An interventional study of Tracheal intubation and Propofol and remifentanil anesthesia in Tracheal Intubation, sponsored by Hopital Foch. Completed at 2 sites in France. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2016-10-31.
Sponsored by Hopital Foch · Not applicable, Interventional, and Treatment
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. .
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.
Hopital Foch is the lead sponsor of 208 studies on the registry; 21 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Tracheal intubation will be performed using a Macintosh laryngoscope. All patients will received propofol and remifentanil anesthesia.
Procedure: Tracheal intubation · Drug: Propofol and remifentanil anesthesia
Tracheal intubation will be performed using a McGrath Mac videolaryngoscope. All patients will received propofol and remifentanil anesthesia.
Procedure: Tracheal intubation · Drug: Propofol and remifentanil anesthesia
Tracheal intubation will be performed using a Macintosh laryngoscope or a McGrath Mac videolaryngoscope
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.
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.
Time frame: 1 hour
Characteristics of anesthesia
Peak concentration of propofol
Time frame: one hour
Characteristics of anesthesia
doses of propofol and of remifentanil (from beginning of the induction to 5 minutes after tracheal intubation)
Time frame: one hour
Characteristics of anesthesia
values of bispectral index (from beginning of the induction to 5 minutes after tracheal intubation)
Time frame: one hour
Characteristics of tracheal intubation
time to obtain the first capnogram
Time frame: one hour
Characteristics of tracheal intubation
visualization of the glottis (score of Cormak and Lehane modified by Yentis, POGO score
Time frame: one hour
Characteristics of tracheal intubation
use of alternative techniques for intubation
Time frame: one hour
Characteristics of tracheal intubation
esophageal intubation
Time frame: one hour
Characteristics of tracheal intubation
incidence of arterial oxygen desaturation (SpO2 \<92%)
Time frame: one hour
Characteristics of tracheal intubation
hemodynamic effects of induction and tracheal intubation
Time frame: one hour
Complications of intubation
Throat pain and hoarseness
Time frame: one day
Ergonomic evaluation of the device
questionnaire Qusi
Time frame: one hour
This study is completed, as verified in Oct 2016. You cannot join it, but the record below documents what was studied.
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Hopital Foch