The Effect of Blood Pressure on the Postoperative Cognitive Dysfunction

Mild Cognitive Impairment Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02536885
• Other study ID #: 201508-S21P
• Status: Completed
• Phase: N/A
• Start date: September 2015
• Est. completion date: July 2018

Study information

• Verified date: August 2018
• Source: University Hospital Hradec Kralove
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: July 2018
• Est. primary completion date: June 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cognitive Dysfunction
• Mild Cognitive Impairment

Intervention

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.
• 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.

Locations

Country	Name	City	State
Czechia	University Hospital Hradec Kralove	Hradec Kralove

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital Hradec Kralove

Country where clinical trial is conducted

Czechia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in cognitive behavior	measured by Addenbrooks cognitive test	within the first 3 days after surgery