NCT02455921

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Jun 2015

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 20, 2015

Completed
8 days until next milestone

First Posted

Study publicly available on registry

May 28, 2015

Completed
4 days until next milestone

Study Start

First participant enrolled

June 1, 2015

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2018

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2018

Completed
Last Updated

October 24, 2018

Status Verified

October 1, 2018

Enrollment Period

2.8 years

First QC Date

May 20, 2015

Last Update Submit

October 23, 2018

Conditions

Anesthesia; Functional

Outcome Measures

Primary Outcomes (1)

  • time of achieving extubation

    time of achieving extubation

    10 min

Secondary Outcomes (2)

  • signs of residual neuromuscular blockade

    1 hour

  • Behavioural function

    up to 15th postoperative day

Study Arms (2)

sugammadex

ACTIVE COMPARATOR

iv sugammadex 2 mg/Kg

Drug: Sugammadex

neostigmine - atropine

ACTIVE COMPARATOR

iv neostigmine 0,05 mg/Kg - atropine 0,02 mg/kg Efficacy, safety and effect on cognitive and behavioural function

Drug: neostigmine - atropine

Interventions

neostigmine - atropineDRUG

Efficacy, safety and effect on cognitive and behavioural function

neostigmine - atropine
SugammadexDRUG

Efficacy, safety and effect on cognitive and behavioural function

Also known as: Bridion
sugammadex

Eligibility Criteria

Age6 Years - 12 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • \- Children undergoing ENT surgery under general anaesthesia.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

2nd Department of Anesthesiology, Attikon University Hospital

Athens, Attica, 12462, Greece

Location

Related 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. Polish.

    PMID: 21413422BACKGROUND

MeSH Terms

Interventions

Sugammadex

Intervention Hierarchy (Ancestors)

gamma-CyclodextrinsCyclodextrinsMacrocyclic CompoundsPolycyclic CompoundsDextrinsStarchGlucansPolysaccharidesCarbohydrates

Study Officials

  • Paraskevi C Matsota, Assoc. Prof.

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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
SCREENING
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor of Anaesthesiology

Study Record Dates

First Submitted

May 20, 2015

First Posted

May 28, 2015

Study Start

June 1, 2015

Primary Completion

March 1, 2018

Study Completion

April 1, 2018

Last Updated

October 24, 2018

Record last verified: 2018-10

Data Sharing

IPD Sharing
Will not share

Locations

GR(1)