Anesthesia,GeneralNCT05598567
Hemodynamic Parameters and Cardiac Enzyme Levels in Patients Undergoing General Anesthesia
An observational study of Anesthesia,General and Cardiac Event, run by Duzce University at 1 site in Turkey (Türkiye).
Trial summary
The goal of this observational study is to learn about the effects of total intravenous general anesthesia with target controlled infusion and sevoflurane based balanced general anesthesia on hemodynamic parameters and cardiac enzyme levels in patients undergoing total abdominal hysterectomy. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Anesthesia,General, Cardiac Event
- What is being tested?
- sevoflurane based balanced general anesthesia
- Type of treatment
- Injection or infusion
- How many people
- 140 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 6 Jun 2022to 1 Mar 2024
- 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 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: 140 patients between age 18 and 80 years who meet the inclusion criteria and sign informed consent will be included.
Who may be able to join
- Patients over the age of 18 who will undergo Total Abdominal Hysterectomy under general anesthesia
- Patients in risk group I, II,III according to the American Society of Anesthesiologists (ASA) classification
Who cannot join
- Patients for whom Intensive Care Unit (ICU) indication is required
- Chronic obstructive pulmonary disease,
- Personal or family history of malignant hyperthermia,
- Morbid obesity,
- Alcohol or drug addiction,
- History of liver or kidney disease,
Show all 12Show fewer
- History of cardiac surgery,
- Coronary artery disease or heart failure,
- Significant anemia or hemoglobinopathy,
- Hypotension, hypovolemia, sepsis,
- Decompensated diabetic patients,
- Those who are allergic to propofol and halogens
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Duzce University Faculty of Medicine
Düzce, 81000
About this study
Official title: Evaluation of Hemodynamic Parameters and Cardiac Enzyme Levels in Patients Undergoing Total Abdominal Hysterectomy Under TCI-TIVA and Sevoflurane Based General Anesthesia
The goal of this observational study is to learn about the effects of total intravenous general anesthesia with target controlled infusion and sevoflurane based balanced general anesthesia on hemodynamic parameters and cardiac enzyme levels in patients undergoing total abdominal hysterectomy.
Read the detailed description
Total intravenous anesthesia (TIVA) is a common anesthesia method used today as an alternative to inhalation anesthesia. Loss of consciousness is an important component of general anesthesia, in order to give the patient safe analgesia and not to remember any adverse events related to the operation.
While the depth of anesthesia can be controlled by monitoring the minimum alveolar concentration (MAK) in the ventilator devices in the modern operating room , there was no more objective method than measuring the plasma level of drugs in intravenous anesthesia. The schemes created by the anesthetists according to plasma drug levels were used when administering total intravenous anesthesia. Target Controlled Anesthesia (TCI) devices on the other hand, are pumps that have been used more frequently recently and that can deliver the required blood concentration of a drug in bolus and infusion form according to pharmacokinetic models calculated with personal data. In TCI anesthesia, intravenous infusion of anesthetics provides a more stable drug concentration in the plasma and at the site of action compared to repeated bolus techniques. Thus, it is ensured that the results such as excessively high or excessively low administration of drugs are avoided and the drug remains in the therapeutic range.
In inhalation anesthesia, anesthetic substances are absorbed from the alveoli, pass into the bloodstream and reach the brain. Tracheal intake of the anesthetic agents used in this method is rapid and the depth of anesthesia can be controlled. However , the patient should be monitored and followed up for complications . An ideal inhalation anesthetic has a minimal effect on the cardiovascular and respiratory systems and has no toxic effects on these systems. Due to these properties, the most commonly used anesthetic drugs for inhalation anesthesia today are isoflurane and sevoflurane. In terms of its cardiopulmonary effects, Sevoflurane is reported to provide faster and deeper anesthesia than other anesthetics.
Aim: In this study, the researchers aim to compare the change of cardiac enzyme levels from baseline in patients undergoing total abdominal hysterectomy under general anesthesia with TCI anesthesia and sevoflurane based balanced anesthesia.
Method: 140 patients who meet the inclusion criteria and signed informed consent will be included. All patients will be monitored with routine anesthesia monitoring and bispectral index (BIS), all parameters will be checked and recorded in 5 minute intervals throughout the operation. 70 patients will receive TCI-TIVA and 70 patients will receive sevoflurane based balanced anesthesia. Creatin kinase (CK), Creatin kinase - myoglobin binding (CK-MB), Troponin I values will be determined 3 times; before the induction of anesthesia, after the extubation of the patient at the end of the operation and 8 hours after the end of the operation.
Statistical analysis: It is planned to use 'Independent Samples t test' or 'Mann-Whitney U test' in comparison of the groups, depending on the distribution of the data. Chi-square tests will be used to examine the relationships between categorical variables. 'Repeated Measure ANOVA' will be used in the evaluation of repeated measurements. Correlations between continuous variables will be analyzed by Pearson or Spearman correlation analysis, depending on the distribution of the data.
