Evaluation of Cognitive Functions by Cerebral Pulse Oximetry

Sponsor
Tepecik Training and Research Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT03827083
Collaborator
(none)
40
1
11.1
3.6

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: cerebral pulse oximetry

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 Design

Study Type:
Observational
Actual Enrollment :
40 participants
Observational Model:
Other
Time Perspective:
Prospective
Official Title:
Evaluation of Cognitive Functions by Cerebral Pulse Oximetry After General Anesthesia and Spinal Anesthesia in Geriatric Patients With Orthopedic Surgery
Actual Study Start Date :
Jan 9, 2019
Actual Primary Completion Date :
Jul 12, 2019
Actual Study Completion Date :
Dec 12, 2019

Arms and Interventions

Arm 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
  • Outcome Measures

    Primary Outcome Measures

    1. mini-mental testing [preoperative and postoperative 48 hours mini-mental test change]

      pre-op and post-op mini-mental testing

    2. cerebral pulse oxymetry value [change in peroperative cerebral pulse oxymetry value]

      peroperative cerebral pulse oxymetry value

    Secondary Outcome Measures

    1. 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

    2. 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

    3. 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

    4. 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

    5. hemoglobin value [before 24 hours and after 24 hours of surgery]

      hemoglobin value

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    65 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 İzmir Tepecik TRH İzmir Turkey

    Sponsors and Collaborators

    • Tepecik Training and Research Hospital

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Fatih Mehmet Kurt, Principal İnvestigator, Tepecik Training and Research Hospital
    ClinicalTrials.gov Identifier:
    NCT03827083
    Other Study ID Numbers:
    • Fatih Mehmet Kurt
    First Posted:
    Feb 1, 2019
    Last Update Posted:
    Feb 2, 2021
    Last Verified:
    Feb 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Fatih Mehmet Kurt, Principal İnvestigator, Tepecik Training and Research Hospital
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Feb 2, 2021