Anesthesia; FunctionalPhase 4NCT02455921
Neuromuscular Blockade Reversal Agent Effect on Postoperative Cognitive Function and Behaviour in Children
A Phase 4 study testing neostigmine - atropine and Sugammadex in people with Anesthesia; Functional, run by Attikon Hospital at 1 site in Greece.
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. Read more about this study
- Who is it for?
- Ages 6 to 12 years
- Conditions the study is for
- Anesthesia; Functional
- What is being tested?
- neostigmine - atropine and Sugammadex
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteGreece
- Study dates
- Jun 2015to Apr 2018
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children undergoing ENT surgery under general anaesthesia.
Who cannot join
- Parents refusal
- Cognitive impairment
- Difficulty in communication due to language issues
- Psychiatric disorder
- Severe systematic disorder
- Known allergy to any drug used
Trial locations and contacts
1 site in 1 country.
Greece1 site
2nd Department of Anesthesiology, Attikon University Hospital
Athens, Attica, 12462
About this study
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
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.
Read the 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:
- Emotionality, Activity, Sociability \& Impulsivity (EASI) Scale
- The Modified Mini-Mental State (3MS) Test - Version G Greek
- Yale Preoperative Anxiety Scale
- Aldrete score
- Emergence Delirium (PAED) scale
- Wong-Baker scale
- Visual Analogue Scale (VAS) (0-10)
- Child Post- Hospital Behavior Questionnaire (PHBQ)]
- 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
- Being tested
- neostigmine - atropine, Sugammadex
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
neostigmine - atropineDrug
Efficacy, safety and effect on cognitive and behavioural function
SugammadexDrug
Also called Bridion
Efficacy, safety and effect on cognitive and behavioural function
| Study group | Role | What they receive |
|---|---|---|
| sugammadex | Active comparator | iv sugammadex 2 mg/Kg Receives: 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 Receives: Drug: neostigmine - atropine |
What is being measured
The primary outcome is the main question the study is designed to answer.
time of achieving extubation
time of achieving extubation
Measured: 10 min
Secondary outcomes (2)
signs of residual neuromuscular blockade
number of participants with signs of residual
Measured: 1 hour
Behavioural function
changes using Battery test
Measured: up to 15th postoperative day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2015 (estimated)
- Study startJun 2015
- Primary completionMar 2018
- Study completionApr 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Anesthesia; FunctionalStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Attikon Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Paraskevi Matsota, Attikon Hospital
- Investigators
- Paraskevi C Matsota, Assoc. Prof., Principal investigator, 2nd Department of Anesthesiology, Attikon University Hospital Athens, Attiki Greece
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02455921
- Sponsor's protocol ID
- EBD 712/19-3-15
- Status last verified
- Oct 2018
- First submitted
- 20 May 2015
- Last updated
- 24 Oct 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 21413422
Study at a glance
From the registry record, last updated by the sponsor on 24 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02455921
- Acronym / sponsor ID
- EBD 712/19-3-15
- Conditions
- Anesthesia; Functional
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Attikon HospitalUniversity, hospital or other
- Study start
- Jun 2015 (actual)
- Primary completion
- Mar 2018 (actual)
- Study completion
- Apr 2018 (actual)
- First posted
- 28 May 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Emotionality, Activity, Sociability \& Impulsivity (EASI) Scale
- The Modified Mini-Mental State (3MS) Test - Version G Greek
- Yale Preoperative Anxiety Scale
- Aldrete score
- Emergence Delirium (PAED) scale
- Wong-Baker scale
- Visual Analogue Scale (VAS) (0-10)
- Child Post- Hospital Behavior Questionnaire (PHBQ)]
- 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 design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| sugammadex | Active comparator | Drug: Sugammadexiv sugammadex 2 mg/Kg |
| neostigmine - atropine | Active comparator | Drug: neostigmine - atropineiv neostigmine 0,05 mg/Kg - atropine 0,02 mg/kg Efficacy, safety and effect on cognitive and behavioural function |
Who may qualify
- Ages
- 6 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Children undergoing ENT surgery under general anaesthesia.
Key exclusion criteria (6 listed)
- Parents refusal
- Cognitive impairment
- Difficulty in communication due to language issues
- Psychiatric disorder
- Severe systematic disorder
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| neostigmine - atropineEfficacy, safety and effect on cognitive and behavioural function | Drug | neostigmine - atropine |
| SugammadexAlso: BridionEfficacy, safety and effect on cognitive and behavioural function | Drug | sugammadex |
Primary outcome
time of achieving extubation
Time frame: 10 min
time of achieving extubation
2 secondary outcomes
signs of residual neuromuscular blockade
Time frame: 1 hour
Behavioural function
Time frame: up to 15th postoperative day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Oct 2018.
- Background: PubMed 21413422Glinka L, Onichimowski D, Sieniuta P, Korecki A. [Sugammadex--two years in clinical practice]. Anestezjol Intens Ter. 2010 Jul-Sep;42(3):155-9. Polish.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Paraskevi C Matsota, Assoc. Prof. principal investigator
2nd Department of Anesthesiology, Attikon University Hospital Athens, Attiki Greece
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing neostigmine - atropine and Sugammadex in people with Anesthesia; Functional, run by Attikon Hospital at 1 site in Greece.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Greece. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
time of achieving extubation (time frame: 10 min). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02455921, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Oct 2018.