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

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ClinicalTrials.gov Identifier: NCT01161004
Recruitment Status : Completed
First Posted : July 13, 2010
Last Update Posted : May 24, 2017
Sponsor:
Information provided by (Responsible Party):
Hopital Foch

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.


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

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Care Provider, 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)
Study Start Date : September 2010
Actual Primary Completion Date : August 2011
Actual Study Completion Date : August 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anesthesia
U.S. FDA Resources

Arm Intervention/treatment
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 5 minutes after the first bolus of sugammadex.

The study is finished 5 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 5 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 5 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



Primary Outcome Measures :
  1. modification of bispectral and neurosenses indices following sugammadex injection [ Time Frame: day 1 after anesthesia ]

Secondary Outcome Measures :
  1. efficacy of sugammadex to reverse myorelaxation [ Time Frame: day 1 after anesthesia ]
  2. clinical signs of recovery after sugammadex injection [ Time Frame: day 1 after anesthesia ]
  3. residual myorelaxation in the post-anesthesia care unit [ Time Frame: day 1 after anesthesia ]
  4. score of White and Song during the three first postoperative hours [ Time Frame: day 1 after anesthesia ]
  5. duration of stay in the postanesthesia care unit [ Time Frame: day 1 after anesthesia ]
  6. occurence of explicit memorisation [ Time Frame: day 1 after anesthesia ]


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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01161004


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