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NCT Number: NCT04584827

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

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Having an intracranial mass operation with craniotomy
  • No history of congestive heart failure
  • No kidney and liver dysfunction
  • Not pregnant
  • Not taking inotropic drugs during the operation
  • Receiving less than four red blood product replacements during the operation

Exclusion criteria

  • Patients with a history of congestive heart failure
  • Patients with kidney and liver dysfunction
  • Patients who need an inotropic agent to adjust blood pressure during the operation
  • Patients who have undergone four or more red blood product transfusions during the operation
  • Pregnant patients

Treatment and study plan

lactate level

Other

Lactate, a byproduct of glycolysis, is an indicator of weak tissue perfusion and a useful biomarker with prognostic value in various diseases. Lactate value is calculated by blood gas.

Other names: lac

Glasgow Outcome Scale

Other

Glasgow Outcome Scale; It is a scale developed to categorize people suffering from head trauma or non-traumatic acute brain injury into broad outcome categories. It shows postoperative mortality and morbidity of patients who underwent intracranial surgery.

Other names: GOS

Primary outcomes

  1. lactate level

    Time frame: change from operation to post-op second day (4 time)

    Lactate, a byproduct of glycolysis, is an indicator of weak tissue perfusion and a useful biomarker with prognostic value in various diseases. Lactate value is calculated by blood gas.

Secondary outcomes

  1. Glasgow Outcome Scale

    Time frame: 30 days after the operation (1 time)

    Glasgow Outcome Scale; It is a scale developed to categorize people suffering from head trauma or non-traumatic acute brain injury into broad outcome categories. It shows postoperative mortality and morbidity of patients who underwent intracranial surgery. Glasgow Outcome Scale is a five-point scale. 1 point is considered death and five points as good recovery. As the score increases, morbidity and mortality decrease.

Sponsors and collaborators

Lead sponsor

Trakya University

Other

Registry information

Important dates

Study start
2019
Primary completion
2021
Study completion
2022
First posted
Oct 14, 2020
Registry last updated
Jan 19, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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