Postoperative Cognitive Dysfunction in Patients Undergoing Pituitary Removal Surgery

October 24, 2018 updated by: Cennet Tor Kılıc, Kocaeli University
As postoperative cognitive dysfunction rates are high especially in elder patients, cognitive dysfunction is not diagnosed and treated effectively. This statement is associated with prolonged hospital stays by increasing morbidity. We wanted to see the incidency of postoperative cognitive dysfunction in patients undergoing elective pituitary tumor removal surgery.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

90

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Kocaeli, Turkey, 41350
        • Recruiting
        • Kocaeli University
        • Contact:
          • Cennet Tor Kılıç
          • Phone Number: +902623038473

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Undergoing elective pituitary tumor removal surgery

Description

Inclusion Criteria:

  • ASA I-II patients
  • Undergoing elective pituitery tumor removal surgery

Exclusion Criteria:

  • >II ASA scores
  • Using antidepressant agents
  • Patient refusal
  • Mental diseases

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Group1
patients undergoing pituitary tumor removal surgery will be tested with standardized minimental testing.
Diagnostic test: standardized minimental testing
To diagnose postoperative cognitive dysfunction

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
minimental test score
Time Frame: preoperative 24th hour
scores between 0-30
preoperative 24th hour
minimental test score
Time Frame: postoperative 4th hour
scores between 0-30
postoperative 4th hour
minimental test score
Time Frame: postoperative 24th hour
scores between 0-30
postoperative 24th hour
minimental test score
Time Frame: one month after discharged
scores between 0-30
one month after discharged

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kocaeli University

Investigators

  • Principal Investigator: Cennet Tor Kılıç, Kocaeli University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

November 1, 2018

Primary Completion (Anticipated)

February 1, 2019

Study Completion (Anticipated)

March 1, 2019

Study Registration Dates

First Submitted

October 22, 2018

First Submitted That Met QC Criteria

October 24, 2018

First Posted (Actual)

October 25, 2018

Study Record Updates

Last Update Posted (Actual)

October 25, 2018

Last Update Submitted That Met QC Criteria

October 24, 2018

Last Verified

October 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GOKAEK 2017/153

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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