Does the Use of a Videolaryngoscope Modifies Anesthetic Induction ? (MGM-PicRemi)

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. .

Study Overview

• Status: Completed
• Conditions: Tracheal Intubation
• Intervention / Treatment: Procedure: Tracheal intubation; Drug: Propofol and remifentanil anesthesia

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 Type: Interventional
• Enrollment (Actual): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Hauts de Seine
    • Levallois-Perret, Hauts de Seine, France, 92300
      • Institut hospitalier franco-britannique
    • Suresnes, Hauts de Seine, France, 92151
      • Hopital Foch

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Macintosh laryngoscope; Tracheal intubation will be performed using a Macintosh laryngoscope. All patients will received propofol and remifentanil anesthesia.	Procedure: Tracheal intubation; Tracheal intubation will be performed using a Macintosh laryngoscope or a McGrath Mac videolaryngoscope; Drug: Propofol and remifentanil anesthesia; 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.
Experimental: McGrath Mac videolaryngoscope; Tracheal intubation will be performed using a McGrath Mac videolaryngoscope. All patients will received propofol and remifentanil anesthesia.	Procedure: Tracheal intubation; Tracheal intubation will be performed using a Macintosh laryngoscope or a McGrath Mac videolaryngoscope; Drug: Propofol and remifentanil anesthesia; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Characteristics of anesthesia	Peak concentration of propofol	one hour
Characteristics of anesthesia	doses of propofol and of remifentanil (from beginning of the induction to 5 minutes after tracheal intubation)	one hour
Characteristics of anesthesia	values of bispectral index (from beginning of the induction to 5 minutes after tracheal intubation)	one hour
Characteristics of tracheal intubation	time to obtain the first capnogram	one hour
Characteristics of tracheal intubation	visualization of the glottis (score of Cormak and Lehane modified by Yentis, POGO score	one hour
Characteristics of tracheal intubation	use of alternative techniques for intubation	one hour
Characteristics of tracheal intubation	esophageal intubation	one hour
Characteristics of tracheal intubation	incidence of arterial oxygen desaturation (SpO2 <92%)	one hour
Characteristics of tracheal intubation	hemodynamic effects of induction and tracheal intubation	one hour
Complications of intubation	Throat pain and hoarseness	one day
Ergonomic evaluation of the device	questionnaire Qusi	one hour

Collaborators and Investigators

• Sponsor: Hopital Foch
• Investigators: Principal Investigator: Michel Chandon, MD, Hopital Foch

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start: September 1, 2014
• Primary Completion (Actual): February 1, 2015
• Study Completion (Actual): February 1, 2015

Study Registration Dates

• First Submitted: September 4, 2014
• First Submitted That Met QC Criteria: September 19, 2014
• First Posted (Estimate): September 22, 2014

Study Record Updates

• Last Update Posted (Estimate): October 31, 2016
• Last Update Submitted That Met QC Criteria: October 28, 2016
• Last Verified: October 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Analgesics, Opioid; Narcotics; Hypnotics and Sedatives; Remifentanil; Propofol
• Other Study ID Numbers: 2013/43; 2013-A01308-37 (Other Identifier: ANSM)