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

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

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.

Study Overview

• Status: Completed
• Conditions: Anesthesia
• Intervention / Treatment: Drug: Sugammadex - Nacl 9/00; Drug: Nacl 9/00 - sugammadex

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Phase 4

Contacts and Locations

Study Locations

• France
  • Suresnes, France, 92151
    • Hôpital Foch

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / 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 Names: 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 Names: Sugammadex: Bridion

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Hopital Foch

Publications and helpful links

General Publications

• 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. doi: 10.1093/bja/aei120. Epub 2005 Mar 18.
• Le Guen M, Roussel C, Chazot T, Dumont GA, Liu N, Fischler M. Reversal of neuromuscular blockade with sugammadex during continuous administration of anaesthetic agents: a double-blind randomised crossover study using the bispectral index. Anaesthesia. 2020 May;75(5):583-590. doi: 10.1111/anae.14897. Epub 2019 Dec 5.

Study record dates

Study Major Dates

• Study Start: September 1, 2010
• Primary Completion (Actual): August 1, 2011
• Study Completion (Actual): August 1, 2011

Study Registration Dates

• First Submitted: July 9, 2010
• First Submitted That Met QC Criteria: July 12, 2010
• First Posted (Estimate): July 13, 2010

Study Record Updates

• Last Update Posted (Actual): May 24, 2017
• Last Update Submitted That Met QC Criteria: May 23, 2017
• Last Verified: May 1, 2017

More Information

Terms related to this study

• Other Study ID Numbers: 2010/01