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

Metabolic Acidosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05940935
• Other study ID #: TÜTF-GOBAEK 2023/210
• Status: Completed
• Start date: May 22, 2023
• Est. completion date: August 15, 2023

Study information

• Verified date: November 2023
• Source: Trakya University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 35
• Est. completion date: August 15, 2023
• Est. primary completion date: June 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acidosis
• Craniotomy
• Metabolic Acidosis

Intervention

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.

Locations

Country	Name	City	State
Turkey	Trakya University	Edirne	Centrum

Sponsors (1)

Lead Sponsor	Collaborator
Trakya University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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