The Effect of Nimodipine on the Postoperative Cognitive Dysfunction

Mild Cognitive Impairment Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02537080
• Other study ID #: 201508-S22P
• Status: Terminated
• Phase: N/A
• Start date: September 2015
• Est. completion date: December 2017

Study information

• Verified date: September 2019
• Source: University Hospital Hradec Kralove
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 15
• Est. completion date: December 2017
• Est. primary completion date: December 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cognitive Dysfunction
• Mild Cognitive Impairment

Intervention

Drug:
• Nimodipine group
the stability of the blood pressure will be managed in interval plus minus 15% of patient's resting blood pressure
• Control group
the stability of the blood pressure will be managed in interval plus minus 15% of patient's resting blood pressure

Locations

Country	Name	City	State
Czechia	University Hospital	Hradec Kralove

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital Hradec Kralove

Country where clinical trial is conducted

Czechia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in cognitive behavior	measured by Addenbrooks cognitive test	within the first 3 days after surgery