The Effect of Nimodipine on the Postoperative Cognitive Dysfunction

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-09-30

Study Completion Date

2017-12-31

Brief Summary

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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.

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Detailed Description

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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

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Mild Cognitive Impairment

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Nimodipine group

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

Group Type EXPERIMENTAL

Nimodipine group

Intervention Type DRUG

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

Control group

1 tbl of placebo will be administered orally with premedication

Group Type EXPERIMENTAL

Control group

Intervention Type DRUG

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

Interventions

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Nimodipine group

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

Intervention Type DRUG

Control group

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

Intervention Type DRUG

Other Intervention Names

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nimodipine placebo

Eligibility Criteria

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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

Minimum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No