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CompletedNCT05145049Updated May 16, 2024

The Relationship of Anesthesia Method With Serum Lactate Level in Craniotomies

An observational study in Intracranial Neoplasm, Hyperlactatemia and Brain Tumor, sponsored by Ankara Diskapi Training and Research Hospital. Completed at 1 site in Turkey. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-05-16.

Sponsored by Ankara Diskapi Training and Research Hospital · Observational

Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
110
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Intracranial Neoplasm
  • Hyperlactatemia
  • Brain Tumor
  • Hypoperfusion

Keywords

  • hyperlactatemia
  • craniotomy
  • total intravenous anesthesia
  • general anesthesia
03

In context

Brain Neoplasms

2,440 studies on the registry are indexed under Brain Neoplasms; 540 are open to participants now.

This study's enrollment of 110 is above the median of 99 across 433 observational studies indexed under Brain Neoplasms.

Browse Brain Neoplasms studies →

Lead sponsor

Ankara Diskapi Training and Research Hospital is the lead sponsor of 19 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • emergency
  • In situations that may cause hyperlactatemia (such as sepsis, hepatic or renal failure, shock state, or patients who need inotropic support)
05

Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
110 participants (actual)
Target follow-up
3 Months
Patient registry
Yes
06

What researchers measure

Primary outcomes

  1. lactate level

    basal lactate level via arterial blood gas at the beginning of surgery

    Time frame: 0.hour

  2. lactate level

    lactate level via arterial blood gas at one hour after the beginning of surgery

    Time frame: 1.hour

  3. lactate level

    lactate level via arterial blood gas at three hour after the beginning of surgery

    Time frame: 3.hour

  4. lactate level

    lactate level via arterial blood gas at the end of the surgery

    Time frame: after extubation at the end of surgery

07

Study locations

1 site
  • Diskapi Training and Research Hospital
    Ankara, 06110, Turkey
08

References and documents

Publications

  • Andersen LW, Mackenhauer J, Roberts JC, Berg KM, Cocchi MN, Donnino MW. Etiology and therapeutic approach to elevated lactate levels. Mayo Clin Proc. 2013 Oct;88(10):1127-40. doi: 10.1016/j.mayocp.2013.06.012. PubMed 24079682 ↗
  • Branco M, Linhares P, Carvalho B, Santos P, Costa BM, Vaz R. Serum lactate levels are associated with glioma malignancy grade. Clin Neurol Neurosurg. 2019 Nov;186:105546. doi: 10.1016/j.clineuro.2019.105546. Epub 2019 Oct 1. PubMed 31605893 ↗
  • Bharadwaj S, Venkatraghavan L, Mariappan R, Ebinu J, Meng Y, Khan O, Tung T, Reyhani S, Bernstein M, Zadeh G. Serum lactate as a potential biomarker of non-glial brain tumors. J Clin Neurosci. 2015 Oct;22(10):1625-7. doi: 10.1016/j.jocn.2015.05.009. Epub 2015 Jun 19. PubMed 26100160 ↗
  • Mariappan R, Venkatraghavan L, Vertanian A, Agnihotri S, Cynthia S, Reyhani S, Tung T, Khan OH, Zadeh G. Serum lactate as a potential biomarker of malignancy in primary adult brain tumours. J Clin Neurosci. 2015 Jan;22(1):144-8. doi: 10.1016/j.jocn.2014.06.005. Epub 2014 Aug 27. PubMed 25172017 ↗
  • Ioannoni E, Grande G, Olivi A, Antonelli M, Caricato A, Montano N. Factors affecting serum lactate in patients with intracranial tumors - A report of our series and review of the literature. Surg Neurol Int. 2020 Mar 6;11:39. doi: 10.25259/SNI_552_2019. eCollection 2020. PubMed 32257565 ↗
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Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Nov 2021 to primary completion in Sep 2022, 10 months.

Of 181 non-industry observational studies under Brain Neoplasms, half reached primary completion within 82 months of starting (the median), counting those still running; a quarter within 42 and three quarters within 269. This study's 10 months is below that.

Counting every sponsor, half of 199 studies reached it within 82 months; a quarter within 41 and three quarters within 269.

How these figures are worked out, and which studies are left out of them.

Registered
Nov 8, 2021
First posted
Dec 6, 2021
StartActual
Nov 1, 2021
Primary completionActual
Sep 1, 2022
CompletionActual
Nov 30, 2022
Last update
May 16, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on May 16, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05145049
Lead sponsor
Ankara Diskapi Training and Research Hospital
Responsible party
Fatma Özkan Sipahioğlu (Principal Investigator, Anesthesiologist, Ankara Diskapi Training and Research Hospital) — Principal investigator
First posted
Dec 6, 2021
Start date
Nov 1, 2021
Primary completion
Sep 1, 2022
Completion
Nov 30, 2022
Last update
May 16, 2024

Study contacts

Fatma Özkan Sipahioglu
principal investigator · Ankara Diskapi Research and Training Hospital

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in May 2024. You cannot join it, but the record below documents what was studied.

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