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NCT Number: NCT07571980

The Effects of Low-Flow and Normal-Flow Sevoflurane Anesthesia on Frontal QRS-T Angle and TP-e Interval

Laparoscopic cholecystectomy procedures involve pneumoperitoneum and volatile anesthetics, both of which can significantly influence cardiovascular physiology and autonomic balance. While volatile anesthetics are known to affect myocardial repolarization, the specific impact of Low-Flow Anesthesia (LFA)-a cost-effective and environmentally friendly technique-on these cardiac markers remains under-researched.

This prospective observational study aims to compare the effects of low-flow versus normal-flow sevoflurane anesthesia on two critical non-invasive biomarkers of ventricular repolarization: the Frontal QRS-T angle and the Tp-e interval. These parameters are essential for predicting electrical instability and the risk of malignant arrhythmias. The study will evaluate a total of 128 patients to determine whether different fresh gas flow rates lead to significant changes in cardiac electrophysiological stability during the perioperative and early postoperative periods.

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Key information

About this study

This prospective observational study is designed to investigate the electrophysiological effects of different fresh gas flow rates during sevoflurane anesthesia in patients undergoing elective laparoscopic cholecystectomy. Laparoscopic procedures involving pneumoperitoneum and volatile anesthetics are known to influence autonomic nervous system balance and cardiovascular stability. While the impact of inhalation agents on myocardial repolarization is documented, the specific effects of Low-Flow Anesthesia (LFA)-an environmentally and economically favorable technique-on markers of electrical instability remain to be fully elucidated. The primary objective is to evaluate and compare the effects of low-flow and normal-flow sevoflurane techniques on the Frontal QRS-T angle and the Tp-e interval, which serve as critical non-invasive biomarkers for predicting malignant arrhythmia risk and reflecting the transmural distribution of ventricular repolarization.

The study protocol involves 128 patients, a sample size determined by power analysis (80% power, 0.05 alpha) to account for a predicted 35% difference between groups and potential dropouts. Patients are observationally assigned to either the Low-Flow Group (LFG) or the Normal-Flow Group (NFG) according to routine clinical practice. Following a standardized induction and an initial stabilization phase at 4-6 L/min, flow rates are adjusted once the target concentration (MACage +1) is reached: the LFG is reduced to 0.5 L/min, while the NFG is maintained at 2 L/min. Ventilation is managed to keep EtCO2 between 35-45 mmHg. Data collection is performed via high-resolution ECG recordings at four time points: preoperative baseline (T1), 5 minutes post-intubation (T2), 15 minutes post-intubation (T3), and 15 minutes postoperatively (T4).

Another key focus of this research is the detailed analysis of secondary outcomes, including the monitoring of hemodynamic stability (mean arterial pressure and heart rate) across all time points. Furthermore, the study aims to characterize the electrophysiological profile of each technique by analyzing the Tp-e/QT ratio and calculating time-dependent variations in repolarization parameters, specifically the delta changes from baseline to intraoperative stages (ΔT1-T2 and ΔT1-T3). Additionally, a cost-effectiveness analysis will be conducted by determining the total volume of volatile anesthetic consumed in both techniques. Statistical analysis will involve independent samples t-tests for inter-group comparisons, while repeated measures ANOVA with Bonferroni correction will evaluate time-dependent changes. Pearson correlation analysis will be utilized to assess the relationships between continuous variables, providing a comprehensive assessment of the safety and efficacy of low-flow versus normal-flow anesthesia management.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients aged 18 years and older.
  • Patients scheduled for elective or semi-elective laparoscopic cholecystectomy.
  • Patients who provide written voluntary informed consent.
  • Patients with a predicted surgical duration between 60 and 180 minutes.

Exclusion criteria

  • Patients with heart failure.
  • Patients with valvular heart disease or pathology.
  • Patients with hemodynamic instability.
  • Patients requiring blood transfusion.
  • Patients with a preoperative corrected QT (QTc) interval > 450 ms.
  • Patients with a known history of cardiac arrhythmia.
  • Patients scheduled for emergency surgery.
  • Patients with a known risk or family history of malignant hyperthermia.
  • Use of medications associated with QT interval prolongation (e.g., ketamine, 5-HT3 antagonists, quetiapine, etc.).

Treatment and study plan

low flow anesthesia

Procedure

Fresh Gas Flow (FGF) reduced to 0.5 L/min after the target concentration (MACage +1) is reached.

Primary outcomes

  1. Frontal QRS-T angle

    Time frame: Pre-operative period, 5 minutes after induction, 15 minutes after induction, post operative 15th minute

    electrocardiogram

  2. Tp-e interval

    Time frame: Pre-operative period, 5 minutes after induction, 15 minutes after induction, post-operative 15th minute

    electrocardiogram

Secondary outcomes

  1. blood pressure

    Time frame: during peri-operative period

    Non-invasive blood pressure (NIBP) monitor

  2. heart rate

    Time frame: during peri-operative period

    electrocardiogram

  3. Tp-e/QT ratio

    Time frame: Pre-operative period, 5 minutes after induction, 15 minutes after induction, post-operative 15th minute

    electrocardiogram

  4. Total amount of volatile anesthetic consumed

    Time frame: end of operation

    Mindray anesthesia machine

  5. Total amount of Remifentanil consumed

    Time frame: end of operation

    infusion pump

Sponsors and collaborators

Lead sponsor

Istanbul University

Other

Registry information

Official study title

The Effects of Low-Flow and Normal-Flow Sevoflurane Anesthesia on Frontal QRS-T Angle and TP-e Interval in Patients Undergoing Elective Laparoscopic Cholecystectomy

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
May 7, 2026
Registry last updated
May 7, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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