Post Operative Cognitive DysfunctionNCT02419352
Sugammadex and Cognitive Function
A study testing Sugammadex and Neostigmine/atropine in people with Post Operative Cognitive Dysfunction, run by Attikon Hospital at 1 site in Greece.
Trial summary
Post operative cognitive dysfunction (POCD) is recognized as a frequent complication after both cardiac and non cardiac surgery, affecting approximately 1/3 of the patients. The aim of this study is to examine the possible effect of the novel reversal agent sugammadex versus neostigmine/ atropine combination on… Read more about this study
- Who is it for?
- Ages 40 years and olderHealthy volunteers can take part
- Conditions the study is for
- Post Operative Cognitive Dysfunction
- What is being tested?
- Sugammadex and Neostigmine/atropine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 1 siteGreece
- Study dates
- Sep 2010to Dec 2015
- Phase
- Interventional
- 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 40 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients aged >40 years old
- ASA I-III
- Patients scheduled for elective surgery with general anaesthesia.
Who cannot join
- Neuro-, vascular-, orthopedic- or cardiac surgery
- Known psychiatric or disease of the CNS
- History of craniotomy
- Receiving tranquillisers or antidepressants on a regular basis pre-operatively
- Alcoholism or drug dependence
- History of stroke
Show all 9Show fewer
- Refusal of patient
- Inability to read or write
- MMSE < 22 pre-operatively
Trial locations and contacts
1 site in 1 country.
Greece1 site
2nd Department of Anesthesiology, Attikon Hospital, 1 Rimini str.
Athens, 12462
About this study
Official title: Effect of Sugammadex Versus Neostigmine/Atropine Combination on Cognitive Function After Elective Adult Surgery
Post operative cognitive dysfunction (POCD) is recognized as a frequent complication after both cardiac and non cardiac surgery, affecting approximately 1/3 of the patients. The aim of this study is to examine the possible effect of the novel reversal agent sugammadex versus neostigmine/ atropine combination on cognitive function of adult patients after elective surgery during the early post operative period as well as at discharge.
- Conditions
- Post Operative Cognitive Dysfunction
- Being tested
- Sugammadex, Neostigmine/atropine
- Keywords
- Cognitive function
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SugammadexDrug
Also called Bridion
Neostigmine/atropineDrug
| Study group | Role | What they receive |
|---|---|---|
| Sugammadex | Active comparator | Sugammadex is administered to reverse rocuronium-induced neuromuscular blockade at the end of elective surgery. Receives: Drug: Sugammadex |
| Neostigmine/atropine | Active comparator | Neostigmine combined to atropine is administered to reverse rocuronium-induced neuromuscular blockade at the end of elective surgery. Receives: Drug: Neostigmine/atropine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the Mini-Mental State Evaluation test
Measured: Preoperatively, 1 hour postoperatively, at discharge (1-15 days postoperatively)
Change in the clock-drawing test
Measured: Preoperatively, 1 hour postoperatively, at discharge (1-15 days postoperatively)
Change in the Isaacs set test
Measured: Preoperatively, 1 hour postoperatively, at discharge (1-15 days postoperatively)
Secondary outcomes (1)
Time from reversal agent administration to extubation
Measured: After reversal agent administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2015 (estimated)
- Study startSep 2010
- Primary completionDec 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post Operative Cognitive DysfunctionStudies 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 N/A
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 160 participants (actual)
Sponsor and investigators
- Lead sponsor
- Attikon Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chrysanthi Batistaki, Attikon Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02419352
- Sponsor's protocol ID
- 331/21-9-10
- Status last verified
- Apr 2020
- First submitted
- 8 Apr 2015
- Last updated
- 13 Apr 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Sugammadex Versus Neostigmine/Atropine Combination on Cognitive Function After Elective Adult Surgery
- ClinicalTrials.gov ID
- NCT02419352
- Acronym / sponsor ID
- 331/21-9-10
- Conditions
- Post Operative Cognitive Dysfunction
- Keywords
- Cognitive function
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 160 participants (actual)
- Lead sponsor
- Attikon HospitalUniversity, hospital or other
- Study start
- Sep 2010
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 17 Apr 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.
Post operative cognitive dysfunction (POCD) is recognized as a frequent complication after both cardiac and non cardiac surgery, affecting approximately 1/3 of the patients. The aim of this study is to examine the possible effect of the novel reversal agent sugammadex versus neostigmine/ atropine combination on cognitive function of adult patients after elective surgery during the early post operative period as well as at discharge.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sugammadex | Active comparator | Drug: SugammadexSugammadex is administered to reverse rocuronium-induced neuromuscular blockade at the end of elective surgery. |
| Neostigmine/atropine | Active comparator | Drug: Neostigmine/atropineNeostigmine combined to atropine is administered to reverse rocuronium-induced neuromuscular blockade at the end of elective surgery. |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients aged >40 years old
- ASA I-III
- Patients scheduled for elective surgery with general anaesthesia.
Key exclusion criteria (9 listed)
- Neuro-, vascular-, orthopedic- or cardiac surgery
- Known psychiatric or disease of the CNS
- History of craniotomy
- Receiving tranquillisers or antidepressants on a regular basis pre-operatively
- Alcoholism or drug dependence
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 |
|---|---|---|
| SugammadexAlso: Bridion | Drug | Sugammadex |
| Neostigmine/atropine | Drug | Neostigmine/atropine |
Primary outcome
Change in the Mini-Mental State Evaluation test
Time frame: Preoperatively, 1 hour postoperatively, at discharge (1-15 days postoperatively)
Change in the clock-drawing test
Time frame: Preoperatively, 1 hour postoperatively, at discharge (1-15 days postoperatively)
Change in the Isaacs set test
Time frame: Preoperatively, 1 hour postoperatively, at discharge (1-15 days postoperatively)
1 secondary outcome
Time from reversal agent administration to extubation
Time frame: After reversal agent administration
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 13 Apr 2020.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sugammadex and Neostigmine/atropine in people with Post Operative Cognitive Dysfunction, 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 3 inclusion and 9 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 13 Apr 2020. 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.
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?
Change in the Mini-Mental State Evaluation test (time frame: Preoperatively, 1 hour postoperatively, at discharge (1-15 days postoperatively)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 13 Apr 2020.