NCT03775343

Brief Summary

This project will investigate changes in cognitive function in the early postoperative phase (\<24 hours) after minor surgery in patients of older age (≥65 years).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
75

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Oct 2018

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 6, 2018

Completed
20 days until next milestone

First Submitted

Initial submission to the registry

October 26, 2018

Completed
2 months until next milestone

First Posted

Study publicly available on registry

December 13, 2018

Completed
4.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 28, 2023

Completed
2 days until next milestone

Study Completion

Last participant's last visit for all outcomes

August 30, 2023

Completed
Last Updated

August 30, 2023

Status Verified

August 1, 2023

Enrollment Period

4.9 years

First QC Date

October 26, 2018

Last Update Submit

August 29, 2023

Conditions

Cognitive Decline

Keywords

AnesthesiaPostoperative cognitive decline

Outcome Measures

Primary Outcomes (1)

  • Neuropsychological Test Battery Vienna (NTBV)

    The Neuropsychological Test Battery Vienna (NTBV) ist a cognitive test to assess a broad range of cognitive abilities.(Lehrner J., 2007) It was created to detect cognitive impairment in Alzheimer's Disease (Lehrner J., 2007). The investigators will investigate changes in NTBV between baseline compared to 24 hour after minor surgery using regression based z-score analyses (-1,5 - + 1,5 standard deviation(SD) ; \> -1,5 SD indicating a larger decline in cognitive function).

    before surgery (baseline) and 24 hours after surgery

Secondary Outcomes (1)

  • Neuropsychological Test Battery Vienna (NTBV)

    before surgery(baseline) and 6 hours after surgery

Other Outcomes (7)

  • Blood sampling- S100b levels

    before surgery, at the end point of surgery, 6 and 24 hours after surgery

  • Blood sampling- IL-6 levels

    before surgery, at the end point of surgery, 6 and 24 hours after surgery

  • Blood sampling- CRP levels

    before surgery, at the end point of surgery, 6 and 24 hours after surgery

  • +4 more other outcomes

Study Arms (3)

General Anesthesia

General anesthesia: 25 patients older than 65 years, undergoing elective eye surgery under general anesthesia. Intervention: neurocognitive testing (Neurocognitive Test Battery) preoperative, 6 and 24 hours postoperative. Blood sampling before surgery (baseline), immediately postoperative, 6 and 24 hours after surgery.

Diagnostic Test: Neurocognitive Test BatteryDiagnostic Test: Blood sampling

Local anesthesia with sedoanalgesia

25 patients older than 65 years, undergoing elective eye surgery under local anesthesia in combination with sedoanalgesia. Intervention: neurocognitive testing (Neurocognitive Test Battery) preoperative, 6 and 24 hours postoperative Blood sampling before surgery (baseline), immediately postoperative, 6 and 24 hours after surgery.

Diagnostic Test: Neurocognitive Test BatteryDiagnostic Test: Blood sampling

Control Group

25 patients, not undergoing any operative intervention. To determine a normal reference value of cognitive functions, a group of 25 individuals without an operative intervention will be recruited as a control group. Intervention: neurocognitive testing (Neurocognitive Test Battery) at 3 determined time points (0, 6 and 24 hours)

Diagnostic Test: Neurocognitive Test Battery

Interventions

Neurocognitive Test BatteryDIAGNOSTIC_TEST

neurocognitive testing: preoperative(baseline), 6 and 24 hours postoperative.

Control GroupGeneral AnesthesiaLocal anesthesia with sedoanalgesia
Blood samplingDIAGNOSTIC_TEST

Blood sampling before surgery (baseline), immediately postoperative, 6 and 24 hours after surgery, investigating plasma levels of S 100-B, CRP, vitamines, homocysteine and folic acid

General AnesthesiaLocal anesthesia with sedoanalgesia

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)
Sampling MethodProbability Sample
Study Population

50 patients 65 years and older without any significant mental (MMSE ≥24) or neuropsychiatric disorders scheduled for elective ocular surgery requiring general anaesthesia or sedoanalgesia will be undergoing serial cognitive assessements pre- and postoperatively over 3 time-points. To determine a normal reference value of cognitive functions, a group of 25 participants in the same age (≥65 years)and without surgical intervention will be recruited as a control group and undergo serial cognitive assessements over 3 time-points.

You may qualify if:

  • Patients age 65 and older
  • scheduled to undergo elective ocular surgery
  • American Society of Anesthesiologists class I, II or III
  • MMSE score ≥ 24
  • The people signed informed consent.
  • Expected surgical duration \<90 minutes
  • Able to follow study instructions.

You may not qualify if:

  • Patients age \< 65 years
  • Emergent nature of the ocular surgery
  • American Society of Anesthesiologists class IV
  • MMSE score \< 24
  • unsigned informed consent
  • Expected surgical duration \>90 minutes
  • Not able to follow study instructions.
  • History of psychiatric or neurologic disorders (epilepsy, trauma, stroke,depressive disorders, hemorrhage, transient ischemic attack
  • Drug or substance abuse history

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medical University Vienna

Vienna, 1090, Austria

Location

Related Publications (2)

  • Lehrner, J.; Maly, J.; Gleiß, A.; Auff, E. & Dal-Bianco, P., Demenzdiagnostik mit Hilfe der Vienna Neuropsychologischen Testbatterie (VNTB): Standardisierung, Normierung und Validierung, Psychol. Österreich, 4, 358-365, 2007.

    BACKGROUND

  • Foki T, Hitzl D, Pirker W, Novak K, Pusswald G, Auff E, Lehrner J. Erratum to: Assessment of individual cognitive changes after deep brain stimulation surgery in Parkinson's disease using the Neuropsychological Test Battery Vienna short version. Wien Klin Wochenschr. 2017 Aug;129(15-16):585-587. doi: 10.1007/s00508-017-1210-2. No abstract available.

    PMID: 28741045BACKGROUND

Related Links

Biospecimen

Retention: SAMPLES WITH DNA

samples of blood taken before and after intervention, investigating biomarkers for cognitive impairment

MeSH Terms

Conditions

Cognitive DysfunctionPostoperative Cognitive Complications

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Cognition DisordersNeurocognitive DisordersMental DisordersPostoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Specimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisPuncturesSurgical Procedures, OperativeInvestigative Techniques

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

October 26, 2018

First Posted

December 13, 2018

Study Start

October 6, 2018

Primary Completion

August 28, 2023

Study Completion

August 30, 2023

Last Updated

August 30, 2023

Record last verified: 2023-08

Locations

AU(1)