NCT07571980

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

65
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
128

participants targeted

Target at P50-P75 for all trials

Timeline
15mo left

Started May 2026

Status
not yet recruiting

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

Completed
7 days until next milestone

First Posted

Study publicly available on registry

May 7, 2026

Completed
8 days until next milestone

Study Start

First participant enrolled

May 15, 2026

Expected
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 15, 2027

3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 15, 2027

Last Updated

May 7, 2026

Status Verified

April 1, 2026

Enrollment Period

1 year

First QC Date

April 30, 2026

Last Update Submit

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.

Procedure: low flow anesthesia

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.

Low-Flow Group (LFG)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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.

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: 15318470BACKGROUND
  • 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.

    PMID: 27175685BACKGROUND
  • 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.

    PMID: 36225439BACKGROUND

MeSH Terms

Conditions

Arrhythmias, Cardiac

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

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