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The Relationship of Anesthesia Method With Serum Lactate Level in Craniotomies

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ClinicalTrials.gov Identifier: NCT05145049
Recruitment Status : Recruiting
First Posted : December 6, 2021
Last Update Posted : July 22, 2022
Sponsor:
Information provided by (Responsible Party):
Fatma Özkan Sipahioğlu, Ankara Diskapi Training and Research Hospital

Brief Summary:
The investigators aimed to research the incidence of hyperlactatemia in craniotomy cases, the relationship of lactate elevation with tumor type and other factors that may be related, and whether the general anesthesia method applied (inhalation anesthesia or total ıntravenous anesthesia) affects lactate level.

Condition or disease
Intracranial Neoplasm Hyperlactatemia Brain Tumor Hypoperfusion

Detailed Description:
Lactate level is one of the easy-to-measure parameters that are frequently used in anesthesia and intensive care clinical practice, especially to evaluate the severity of disease and the response to treatment. In patients with high lactate levels, the first considerations are hypoperfusion and sepsis. However, many causes such as trauma, seizures, ischemia, diabetic ketoacidosis, thiamine deficiency, malignancies, liver dysfunction, genetic disorders, toxins, drugs, etc. can be associated with increased lactate. Many tissues in the body can produce lactate. 25% of production is from muscle, 25% skin, 20% brain, 20% RBC and 10% bowel cells. Some malignancies, especially hematological cancers, have also been associated with increased lactate. In recent years, it has been reported that serum lactate levels are associated with the degree of glial tumor malignancy, and that lactate can even be used as a non-invasive malignancy biomarker in brain tumors. In a recent study, it was reported that the type of 'glioblastoma multiforme' among patients who underwent craniotomy with the diagnosis of intracranial brain tumor was an independent influencer factor for preoperative and postoperative hyperlactatemia. Anesthesia is one of the factors that can affect lactate levels due to its effect on systemic perfusion and the hepatic effects of anesthetic drugs. It looks like that there is no study in the literature on the effect of anesthesia technique on hyperlactatemia in patients who underwent craniotomy. Therefore the investigators aimed to research the incidence of hyperlactatemia in craniotomy cases, the relationship of lactate elevation with tumor type and other factors that may be related, and whether the general anesthesia method applied (inhalation anesthesia or total ıntravenous anesthesia) affects lactate level.

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 100 participants
Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration: 2 Weeks
Official Title: The Relationship of Anesthesia Method With Serum Lactate Level in Craniotomies
Actual Study Start Date : November 1, 2021
Estimated Primary Completion Date : September 1, 2022
Estimated Study Completion Date : November 2022



Primary Outcome Measures :
  1. lactate level [ Time Frame: 0.hour ]
    basal lactate level via arterial blood gas at the beginning of surgery

  2. lactate level [ Time Frame: 1.hour ]
    lactate level via arterial blood gas at one hour after the beginning of surgery

  3. lactate level [ Time Frame: 3.hour ]
    lactate level via arterial blood gas at three hour after the beginning of surgery

  4. lactate level [ Time Frame: after extubation at the end of surgery ]
    lactate level via arterial blood gas at the end of the surgery



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
All patients who scheduled to undergo elective craniotomy for an intracranial mass older than 18 years old
Criteria

Inclusion Criteria:

  • Scheduled to undergo elective craniotomy for an intracranial mass
  • adult patients

Exclusion Criteria:

  • emergency
  • In situations that may cause hyperlactatemia (such as sepsis, hepatic or renal failure, shock state, or patients who need inotropic support)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05145049


Contacts
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Contact: Fatma Özkan Sipahioglu, specialist +905531362875 ftmozkan_uzmdr@yahoo.com

Locations
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Turkey
Diskapi Training and Research Hospital Recruiting
Ankara, Turkey, 06110
Contact: Fatma Özkan Sipahioglu, specialist    05531362875    ftmozkan_uzmdr@yahoo.com   
Sub-Investigator: Funda Atar, specialist         
Sponsors and Collaborators
Ankara Diskapi Training and Research Hospital
Investigators
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Principal Investigator: Fatma Özkan Sipahioglu Ankara Diskapi Research and Training Hospital
Publications of Results:
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Responsible Party: Fatma Özkan Sipahioğlu, Principal Investigator, Anesthesiologist, Ankara Diskapi Training and Research Hospital
ClinicalTrials.gov Identifier: NCT05145049    
Other Study ID Numbers: Lactate
First Posted: December 6, 2021    Key Record Dates
Last Update Posted: July 22, 2022
Last Verified: July 2022
Keywords provided by Fatma Özkan Sipahioğlu, Ankara Diskapi Training and Research Hospital:
hyperlactatemia
craniotomy
total intravenous anesthesia
general anesthesia
Additional relevant MeSH terms:
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Brain Neoplasms
Hyperlactatemia
Central Nervous System Neoplasms
Nervous System Neoplasms
Neoplasms by Site
Neoplasms
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Metabolic Diseases