Postoperative Cognitive DysfunctionNCT04279132
EFFECT OF ANESTHESİA TECHNIQUES ON POSTOPERATİVE COGNİTİVE DYSFUNCTION FOR MMSE AND NSE LEVEL
An observational study of Postoperative Cognitive Dysfunction and NEURON SPECIFIC ENOLASE, run by Erzincan University at 1 site in Turkey (Türkiye).
Trial summary
The aim of this study is to compare the effects of total intravenous anesthesia and inhalation anesthesia methods on postoperative cognitive dysfunction according to Mini Mental State Examination scores and Neuron Specific Enolase levels in lumbar disc herniectomy operations. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Postoperative Cognitive Dysfunction, NEURON SPECIFIC ENOLASE, MINI MENTAL STATE EXAMINATION TEST
- What is being tested?
- POSTOPERATIVE COGNITIVE DYSFUNCTION
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 80 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 21 Mar 2020to 21 Jul 2020
- How long will I take part?
- 1 Day
- Phase
- Observational
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Lumbal disc herniectomy operation is planned for ASA I, II and III risk group between the ages of 18-65.
Who may be able to join
- -Lumbal disc herniectomy operation 18-65 age
Who cannot join
- Patients before and after the coronary artery bypass graft surgery
- patients in the last trimester of pregnancy
- patients with severe heart failure
- liver failure
- kidney failure
- malignant hyperthermia
Show all 13Show fewer
- lactating patients
- patients with vision or hearing problems
- patients having difficulty in understanding and speaking Turkish
- Parkinson's and Alzheimer's disease
- alcohol and drug addicts
- morbidly obese patients
- intraoperative hypotension, hypertension and hypoxemia
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Erzincan Byu
Erzincan
TÜLAY CEREN ÖLMEZTÜRK KARAKURT, 05058616006, ceren_olmezturk_@hotmail.com
About this study
Official title: THE EFFECT OF TOTAL INTRAVENOUS ANESTHESIA AND INHALATION ANESTHESIA TECHNIQUES FOR MINI MENTAL STATE EXAMINATION TEST AND NEURON SPECIFIC ENOLASE LEVEL IN LUMBAR DISK HERNIECTOMY OPERATIONS
The aim of this study is to compare the effects of total intravenous anesthesia and inhalation anesthesia methods on postoperative cognitive dysfunction according to Mini Mental State Examination scores and Neuron Specific Enolase levels in lumbar disc herniectomy operations.
- Conditions
- Postoperative Cognitive Dysfunction, NEURON SPECIFIC ENOLASE, MINI MENTAL STATE EXAMINATION TEST
- Being tested
- POSTOPERATIVE COGNITIVE DYSFUNCTION
- Medical subject headings
- Postoperative Cognitive Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
POSTOPERATIVE COGNITIVE DYSFUNCTIONBehavioural
NEURON SPECIFIC ENOLASE LEVELS IN LUMBAR DISC HERNIECTOMY WITH GENERAL ANESTHESIA MODALITIES
| Study group | Role | What they receive |
|---|---|---|
| TOTAL INTRAVENOUS ANESTHESIA | Not described Receives: Behavioral: POSTOPERATIVE COGNITIVE DYSFUNCTION | |
| INHALATION ANESTHESIA | Not described Receives: Behavioral: POSTOPERATIVE COGNITIVE DYSFUNCTION |
What is being measured
The primary outcome is the main question the study is designed to answer.
MINI MENTAL STATE EXAMINATION TEST
BELOW 27 SCORE IS ASSOSIATED WITH POSTOPERATIVE COGNITIVE DYSFUNCTION
Measured: 1 MONTH
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2020
- Study start21 Mar 2020 (estimated)
- Primary completion21 May 2020 (estimated)
- Study completion21 Jul 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Postoperative 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 80 participants (estimated)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Erzincan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, TULAY CEREN OLMEZTURK KARAKURT, Erzincan University
- Investigators
- TÜLAY CEREN ÖLMEZTÜRK KARAKURT, Principal investigator, ERZINCAN BYU
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04279132
- Sponsor's protocol ID
- 19/10
- Status last verified
- Feb 2020
- First submitted
- 19 Feb 2020
- Last updated
- 20 Feb 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Goswami U, Babbar S, Tiwari S. Comparative evaluation of the effects of propofol and sevoflurane on cognitive function and memory in patients undergoing laparoscopic cholecystectomy: A randomised prospective study. Indian J Anaesth. 2015 Mar;59(3):150-5. doi: 10.4103/0019-5049.153036.
PubMed 25838586Luescher T, Mueller J, Isenschmid C, Kalt J, Rasiah R, Tondorf T, Gamp M, Becker C, Sutter R, Tisljar K, Schuetz P, Marsch S, Hunziker S. Neuron-specific enolase (NSE) improves clinical risk scores for prediction of neurological outcome and death in cardiac arrest patients: Results from a prospective trial. Resuscitation. 2019 Sep;142:50-60. doi: 10.1016/j.resuscitation.2019.07.003. Epub 2019 Jul 12.
