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

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01161004

Acronym

Sugarecovery

Enrollment

Registered

2010-07-13

Start date

2010-09-30

Completion date

2011-08-31

Last updated

2017-05-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anesthesia

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.

Interventions

DRUGSugammadex - 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

DRUGNacl 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.

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
modification of bispectral and neurosenses indices following sugammadex injection	day 1 after anesthesia

Secondary

Measure	Time frame
clinical signs of recovery after sugammadex injection	day 1 after anesthesia
residual myorelaxation in the post-anesthesia care unit	day 1 after anesthesia
efficacy of sugammadex to reverse myorelaxation	day 1 after anesthesia
duration of stay in the postanesthesia care unit	day 1 after anesthesia
occurence of explicit memorisation	day 1 after anesthesia
score of White and Song during the three first postoperative hours	day 1 after anesthesia

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026