A Phase 4 interventional study of neostigmine - atropine and Sugammadex in Anesthesia; Functional, sponsored by Attikon Hospital. Completed at 1 site in Greece. Open to participants aged 6 Years to 12 Years. Per ClinicalTrials.gov, last updated 2018-10-24.
Sponsored by Attikon Hospital · Phase 4, Interventional, and Screening
The aim of this prospective randomized study is to investigate comparatively the effect of neostigmine-atropine versus sugammadex on speed and quality of recovery and on postoperative cognitive function \& behavior in children undergoing ENT surgery under general anaesthesia.
The aim of this prospective randomized study is to investigate comparatively the effect of neostigmine-atropine vs sugammadex on time of achieving extubation, quality of recovery, postoperative cognitive function and behaviour of children undergoing ENT surgery under general anaesthesia.
In this study after parental approval has been obtained, children with age 6-12 yrs undergoing tonsillectomy and/or adenoidectomy under general anaesthesia will be included. General anaesthesia will be performed using Total Intravenous Anaesthesia (TIVA) technique with continuous infusion of propofol and remifentanil. Rocuronium will be used to achieve neuromuscular blockade (NMB). Neuromuscular reversal will be performed using either atropine-neostigmine or sugammadex. Patients will be divided into 2 groups according to the type of NMB reversal agent used. Intraoperative monitoring will include Bispectral Index Sedation (BIS), SpO2, capnography, noninvasive measurements of blood pressure, heart rate and train of four (TOF).
Children will be assessed preoperatively (one day before surgery and at the morning of day of surgery), intraoperatively, immediate postoperatively and will be followed up for 15 postoperative days. Additionally, parents will be cooperated and questioned.
The primary end-points of the study include the comparative investigation of the effect of neostigmine-atropine vs sugammadex on time of achieving extubation, quality of recovery, and postoperative cognitive function of children. Secondary endpoints will include side effects, signs of residual neuromuscular blockade, agitation and postoperative behavioural changes of children.
For this purpose the following scales and questionnaires will be used:
All the questionnaires will be translated, culturally adapted and validated in Greek. Analysis of the data will include pair wise T test in order to find statistical differences between the two techniques and regression analysis models in order to revile significant correlations between dependent and independent variables. Statistical analysis will be performed with the use of SPSS21 for Windows.
Attikon Hospital is the lead sponsor of 83 studies on the registry; 17 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
iv sugammadex 2 mg/Kg
Drug: Sugammadex
iv neostigmine 0,05 mg/Kg - atropine 0,02 mg/kg Efficacy, safety and effect on cognitive and behavioural function
Drug: neostigmine - atropine
Efficacy, safety and effect on cognitive and behavioural function
Efficacy, safety and effect on cognitive and behavioural function
Also known as: Bridion
time of achieving extubation
time of achieving extubation
Time frame: 10 min
signs of residual neuromuscular blockade
number of participants with signs of residual
Time frame: 1 hour
Behavioural function
changes using Battery test
Time frame: up to 15th postoperative day
Plan to share: No
This study is completed, as verified in Oct 2018. You cannot join it, but the record below documents what was studied.
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Attikon Hospital