- Conditions
- Anesthesia,General, Cardiac Event
- Being tested
- target controlled infusion - total intravenous general anesthesia, sevoflurane based balanced general anesthesia
- Keywords
- anesthesia, general, target controlled infusion, inhalational anesthesia, cardiac enzymes
- Medical subject headings
- Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
target controlled infusion - total intravenous general anesthesiaOther
Both interventions are subtypes of general anesthesia.
sevoflurane based balanced general anesthesiaOther
Both interventions are subtypes of general anesthesia.
| Study group | Role | What they receive |
|---|---|---|
| TCI Group | Anesthesia induction will be provided by infusion of Propofol and Remifentanil with an infusion pump device called TCI (target controlled infusion). When the bispectral index (processed EEG) levels drop below 60, rocuronium will be administered at a dose of 0.6 mg/kg, and 3 minutes after that, endotracheal intubation will be performed. Propofol and Remifentanil infusion and TCI-TIVA will be continued in the maintenance of anesthesia.
Basal values of CK, CK-MB, Troponin-I will be studied in the preoperative period. In the postoperative period, CK, CK-MB, Troponin-I values will be studied 2 times; immediately at the end of the operation and in the 8th hour from the end of the operation. Receives: Other: target controlled infusion - total intravenous general anesthesia | |
| Sevoflurane Group | Anesthesia induction will be provided by administration of propofol 2 mg/kg, remifentanil 1 mcg/kg . When the processed EEG levels drop below 60, rocuronium will be administered at a dose of 0.6 mg/kg. 3 minutes after that, endotracheal intubation will be performed. Conventional balanced inhalation-intravenous anesthesia will be provided by administering remifentanil at 0.05 mcg/kg/min and sevoflurane 2% in the maintenance of anesthesia.
Basal values of CK, CK-MB, Troponin-I will be studied in the preoperative period. In the postoperative period, CK, CK-MB, Troponin-I values will be studied 2 times; immediately at the end of the operation and in the 8th hour from the end of the operation. Receives: Other: sevoflurane based balanced general anesthesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in the cardiac enzyme levels
Basal values of CK, CK-MB, Troponin-I will be studied in the preoperative period. In the postoperative period, CK, CK-MB, Troponin-I values will be studied 2 times; immediately at the end of the operation and in the 8th hour from the end of the operation.
Measured: 3 times in 24 hours in the perioperative period
Change from baseline in the hemodynamic parameters : Systolic and diastolic blood pressures (SAP and DAP)
All patients will be monitored with routine anesthesia monitoring and bispectral index: SAP and DAP in mmHg will be checked and recorded in 5 minute intervals throughout the operation.
Measured: SAP, DAP will be checked and recorded every 5 minutes throughout the operation time: from the beginning of anesthesia induction until the end of operation, in an estimated period of up to 6 hours.
Change from baseline in the hemodynamic parameters : Heart rate (HR)
All patients will be monitored with routine anesthesia monitoring and bispectral index: Heart rate (HR) in bpm , will be checked and recorded in 5 minute intervals throughout the operation.
Measured: HR will be checked and recorded every 5 minutes throughout the operation time: from the beginning of anesthesia induction until the end of operation, in an estimated period of up to 6 hours.
Change from baseline in the hemodynamic parameters : Peripheral oxygen saturation (sPO2)
All patients will be monitored with routine anesthesia monitoring and bispectral index: Peripheral oxygen saturation (sPO2) in percent (%) will be checked and recorded in 5 minute intervals throughout the operation.
Measured: sPO2 will be checked and recorded every 5 minutes throughout the operation time: from the beginning of anesthesia induction until the end of operation, in an estimated period of up to 6 hours.
Change from baseline in the hemodynamic parameters : Bispectral index (BIS)
All patients will be monitored with routine anesthesia monitoring and bispectral index: Bispectral index (BİS) will be checked and recorded in 5 minute intervals throughout the operation.
