Recovery Effect of Sugammadex Measured by Bispectral and Neurosense Indices

Anesthesia Clinical Trial

— Sugarecovery  

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01161004
• Other study ID #: 2010/01
• Status: Completed
• Phase: Phase 4
• First received: July 9, 2010
• Last updated: May 23, 2017
• Start date: September 2010
• Est. completion date: August 2011

Study information

• Verified date: May 2017
• Source: Hopital Foch
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: August 2011
• Est. primary completion date: August 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Anesthesia

Intervention

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
• 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.

Locations

Country	Name	City	State
France	Hopital Foch	Suresnes

Sponsors (1)

Lead Sponsor	Collaborator
Hopital Foch

Country where clinical trial is conducted

France, 

References & Publications (1)

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. Epub 2005 Mar 18. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	modification of bispectral and neurosenses indices following sugammadex injection		day 1 after anesthesia
Secondary	efficacy of sugammadex to reverse myorelaxation		day 1 after anesthesia
Secondary	clinical signs of recovery after sugammadex injection		day 1 after anesthesia
Secondary	residual myorelaxation in the post-anesthesia care unit		day 1 after anesthesia
Secondary	score of White and Song during the three first postoperative hours		day 1 after anesthesia
Secondary	duration of stay in the postanesthesia care unit		day 1 after anesthesia
Secondary	occurence of explicit memorisation		day 1 after anesthesia