Clinical Trial Details
— Status: Completed
Administrative data
NCT number |
NCT04584827 |
Other study ID # |
TÜTF-BAEK 2019/450 |
Secondary ID |
|
Status |
Completed |
Phase |
|
First received |
|
Last updated |
|
Start date |
December 10, 2019 |
Est. completion date |
July 10, 2022 |
Study information
Verified date |
January 2023 |
Source |
Trakya University |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Observational
|
Clinical Trial Summary
The aim of this study is to determine the effects of the level of metabolites used in routine
on mortality and morbidity in patients who will undergo intracranial surgery with craniotomy.
Description:
In this study, in patients who are planned to have an intracranial mass operation with
craniotomy, their medical histories, demographic features, comorbidities, preoperative
radiotherapy treatment, the parameters examined in the preoperative routine will be collected
as a file scan (previous operations, GKS, laboratory values). The classification of patients
according to the 2016 World Health Organization Central Classification of Nervous System
Tumors (WHO-CNS classification) and whether it is glial or non glial will be recorded from
the clinical file. Intraoperative; hemodynamic data of patients; heart rate, diastolic,
systolic and mean arterial pressures, fluid and blood products delivered, anesthetic and
other medications, and blood gas samples will be written from the anesthesia document after
the operation is finished. For the study, the application of the anesthesiologist for the
patient will not be interfered. If postoperative patients are sent to the intensive care
unit, their laboratory values and clinical observations (mortality, morbidity, neurological
sequelae, imaging techniques, GOSE (Glasgow outcome skale)) will be recorded. In our study,
mortality and morbidity will be evaluated 30 days postoperatively, and if the patient was
sent to the service from the intensive care unit in this process, the values in the
postoperative clinic (mortality, morbidity, neurological evaluation, imaging techniques,
pathology results) will be recorded from the patient document. If the patient was discharged
30 days before, outpatient data will be recorded. The patients will be classified by
evaluating the collected data (intraoperative hemodynamic data, blood transfusions,
postoperative neurological sequel, postoperative complications and mortality).
In our study; the effects of lactate level on mortality and morbidity will be investigated in
patients undergoing an intracranial mass operation with general anesthesia.