The Effect of Nimodipine on the Postoperative Cognitive Dysfunction

University Hospital Hradec Kralove

Status: Terminated

Conditions: Mild Cognitive Impairment

Treatments: Drug: Nimodipine group; Drug: Control group

Study type: Interventional

Funder types: Other

Identifiers

NCT02537080

201508-S22P

Details and patient eligibility

About

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.

Full 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.

Enrollment: 15 patients

Sex: All

Ages: 60+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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15 participants in 2 patient groups

Nimodipine group

Experimental group

Description:

1 tbl of 30 mg nimodipine will be administered orally with premedication

Treatment:

Drug: Nimodipine group

Control group

Experimental group

Description:

1 tbl of placebo will be administered orally with premedication

Treatment:

Drug: Control group