Mild Cognitive ImpairmentNCT02537080
The Effect of Nimodipine on the Postoperative Cognitive Dysfunction
A study testing Nimodipine group in people with Mild Cognitive Impairment, run by University Hospital Hradec Kralove at 1 site in Czechia.
Trial summary
The calcium channel blocker nimodipine dilates cerebral blood vessels and can pass through the blood-brain barrier, providing neuroprotective effects by selectively improving cerebral blood flow and inhibiting neuronal necrosis and apoptosis. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Mild Cognitive Impairment
- What is being tested?
- Nimodipine group
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteCzechia
- Study dates
- Sep 2015to Dec 2017
- 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 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Glascow coma scale GCS 15 preoperatively
- American Society of Anesthesiologists ASA risk I - III
- planned brain surgery
- duration of procedure up to 4 hours.
Who cannot join
- blood pressure below 130/80 torr preoperatively
- previous vascular surgery
- concomitant use of antiepileptic drugs, rifampicin
- allergy to nimodipine
- known liver cirrhosis
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Nimodipine in the Preoperative Period on the Onset of Postoperative Cognitive Dysfunction in Adults
The calcium channel blocker nimodipine dilates cerebral blood vessels and can pass through the blood-brain barrier, providing neuroprotective effects by selectively improving cerebral blood flow and inhibiting neuronal necrosis and apoptosis. Nimodipine significantly inhibited the production of tumor necrosis factor TNF-α and interleukin IL-1β, and also of nitric oxide and prostaglandin E2 from lipopolysaccharide-stimulated microglia. Abnormal cytokine networks are important in the development of nerve cell damage that leads to cognitive impairment.
Read the detailed description
All patients aged above 60 years undergoing planned neurosurgical operations in the duration up to 4 hours under general anesthesia will be included in the study. The patients will not be sedated by any type of benzodiazepine. A dose of 30 mg nimodipine or placebo will be applied 45 minutes before the surgery according to the randomization. Anesthesia will be managed according to the standardised protocol. Concentration of desflurane will be adjusted according to entropy values (target 40-50). Analgetics will be applied according to surgical pleth index (SPI) values. Sufentanil will not be applied in the last 15 minutes. Extubation will be performed at the operating theatre when meeting all extubation criteria including train of four ratio (TOFR) above 92%. Neither syntophylline, nor pharmacological decurarization (syntostigmine) will be applied to the patients.During the surgery, blood pressure will be maintained within ± 15% of the patient's normal blood pressure. Cognitive dysfunction tests will be executed on the day before the surgery, two hours after the surgery and on the third postoperative day.
- Conditions
- Mild Cognitive Impairment
- Being tested
- Nimodipine group, Control group
- Keywords
- Postoperative cognitive dysfunction, Nimodipin, Anesthesia
- Medical subject headings
- Cognitive Dysfunction, Postoperative Cognitive Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nimodipine groupDrug
Also called nimodipine
the stability of the blood pressure will be managed in interval plus minus 15% of patient's resting blood pressure
Control groupDrug
Also called placebo
the stability of the blood pressure will be managed in interval plus minus 15% of patient's resting blood pressure
| Study group | Role | What they receive |
|---|---|---|
| Nimodipine group | Experimental | 1 tbl of 30 mg nimodipine will be administered orally with premedication Receives: Drug: Nimodipine group |
| Control group | Experimental | 1 tbl of placebo will be administered orally with premedication Receives: Drug: Control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in cognitive behavior
measured by Addenbrooks cognitive test
Measured: within the first 3 days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2015 (estimated)
- Study startSep 2015
- Primary completionDec 2017
- Study completionDec 2017
Why it stopped: higher POCD in nimodipine Group
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mild Cognitive ImpairmentStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital Hradec Kralove
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dostalova Vlasta, MD, PhD, University Hospital Hradec Kralove
- Investigators
- Vlasta Dostalova, MD, PhD, Study director, University Hospital Hradec Kralove
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02537080
- Sponsor's protocol ID
- 201508-S22P
- Status last verified
- Sep 2019
- First submitted
- 27 Aug 2015
- Last updated
