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The Effect of Nimodipine on the Postoperative Cognitive Dysfunction

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ClinicalTrials.gov Identifier: NCT02537080
Recruitment Status : Terminated (higher POCD in nimodipine Group)
First Posted : September 1, 2015
Last Update Posted : October 18, 2016
Sponsor:
Information provided by (Responsible Party):
Dostalova Vlasta, MD, PhD, 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.

Condition or disease Intervention/treatment Phase
Mild Cognitive Impairment Drug: Nimodipine group Drug: Control group Not Applicable

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 Type : Interventional  (Clinical Trial)
Actual Enrollment : 15 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Effect of Nimodipine in the Preoperative Period on the Onset of Postoperative Cognitive Dysfunction in Adults
Study Start Date : September 2015
Estimated Primary Completion Date : December 2017
Estimated Study Completion Date : December 2017

Resource links provided by the National Library of Medicine

Drug Information available for: Nimodipine

Arm Intervention/treatment
Experimental: Nimodipine group
1 tbl of 30 mg nimodipine will be administered orally with premedication
Drug: Nimodipine group
the stability of the blood pressure will be managed in interval plus minus 15% of patient's resting blood pressure
Other Name: nimodipine

Experimental: Control group
1 tbl of placebo will be administered orally with premedication
Drug: Control group
the stability of the blood pressure will be managed in interval plus minus 15% of patient's resting blood pressure
Other Name: placebo




Primary Outcome Measures :
  1. Change in cognitive behavior [ Time Frame: within the first 3 days after surgery ]
    measured by Addenbrooks cognitive test



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Ages Eligible for Study:   60 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02537080


Locations
Czech Republic
University Hospital
Hradec Kralove, Czech Republic, 50005
Sponsors and Collaborators
University Hospital Hradec Kralove
Investigators
Study Director: Vlasta Dostalova, MD, PhD University Hospital Hradec Kralove

Responsible Party: Dostalova Vlasta, MD, PhD, Vlasta Dostalova, MD, PhD, University Hospital Hradec Kralove
ClinicalTrials.gov Identifier: NCT02537080     History of Changes
Other Study ID Numbers: 201508-S22P
First Posted: September 1, 2015    Key Record Dates
Last Update Posted: October 18, 2016
Last Verified: October 2016

Keywords provided by Dostalova Vlasta, MD, PhD, University Hospital Hradec Kralove:
Postoperative cognitive dysfunction
Nimodipin
Anesthesia

Additional relevant MeSH terms:
Cognitive Dysfunction
Cognition Disorders
Neurocognitive Disorders
Mental Disorders
Nimodipine
Antihypertensive Agents
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Vasodilator Agents