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

• Sponsor: Trakya University (Other)
• Overall Status: Active, not recruiting
• CT.gov ID: NCT05940935
• Collaborator: (none)
• Enrollment: 35
• Location: 1
• Anticipated Duration (Months): 1.8
• Patients Per Site Per Month: 19.7

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Metabolic Acidosis; Antiepileptic Drugs; Craniotomy; Anesthesia Management	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 Design

• Study Type: Observational
• Actual Enrollment: 35 participants
• Observational Model: Case-Control
• Time Perspective: Retrospective
• Official Title: The Relationship of Developing Metabolic Acidosis With Antiepleptic Drugs in Craniotomy Operations; Does Topiramat or Zonisamide Cause Metabolic Acidosis?
• Actual Study Start Date: May 22, 2023
• Anticipated Primary Completion Date: Jun 30, 2023
• Anticipated Study Completion Date: Jul 15, 2023

Arms and Interventions

Arm	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.

Outcome Measures

Primary Outcome Measures

1. 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.

2. 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.

3. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Trakya University	Edirne	Centrum	Turkey	22030

Sponsors and Collaborators

• Trakya University

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Onur Kucuk, Department of anesthesiology and reanimation, Principal Investigator, Resident Doctor, Trakya University
• ClinicalTrials.gov Identifier: NCT05940935
• Other Study ID Numbers: TÜTF-GOBAEK 2023/210
• First Posted: Jul 11, 2023
• Last Update Posted: Jul 11, 2023
• Last Verified: Jul 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Onur Kucuk, Department of anesthesiology and reanimation, Principal Investigator, Resident Doctor, Trakya University: Antiepileptic Drugs; Metabolic Acidosis; Anesthesia Management; Craniotomy
• Additional relevant MeSH terms: Acidosis

Study Results

No Results Posted as of Jul 11, 2023