Does the Use of a Videolaryngoscope Modifies Anesthetic Induction ?

Tracheal Intubation Clinical Trial

— MGM-PicRemi  

Official title:

Does the Use of a Videolaryngoscope Modifies Anesthetic Induction ?

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02245789
• Other study ID #: 2013/43
• Secondary ID: 2013-A01308-37
• Status: Completed
• Phase: N/A
• First received: September 4, 2014
• Last updated: October 28, 2016
• Start date: September 2014
• Est. completion date: February 2015

Study information

• Verified date: October 2016
• Source: Hopital Foch
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé
• Study type: Interventional

Clinical Trial 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. .

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: February 2015
• Est. primary completion date: February 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Tracheal Intubation

Intervention

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.

Locations

Country	Name	City	State
France	Institut Hospitalier Franco-Britannique	Levallois-Perret	Hauts de Seine
France	Hopital Foch	Suresnes	Hauts de Seine

Sponsors (1)

Lead Sponsor	Collaborator
Hopital Foch

Country where clinical trial is conducted

France, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	Characteristics of anesthesia	Peak concentration of propofol	one hour	No
Secondary	Characteristics of anesthesia	doses of propofol and of remifentanil (from beginning of the induction to 5 minutes after tracheal intubation)	one hour	No
Secondary	Characteristics of anesthesia	values of bispectral index (from beginning of the induction to 5 minutes after tracheal intubation)	one hour	No
Secondary	Characteristics of tracheal intubation	time to obtain the first capnogram	one hour	No
Secondary	Characteristics of tracheal intubation	visualization of the glottis (score of Cormak and Lehane modified by Yentis, POGO score	one hour	No
Secondary	Characteristics of tracheal intubation	use of alternative techniques for intubation	one hour	No
Secondary	Characteristics of tracheal intubation	esophageal intubation	one hour	No
Secondary	Characteristics of tracheal intubation	incidence of arterial oxygen desaturation (SpO2 <92%)	one hour	No
Secondary	Characteristics of tracheal intubation	hemodynamic effects of induction and tracheal intubation	one hour	No
Secondary	Complications of intubation	Throat pain and hoarseness	one day	No
Secondary	Ergonomic evaluation of the device	questionnaire Qusi	one hour	No