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

NCT ID: NCT02455921

Last Updated: 2018-10-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-06-30
• Study Completion Date: 2018-04-30

Brief 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.

Conditions

Anesthesia; Functional

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SCREENING
• Blinding Strategy: SINGLE

Study Groups

sugammadex

iv sugammadex 2 mg/Kg

Group Type: ACTIVE_COMPARATOR

Sugammadex

Intervention Type: DRUG

Efficacy, safety and effect on cognitive and behavioural function

neostigmine - atropine

iv neostigmine 0,05 mg/Kg - atropine 0,02 mg/kg

Efficacy, safety and effect on cognitive and behavioural function

Group Type: ACTIVE_COMPARATOR

neostigmine - atropine

Intervention Type: DRUG

Efficacy, safety and effect on cognitive and behavioural function

Interventions

neostigmine - atropine

Efficacy, safety and effect on cognitive and behavioural function

Intervention Type: DRUG

Sugammadex

Efficacy, safety and effect on cognitive and behavioural function

Intervention Type: DRUG

Other Intervention Names

Bridion

Eligibility Criteria

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

• Minimum Eligible Age: 6 Years
• Maximum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Attikon Hospital

OTHER

Sponsor Role: lead

Responsible Party

Paraskevi Matsota

Associate Professor of Anaesthesiology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Paraskevi C Matsota, Assoc. Prof.

Role: PRINCIPAL_INVESTIGATOR

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

Locations

2nd Department of Anesthesiology, Attikon University Hospital

Athens, Attica, Greece

Countries

Greece

References

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.

Reference Type: BACKGROUND

PMID: 21413422 (View on PubMed)

Other Identifiers

EBD 712/19-3-15

Identifier Type: -

Identifier Source: org_study_id