Neuromuscular Blockade Reversal Agent Effect on Postoperative Cognitive Function and Behaviour in Children

Comparative Effect of Neuromuscular Blockade Reversal Agent on Extubation Conditions, Postoperative Cognitive Function and Behaviour of School-aged Children Undergoing Ear Note Throat (ENT) Surgery

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.

Study Overview

• Status: Completed
• Conditions: Anesthesia; Functional
• Intervention / Treatment: Drug: Sugammadex; Drug: neostigmine - atropine

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.

• Study Type: Interventional
• Enrollment (Actual): 200
• Phase: Phase 4

Contacts and Locations

Study Locations

• Greece
  • Attiki
    • Athens, Attiki, Greece, 12462
      • 2nd Department of Anesthesiology, Attikon University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 years to 12 years (CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

- Children undergoing ENT surgery under general anaesthesia.

Exclusion Criteria:

• Parents refusal
• Cognitive impairment
• Difficulty in communication due to language issues
• Psychiatric disorder
• Severe systematic disorder
• Known allergy to any drug used

Study Plan

How is the study designed?

Design Details

• Primary Purpose: SCREENING
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: sugammadex; iv sugammadex 2 mg/Kg	Drug: Sugammadex; Efficacy, safety and effect on cognitive and behavioural function; Other Names: Bridion
Active Comparator: neostigmine - atropine; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
time of achieving extubation	time of achieving extubation	10 min

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
signs of residual neuromuscular blockade	number of participants with signs of residual	1 hour
Behavioural function	changes using Battery test	up to 15th postoperative day

Collaborators and Investigators

• Sponsor: Attikon Hospital
• Investigators: Principal Investigator: Paraskevi C Matsota, Assoc. Prof., 2nd Department of Anesthesiology, Attikon University Hospital Athens, Attiki Greece

Publications and helpful links

General Publications

• Glinka L, Onichimowski D, Sieniuta P, Korecki A. [Sugammadex--two years in clinical practice]. Anestezjol Intens Ter. 2010 Jul-Sep;42(3):155-9. Polish.

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2015
• Primary Completion (Actual): March 1, 2018
• Study Completion (Actual): April 1, 2018

Study Registration Dates

• First Submitted: May 20, 2015
• First Submitted That Met QC Criteria: May 27, 2015
• First Posted (Estimate): May 28, 2015

Study Record Updates

• Last Update Posted (Actual): October 24, 2018
• Last Update Submitted That Met QC Criteria: October 23, 2018
• Last Verified: October 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Anti-Arrhythmia Agents; Parasympatholytics; Autonomic Agents; Peripheral Nervous System Agents; Muscarinic Antagonists; Cholinergic Antagonists; Cholinergic Agents; Enzyme Inhibitors; Adjuvants, Anesthesia; Bronchodilator Agents; Anti-Asthmatic Agents; Respiratory System Agents; Cholinesterase Inhibitors; Mydriatics; Parasympathomimetics; Atropine; Neostigmine
• Other Study ID Numbers: EBD 712/19-3-15

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No