Evaluation of Cognitive Functions by Cerebral Pulse Oximetry

NCT ID: NCT03827083

Last Updated: 2021-02-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

40 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-01-09

Study Completion Date

2019-12-12

Brief Summary

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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

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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.

Conditions

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Anesthesia Cognitive Dysfunction

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Study Groups

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Spinal anesthesia

Evaluation of cognitive functions of patients under 65 years of age with lower extremity surgery by cerebral pulse oximetry

cerebral pulse oximetry

Intervention Type OTHER

Cognitive Functions by Cerebral Pulse Oximetry After General Anesthesia and Spinal Anesthesia

General anesthesia

Evaluation of cognitive functions of patients under 65 years of age with lower extremity surgery by cerebral pulse oximetry

cerebral pulse oximetry

Intervention Type OTHER

Cognitive Functions by Cerebral Pulse Oximetry After General Anesthesia and Spinal Anesthesia

Interventions

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cerebral pulse oximetry

Cognitive Functions by Cerebral Pulse Oximetry After General Anesthesia and Spinal Anesthesia

Intervention Type OTHER

Other Intervention Names

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postoperative cognitive dysfunctions

Eligibility Criteria

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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
Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Tepecik Training and Research Hospital

OTHER

Sponsor Role lead

Responsible Party

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Fatih Mehmet Kurt

Principal İnvestigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Fatih Mehmet Kurt, MD

Role: PRINCIPAL_INVESTIGATOR

Tepecik Train and Research Hospital

Locations

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İzmir Tepecik TRH

Izmir, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

References

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Papadopoulos G, Karanikolas M, Liarmakopoulou A, Papathanakos G, Korre M, Beris A. Cerebral oximetry and cognitive dysfunction in elderly patients undergoing surgery for hip fractures: a prospective observational study. Open Orthop J. 2012;6:400-5. doi: 10.2174/1874325001206010400. Epub 2012 Sep 3.

Reference Type BACKGROUND
PMID: 22962570 (View on PubMed)

Guo JY, Fang JY, Xu SR, Wei M, Huang WQ. Effects of propofol versus sevoflurane on cerebral oxygenation and cognitive outcome in patients with impaired cerebral oxygenation. Ther Clin Risk Manag. 2016 Jan 18;12:81-5. doi: 10.2147/TCRM.S97066. eCollection 2016.

Reference Type BACKGROUND
PMID: 26848269 (View on PubMed)

Kok WF, van Harten AE, Koene BM, Mariani MA, Koerts J, Tucha O, Absalom AR, Scheeren TW. A pilot study of cerebral tissue oxygenation and postoperative cognitive dysfunction among patients undergoing coronary artery bypass grafting randomised to surgery with or without cardiopulmonary bypass*. Anaesthesia. 2014 Jun;69(6):613-22. doi: 10.1111/anae.12634. Epub 2014 Apr 22.

Reference Type BACKGROUND
PMID: 24750013 (View on PubMed)

Jo YY, Kim JY, Lee MG, Lee SG, Kwak HJ. Changes in cerebral oxygen saturation and early postoperative cognitive function after laparoscopic gastrectomy: a comparison with conventional open surgery. Korean J Anesthesiol. 2016 Feb;69(1):44-50. doi: 10.4097/kjae.2016.69.1.44. Epub 2016 Jan 28.

Reference Type BACKGROUND
PMID: 26885301 (View on PubMed)

Other Identifiers

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Fatih Mehmet Kurt

Identifier Type: -

Identifier Source: org_study_id

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