Sugammadex and neurogical effects central

Sugammadex and neurogical effects central - SENC

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2014-005197-11-IT

Enrollment

Registered

2015-05-12

Start date

2015-04-24

Completion date

Unknown

Last updated

2024-12-16

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

Conditions

patient undergoing elective surgery for which has been indicated only the general anesthesia with tracheal intubation and curarization MedDRA version: 18.0 Level: LLT Classification code 10002323 Term: Anesthesia general System Organ Class: 100000004865

Interventions

Trade Name: BRIDION - 100 MG/ML SOLUZIONE INIETTABILE - USO ENDOVENOSO - FLACONCINO (VETRO) TAPPO DI GOMMA E CAPSULA DI CHIUSURA A STRAPPO-5 ML (100MG/ML) 10 X 5 ML Product Name: Bridion 100 mg/ml Pha

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: women Aged between 18 and 65 years old Risk class ASA I-II indication for tracheal intubation surgery is indicated only general anesthesia Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 56 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: Age below 18 years and 65 years Acute or chronic renal insufficiency (serum creatinine = 1.5) Hepatic impairment (PTINR, transaminases, LDH, bilirubin 1.5 times the normal value, PTL <70,000 mm3) Emergency operations Neurological disorders in treatment (including Parkinson's) Known hypersensitivity to sugammadex or neostigmine or excipients contained therein Subjects with asthma

Design outcomes

Primary

Measure	Time frame
Main Objective: neurogical effects resulting from the use of Sugammadex or Neostigmina;Secondary Objective: reversal of neuromuscolar blockade induced by rocurobìnium or vecuroniom of adult (TOF ratio>0.9);Primary end point(s): neurogical central effects-evaluation of the appearance of the '"arousal" on the EEG pattern following the administration of the reverse in the absence of variation of the anesthesia plan. L '"arousal" is defined as an abrupt change in the frequency electroencephalographic baseline that includes the appearance of alpha waves and / or theta and / or delta with a greater frequency of 16 Hz and a duration of at least 3 seconds. This frequency change should be observed in both channels.;Timepoint(s) of evaluation of this end point: for 20 minutes plus 20 minutes previous to and following the administration of sugammadex or neostigmin	—

Measure

Time frame

Main Objective: neurogical effects resulting from the use of Sugammadex or Neostigmina;Secondary Objective: reversal of neuromuscolar blockade induced by rocurobìnium or vecuroniom of adult (TOF ratio>0.9);Primary end point(s): neurogical central effects-evaluation of the appearance of the '"arousal" on the EEG pattern following the administration of the reverse in the absence of variation of the anesthesia plan. L '"arousal" is defined as an abrupt change in the frequency electroencephalographic baseline that includes the appearance of alpha waves and / or theta and / or delta with a greater frequency of 16 Hz and a duration of at least 3 seconds. This frequency change should be observed in both channels.;Timepoint(s) of evaluation of this end point: for 20 minutes plus 20 minutes previous to and following the administration of sugammadex or neostigmin

—

Secondary

Measure	Time frame
Secondary end point(s): ///;Timepoint(s) of evaluation of this end point: ///	—

Countries

Italy

Contacts

Public ContactUSC Anestesia e Rianimazione I

A.O Papa Giovanni XXIII

abenigni@hpg23.it0352675110

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026