Evaluation of Cognitive Functions by Cerebral Pulse Oximetry

NCT03827083 | Completed

• 1 other identifier: Fatih Mehmet Kurt
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Anesthesia; Cognitive Dysfunction

Keywords

spinal and general anesthesia; cerebral pulse oxymetry; cognitive dysfunction

Outcome Measures

Primary Outcomes (2)

• mini-mental testing

  pre-op and post-op mini-mental testing

  preoperative and postoperative 48 hours mini-mental test change

• cerebral pulse oxymetry value

  peroperative cerebral pulse oxymetry value

  change in peroperative cerebral pulse oxymetry value

Secondary Outcomes (5)

• 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

  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

  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

  before 24 hours and after 24 hours of surgery

Study Arms (2)

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

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

Interventions

cerebral pulse oximetry OTHER

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

Also known as: postoperative cognitive dysfunctions

General anesthesia; Spinal anesthesia

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Tepecik Training and Research Hospital: lead

Study Sites (1)

İzmir Tepecik TRH

Izmir, Turkey (Türkiye)

Location

Related Publications (4)

• 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.

  PMID: 22962570 BACKGROUND

• 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.

  PMID: 26848269 BACKGROUND

• 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.

  PMID: 24750013 BACKGROUND

• 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.

  PMID: 26885301 BACKGROUND

MeSH Terms

Conditions

Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Study Officials

• Fatih Mehmet Kurt, MD

  Tepecik Train and Research Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal İnvestigator

Study Record Dates

• First Submitted: January 4, 2019
• First Posted: February 1, 2019
• Study Start: January 9, 2019
• Primary Completion: July 12, 2019
• Study Completion: December 12, 2019
• Last Updated: February 2, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)