Recovery Effect of Sugammadex Measured by Bispectral and Neurosense Indices

NCT01161004 | Completed Phase 4

• 1 other identifier: 2010/01
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Anesthesia

Outcome Measures

Primary Outcomes (1)

• modification of bispectral and neurosenses indices following sugammadex injection

  day 1 after anesthesia

Secondary Outcomes (6)

• 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

Study Arms (2)

Sugammadex - Nacl 9/00

EXPERIMENTAL

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

Nacl 9/00 - sugammadex

EXPERIMENTAL

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

Interventions

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

Also known as: Sugammadex: Bridion

Sugammadex - Nacl 9/00

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.

Also known as: Sugammadex: Bridion

Nacl 9/00 - sugammadex

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• patients scheduled to receive general anesthesia with muscle relaxation

You may not qualify if:

• 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

Sponsors & Collaborators

• Hopital Foch: lead

Study Sites (1)

Hopital Foch

Suresnes, 92151, France

Location

Related Publications (2)

• 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.

  PMID: 15778268 BACKGROUND

• 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.

  PMID: 31808151 DERIVED

MeSH Terms

Interventions

Sugammadex

Intervention Hierarchy (Ancestors)

gamma-Cyclodextrins; Cyclodextrins; Macrocyclic Compounds; Polycyclic Compounds; Dextrins; Starch; Glucans; Polysaccharides; Carbohydrates

Study Officials

• Marc Fischler, MD

  Hopital Foch

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 9, 2010
• First Posted: July 13, 2010
• Study Start: September 1, 2010
• Primary Completion: August 1, 2011
• Study Completion: August 1, 2011
• Last Updated: May 24, 2017

Record last verified: 2017-05

Locations

FR (1)