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Completed

NCT Number: NCT02245789

Does the Use of a Videolaryngoscope Modifies Anesthetic Induction ?

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. .

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Key information

Conditions

Tracheal Intubation

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Institut Hospitalier Franco-Britannique, Levallois-Perret, Hauts de Seine, France

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

tracheal intubation

Procedure

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

Propofol and remifentanil anesthesia

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.

Primary outcomes

  1. Required dose of opioid to counteract nociceptive stimulation

    Time frame: 1 hour

    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.

Secondary outcomes

  1. Characteristics of anesthesia

    Time frame: one hour

    Peak concentration of propofol

  2. Characteristics of anesthesia

    Time frame: one hour

    doses of propofol and of remifentanil (from beginning of the induction to 5 minutes after tracheal intubation)

  3. Characteristics of anesthesia

    Time frame: one hour

    values of bispectral index (from beginning of the induction to 5 minutes after tracheal intubation)

  4. Characteristics of tracheal intubation

    Time frame: one hour

    time to obtain the first capnogram

  5. Characteristics of tracheal intubation

    Time frame: one hour

    visualization of the glottis (score of Cormak and Lehane modified by Yentis, POGO score

  6. Characteristics of tracheal intubation

    Time frame: one hour

    use of alternative techniques for intubation

  7. Characteristics of tracheal intubation

    Time frame: one hour

    esophageal intubation

  8. Characteristics of tracheal intubation

    Time frame: one hour

    incidence of arterial oxygen desaturation (SpO2 <92%)

  9. Characteristics of tracheal intubation

    Time frame: one hour

    hemodynamic effects of induction and tracheal intubation

  10. Complications of intubation

    Time frame: one day

    Throat pain and hoarseness

  11. Ergonomic evaluation of the device

    Time frame: one hour

    questionnaire Qusi

Sponsors and collaborators

Lead sponsor

Hopital Foch

Other

Registry information

Acronym: MGM-PicRemi

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Sep 22, 2014
Registry last updated
Oct 31, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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