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NCT04584827 | COMPLETED | Lactate


Evaluation of Lactate in Patients Undergoing Glial and Non Glial Mass Surgery With Craniotomy
Sponsor:

Trakia University

Information provided by (Responsible Party):

Onur Kucuk

Brief 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.

Condition or disease

Lactate

Brain Tumor

Post-Op Complication

Intervention/treatment

lactate level

Glasgow Outcome Scale

Detailed 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.

Study Type : OBSERVATIONAL
Estimated Enrollment : 100 participants
Official Title : Evaluation of Lactate in Patients Undergoing Glial and Non Glial Mass Surgery With Craniotomy
Actual Study Start Date : 2019-12-10
Estimated Primary Completion Date : 2021-12-10
Estimated Study Completion Date : 2022-07-10

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
Criteria
Inclusion Criteria
  • 1. Having an intracranial mass operation with craniotomy
  • 2. No history of congestive heart failure
  • 3. No kidney and liver dysfunction
  • 4. Not pregnant
  • 5. Not taking inotropic drugs during the operation
  • 6. Receiving less than four red blood product replacements during the operation
Exclusion Criteria
  • 1. Patients with a history of congestive heart failure
  • 2. Patients with kidney and liver dysfunction
  • 3. Patients who need an inotropic agent to adjust blood pressure during the operation
  • 4. Patients who have undergone four or more red blood product transfusions during the operation
  • 5. Pregnant patients

Evaluation of Lactate in Patients Undergoing Glial and Non Glial Mass Surgery With Craniotomy

Location Details

NCT04584827


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Locations


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Turkey, Center

Trakia University

Edirne, Center, Turkey, 22030

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