The Effect of Nimodipine on the Postoperative Cognitive Dysfunction

NCT02537080 | Terminated

• 1 other identifier: 201508-S22P
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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.

Conditions

Mild Cognitive Impairment

Keywords

Postoperative cognitive dysfunction; Nimodipin; Anesthesia

Outcome Measures

Primary Outcomes (1)

• Change in cognitive behavior

  measured by Addenbrooks cognitive test

  within the first 3 days after surgery

Study Arms (2)

Nimodipine group

EXPERIMENTAL

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

Drug: Nimodipine group

Control group

EXPERIMENTAL

1 tbl of placebo will be administered orally with premedication

Drug: Control group

Interventions

Nimodipine group DRUG

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

Also known as: nimodipine

Nimodipine group

Control group DRUG

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

Also known as: placebo

Control group

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Glascow coma scale GCS 15 preoperatively
• American Society of Anesthesiologists ASA risk I - III
• planned brain surgery
• duration of procedure up to 4 hours.

You may not qualify if:

• blood pressure below 130/80 torr preoperatively
• previous vascular surgery
• concomitant use of antiepileptic drugs, rifampicin
• allergy to nimodipine
• known liver cirrhosis

Sponsors & Collaborators

• University Hospital Hradec Kralove: lead

Study Sites (1)

University Hospital

Hradec Králové, 50005, Czechia

Location

MeSH Terms

Conditions

Cognitive Dysfunction; Postoperative Cognitive Complications

Interventions

Nimodipine; Control Groups

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Dihydropyridines; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Nicotinic Acids; Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• Vlasta Dostalova, MD, PhD

  University Hospital Hradec Kralove

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Vlasta Dostalova, MD, PhD

Study Record Dates

• First Submitted: August 27, 2015
• First Posted: September 1, 2015
• Study Start: September 1, 2015
• Primary Completion: December 1, 2017
• Study Completion: December 1, 2017
• Last Updated: October 1, 2019

Record last verified: 2019-09

Locations

CZ (1)