NCT02536885

The Effect of Blood Pressure on the Postoperative Cognitive Dysfunction

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (actual)
• Sponsor: University Hospital Hradec Kralove · Academic / Other
• Sex: All
• Age: 60 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

• Mild Cognitive Impairment

Interventions

Type	Name	Description
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.
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.

Timeline

• Start date: 2015-09-01
• Primary completion: 2018-06-01
• Completion: 2018-07-01
• First posted: 2015-09-01
• Last updated: 2018-08-22

Locations

1 site across 1 country: Czechia