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OpenTrials
Completed

NCT Number: NCT01161004

Recovery Effect of Sugammadex Measured by Bispectral and Neurosense Indices

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.

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Key information

Conditions

Anesthesia

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Hopital Foch

Suresnes, 92151, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Sugammadex - Nacl 9/00

Drug
  • 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 names: Sugammadex: Bridion

Nacl 9/00 - sugammadex

Drug
  • 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 names: Sugammadex: Bridion

Primary outcomes

  1. modification of bispectral and neurosenses indices following sugammadex injection

    Time frame: day 1 after anesthesia

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Hopital Foch

Other

Registry information

Official study title

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

Acronym: Sugarecovery

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Jul 13, 2010
Registry last updated
May 24, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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