NCT07524296

Brief 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

Trial Health

87
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 4, 2023

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 4, 2023

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 15, 2024

Completed
2.1 years until next milestone

First Submitted

Initial submission to the registry

March 6, 2026

Completed
1 month until next milestone

First Posted

Study publicly available on registry

April 13, 2026

Completed
Last Updated

April 13, 2026

Status Verified

April 1, 2026

Enrollment Period

2 months

First QC Date

March 6, 2026

Last Update Submit

April 6, 2026

Conditions

Pregnant WomenCesarean Birth

Keywords

QT intervalqt interval prolongationqt intervals changesspinal anesthesiapropofolgeneral anesthesiasevoflurane

Outcome Measures

Primary Outcomes (1)

  • Duration of QTc interval

    QT interval measurements were automatically obtained from lead II, and corrected QT (QTc) values were derived by applying Bazett's formula (QTc = QT/√RR \[s\]) via the ECG monitoring system.

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

Secondary Outcomes (1)

  • Hemodynamic changes

    Before anesthesia induction to postoperative period

Study Arms (2)

Spinal anesthesia

EXPERIMENTAL

Patients scheduled for elective cesarean section under spinal anesthesia

Diagnostic Test: QT and QTc interval

General anesthesia

ACTIVE COMPARATOR

Patients scheduled for elective cesarean section under general anesthesia

Diagnostic Test: QT and QTc interval

Interventions

QT and QTc intervalDIAGNOSTIC_TEST

Measurement of QT and QTc duration on ECG

General anesthesiaSpinal anesthesia

Eligibility Criteria

Age18 Years+
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsPregnant women who scheduled to elecetive cesarean section delivery.
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • pregnant women who scheduled for an elective cesarean section delivery

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Haseki Traininng and Research Hospital

Istanbul, Turkey (Türkiye)

Location

Related Publications (1)

  • Deniz Y, Okyay D, Hanci V, Yurtlu S, Ayoglu H, Ozkocak Turan I. The effect of levobupivacaine and bupivacaine on QT, corrected QT (Qtc), and P wave dispersions in cesarean section. Braz J Anesthesiol. 2013 Mar-Apr;63(2):202-8. doi: 10.1016/S0034-7094(13)70216-2.

    PMID: 23601262BACKGROUND

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
associate prof

Study Record Dates

First Submitted

March 6, 2026

First Posted

April 13, 2026

Study Start

October 4, 2023

Primary Completion

December 4, 2023

Study Completion

February 15, 2024

Last Updated

April 13, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will share

All collected IPD

Shared Documents
STUDY PROTOCOL, SAP
Time Frame
Beginning 1 months and ending 36 months following article publication.
Access Criteria
Proposals should be directed to drsinanuzman@yahoo.com

Locations

TU(1)