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?

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

Study Overview

• Status: Completed
• Conditions: Craniotomy; Metabolic Acidosis; Anesthesia Management; Antiepileptic Drugs
• Intervention / Treatment: Procedure: Arterial Blood Gas Base Deficit

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.

• Study Type: Observational
• Enrollment (Actual): 35

Contacts and Locations

Study Locations

• Turkey
  • Centrum
    • Edirne, Centrum, Turkey, 22030
      • Trakya University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Patients who underwent craniotomy and intracranial surgery at Trakya University Medical Faculty Hospital and used antiepileptic drugs were included in the study as a retrospective file review. The files of 35 patients who met the study criteria were reviewed retrospectively.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

4

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Group 1; Patients who have used Zonisamide or Topiramate	Procedure: Arterial 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.
Group 2; Patients who have used Lacosamide	Procedure: Arterial 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.
Group 3; Patients who have used Carbamazepine	Procedure: Arterial 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.
Group 4; Patients who have used levetiracetam	Procedure: Arterial 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Preoperative Metabolic Acidosis	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.	Baseline
Intraoperative Metabolic Acidosis	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.	during the operation
Postoperative Metabolic Acidosis	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.	Day 1

Collaborators and Investigators

• Sponsor: Trakya University
• Investigators: Principal Investigator: SEVTAP HEKİMOĞLU ŞAHİN, Professor, Trakya University

Study record dates

Study Major Dates

• Study Start (Actual): May 22, 2023
• Primary Completion (Actual): June 30, 2023
• Study Completion (Actual): August 15, 2023

Study Registration Dates

• First Submitted: June 21, 2023
• First Submitted That Met QC Criteria: July 7, 2023
• First Posted (Actual): July 11, 2023

Study Record Updates

• Last Update Posted (Actual): November 7, 2023
• Last Update Submitted That Met QC Criteria: November 2, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: Craniotomy; Antiepileptic Drugs; Metabolic Acidosis; Anesthesia Management
• Additional Relevant MeSH Terms: Metabolic Diseases; Acid-Base Imbalance; Acidosis
• Other Study ID Numbers: TÜTF-GOBAEK 2023/210

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No