Evaluation of Cognitive Functions by Cerebral Pulse Oximetry

Completed

• Conditions: Anesthesia; Cognitive Dysfunction
• Interventions: Other: cerebral pulse oximetry

• Registration Number: NCT03827083
• Lead Sponsor: Tepecik Training and Research Hospital

Brief Summary

General and Spinal Anesthesia can be used in geriatric patients in orthopedic surgery. Post-op cognitive dysfunction can be seen in orthopedic surgeries in this group of patients.

In this study, the investigators aimed to compare cognitive functions between spinal and general anesthesia using cerebral and systemic oxygenation, hemodynamic data and pre-op, post-op cognitive function tests.

Detailed Description

Cerebral Oximeter is a monitoring application based on the measurement of regional oxygen saturation by transcutaneous route by near infrared spectroscopy technology. With this system that analyzes the intraparenchymal and microcirculation in the frontal cortex, cerebral oxygenation changes caused by possible hypoxemia are followed. Unlike pulse oximeter, it works in non-pulsatile conditions. In other words, continuous, real-time and safe oxygen saturation is continued to be measured even in the case of cardiopulmonary arrest. It is a significant advantage of noninvasive measurement according to jugular venous oxygen saturation measurement. For normal healthy people, the accepted normal range is 58-82%, while 0 to 15% of measurements are important for providing CPR process information.

Oxygen saturation measured by cerebral oximetry is different from that measured by other oxygen saturation measurement techniques. The main reason for this is the technique itself and the region where it is used. The radiation emitted by the cerebral oximetry sensor is aimed at the microvessel structure with venous and arterial mix. Since the contribution of venous and arterial blood volume in this structure is between 70-75% and 30-25%, different results are obtained based on only arterial or just venous bed measurements. In this sense, the measured saturation value is lower than the arterial oxygen and pulse oximetry saturation values; higher than venous values.

The ratio of oxyhemoglobin to the total hemoglobin below the region under evaluation of the system is expressed as, value in% System and reflected to the user as Regional Oxygen Saturation (rSO2). There are publications that can be used not only for cerebral but also for different tissues (ischemic limb, kidney, etc.).

General and Spinal Anesthesia can be used in geriatric patients in orthopedic surgery. Post-op cognitive dysfunction may be seen in orthopedic surgery in this patient group. There are not enough studies showing the correlation of cognitive functions with cerebral pulse oximetry after general and spinal anesthesia. In this study, the investigators aimed to compare cognitive functions between spinal and general anesthesia using cerebral and systemic oxygenation, hemodynamic data and pre-op, post-op cognitive function tests.

Study Timeline

• Study First Submitted: 2019-01-04
• Study Start: 2019-01-09
• Study First Submitted QC: 2019-01-31
• Study First Posted: 2019-02-01
• Primary Completion: 2019-07-12
• Study Completion: 2019-12-12
• Status Verified: 2021-02
• Last Update Submitted: 2021-02-01
• Last Update Posted: 2021-02-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• ASA 1-2
• patients with lower extremity surgery
• Cognitive functions sufficient

Exclusion Criteria

• Brain functions affected
• Peri-operative MAP <60 ones
• Those with electrolyte dysfunctions
• Those who need more blood and blood transfusion
• Patients with ASA 3 and above

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Spinal anesthesia	cerebral pulse oximetry	Evaluation of cognitive functions of patients under 65 years of age with lower extremity surgery by cerebral pulse oximetry
General anesthesia	cerebral pulse oximetry	Evaluation of cognitive functions of patients under 65 years of age with lower extremity surgery by cerebral pulse oximetry

Primary Outcome Measures

Name	Time	Method
mini-mental testing	preoperative and postoperative 48 hours mini-mental test change	pre-op and post-op mini-mental testing
cerebral pulse oxymetry value	change in peroperative cerebral pulse oxymetry value	peroperative cerebral pulse oxymetry value

Secondary Outcome Measures

Name	Time	Method
Heart rate	1 min before induction, 1 min after induction or sedation, at surgical incision, 15 min of surgery, 30 min of surgery, 45 min of surgery, 60 min of surgery, leaving the operation room, at recovery and post-op 48 hours	Heart rate
systolic blood pressure	1 min before induction, 1 min after induction or sedation, at surgical incision, 15 min of surgery, 30 min of surgery, 45 min of surgery, 60 min of surgery, leaving the operation room, at recovery and post-op 48 hours	systolic blood pressure
diastolic blood pressure	1 min before induction, 1 min after induction or sedation, at surgical incision, 15 min of surgery, 30 min of surgery, 45 min of surgery, 60 min of surgery, leaving the operation room, at recovery and post-op 48 hours	diastolic blood pressure
hemoglobin value	before 24 hours and after 24 hours of surgery	hemoglobin value
peripheral oxygen saturation	1 min before induction, 1 min after induction or sedation, at surgical incision, 15 min of surgery, 30 min of surgery, 45 min of surgery, 60 min of surgery, leaving the operation room, at recovery and post-op 48 hours	peripheral oxygen saturation

Trial Locations

Locations (1)

İzmir Tepecik TRH; 🇹🇷 İzmir, Turkey