The Effects of Low-Flow and Normal-Flow Sevoflurane Anesthesia on Frontal QRS-T Angle and TP-e Interval
1 other identifier
observational
128
0 countries
N/A
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started May 2026
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 30, 2026
CompletedFirst Posted
Study publicly available on registry
May 7, 2026
CompletedStudy Start
First participant enrolled
May 15, 2026
ExpectedPrimary Completion
Last participant's last visit for primary outcome
May 15, 2027
Study Completion
Last participant's last visit for all outcomes
August 15, 2027
May 7, 2026
April 1, 2026
1 year
April 30, 2026
April 30, 2026
Conditions
Outcome Measures
Primary Outcomes (2)
Frontal QRS-T angle
electrocardiogram
Pre-operative period, 5 minutes after induction, 15 minutes after induction, post operative 15th minute
Tp-e interval
electrocardiogram
Pre-operative period, 5 minutes after induction, 15 minutes after induction, post-operative 15th minute
Secondary Outcomes (5)
blood pressure
during peri-operative period
heart rate
during peri-operative period
Tp-e/QT ratio
Pre-operative period, 5 minutes after induction, 15 minutes after induction, post-operative 15th minute
Total amount of volatile anesthetic consumed
end of operation
Total amount of Remifentanil consumed
end of operation
Study Arms (2)
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.
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.
Interventions
Fresh Gas Flow (FGF) reduced to 0.5 L/min after the target concentration (MACage +1) is reached.
Eligibility Criteria
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.
You may qualify if:
- 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.
You may not qualify if:
- 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.).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (3)
Yildirim H, Adanir T, Atay A, Katircioglu K, Savaci S. The effects of sevoflurane, isoflurane and desflurane on QT interval of the ECG. Eur J Anaesthesiol. 2004 Jul;21(7):566-70. doi: 10.1017/s0265021504007112.
PMID: 15318470BACKGROUNDKim NY, Han DW, Koh JC, Rha KH, Hong JH, Park JM, Kim SY. Effect of Dexmedetomidine on Heart Rate-Corrected QT and Tpeak-Tend Intervals During Robot-Assisted Laparoscopic Prostatectomy With Steep Trendelenburg Position: A Prospective, Randomized, Double-Blinded, Controlled Study. Medicine (Baltimore). 2016 May;95(19):e3645. doi: 10.1097/MD.0000000000003645.
PMID: 27175685BACKGROUNDBingol Tanriverdi T, Tercan M, Patmano G, Tanriverdi Z, Gusun Halitoglu A, Kaya A. The Effect of Low-Flow and Normal-Flow Desflurane Anesthesia on the Frontal QRS-T Angle in Patients Undergoing Rhinoplasty Operation: A Randomized Prospective Study. Cureus. 2022 Sep 8;14(9):e28920. doi: 10.7759/cureus.28920. eCollection 2022 Sep.
PMID: 36225439BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- specialist in anesthesiology
Study Record Dates
First Submitted
April 30, 2026
First Posted
May 7, 2026
Study Start (Estimated)
May 15, 2026
Primary Completion (Estimated)
May 15, 2027
Study Completion (Estimated)
August 15, 2027
Last Updated
May 7, 2026
Record last verified: 2026-04