NCT02537080

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
• Phase: N/A
• Study type: Interventional
• Enrollment: 15 (actual)
• Sponsor: University Hospital Hradec Kralove · Academic / Other
• Sex: All
• Age: 60 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Mild Cognitive Impairment

Interventions

Type	Name	Description
DRUG	Nimodipine group	the stability of the blood pressure will be managed in interval plus minus 15% of patient's resting blood pressure
DRUG	Control group	the stability of the blood pressure will be managed in interval plus minus 15% of patient's resting blood pressure

Timeline

• Start date: 2015-09-01
• Primary completion: 2017-12-01
• Completion: 2017-12-01
• First posted: 2015-09-01
• Last updated: 2019-10-01

Locations

1 site across 1 country: Czechia