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

NCT05940935 | Completed DMC

• 1 other identifier: TÜTF-GOBAEK 2023/210
• Study Type: observational
• Target: 35
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Metabolic Acidosis; Antiepileptic Drugs; Craniotomy; Anesthesia Management

Keywords

Antiepileptic Drugs; Metabolic Acidosis; Anesthesia Management; Craniotomy

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (4)

Group 1

Patients who have used Zonisamide or Topiramate

Procedure: Arterial Blood Gas Base Deficit

Group 2

Patients who have used Lacosamide

Procedure: Arterial Blood Gas Base Deficit

Group 3

Patients who have used Carbamazepine

Procedure: Arterial Blood Gas Base Deficit

Group 4

Patients who have used levetiracetam

Procedure: Arterial Blood Gas Base Deficit

Interventions

Arterial Blood Gas Base Deficit PROCEDURE

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 1; Group 2; Group 3; Group 4

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Patients undergoing intracranial surgery with craniotomy and using antiepileptic drugs
• ASA I-III
• Patients undergoing elective surgery

You may not qualify if:

• 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

Sponsors & Collaborators

• Trakya University: lead

Study Sites (1)

Trakya University

Edirne, Centrum, 22030, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Acidosis

Condition Hierarchy (Ancestors)

Acid-Base Imbalance; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• SEVTAP HEKİMOĞLU ŞAHİN, Professor

  Trakya University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Department of anesthesiology and reanimation, Principal Investigator, Resident Doctor

Study Record Dates

• First Submitted: June 21, 2023
• First Posted: July 11, 2023
• Study Start: May 22, 2023
• Primary Completion: June 30, 2023
• Study Completion: August 15, 2023
• Last Updated: November 7, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)