Does the Use of a Videolaryngoscope Modifies Anesthetic Induction ?

Not Applicable

Completed

• Conditions: Tracheal Intubation
• Interventions: Procedure: Tracheal intubation; Drug: Propofol and remifentanil anesthesia

• Registration Number: NCT02245789
• Lead Sponsor: Hopital Foch

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.

Study Timeline

• Study Start: 2014-09
• Study First Submitted: 2014-09-04
• Study First Submitted QC: 2014-09-19
• Study First Posted: 2014-09-22
• Primary Completion: 2015-02
• Study Completion: 2015-02
• Status Verified: 2016-10
• Last Update Submitted: 2016-10-28
• Last Update Posted: 2016-10-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• patient scheduled for a general anesthesia with orotracheal intubation

Read More

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

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
McGrath Mac videolaryngoscope	Propofol and remifentanil anesthesia	Tracheal intubation will be performed using a McGrath Mac videolaryngoscope. All patients will received propofol and remifentanil anesthesia.
Macintosh laryngoscope	Propofol and remifentanil anesthesia	Tracheal intubation will be performed using a Macintosh laryngoscope. All patients will received propofol and remifentanil anesthesia.
Macintosh laryngoscope	Tracheal intubation	Tracheal intubation will be performed using a Macintosh laryngoscope. All patients will received propofol and remifentanil anesthesia.
McGrath Mac videolaryngoscope	Tracheal intubation	Tracheal intubation will be performed using a McGrath Mac videolaryngoscope. All patients will received propofol and remifentanil anesthesia.

Primary Outcome Measures

Name	Time	Method
Required dose of opioid to counteract nociceptive stimulation	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 Outcome Measures

Name	Time	Method
Characteristics of anesthesia	one hour	values of bispectral index (from beginning of the induction to 5 minutes after tracheal intubation)
Characteristics of tracheal intubation	one hour	hemodynamic effects of induction and tracheal intubation
Complications of intubation	one day	Throat pain and hoarseness
Ergonomic evaluation of the device	one hour	questionnaire Qusi

Trial Locations

Locations (2)

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

Hopital Foch; 🇫🇷 Suresnes, Hauts de Seine, France