The Effect of Nimodipine on the Postoperative Cognitive Dysfunction

Not Applicable

Terminated

• Conditions: Mild Cognitive Impairment
• Interventions: Drug: Nimodipine group; Drug: Control group

• Registration Number: NCT02537080
• Lead Sponsor: University Hospital Hradec Kralove

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.

Study Timeline

• Study First Submitted: 2015-08-27
• Study First Submitted QC: 2015-08-31
• Study Start: 2015-09
• Study First Posted: 2015-09-01
• Primary Completion: 2017-12
• Study Completion: 2017-12
• Status Verified: 2019-09
• Last Update Submitted: 2019-09-28
• Last Update Posted: 2019-10-01

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 15

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Nimodipine group	Nimodipine group	1 tbl of 30 mg nimodipine will be administered orally with premedication
Control group	Control group	1 tbl of placebo will be administered orally with premedication

Primary Outcome Measures

Name	Time	Method
Change in cognitive behavior	within the first 3 days after surgery	measured by Addenbrooks cognitive test

Trial Locations

Locations (1)

University Hospital; 🇨🇿 Hradec Kralove, Czechia