Measured: BIS in percent (%) will be checked and recorded every 5 minutes throughout the operation time: from the beginning of anesthesia induction until the end of operation, in an estimated period of up to 6 hours.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2022
- Study start6 Jun 2022
- Primary completion1 Mar 2024
- Study completion1 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anesthesia,GeneralStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 140 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duzce University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, yavuz demiraran, Duzce University
- Investigators
- Yavuz Demiraran, Study chair, Düzce University Faculty of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05598567
- Sponsor's protocol ID
- drozlemersoy4
- Status last verified
- Mar 2024
- First submitted
- 19 Oct 2022
- Last updated
- 13 Mar 2024
- Results posted
- No
- 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 13 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Hemodynamic Parameters and Cardiac Enzyme Levels in Patients Undergoing Total Abdominal Hysterectomy Under TCI-TIVA and Sevoflurane Based General Anesthesia
- ClinicalTrials.gov ID
- NCT05598567
- Acronym / sponsor ID
- drozlemersoy4
- Conditions
- Anesthesia,General, Cardiac Event
- Keywords
- anesthesia, general, target controlled infusion, inhalational anesthesia, cardiac enzymes
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 140 participants (actual)
- Lead sponsor
- Duzce UniversityUniversity, hospital or other
- Study start
- 6 Jun 2022 (actual)
- Primary completion
- 1 Mar 2024 (actual)
- Study completion
- 1 Mar 2024 (actual)
- First posted
- 28 Oct 2022 (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 goal of this observational study is to learn about the effects of total intravenous general anesthesia with target controlled infusion and sevoflurane based balanced general anesthesia on hemodynamic parameters and cardiac enzyme levels in patients undergoing total abdominal hysterectomy.
Detailed description
Total intravenous anesthesia (TIVA) is a common anesthesia method used today as an alternative to inhalation anesthesia. Loss of consciousness is an important component of general anesthesia, in order to give the patient safe analgesia and not to remember any adverse events related to the operation.
While the depth of anesthesia can be controlled by monitoring the minimum alveolar concentration (MAK) in the ventilator devices in the modern operating room , there was no more objective method than measuring the plasma level of drugs in intravenous anesthesia. The schemes created by the anesthetists according to plasma drug levels were used when administering total intravenous anesthesia. Target Controlled Anesthesia (TCI) devices on the other hand, are pumps that have been used more frequently recently and that can deliver the required blood concentration of a drug in bolus and infusion form according to pharmacokinetic models calculated with personal data. In TCI anesthesia, intravenous infusion of anesthetics provides a more stable drug concentration in the plasma and at the site of action compared to repeated bolus techniques. Thus, it is ensured that the results such as excessively high or excessively low administration of drugs are avoided and the drug remains in the therapeutic range.
In inhalation anesthesia, anesthetic substances are absorbed from the alveoli, pass into the bloodstream and reach the brain. Tracheal intake of the anesthetic agents used in this method is rapid and the depth of anesthesia can be controlled. However , the patient should be monitored and followed up for complications . An ideal inhalation anesthetic has a minimal effect on the cardiovascular and respiratory systems and has no toxic effects on these systems. Due to these properties, the most commonly used anesthetic drugs for inhalation anesthesia today are isoflurane and sevoflurane. In terms of its cardiopulmonary effects, Sevoflurane is reported to provide faster and deeper anesthesia than other anesthetics.
Aim: In this study, the researchers aim to compare the change of cardiac enzyme levels from baseline in patients undergoing total abdominal hysterectomy under general anesthesia with TCI anesthesia and sevoflurane based balanced anesthesia.
Method: 140 patients who meet the inclusion criteria and signed informed consent will be included. All patients will be monitored with routine anesthesia monitoring and bispectral index (BIS), all parameters will be checked and recorded in 5 minute intervals throughout the operation. 70 patients will receive TCI-TIVA and 70 patients will receive sevoflurane based balanced anesthesia. Creatin kinase (CK), Creatin kinase - myoglobin binding (CK-MB), Troponin I values will be determined 3 times; before the induction of anesthesia, after the extubation of the patient at the end of the operation and 8 hours after the end of the operation.
Statistical analysis: It is planned to use 'Independent Samples t test' or 'Mann-Whitney U test' in comparison of the groups, depending on the distribution of the data. Chi-square tests will be used to examine the relationships between categorical variables. 'Repeated Measure ANOVA' will be used in the evaluation of repeated measurements. Correlations between continuous variables will be analyzed by Pearson or Spearman correlation analysis, depending on the distribution of the data.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TCI Group | – | Other: target controlled infusion - total intravenous general anesthesiaAnesthesia induction will be provided by infusion of Propofol and Remifentanil with an infusion pump device called TCI (target controlled infusion). When the bispectral index (processed EEG) levels drop below 60, rocuronium will be administered at a dose of 0.6 mg/kg, and 3 minutes after that, endotracheal intubation will be performed. Propofol and Remifentanil infusion and TCI-TIVA will be continued in the maintenance of anesthesia. Basal values of CK, CK-MB, Troponin-I will be studied in the preoperative period. In the postoperative period, CK, CK-MB, Troponin-I values will be studied 2 times; immediately at the end of the operation and in the 8th hour from the end of the operation. |
| Sevoflurane Group | – | Other: sevoflurane based balanced general anesthesiaAnesthesia induction will be provided by administration of propofol 2 mg/kg, remifentanil 1 mcg/kg . When the processed EEG levels drop below 60, rocuronium will be administered at a dose of 0.6 mg/kg. 3 minutes after that, endotracheal intubation will be performed. Conventional balanced inhalation-intravenous anesthesia will be provided by administering remifentanil at 0.05 mcg/kg/min and sevoflurane 2% in the maintenance of anesthesia. Basal values of CK, CK-MB, Troponin-I will be studied in the preoperative period. In the postoperative period, CK, CK-MB, Troponin-I values will be studied 2 times; immediately at the end of the operation and in the 8th hour from the end of the operation. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- 140 patients between age 18 and 80 years who meet the inclusion criteria and sign informed consent will be included.
