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

Anesthesia; Functional Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02455921
• Other study ID #: EBD 712/19-3-15
• Status: Completed
• Phase: Phase 4
• Start date: June 2015
• Est. completion date: April 2018

Study information

• Verified date: October 2018
• Source: Attikon Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: April 2018
• Est. primary completion date: March 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years to 12 Years

Eligibility

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

Related Conditions & MeSH terms

• Anesthesia; Functional

Intervention

Drug:
• neostigmine - atropine
Efficacy, safety and effect on cognitive and behavioural function
• Sugammadex
Efficacy, safety and effect on cognitive and behavioural function

Locations

Country	Name	City	State
Greece	2nd Department of Anesthesiology, Attikon University Hospital	Athens	Attiki

Sponsors (1)

Lead Sponsor	Collaborator
Attikon Hospital

Country where clinical trial is conducted

Greece, 

References & Publications (1)

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	time of achieving extubation	time of achieving extubation	10 min
Secondary	signs of residual neuromuscular blockade	number of participants with signs of residual	1 hour
Secondary	Behavioural function	changes using Battery test	up to 15th postoperative day