

Interventions

Tracheal intubationPROCEDURE

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

Macintosh laryngoscopeMcGrath Mac videolaryngoscope
Propofol and remifentanil anesthesiaDRUG

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.

Macintosh laryngoscopeMcGrath Mac videolaryngoscope

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • patient scheduled for a general anesthesia with orotracheal intubation

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Institut Hospitalier Franco-Britannique

Levallois-Perret, Hauts de Seine, 92300, France

Location

Hopital Foch

Suresnes, Hauts de Seine, 92151, France

Location

Related Publications (2)

  • 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.

    PMID: 21233500BACKGROUND

  • 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.

    PMID: 28930848DERIVED

MeSH Terms

Interventions

Intubation, IntratrachealPropofol

Intervention Hierarchy (Ancestors)

Airway ManagementTherapeuticsIntubationInvestigative TechniquesPhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic Chemicals

Study Officials

  • Michel Chandon, MD

    Hopital Foch

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 4, 2014

First Posted

September 22, 2014

Study Start

September 1, 2014

Primary Completion

February 1, 2015

Study Completion

February 1, 2015

Last Updated

October 31, 2016

Record last verified: 2016-10

Locations

FR(2)