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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05940935
Other study ID # TÜTF-GOBAEK 2023/210
Secondary ID
Status Completed
Phase
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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