The Effect of Blood Pressure on the Postoperative Cognitive Dysfunction

Not Applicable

Completed

• Conditions: Mild Cognitive Impairment
• Interventions: Procedure: Restrictive group; Procedure: Liberal group

• Registration Number: NCT02536885
• Lead Sponsor: 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.

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.

Study Timeline

• Study First Submitted: 2015-08-27
• Study First Submitted QC: 2015-08-31
• Study Start: 2015-09
• Study First Posted: 2015-09-01
• Primary Completion: 2018-06
• Study Completion: 2018-07
• Status Verified: 2018-08
• Last Update Submitted: 2018-08-21
• Last Update Posted: 2018-08-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Restrictive group	Restrictive group	During the surgery, blood pressure of the patients will be maintained within ± 10% of the patient's normal blood pressure.
Liberal group	Liberal group	During the surgery, blood pressure of the patients will be maintained within ± 25% of the patient's normal blood pressure.

Primary Outcome Measures

Name	Time	Method
Change in cognitive behavior	within the first 3 days after surgery	measured by Addenbrooks cognitive test

Trial Locations

Locations (1)

University Hospital Hradec Kralove; 🇨🇿 Hradec Kralove, Czechia