Clinical trial NCT02245789: Does the Use of a Videolaryngoscope Modifies Anesthetic Induction ?
Official title: Does the Use of a Videolaryngoscope Modifies Anesthetic Induction ?
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Tracheal Intubation
Lead sponsor: Hopital Foch
Sponsor class: OTHER
First posted: 2014-09-22
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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. .

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Required dose of opioid to counteract nociceptive stimulation
timeFrame: 1 hour
Secondary outcomes:
measure: Characteristics of anesthesia
timeFrame: one hour
measure: Characteristics of anesthesia
timeFrame: one hour
measure: Characteristics of anesthesia
timeFrame: one hour
measure: Characteristics of tracheal intubation
timeFrame: one hour
measure: Characteristics of tracheal intubation
timeFrame: one hour
measure: Characteristics of tracheal intubation
timeFrame: one hour
measure: Characteristics of tracheal intubation
timeFrame: one hour
measure: Characteristics of tracheal intubation
timeFrame: one hour
measure: Characteristics of tracheal intubation
timeFrame: one hour
measure: Complications of intubation
timeFrame: one day
measure: Ergonomic evaluation of the device
timeFrame: one hour
Other outcomes:
Locations:
city: Levallois-Perret
country: France
facility: Institut Hospitalier Franco-Britannique
state: Hauts de Seine
city: Suresnes
country: France
facility: Hopital Foch
state: Hauts de Seine
Study officials:
affiliation: Hopital Foch
name: Michel Chandon, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.