Key inclusion criteria (2 listed)
- Patients over the age of 18 who will undergo Total Abdominal Hysterectomy under general anesthesia
- Patients in risk group I, II,III according to the American Society of Anesthesiologists (ASA) classification
Key exclusion criteria (12 listed)
- Patients for whom Intensive Care Unit (ICU) indication is required
- Chronic obstructive pulmonary disease,
- Personal or family history of malignant hyperthermia,
- Morbid obesity,
- Alcohol or drug addiction,
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 |
|---|---|---|
| target controlled infusion - total intravenous general anesthesiaBoth interventions are subtypes of general anesthesia. | Other | TCI Group |
| sevoflurane based balanced general anesthesiaBoth interventions are subtypes of general anesthesia. | Other | Sevoflurane Group |
Primary outcome
Change from baseline in the cardiac enzyme levels
Time frame: 3 times in 24 hours in the perioperative period
Basal values of CK, CK-MB, Troponin-I will be studied in the preoperative period. In the postoperative period, CK, CK-MB, Troponin-I values will be studied 2 times; immediately at the end of the operation and in the 8th hour from the end of the operation.
Change from baseline in the hemodynamic parameters : Systolic and diastolic blood pressures (SAP and DAP)
Time frame: SAP, DAP will be checked and recorded every 5 minutes throughout the operation time: from the beginning of anesthesia induction until the end of operation, in an estimated period of up to 6 hours.
All patients will be monitored with routine anesthesia monitoring and bispectral index: SAP and DAP in mmHg will be checked and recorded in 5 minute intervals throughout the operation.
Change from baseline in the hemodynamic parameters : Heart rate (HR)
Time frame: HR will be checked and recorded every 5 minutes throughout the operation time: from the beginning of anesthesia induction until the end of operation, in an estimated period of up to 6 hours.
All patients will be monitored with routine anesthesia monitoring and bispectral index: Heart rate (HR) in bpm , will be checked and recorded in 5 minute intervals throughout the operation.
Change from baseline in the hemodynamic parameters : Peripheral oxygen saturation (sPO2)
Time frame: sPO2 will be checked and recorded every 5 minutes throughout the operation time: from the beginning of anesthesia induction until the end of operation, in an estimated period of up to 6 hours.
All patients will be monitored with routine anesthesia monitoring and bispectral index: Peripheral oxygen saturation (sPO2) in percent (%) will be checked and recorded in 5 minute intervals throughout the operation.
Change from baseline in the hemodynamic parameters : Bispectral index (BIS)
Time frame: BIS in percent (%) will be checked and recorded every 5 minutes throughout the operation time: from the beginning of anesthesia induction until the end of operation, in an estimated period of up to 6 hours.
All patients will be monitored with routine anesthesia monitoring and bispectral index: Bispectral index (BİS) will be checked and recorded in 5 minute intervals throughout the operation.
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 13 Mar 2024.
- Individual participant dataSharing planned: No
Related trials for Anesthesia,General
Not yet recruitingPhase 4
Effect of Neuromuscular Blocking Agent Use on Video Laryngeal Mask Airway Insertion
Airway Management, Supraglottic Airway Device Insertion
Active, not recruitingObservational study
Dexmedetomidine Nasal Spray and Postoperative Sore Throat After Bronchoscopy
Postoperative Sore Throat, Bronchoscopy
Recruiting
Conscious Sedation Versus General Anesthesia for Pulsed Field Ablation in Paroxysmal Atrial Fibrillation
Paroxysmal Atrial Fibrillation
Not yet recruiting
Effect of a Brief Educational Intervention on Endotracheal Tube Cuff Pressure
Intubation, Endotracheal Tube Cuff Pressure
Enrolling by invitation
Long-term Follow-up of Bio-signals and Quality of Recovery Following Implementation of ERAS Based on the Mobile Application
Gynecologic Surgery, General Anesthesia
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.
Yavuz Demiraran study chair
Düzce University Faculty of Medicine
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 Anesthesia,General and Cardiac Event, run by Duzce 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 2 inclusion and 12 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 13 Mar 2024. 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?
Change from baseline in the cardiac enzyme levels (time frame: 3 times in 24 hours in the perioperative period). The study lists 5 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 13 Mar 2024.