Recovery Effect of Sugammadex Measured by Bispectral and Neurosense Indices (Sugarecovery)

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2014 by Hopital Foch
Sponsor:
Information provided by (Responsible Party):
Hopital Foch
ClinicalTrials.gov Identifier:
NCT01161004
First received: July 9, 2010
Last updated: January 7, 2014
Last verified: January 2014
  Purpose

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.


Condition Intervention Phase
Anesthesia
Drug: Sugammadex - Nacl 9/00
Drug: Nacl 9/00 - sugammadex
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
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)

Further study details as provided by Hopital Foch:

Primary Outcome Measures:
  • modification of bispectral and neurosenses indices following sugammadex injection [ Time Frame: day 1 after anesthesia ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • efficacy of sugammadex to reverse myorelaxation [ Time Frame: day 1 after anesthesia ] [ Designated as safety issue: No ]
  • clinical signs of recovery after sugammadex injection [ Time Frame: day 1 after anesthesia ] [ Designated as safety issue: No ]
  • residual myorelaxation in the post-anesthesia care unit [ Time Frame: day 1 after anesthesia ] [ Designated as safety issue: No ]
  • score of White and Song during the three first postoperative hours [ Time Frame: day 1 after anesthesia ] [ Designated as safety issue: No ]
  • duration of stay in the postanesthesia care unit [ Time Frame: day 1 after anesthesia ] [ Designated as safety issue: No ]
  • occurence of explicit memorisation [ Time Frame: day 1 after anesthesia ] [ Designated as safety issue: No ]

Estimated Enrollment: 50
Study Start Date: September 2010
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Sugammadex - Nacl 9/00

Sugammadex - Nacl 9/00:

Patients will first receive 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.

In case of complete reversal of myorelaxation, total intravenous anesthesia is stopped and patients are allowed to awake.

In the adverse case, patients wil receive Nacl 9/00 10 minutes after the first bolus of sugammadex.

The study is finished 10 minutes after this second injection and care is let to the choice of the anesthesiologist in charge.

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
Other Name: Sugammadex: Bridion
Experimental: Nacl 9/00 - sugammadex

Nacl 9/00 - Sugammadex :

Patients wil first receive Nacl 9/00. In case of complete reversal of myorelaxation, total intravenous anesthesia is stopped and patients are allowed to awake.

In the adverse case, patients wil receive sugammadex 10 minutes after the first bolus of Nacl 9/00.

Sugammadex is given as: 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.

The study is finished 10 minutes after the injection of sugammadex and care is let to the choice of the anesthesiologist in charge.

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.
Other Name: Sugammadex: Bridion

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01161004

Contacts
Contact: Morgan Le Guen, MD 46252442 ext 00331 m.leguen@hopital-foch.org

Locations
France
Hopital Foch Recruiting
Suresnes, France, 92151
Sponsors and Collaborators
Hopital Foch
Investigators
Study Chair: Marc Fischler, MD Hopital Foch
  More Information

Publications:
Responsible Party: Hopital Foch
ClinicalTrials.gov Identifier: NCT01161004     History of Changes
Other Study ID Numbers: 2010/01
Study First Received: July 9, 2010
Last Updated: January 7, 2014
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

ClinicalTrials.gov processed this record on September 18, 2014