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

April 30, 2026 updated by: Cansu UZUNTURK, Istanbul University

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

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.

Study Overview

Status

Not yet recruiting

Intervention / Treatment

Detailed Description

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.

Study Type

Observational

Enrollment (Estimated)

128

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Probability Sample

Study Population

The study population consists of adult patients (aged 18 years and older) scheduled for elective or semi-elective laparoscopic cholecystectomy at a tertiary care training and research hospital.

Description

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.).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Low-Flow Group (LFG)
Anesthesia induction and initial stabilization (first 6-8 minutes at 4-6 L/min) follow standard hospital protocols. Fresh Gas Flow (FGF) reduced to 0.5 L/min after the target concentration (MACage +1) is reached. Ventilation parameters are adjusted to maintain end-tidal carbon dioxide (EtCO2) between 35-45 mmHg with a minimum FiO2 of 0.30. Volatile anesthetics are discontinued 15 minutes before the estimated end of surgery. Pre-oxygenation and wash-out are performed at 5-6 L/min with 80% oxygen prior to extubation.
Fresh Gas Flow (FGF) reduced to 0.5 L/min after the target concentration (MACage +1) is reached.
Normal-Flow Group (NFG)
Anesthesia induction and initial stabilization (first 6-8 minutes at 4-6 L/min) follow standard hospital protocols. Fresh Gas Flow (FGF) maintained at 2 L/min during anesthesia maintenance. Ventilation parameters are adjusted to maintain end-tidal carbon dioxide (EtCO2) between 35-45 mmHg with a minimum FiO2 of 0.30. Volatile anesthetics are discontinued 15 minutes before the estimated end of surgery. Pre-oxygenation and wash-out are performed at 5-6 L/min with 80% oxygen prior to extubation.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Frontal QRS-T angle
Time Frame: Pre-operative period, 5 minutes after induction, 15 minutes after induction, post operative 15th minute
electrocardiogram
Pre-operative period, 5 minutes after induction, 15 minutes after induction, post operative 15th minute
Tp-e interval
Time Frame: Pre-operative period, 5 minutes after induction, 15 minutes after induction, post-operative 15th minute
electrocardiogram
Pre-operative period, 5 minutes after induction, 15 minutes after induction, post-operative 15th minute

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
blood pressure
Time Frame: during peri-operative period
Non-invasive blood pressure (NIBP) monitor
during peri-operative period
heart rate
Time Frame: during peri-operative period
electrocardiogram
during peri-operative period
Tp-e/QT ratio
Time Frame: Pre-operative period, 5 minutes after induction, 15 minutes after induction, post-operative 15th minute
electrocardiogram
Pre-operative period, 5 minutes after induction, 15 minutes after induction, post-operative 15th minute
Total amount of volatile anesthetic consumed
Time Frame: end of operation
Mindray anesthesia machine
end of operation
Total amount of Remifentanil consumed
Time Frame: end of operation
infusion pump
end of operation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

May 15, 2026

Primary Completion (Estimated)

May 15, 2027

Study Completion (Estimated)

August 15, 2027

Study Registration Dates

First Submitted

April 30, 2026

First Submitted That Met QC Criteria

April 30, 2026

First Posted (Actual)

May 7, 2026

Study Record Updates

Last Update Posted (Actual)

May 7, 2026

Last Update Submitted That Met QC Criteria

April 30, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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