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

NCT ID: NCT04584827

Last Updated: 2023-01-19

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 100 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2019-12-10
• Study Completion Date: 2022-07-10

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.

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.

Conditions

Lactate; Brain Tumor; Post-Op Complication

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: PROSPECTIVE

Study Groups

complication positive (up to 30 days after surgery)

Complications:

• Moderate to severe intracerebral hemorrhage confirmed in a brain CT scan (Midline shift in brain imaging ≥ 3 mm),
• İntracranial hypertension requiring post op surgical drainage,
• Status epilepticus or seizures,
• The need for tracheal intubation or use of mechanical ventilation after surgery,
• Decrease in GKS,
• Unmanageable agitation that requires restriction or sedation,
• Need for respiratory failure and oxygen therapy,
• Unexpected serious motor deficit
• Died

lactate level

Intervention Type: 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.

Glasgow Outcome Scale

Intervention Type: 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.

complication negative (up to 30 days after surgery)

No complications are seen within 30 days and the patient is healthy

lactate level

Intervention Type: 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.

Glasgow Outcome Scale

Intervention Type: 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.

Interventions

lactate level

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.

Intervention Type: OTHER

Glasgow Outcome Scale

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.

Intervention Type: OTHER

Other Intervention Names

lac; GOS

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Trakya University

OTHER

Sponsor Role: lead

Responsible Party

Onur Kucuk

Department of anesthesiology and reanimation, Research Assistant

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

SEVTAP HEKİMOĞLU ŞAHİN, Professor

Role: PRINCIPAL_INVESTIGATOR

Trakya University

ONUR KÜÇÜK, Resident

Role: PRINCIPAL_INVESTIGATOR

Trakya University

Locations

Trakya University

Edirne, Centrum, Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

TÜTF-BAEK 2019/450

Identifier Type: -

Identifier Source: org_study_id