Metabolic AcidosisNCT05940935
The Relationship of Developing Metabolic Acidosis With Antiepleptic Drugs in Craniotomy Operations
An observational study of Metabolic Acidosis and Antiepileptic Drugs, run by Trakya University at 1 site in Turkey (Türkiye).
Trial summary
The relationship of developing metabolic acidosis with antiepleptic drugs in craniotomy operations Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metabolic Acidosis, Antiepileptic Drugs, Craniotomy
- What is being tested?
- Arterial Blood Gas Base Deficit
- Type of treatment
- Surgery or procedure
- How many people
- 35 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 22 May 2023to 15 Aug 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- Patients undergoing intracranial surgery with craniotomy and using antiepileptic drugs
- ASA I-III
- Patients undergoing elective surgery
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Relationship of Developing Metabolic Acidosis With Antiepleptic Drugs in Craniotomy Operations; Does Topiramat or Zonisamide Cause Metabolic Acidosis?
The relationship of developing metabolic acidosis with antiepleptic drugs in craniotomy operations
Read the 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.
- Being tested
- Arterial Blood Gas Base Deficit
- Keywords
- Antiepileptic Drugs, Metabolic Acidosis, Anesthesia Management, Craniotomy
- Medical subject headings
- Acidosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Arterial Blood Gas Base DeficitProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Patients who have used Zonisamide or Topiramate Receives: Procedure: Arterial Blood Gas Base Deficit | |
| Group 2 | Patients who have used Lacosamide Receives: Procedure: Arterial Blood Gas Base Deficit | |
| Group 3 | Patients who have used Carbamazepine Receives: Procedure: Arterial Blood Gas Base Deficit | |
| Group 4 | Patients who have used levetiracetam Receives: Procedure: Arterial Blood Gas Base Deficit |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2023
- Study start22 May 2023
- Primary completion30 Jun 2023
- Study completion15 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metabolic AcidosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Trakya University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Onur Kucuk, Trakya University
- Investigators
- SEVTAP HEKİMOĞLU ŞAHİN, Professor, Principal investigator, Trakya University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05940935
- Sponsor's protocol ID
- TÜTF-GOBAEK 2023/210
- Status last verified
- Nov 2023
- First submitted
- 21 Jun 2023
- Last updated
- 7 Nov 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Relationship of Developing Metabolic Acidosis With Antiepleptic Drugs in Craniotomy Operations; Does Topiramat or Zonisamide Cause Metabolic Acidosis?
- ClinicalTrials.gov ID
- NCT05940935
- Acronym / sponsor ID
- TÜTF-GOBAEK 2023/210
- Keywords
- Antiepileptic Drugs, Metabolic Acidosis, Anesthesia Management, Craniotomy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Trakya UniversityUniversity, hospital or other
- Study start
- 22 May 2023 (actual)
- Primary completion
- 30 Jun 2023 (actual)
- Study completion
- 15 Aug 2023 (actual)
- First posted
- 11 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Group 1 | – | Procedure: Arterial Blood Gas Base DeficitPatients who have used Zonisamide or Topiramate |
| Group 2 | – | Procedure: Arterial Blood Gas Base DeficitPatients who have used Lacosamide |
| Group 3 | – | Procedure: Arterial Blood Gas Base DeficitPatients who have used Carbamazepine |
| Group 4 | – | Procedure: Arterial Blood Gas Base DeficitPatients who have used levetiracetam |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- Patients undergoing intracranial surgery with craniotomy and using antiepileptic drugs
- ASA I-III
- Patients undergoing elective surgery
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Arterial Blood Gas Base DeficitThe 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. | Procedure or surgery | Group 1, Group 2, Group 3, Group 4 |
Primary outcome
Preoperative Metabolic Acidosis
Time frame: 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.
Intraoperative Metabolic Acidosis
Time frame: 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.
Postoperative Metabolic Acidosis
Time frame: 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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Nov 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
SEVTAP HEKİMOĞLU ŞAHİN, Professor principal investigator
Trakya University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Metabolic Acidosis and Antiepileptic Drugs, run by Trakya University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Preoperative Metabolic Acidosis (time frame: Baseline). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Nov 2023.