PubMed 31306716Baysalman HB, Oğuz G, Açıkgöz G, Aksakal FN, Ünver SJJotTA, Dergisi ICS-JTAvR. Total İntravenöz ve Desfluran Anestezilerinin Erken Derlenme ve Kognitif Fonksiyonlara Etkileri. 2011;39(1).
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- THE EFFECT OF TOTAL INTRAVENOUS ANESTHESIA AND INHALATION ANESTHESIA TECHNIQUES FOR MINI MENTAL STATE EXAMINATION TEST AND NEURON SPECIFIC ENOLASE LEVEL IN LUMBAR DISK HERNIECTOMY OPERATIONS
- ClinicalTrials.gov ID
- NCT04279132
- Acronym / sponsor ID
- 19/10
- Conditions
- Postoperative Cognitive Dysfunction, NEURON SPECIFIC ENOLASE, MINI MENTAL STATE EXAMINATION TEST
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Erzincan UniversityUniversity, hospital or other
- Study start
- 21 Mar 2020 (estimated)
- Primary completion
- 21 May 2020 (estimated)
- Study completion
- 21 Jul 2020 (estimated)
- First posted
- 20 Feb 2020 (actual)
- 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 study is to compare the effects of total intravenous anesthesia and inhalation anesthesia methods on postoperative cognitive dysfunction according to Mini Mental State Examination scores and Neuron Specific Enolase levels in lumbar disc herniectomy operations.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Day
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TOTAL INTRAVENOUS ANESTHESIA | – | Behavioral: POSTOPERATIVE COGNITIVE DYSFUNCTION |
| INHALATION ANESTHESIA | – | Behavioral: POSTOPERATIVE COGNITIVE DYSFUNCTION |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Lumbal disc herniectomy operation is planned for ASA I, II and III risk group between the ages of 18-65.
Key inclusion criteria (1 listed)
- -Lumbal disc herniectomy operation 18-65 age
Key exclusion criteria (13 listed)
- Patients before and after the coronary artery bypass graft surgery
- patients in the last trimester of pregnancy
- patients with severe heart failure
- liver failure
- kidney failure
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 |
|---|---|---|
| POSTOPERATIVE COGNITIVE DYSFUNCTIONNEURON SPECIFIC ENOLASE LEVELS IN LUMBAR DISC HERNIECTOMY WITH GENERAL ANESTHESIA MODALITIES | Behavioural | INHALATION ANESTHESIA, TOTAL INTRAVENOUS ANESTHESIA |
Primary outcome
MINI MENTAL STATE EXAMINATION TEST
Time frame: 1 MONTH
BELOW 27 SCORE IS ASSOSIATED WITH POSTOPERATIVE COGNITIVE DYSFUNCTION
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2020.
- Results publication: PubMed 25838586Goswami U, Babbar S, Tiwari S. Comparative evaluation of the effects of propofol and sevoflurane on cognitive function and memory in patients undergoing laparoscopic cholecystectomy: A randomised prospective study. Indian J Anaesth. 2015 Mar;59(3):150-5. doi: 10.4103/0019-5049.153036.
- Results publication: PubMed 31306716Luescher T, Mueller J, Isenschmid C, Kalt J, Rasiah R, Tondorf T, Gamp M, Becker C, Sutter R, Tisljar K, Schuetz P, Marsch S, Hunziker S. Neuron-specific enolase (NSE) improves clinical risk scores for prediction of neurological outcome and death in cardiac arrest patients: Results from a prospective trial. Resuscitation. 2019 Sep;142:50-60. doi: 10.1016/j.resuscitation.2019.07.003. Epub 2019 Jul 12.
- Results publicationBaysalman HB, Oğuz G, Açıkgöz G, Aksakal FN, Ünver SJJotTA, Dergisi ICS-JTAvR. Total İntravenöz ve Desfluran Anestezilerinin Erken Derlenme ve Kognitif Fonksiyonlara Etkileri. 2011;39(1).
- 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.
TÜLAY CEREN ÖLMEZTÜRK KARAKURT principal investigator
ERZINCAN BYU
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Postoperative Cognitive Dysfunction and NEURON SPECIFIC ENOLASE, run by Erzincan University at 1 site in Turkey (Türkiye).
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 13 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: status not confirmed, as of the sponsor's last update on 20 Feb 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 Turkey (Türkiye). 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact UFUK KUYRUKLUYILDIZ (05325840554, drufuk2001@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
MINI MENTAL STATE EXAMINATION TEST (time frame: 1 MONTH). 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 NCT04279132, which also lists 3 linked publications.
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 20 Feb 2020.