Neuromuscular Blockade Reversal Agent Effect on Postoperative Cognitive Function and Behaviour in Children
Condition: Anesthesia; Functional
Study type: Interventional
Phase: Phase 4

Summary: 
      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.
    

Detailed description: 
      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:

        1. Emotionality, Activity, Sociability & Impulsivity (EASI) Scale

        2. The Modified Mini-Mental State (3MS) Test - Version G Greek

        3. Yale Preoperative Anxiety Scale

        4. Aldrete score

        5. Emergence Delirium (PAED) scale

        6. Wong-Baker scale

        7. Visual Analogue Scale (VAS) (0-10)

        8. Child Post- Hospital Behavior Questionnaire (PHBQ)]

        9. Post discharge repeated questionnaire

      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.
    

Intervention name(s): neostigmine - atropine; Sugammadex
Intervention type(s): Drug; Drug
Intervention description(s): Efficacy, safety and effect on cognitive and behavioural function; Efficacy, safety and effect on cognitive and behavioural function
Other intervention name(s): Bridion
Intervention MeSH terms: Atropine; Neostigmine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Screening