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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sugammadex - Nacl 9/00 | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| modification of bispectral and neurosenses indices following sugammadex injection | day 1 after anesthesia |
| Measure | Description | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Marc Fischler, MD | Hopital Foch | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hopital Foch | Suresnes | 92151 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 15778268 | Background | 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. | |
| 31808151 | Derived | 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. |
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| ID | Term |
|---|---|
| D000077122 | Sugammadex |
| ID | Term |
|---|---|
| D047408 | gamma-Cyclodextrins |
| D003505 | Cyclodextrins |
| D047028 | Macrocyclic Compounds |
| D011083 | Polycyclic Compounds |
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|
| Nacl 9/00 - sugammadex | Drug |
|
|
|
| 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 |
| D003912 |
| Dextrins |
| D013213 | Starch |
| D005936 | Glucans |
| D011134 | Polysaccharides |
| D002241 | Carbohydrates |