- 1 Oct 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Nimodipine in the Preoperative Period on the Onset of Postoperative Cognitive Dysfunction in Adults
- ClinicalTrials.gov ID
- NCT02537080
- Acronym / sponsor ID
- 201508-S22P
- Conditions
- Mild Cognitive Impairment
- Keywords
- Postoperative cognitive dysfunction, Nimodipin, Anesthesia
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: higher POCD in nimodipine Group
- Enrolment
- 15 participants (actual)
- Lead sponsor
- University Hospital Hradec KraloveUniversity, hospital or other
- Study start
- Sep 2015
- Primary completion
- Dec 2017 (actual)
- Study completion
- Dec 2017 (actual)
- First posted
- 1 Sep 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 calcium channel blocker nimodipine dilates cerebral blood vessels and can pass through the blood-brain barrier, providing neuroprotective effects by selectively improving cerebral blood flow and inhibiting neuronal necrosis and apoptosis. Nimodipine significantly inhibited the production of tumor necrosis factor TNF-α and interleukin IL-1β, and also of nitric oxide and prostaglandin E2 from lipopolysaccharide-stimulated microglia. Abnormal cytokine networks are important in the development of nerve cell damage that leads to cognitive impairment.
Detailed description
All patients aged above 60 years undergoing planned neurosurgical operations in the duration up to 4 hours under general anesthesia will be included in the study. The patients will not be sedated by any type of benzodiazepine. A dose of 30 mg nimodipine or placebo will be applied 45 minutes before the surgery according to the randomization. Anesthesia will be managed according to the standardised protocol. Concentration of desflurane will be adjusted according to entropy values (target 40-50). Analgetics will be applied according to surgical pleth index (SPI) values. Sufentanil will not be applied in the last 15 minutes. Extubation will be performed at the operating theatre when meeting all extubation criteria including train of four ratio (TOFR) above 92%. Neither syntophylline, nor pharmacological decurarization (syntostigmine) will be applied to the patients.During the surgery, blood pressure will be maintained within ± 15% of the patient's normal blood pressure. Cognitive dysfunction tests will be executed on the day before the surgery, two hours after the surgery and on the third postoperative day.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Nimodipine group | Experimental | Drug: Nimodipine group1 tbl of 30 mg nimodipine will be administered orally with premedication |
| Control group | Experimental | Drug: Control group1 tbl of placebo will be administered orally with premedication |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Glascow coma scale GCS 15 preoperatively
- American Society of Anesthesiologists ASA risk I - III
- planned brain surgery
- duration of procedure up to 4 hours.
Key exclusion criteria (5 listed)
- blood pressure below 130/80 torr preoperatively
- previous vascular surgery
- concomitant use of antiepileptic drugs, rifampicin
- allergy to nimodipine
- known liver cirrhosis
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 |
|---|---|---|
| Nimodipine groupAlso: nimodipinethe stability of the blood pressure will be managed in interval plus minus 15% of patient's resting blood pressure | Drug | Nimodipine group |
| Control groupAlso: placebothe stability of the blood pressure will be managed in interval plus minus 15% of patient's resting blood pressure | Drug | Control group |
Primary outcome
Change in cognitive behavior
Time frame: within the first 3 days after surgery
measured by Addenbrooks cognitive test
Results and safety
The study was stopped early (reason given: higher POCD in nimodipine Group). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2019.
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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.
Vlasta Dostalova, MD, PhD study director
University Hospital Hradec Kralove
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nimodipine group in people with Mild Cognitive Impairment, run by University Hospital Hradec Kralove at 1 site in Czechia.
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 4 inclusion and 5 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: stopped early, as of the sponsor's last update on 1 Oct 2019. 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 Czechia. 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 was stopped early (reason given: higher POCD in nimodipine Group). Results are not available in the source record.
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 cognitive behavior (time frame: within the first 3 days after surgery). 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 1 Oct 2019; AzTrials last refreshed its copy on 1 Nov 2026.