NCT04279132

Brief Summary

The aim of this study is to compare the effects of total intravenous anesthesia and inhalation anesthesia methods on postoperative cognitive dysfunction according to Mini Mental State Examination scores and Neuron Specific Enolase levels in lumbar disc herniectomy operations.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Mar 2020

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

First Submitted

Initial submission to the registry

February 19, 2020

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 20, 2020

Completed
1 month until next milestone

Study Start

First participant enrolled

March 21, 2020

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 21, 2020

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 21, 2020

Completed
Last Updated

February 20, 2020

Status Verified

February 1, 2020

Enrollment Period

2 months

First QC Date

February 19, 2020

Last Update Submit

February 19, 2020

Conditions

Postoperative Cognitive DysfunctionNEURON SPECIFIC ENOLASEMINI MENTAL STATE EXAMINATION TEST

Outcome Measures

Primary Outcomes (1)

  • MINI MENTAL STATE EXAMINATION TEST

    BELOW 27 SCORE IS ASSOSIATED WITH POSTOPERATIVE COGNITIVE DYSFUNCTION

    1 MONTH

Study Arms (2)

TOTAL INTRAVENOUS ANESTHESIA

Behavioral: POSTOPERATIVE COGNITIVE DYSFUNCTION

INHALATION ANESTHESIA

Behavioral: POSTOPERATIVE COGNITIVE DYSFUNCTION

Interventions

POSTOPERATIVE COGNITIVE DYSFUNCTIONBEHAVIORAL

NEURON SPECIFIC ENOLASE LEVELS IN LUMBAR DISC HERNIECTOMY WITH GENERAL ANESTHESIA MODALITIES

INHALATION ANESTHESIATOTAL INTRAVENOUS ANESTHESIA

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Lumbal disc herniectomy operation is planned for ASA I, II and III risk group between the ages of 18-65.

You may qualify if:

  • Lumbal disc herniectomy operation 18-65 age

You may not qualify if:

  • Patients before and after the coronary artery bypass graft surgery
  • patients in the last trimester of pregnancy
  • patients with severe heart failure
  • liver failure
  • kidney failure
  • malignant hyperthermia
  • lactating patients
  • patients with vision or hearing problems
  • patients having difficulty in understanding and speaking Turkish
  • Parkinson's and Alzheimer's disease
  • alcohol and drug addicts
  • morbidly obese patients
  • intraoperative hypotension, hypertension and hypoxemia

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Erzincan Byu

Erzincan, Turkey (Türkiye)

RECRUITING

Related Publications (3)

  • Goswami U, Babbar S, Tiwari S. Comparative evaluation of the effects of propofol and sevoflurane on cognitive function and memory in patients undergoing laparoscopic cholecystectomy: A randomised prospective study. Indian J Anaesth. 2015 Mar;59(3):150-5. doi: 10.4103/0019-5049.153036.

    PMID: 25838586RESULT

  • Luescher T, Mueller J, Isenschmid C, Kalt J, Rasiah R, Tondorf T, Gamp M, Becker C, Sutter R, Tisljar K, Schuetz P, Marsch S, Hunziker S. Neuron-specific enolase (NSE) improves clinical risk scores for prediction of neurological outcome and death in cardiac arrest patients: Results from a prospective trial. Resuscitation. 2019 Sep;142:50-60. doi: 10.1016/j.resuscitation.2019.07.003. Epub 2019 Jul 12.

    PMID: 31306716RESULT

  • Baysalman HB, Oğuz G, Açıkgöz G, Aksakal FN, Ünver SJJotTA, Dergisi ICS-JTAvR. Total İntravenöz ve Desfluran Anestezilerinin Erken Derlenme ve Kognitif Fonksiyonlara Etkileri. 2011;39(1).

    RESULT

Biospecimen

Retention: SAMPLES WITHOUT DNA

BLOOD SAMPLES

MeSH Terms

Conditions

Postoperative Cognitive Complications

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsCognitive DysfunctionCognition DisordersNeurocognitive DisordersMental Disorders

Study Officials

  • TÜLAY CEREN ÖLMEZTÜRK KARAKURT

    ERZINCAN BYU

    PRINCIPAL INVESTIGATOR

Central Study Contacts

UFUK KUYRUKLUYILDIZ

CONTACT

05325840554drufuk2001@gmail.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
1 Day
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

February 19, 2020

First Posted

February 20, 2020

Study Start

March 21, 2020

Primary Completion

May 21, 2020

Study Completion

July 21, 2020

Last Updated

February 20, 2020

Record last verified: 2020-02

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)