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The Effect of Nimodipine on the Postoperative Cognitive Dysfunction

The Effect of Nimodipine in the Preoperative Period on the Onset of Postoperative Cognitive Dysfunction in Adults

Status
Terminated
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02537080
Enrollment
15
Registered
2015-09-01
Start date
2015-09-30
Completion date
2017-12-31
Last updated
2019-10-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Mild Cognitive Impairment

Keywords

Postoperative cognitive dysfunction, Nimodipin, Anesthesia

Brief 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. 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.

Interventions

the stability of the blood pressure will be managed in interval plus minus 15% of patient's resting blood pressure

DRUGControl group

the stability of the blood pressure will be managed in interval plus minus 15% of patient's resting blood pressure

Sponsors

University Hospital Hradec Kralove
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
60 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Glascow coma scale GCS 15 preoperatively * American Society of Anesthesiologists ASA risk I - III * planned brain surgery * duration of procedure up to 4 hours.

Exclusion criteria

* blood pressure below 130/80 torr preoperatively * previous vascular surgery * concomitant use of antiepileptic drugs, rifampicin * allergy to nimodipine * known liver cirrhosis

Design outcomes

Primary

MeasureTime frameDescription
Change in cognitive behaviorwithin the first 3 days after surgerymeasured by Addenbrooks cognitive test

Countries

Czechia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026