Investigation on occurence of muscle weakness after surgeries

Conditions: The effect of sugammadex and neostigmin on postoperative residual neuromuscular blockade will be investigated, therefore the patients suffering from various conditions undergoing surgery in general anaesthesia with muscle relaxation will be included int he study.sthesia with muscle relaxation will be included in the study.
Therapeutic area: Body processes [G] - Physiological processes [G07]
MedDRA version: 16.0Level: PTClassification code 10057286Term: Neuromuscular blockade reversalSystem Organ Class: 10042613 - Surgical and medical procedures

Registration Number: EUCTR2013-001965-17-HU

Lead Sponsor: Debreceni Egyetem Orvos- és Egészségtudományi Centrum Aneszteziológiai és Intenzív Terápiás Tanszék

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: Not specified

Inclusion Criteria

signed written informed consent sheet
- age 18-65 years
- ASA I-III (American Society of Anesthesiologists physical score)
- BMI 18,5-25 (normal body weight)
- expected opration time at least 50 minutes
- operation requiring intratracheal intubation
- patient in supine position and one arm is accessible

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 90
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

- diseases affecting neuromuscular transmission (myasthenia, myopathy, stroke, severe hepatic or renal insufficiency)
- medications affecting neuromuscular transmission (aminoglycoside antibiotics, magnesium)
- difficult airway, difficult intubation expected
- gravidity
- lactation- acute surgery
- COPD
- glaucoma
- patient participated in an other trial within one month

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The main objective of the trial is to determine the incidence of postoperative residual neuromuscular blockade on arrival to the postanaesthesia care unit after spontaneous recovery from neuromuscular blockade or reversal with sugammadex or neostigmin;Secondary Objective: The secondary objective of the trial is to determine the incendence of recurrent postoperative residual neuromuscular blockade at 20, 40 and 60 minutes after arrival to the postanaesthesia care unit following spontaneous recovery from neuromuscular blockade or reversal with sugammadex or neostgmin;Primary end point(s): The primary endpoint of the study is to define the incidence of postoerpative residual neuromuscular blockade on arrival to the postanaesthesia care unit;Timepoint(s) of evaluation of this end point: On arrival to the postanaesthesia care unit (T0)

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): The secondary endpoint of the study is to determine the incidence of recurrent postoeprative residual neuromuscular blockade at 20, 40 and minutes after arrival to the postanaesthesia care unit;Timepoint(s) of evaluation of this end point: 20, 40, 60 minutes after arrival to the postanaesthesia care unit (T20, T40, T60)