Hemodynamic Parameters and Cardiac Enzyme Levels in Patients Undergoing General Anesthesia

NCT05598567 | Completed

• 1 other identifier: drozlemersoy4
• Study Type: observational
• Target: 140
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Anesthesia,General; Cardiac Event

Keywords

anesthesia, general; target controlled infusion; inhalational anesthesia; cardiac enzymes

Outcome Measures

Primary Outcomes (5)

• 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.

  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.

  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.

  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.

  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.

  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.

Study Arms (2)

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.

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.

Other: sevoflurane based balanced general anesthesia

Interventions

target controlled infusion - total intravenous general anesthesia OTHER

Both interventions are subtypes of general anesthesia.

TCI Group

sevoflurane based balanced general anesthesia OTHER

Both interventions are subtypes of general anesthesia.

Sevoflurane Group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

140 patients between age 18 and 80 years who meet the inclusion criteria and sign informed consent will be included.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Duzce University: lead

Study Sites (1)

Duzce University Faculty of Medicine

Düzce, 81000, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Cardiovascular Diseases

Study Officials

• Yavuz Demiraran

  Düzce University Faculty of Medicine

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: October 19, 2022
• First Posted: October 28, 2022
• Study Start: June 6, 2022
• Primary Completion: March 1, 2024
• Study Completion: March 1, 2024
• Last Updated: March 13, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)