Evaluation of Cognitive Functions by Cerebral Pulse Oximetry

February 1, 2021 updated by: Fatih Mehmet Kurt, Tepecik Training and Research Hospital

Evaluation of Cognitive Functions by Cerebral Pulse Oximetry After General Anesthesia and Spinal Anesthesia in Geriatric Patients With Orthopedic Surgery

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

40

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • İzmir, Turkey
        • Izmir Tepecik TRH

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

65 years and older (OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patients with lower extremity surgery, 65 years and older, ASA 1-2, Cognitive functions sufficient

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Spinal anesthesia
Evaluation of cognitive functions of patients under 65 years of age with lower extremity surgery by cerebral pulse oximetry
Other: cerebral pulse oximetry
Cognitive Functions by Cerebral Pulse Oximetry After General Anesthesia and Spinal Anesthesia
Other Names:
  • postoperative cognitive dysfunctions
General anesthesia
Evaluation of cognitive functions of patients under 65 years of age with lower extremity surgery by cerebral pulse oximetry
Other: cerebral pulse oximetry
Cognitive Functions by Cerebral Pulse Oximetry After General Anesthesia and Spinal Anesthesia
Other Names:
  • postoperative cognitive dysfunctions

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
mini-mental testing
Time Frame: preoperative and postoperative 48 hours mini-mental test change
pre-op and post-op mini-mental testing
preoperative and postoperative 48 hours mini-mental test change
cerebral pulse oxymetry value
Time Frame: change in peroperative cerebral pulse oxymetry value
peroperative cerebral pulse oxymetry value
change in peroperative cerebral pulse oxymetry value

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
peripheral oxygen saturation
Time Frame: 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
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
Time Frame: 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
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
Time Frame: 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
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
Time Frame: 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
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
hemoglobin value
Time Frame: before 24 hours and after 24 hours of surgery
hemoglobin value
before 24 hours and after 24 hours of surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tepecik Training and Research Hospital

Investigators

  • Principal Investigator: Fatih Mehmet Kurt, MD, Tepecik Train and Research Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

January 9, 2019

Primary Completion (ACTUAL)

July 12, 2019

Study Completion (ACTUAL)

December 12, 2019

Study Registration Dates

First Submitted

January 4, 2019

First Submitted That Met QC Criteria

January 31, 2019

First Posted (ACTUAL)

February 1, 2019

Study Record Updates

Last Update Posted (ACTUAL)

February 2, 2021

Last Update Submitted That Met QC Criteria

February 1, 2021

Last Verified

February 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Fatih Mehmet Kurt

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Cognitive Dysfunction

Clinical Trials on cerebral pulse oximetry

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Belarus

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe