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. MedDRA version: 16.0 Level: PT Classification code 10057286 Term: Neuromuscular blockade reversal System Organ Class: 10042613 - Surgical and medical procedures
Conditions
Interventions
Trade Name: Bridion
Pharmaceutical Form: Injection
Other descriptive name: SUGAMMADEX
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 100-
Pharmaceuti
Sponsors
Debreceni Egyetem Orvos- és Egészségtudományi Centrum Aneszteziológiai és Intenzív Terápiás Tanszék
Eligibility
Sex/Gender
All
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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) | — |
Countries
Hungary
Contacts
Public ContactDepartmental Office
University of Debrecen, Medical and Health Science Center, Department of Anaesthesiology and Intensive Care
Outcome results
None listed