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

Completed

• Conditions: Anesthesia Management; Metabolic Acidosis; Antiepileptic Drugs; Craniotomy
• Interventions: Procedure: Arterial Blood Gas Base Deficit

• Registration Number: NCT05940935
• Lead Sponsor: Trakya University

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.

Study Timeline

• Study Start: 2023-05-22
• Study First Submitted: 2023-06-21
• Primary Completion: 2023-06-30
• Study First Submitted QC: 2023-07-07
• Study First Posted: 2023-07-11
• Study Completion: 2023-08-15
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-02
• Last Update Posted: 2023-11-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 35

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Group 3	Arterial Blood Gas Base Deficit	Patients who have used Carbamazepine
Group 4	Arterial Blood Gas Base Deficit	Patients who have used levetiracetam
Group 1	Arterial Blood Gas Base Deficit	Patients who have used Zonisamide or Topiramate
Group 2	Arterial Blood Gas Base Deficit	Patients who have used Lacosamide

Primary Outcome Measures

Name	Time	Method
Intraoperative Metabolic Acidosis	during the operation	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.
Preoperative Metabolic Acidosis	Baseline	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.
Postoperative Metabolic Acidosis	Day 1	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.

Trial Locations

Locations (1)

Trakya University; 🇹🇷 Edirne, Centrum, Turkey