The Effect of Blood Pressure on the Postoperative Cognitive Dysfunction

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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The Effect of the Perioperative Blood Pressure on the Onset of Postoperative Cognitive Dysfunction in Adults

Conditions
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Mild Cognitive Impairment

Intervention / Treatment
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* Procedure: Liberal group
* Procedure: Restrictive group


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Liberal group<br>During the surgery, blood pressure of the patients will be maintained within ± 25% of the patient's normal blood pressure. | Procedure: Liberal group<br>* 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.<br>|
| Experimental: Restrictive group<br>During the surgery, blood pressure of the patients will be maintained within ± 10% of the patient's normal blood pressure. | Procedure: Restrictive group<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in cognitive behavior | measured by Addenbrooks cognitive test | within the first 3 days after surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Postoperative cognitive dysfunction, Blood pressure, Anesthesia