QTc Interval in Cesarean Section Patients

Comparison of the Effects of Spinal and General Anesthesia on the QTc Interval in Cesarean Section Patients

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

Study Overview

• Status: Completed
• Conditions: Pregnant Women; Cesarean Birth
• Intervention / Treatment: Diagnostic test: QT and QTc interval

Detailed Description

Study design and setting:

Researchers designed a prospective randomized study to compare the effects of spinal anesthesia and general anesthesia on the QT interval in patients undergoing elective cesarean section delivery. The study has been approved by the local Institutional Review Board (Ethics Committee of Health Science University Haseki Training and Research Hospital, Istanbul, Türkiye; approval date: 04 October 2023; approval number: 169-2023). The research was performed acoording to the Declaration of Helsinki, and written informed consent was obtained from all participants The study was carried out at a university affiliated hospital with 700-bed in Istanbul, Türkiye between October 4 2023 and December 4 2023.

Patient selection and group allocation The patients enrolled in the study were selected from 64 consecutive pregnant women who scheduled for an elective cesarean section delivery (Figure 1). Exclusion criteria were 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.

In the preoperative ward an intravenous (iv) line was obtained and all the patients received 10 ml/kg isotonic saline) within 20 minutes. The patients were randomly allocated to either the spinal anesthesia group (Group S) or the general anesthesia group (Group G) using sealed envelope method by an independent investigator and then were transferred to the operating room.

Anesthesia procedure In the operating room the patients received isotonic saline at a rate of 8 mL/kg/h for intravenous hydration and prexoxgenation was obtained via face mask for 3 minutes (8 L/min).

In the group G anesthesia was induced with using 1 µg/kg fentanyl and 2-2.5 mg/kg propofol. Muscle relaxation was achieved with 0.6 mg/kg rocuronium and endotracheal intubation was performed with an experienced anesthesiologist at the first attempt. Following intubation, mechanical ventilation was provided in volume-controlled mode using an anesthesia machine (Dräger Primus, Dräger Medical Systems, Inc., Danvers, MA, USA), with a tidal volume set at 6-8 mL/kg based on ideal body weight and a positive end-expiratory pressure of 5 cmH₂O. The respiratory rate was adjusted to maintain end-tidal carbon dioxide (EtCO2) levels between 32 and 36 mmHg. Anesthesia was maintained with sevoflurane at 0.8-1.0 minimum alveolar concentration (MAC) in an oxygen-air mixture (Fraction of inspired oxygen [FiO₂]= 0.4) until the delivery of neonate. Subsequently 1.2 MAC of sevoflurane, additional doses of rocuronium (0.15 mg/kg) and fentanyl (1 µg/kg) were used for the maintenance of anesthesia. At the end of the procedure, residual neuromuscular blockade was antagonized with intravenous sugammadex at a dose of 4 mg/kg. Tracheal extubation was carried out once the patient was fully awake, breathing spontaneously with adequate tidal volumes.

In the group S, the patiets were placed into a sitting position and spinal anesthesia was achieved at either the L4 or L5 interspace using a 25-gauge Whitacre pencil-point spinal needle under strict sterile conditions after intradermal injection of 1 mL 2% lidocaine hydrochloride. Once free flow of cerebrospinal fluid was observed, 12.5 mg (2.5 mL) of hyperbaric bupivacaine (Marcaine Spinal 0.5% Heavy; AstraZeneca, Türkiye) was injected into the subarachnoid compartment for 30 seconds. Following the patients were immediately placed in a supine position and tilted 15 degrees to the left until the delivery of neonate. Oxygen was delivered to patients via a face mask at a rate of 5 L/min. Pinprick test was used to evaluate the level of sensory blockade and T6 dermatome level was considered as acceptable for surgery.

Monitoring Non-invasive blood pressure (NIBP), heart rate (HR), peripheral oxygen saturation (SpO₂), and continuous electrocardiographic (ECG) monitoring were performed throughout the procedure using a standard anesthesia monitor (BeneView T8 Patient Monitor, Shenzhen Mindray Bio-Medical Electronics Co., Ltd., Shenzhen, China). 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.

Duration of QTc intervals were measured and recorded at predefined time points: prior to anesthesia induction in the general anesthesia group (QTc-pre) or before intrathecal injection in the spinal anesthesia group (QTc-pre); at 1, 5, 10 and 15 minutes following endotracheal intubation or intrathecal injection, and following surgical slosure (QTc-post). The difference between the longest and shortest QTc values (ΔQTc) obtained from QTc measurements taken at five-minute intervals was also recorded.

Data collection Demographic and clinical variables, including age, sex, height, weight, body mass index (BMI), comorbidities, and American Society of Anesthesiologists (ASA) physical status were documented. In Group S, the maximum sensory block level was assessed. Cardiopulmonary adverse events such as hypotension (mean arterial pressure ≤ 70 mmHg), hypertension (systolic ≥ 160 mmHg and/or diastolic ≥ 90 mmHg), bradycardia (heart rate ≤ 50 beats/min), tachycardia (heart rate ≥ 100 beats/min), hypoxemia (SpO₂ < 90%) and arrhythmia were also recorded.

Statistical analysis Statistical Package for Social Sciences software for Windows (SPSS, version 27.0; IBM, Chicago, IL, USA) was used to analyse of study data. Quantitative variables were expressed as mean ± standard deviation (SD), while categorical variables were represented as patient numbers and percentages. Normality of quantitative variables was assessed using the Kolmogorov-Smirnov/Shapiro-Wilk test. Normally distrubeted data were compared between the groups using independent Student's t-test, while the Mann-Whitney U test was applied for non-normally distributed variables. Categorical variables were compared using chi-squared or Fisher's exact tests. Duration of QTc within each group were evaluated using repeated measures analysis of variance with Bonferroni correction. Based on a previous study, the duration of QTc was 428 ± 26 ms after C/S performed with spinal anesthesia. Power analysis with α = 0.05 and β = 0.2 revealed that a minimum 25 patients per goup was required to detect at least a 20 ms difference in QTc duration in pregnant patients undergoing general anesthesia. A p-value <0.05 was considered statistically significant.

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey (Türkiye)
  • Istanbul, Turkey (Türkiye)
    • Haseki Traininng and Research Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Spinal anesthesia; Patients scheduled for elective cesarean section under spinal anesthesia	Diagnostic test: QT and QTc interval; Measurement of QT and QTc duration on ECG
Active Comparator: General anesthesia; Patients scheduled for elective cesarean section under general anesthesia	Diagnostic test: QT and QTc interval; Measurement of QT and QTc duration on ECG

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hemodynamic changes	To compare incidence of hypotension between groups	Before anesthesia induction to postoperative period

Collaborators and Investigators

• Sponsor: Haseki Training and Research Hospital

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): October 4, 2023
• Primary Completion (Actual): December 4, 2023
• Study Completion (Actual): February 15, 2024

Study Registration Dates

• First Submitted: March 6, 2026
• First Submitted That Met QC Criteria: April 6, 2026
• First Posted (Actual): April 13, 2026

Study Record Updates

• Last Update Posted (Actual): April 13, 2026
• Last Update Submitted That Met QC Criteria: April 6, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: sevoflurane; general anesthesia; spinal anesthesia; propofol; QT interval; qt interval prolongation; qt intervals changes
• Other Study ID Numbers: 169-2023

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: All collected IPD
• IPD Sharing Time Frame: Beginning 1 months and ending 36 months following article publication.
• IPD Sharing Access Criteria: Proposals should be directed to drsinanuzman@yahoo.com
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No