Sugammadex and neurogical effects central

Phase 1

• 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; Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]

• Registration Number: EUCTR2014-005197-11-IT
• Lead Sponsor: AZIENDA OSPEDALIERA PAPA GIOVANNI XXIII

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-05-12
• Last Update Posted: 10 December 2019

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Not specified
• Target Recruitment: 56

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

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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);Timepoint(s) of evaluation of this end point: for 20 minutes plus 20 minutes previous to and following the administration of sugammadex or neostigmin;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.

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): ///;Timepoint(s) of evaluation of this end point: ///