NCT01161004

Recovery Effect of Sugammadex Measured by Bispectral and Neurosense Indices

Pilot Study of EEG Signs of Awakening Secondary to Injection of Sugammadex: Evaluation by Recording Bispectral Index and NeuroSENSE (Prospective, Double-blind Study)

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 50 (actual)
• Sponsor: Hopital Foch · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Anesthesia

Interventions

Type	Name	Description
DRUG	Sugammadex - Nacl 9/00	* Sugammadex: 4 mg/kg when post tetanic count shows at least 1 or 2 responses; 2 mg/kg when Train of four shows at least 2 responses. * Nacl 9/00: same volume as Sugammadex
DRUG	Nacl 9/00 - sugammadex	* Nacl 9/00: same volume as Sugammadex * Sugammadex: 4 mg/kg when post tetanic count shows at least 1 or 2 responses; 2 mg/kg when Train of four shows at least 2 responses.

Timeline

• Start date: 2010-09-01
• Primary completion: 2011-08-01
• Completion: 2011-08-01
• First posted: 2010-07-13
• Last updated: 2017-05-24

Locations

1 site across 1 country: France