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The Effect of Blood Pressure on the Postoperative Cognitive Dysfunction

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ClinicalTrials.gov Identifier: NCT02536885
Recruitment Status : Completed
First Posted : September 1, 2015
Last Update Posted : August 22, 2018
Sponsor:
Information provided by (Responsible Party):
Dostalova Vlasta, MD, PhD, University Hospital Hradec Kralove

Brief Summary:
Permanent and temporary cognitive impairment in the perioperative period is of great importance to patients. Hypoperfusion due to the intraoperative hypotension is often mentioned as a possible cause of postoperative cognitive dysfunction.

Condition or disease Intervention/treatment Phase
Mild Cognitive Impairment Procedure: Liberal group Procedure: Restrictive group Not Applicable

Detailed Description:
All patients aged above 60 years undergoing planned spinal surgery in the prone position in the duration of 1-3 hours under general anesthesia will be included in the study. In group L (liberal), the value of blood pressure will be corrected with the change of mean arterial pressure (MAP) ± 25% patient's mean arterial pressure, and group R (restrictive) with the change of MAP ± 10%. Cognitive dysfunction tests will be executed on the day before the surgery, two hours after the surgery and on the third postoperative day. 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 syntophyllin, nor pharmacological decurarization (syntostigmin) will be applied to the patients.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Effect of the Perioperative Blood Pressure on the Onset of Postoperative Cognitive Dysfunction in Adults
Study Start Date : September 2015
Actual Primary Completion Date : June 2018
Actual Study Completion Date : July 2018

Arm Intervention/treatment
Experimental: Liberal group
During the surgery, blood pressure of the patients will be maintained within ± 25% of the patient's normal blood pressure.
Procedure: Liberal group
If the pressure decreases below 75% of patient's baseline mean arterial pressure for more than 1 min, continuous application of noradrenalin will be initiated. If the blood pressure increases above 125% of patient's baseline mean arterial pressure for more than 1 min, Ebrantil (urapidil hydrochlorid) will be applied in dose of 5 mg intravenously with the possibility of repeated doses in 2 minutes intervals.

Experimental: Restrictive group
During the surgery, blood pressure of the patients will be maintained within ± 10% of the patient's normal blood pressure.
Procedure: Restrictive group
If the pressure decreases below 90% of patient's baseline mean arterial pressure for more than 1 min, continuous application of noradrenalin will be initiated. If the blood pressure increases above 110% of patient's baseline mean arterial pressure for more than 1 min, Ebrantil (urapidil hydrochlorid) will be applied in dose of 5 mg intravenously with the possibility of repeated doses in 2 minutes intervals.




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:

  • GCS 15
  • ASA risk I - III
  • planned spinal surgery in the prone position
  • duration of the procedure of 1-3 hours

Exclusion Criteria:

  • hypertension above 180/100 torr preoperatively
  • blood pressure below 130/80 torr preoperatively

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): NCT02536885


Locations
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Czechia
University Hospital Hradec Kralove
Hradec Kralove, Czechia, 50005
Sponsors and Collaborators
University Hospital Hradec Kralove
Investigators
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Principal Investigator: Vlasta Dostalova, MD, PhD University Hospital Hradec Kralove
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Responsible Party: Dostalova Vlasta, MD, PhD, University Hospital Hradec Kralove
ClinicalTrials.gov Identifier: NCT02536885    
Other Study ID Numbers: 201508-S21P
First Posted: September 1, 2015    Key Record Dates
Last Update Posted: August 22, 2018
Last Verified: August 2018
Keywords provided by Dostalova Vlasta, MD, PhD, University Hospital Hradec Kralove:
Postoperative cognitive dysfunction
Blood pressure
Anesthesia
Additional relevant MeSH terms:
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Cognitive Dysfunction
Cognition Disorders
Neurocognitive Disorders
Mental Disorders