- ICH GCP
- Yhdysvaltain kliinisten tutkimusten rekisteri
- Kliininen tutkimus NCT07571980
The Effects of Low-Flow and Normal-Flow Sevoflurane Anesthesia on Frontal QRS-T Angle and TP-e Interval
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.
Tutkimuksen yleiskatsaus
Tila
Ehdot
Interventio / Hoito
Yksityiskohtainen kuvaus
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.
Opintotyyppi
Ilmoittautuminen (Arvioitu)
Osallistumiskriteerit
Kelpoisuusvaatimukset
Opintokelpoiset iät
- Aikuinen
- Vanhempi Aikuinen
Hyväksyy terveitä vapaaehtoisia
Näytteenottomenetelmä
Tutkimusväestö
Kuvaus
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.).
Opintosuunnitelma
Miten tutkimus on suunniteltu?
Suunnittelun yksityiskohdat
Kohortit ja interventiot
Ryhmä/Kohortti |
Interventio / Hoito |
|---|---|
|
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.
|
Mitä tutkimuksessa mitataan?
Ensisijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
|---|---|---|
|
Frontal QRS-T angle
Aikaikkuna: 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
Aikaikkuna: 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
|
Toissijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
|---|---|---|
|
blood pressure
Aikaikkuna: during peri-operative period
|
Non-invasive blood pressure (NIBP) monitor
|
during peri-operative period
|
|
heart rate
Aikaikkuna: during peri-operative period
|
electrocardiogram
|
during peri-operative period
|
|
Tp-e/QT ratio
Aikaikkuna: 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
Aikaikkuna: end of operation
|
Mindray anesthesia machine
|
end of operation
|
|
Total amount of Remifentanil consumed
Aikaikkuna: end of operation
|
infusion pump
|
end of operation
|
Yhteistyökumppanit ja tutkijat
Sponsori
Julkaisuja ja hyödyllisiä linkkejä
Yleiset julkaisut
- 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.
- Kim 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.
- Bingol 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.
Opintojen ennätyspäivät
Opi tärkeimmät päivämäärät
Opiskelun aloitus (Arvioitu)
Ensisijainen valmistuminen (Arvioitu)
Opintojen valmistuminen (Arvioitu)
Opintoihin ilmoittautumispäivät
Ensimmäinen lähetetty
Ensimmäinen toimitettu, joka täytti QC-kriteerit
Ensimmäinen Lähetetty (Todellinen)
Tutkimustietojen päivitykset
Viimeisin päivitys julkaistu (Todellinen)
Viimeisin lähetetty päivitys, joka täytti QC-kriteerit
Viimeksi vahvistettu
Lisää tietoa
Tähän tutkimukseen liittyvät termit
Muita asiaankuuluvia MeSH-ehtoja
Muut tutkimustunnusnumerot
- 96-2026
Lääke- ja laitetiedot, tutkimusasiakirjat
Tutkii yhdysvaltalaista FDA sääntelemää lääkevalmistetta
Tutkii yhdysvaltalaista FDA sääntelemää laitetuotetta
Nämä tiedot haettiin suoraan verkkosivustolta clinicaltrials.gov ilman muutoksia. Jos sinulla on pyyntöjä muuttaa, poistaa tai päivittää tutkimustietojasi, ota yhteyttä register@clinicaltrials.gov. Heti kun muutos on otettu käyttöön osoitteessa clinicaltrials.gov, se päivitetään automaattisesti myös verkkosivustollemme .