CompletedNot Applicable

QTc Interval in Cesarean Section Patients

Turkey (Türkiye)50 participantsStarted 2023-10-04

Plain-language summary

The aim of this clinical study is to determine which type of anesthesia has the least effect on the electrical activity of the heart in pregnant women undergoing cesarean section. We expect to answer the following questions at the end of this study: • In pregnant women undergoing cesarean section, does spinal anesthesia have less effect on the electrical activity of the heart, as assessed by electrocardiography (duration of QTc interval), compared to general anesthesia? Researchers will compare spinal anesthesia to general anesthesia to see if spinal anesthesia has less effect on electrocardiography. Participants will: * Receive spinal anesthesia or general anesthesia for cesarean section delivery * Be monitored during the procedure by anesthesia monitor including electrocardiography

Who can participate

Age range

18 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * pregnant women who scheduled for an elective cesarean section delivery Exclusion Criteria: * baseline QTc \>440 ms, use of medications that affect the QTc interval, family history of long QT syndrome, electrocardiographic evidence of arrhythmia and/or conduction abnormalities, or the presence of a permanent pacemaker, contraindications to spinal anesthesia (high intracranial pressure, injection site infection, coagulation disorders, severe hypovolemia, aortic and/or mitral stenosis), history of spinal surgery, congenital spinal deformity or neuromuscular disease, anemia, electrolyte imbalance, significant cardiopulmonary/hepatic/renal disesase, obesity (Body Mass Index \> 30 kg/m2), an American Society of Anesthesiologists (ASA) physical classification ≥III or refusal to participate.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Duration of QTc interval

Timeframe: Before the induction of general anesthesia or spinal anesthesia; 1, 5 and 10 minutes after endotrakeal intubation or spinal anesthesia; after extubation or surgery.

Trial details

NCT IDNCT07524296

SponsorHaseki Training and Research Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-12-04

View on ClinicalTrials.gov More Pregnant Women trials