Clinical trial NCT01161004: Recovery Effect of Sugammadex Measured by Bispectral and Neurosense Indices
Official title: Pilot Study of EEG Signs of Awakening Secondary to Injection of Sugammadex: Evaluation by Recording Bispectral Index and NeuroSENSE (Prospective, Double-blind Study)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Anesthesia
Lead sponsor: Hopital Foch
Sponsor class: OTHER
First posted: 2010-07-13
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: It has been demonstrated that antagonism of neuromuscular blockade (neostigmine 0.04 mg kg-1) affects depth of anaesthesia with an increase in bispectral index (mean maximal change of 7.1) and middle-latency auditory evoked potentials (mean maximal change of 9.7).

Sugammadex has a quicker and more complete effect than neostigmine. This study aims to demonstrate if sugammadex administration increases bispectral and neurosense indices of the depth of anesthesia while patients still receive propofol-remifentanil iv anesthesia.


Eligibility criteria: Inclusion Criteria:

* patients scheduled to receive general anesthesia with muscle relaxation

Exclusion Criteria:

* contra-indication to the administration of propofol, remifentanil, rocuronium and to the use of the Bispectral Index or NeuroSense monitor
* known drug allergy or hypersensitivity to a drug used in the study
* history of central brain injury
* patient treated with a psychotropic agent
* patient with a pacemaker
* severe renal insufficiency
* treatment by toremifene, flucloxacillin or fusidic acid in the preoperative or immediate postoperative period

Primary outcomes:
measure: modification of bispectral and neurosenses indices following sugammadex injection
timeFrame: day 1 after anesthesia
Secondary outcomes:
measure: efficacy of sugammadex to reverse myorelaxation
timeFrame: day 1 after anesthesia
measure: clinical signs of recovery after sugammadex injection
timeFrame: day 1 after anesthesia
measure: residual myorelaxation in the post-anesthesia care unit
timeFrame: day 1 after anesthesia
measure: score of White and Song during the three first postoperative hours
timeFrame: day 1 after anesthesia
measure: duration of stay in the postanesthesia care unit
timeFrame: day 1 after anesthesia
measure: occurence of explicit memorisation
timeFrame: day 1 after anesthesia
Other outcomes:
Locations:
city: Suresnes
country: France
facility: Hopital Foch
Study officials:
affiliation: Hopital Foch
name: Marc Fischler, MD
role: STUDY_CHAIR
References:
citation: Vasella FC, Frascarolo P, Spahn DR, Magnusson L. Antagonism of neuromuscular blockade but not muscle relaxation affects depth of anaesthesia. Br J Anaesth. 2005 Jun;94(6):742-7. doi: 10.1093/bja/aei120. Epub 2005 Mar 18.
citation: Le Guen M, Roussel C, Chazot T, Dumont GA, Liu N, Fischler M. Reversal of neuromuscular blockade with sugammadex during continuous administration of anaesthetic agents: a double-blind randomised crossover study using the bispectral index. Anaesthesia. 2020 May;75(5):583-590. doi: 10.1111/anae.14897. Epub 2019 Dec 5.