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The Relationship of Developing Metabolic Acidosis With Antiepleptic Drugs in Craniotomy Operations

The Relationship of Developing Metabolic Acidosis With Antiepleptic Drugs in Craniotomy Operations; Does Topiramat or Zonisamide Cause Metabolic Acidosis?

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05940935
Enrollment
35
Registered
2023-07-11
Start date
2023-05-22
Completion date
2023-08-15
Last updated
2023-11-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anesthesia Management, Antiepileptic Drugs, Craniotomy, Metabolic Acidosis

Keywords

Antiepileptic Drugs, Metabolic Acidosis, Anesthesia Management, Craniotomy

Brief summary

The relationship of developing metabolic acidosis with antiepleptic drugs in craniotomy operations

Detailed description

Metabolic acidosis is a life-threatening complication in the perioperative, intraoperative and postoperative period. It can cause decreased cardiac output, electrolyte imbalance, surgical bleeding and neurological complications, even coma and death in surgical patients. Topiramate and zonisamide are sulfonamide derivative compounds used in the treatment of epilepsy. It has been shown in studies that both drugs have a strong inhibition of carbonic anhydrase enzyme. Recent case reports suggest that both drugs may cause metabolic acidosis by lowering serum bicarbonate levels in some patients. Aim in this study is to determine the relationship between preoperative, intraoperative and postoperative metabolic acidosis and to emphasize the importance of anesthesia management in patients who have undergone craniotomy and use antiepileptic drugs.

Interventions

PROCEDUREArterial Blood Gas Base Deficit

The base deficit values in the preoperative, intraoperative and postoperative blood gases taken from the patients and the presence and severity of metabolic acidosis were evaluated. Metabolic acidosis severity was defined by base deficit levels: mild from -3 to -5, moderate from -5 to -10, and severe metabolic acidosis below -10.

Sponsors

Trakya University
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Patients undergoing intracranial surgery with craniotomy and using antiepileptic drugs * ASA I-III * Patients undergoing elective surgery

Exclusion criteria

* Patients with a surgical procedure time of more than 5 hours * Patients who received more than 2 units of blood transfusion during the operation * Patients taking other drugs that can cause metabolic acidosis * Patients with diabetes mellitus, diabetes insipidus, hepatic or renal disease

Design outcomes

Primary

MeasureTime frameDescription
Preoperative Metabolic AcidosisBaselineThe base deficit values in the preoperative, intraoperative and postoperative blood gases taken from the patients and the presence and severity of metabolic acidosis were evaluated. Metabolic acidosis severity was defined by base deficit levels: mild from -3 to -5, moderate from -5 to -10, and severe metabolic acidosis below -10.
Intraoperative Metabolic Acidosisduring the operationThe base deficit values in the preoperative, intraoperative and postoperative blood gases taken from the patients and the presence and severity of metabolic acidosis were evaluated. Metabolic acidosis severity was defined by base deficit levels: mild from -3 to -5, moderate from -5 to -10, and severe metabolic acidosis below -10.
Postoperative Metabolic AcidosisDay 1The base deficit values in the preoperative, intraoperative and postoperative blood gases taken from the patients and the presence and severity of metabolic acidosis were evaluated. Metabolic acidosis severity was defined by base deficit levels: mild from -3 to -5, moderate from -5 to -10, and severe metabolic acidosis below -10.

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026