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临床试验/NCT05598567
NCT05598567已完成不适用

Evaluation of Hemodynamic Parameters and Cardiac Enzyme Levels in Patients Undergoing Total Abdominal Hysterectomy Under TCI-TIVA and Sevoflurane Based General Anesthesia

Duzce University1 个研究点 分布在 1 个国家目标入组 140 人开始时间: 2022年6月6日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
140
试验地点
1
主要终点
Change from baseline in the hemodynamic parameters : Heart rate (HR)

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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,
  • 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

结局指标

主要结局

Change from baseline in the hemodynamic parameters : Heart rate (HR)

时间窗: 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)

时间窗: 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 cardiac enzyme levels

时间窗: 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 : Bispectral index (BIS)

时间窗: 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.

Change from baseline in the hemodynamic parameters : Systolic and diastolic blood pressures (SAP and DAP)

时间窗: 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.

次要结局

未报告次要终点

研究者

发起方
Duzce University
申办方类型
Other
责任方
Principal Investigator
主要研究者

yavuz demiraran

Professor

Duzce University

研究点 (1)

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