The Effects of Different Anesthetic Techniques on QT, Corrected QT (QTc), and P Wave Dispersions in Cesarean Section

Phase 4

Completed

• Conditions: Anesthesia; Reaction; Caesarean Section
• Interventions: Drug: Bupivacaine; Drug: Sevoflurane

• Registration Number: NCT03134677
• Lead Sponsor: Trakya University

Brief Summary

This study evaluates the effects of different anesthetic techniques on QT, QTc, and Pwd in cesarean section. Half of participants received general anesthesia, while the other half received spinal anesthesia Electrocardiography (ECG) recordings were performed at preoperative, 5, 15, 30 min after initiation anesthesia and 30 min post-operatively. Hemodynamic state were also recorded at the same time intervals. QT, corrected QT (QTc), QT dispersion (QTd), QTc dispersion (QTcd), P-wave dispersion (Pwd), corrected JT interval, T wave (Tp-e), transmular dispersion of repolarization durations were measured from ECG records at predetermined time intervals of spinal or general anesthesia.

Detailed Description

The anesthetic drugs used according general or regional anesthesia techniques can display proarrhythmic and antiarrhythmic effects by inducing cardiac electrical signals with different pathways.In addition, comorbid disease, hormonal changes, surgery procedures, and drug therapy can all cause arrhythmia in the intraoperative period. Likewise, pregnancy causes many changes hormonal and physiological in women. Hemodynamic and hormonal changes during pregnancy can cause effects proarrhythmogenic that cause premature atrial and ventricular beats to develop.

Study Timeline

• Study Start: 2014-07-23
• Primary Completion: 2016-07-23
• Study Completion: 2016-08-23
• Study First Submitted: 2017-03-30
• Study First Submitted QC: 2017-04-25
• Status Verified: 2017-05
• Study First Posted: 2017-05-01
• Last Update Submitted: 2017-05-04
• Last Update Posted: 2017-05-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 90

Inclusion Criteria

1. American Society of Anesthesiologists physical status I-II
2. ages 20-40 years
3. parturient patients

Exclusion Criteria

1. spinal cord and peripheral nervous system diseases;
2. hypovolemic and hemorrhagic shock;
3. increased intracranial pressure;
4. severe anemia;
5. systemic infection;
6. scoliosis;
7. congenital spinal anomalies;
8. vertebral colon metastatic lesions;
9. anticoagulant drug use;
10. diabetes mellitus;
11. hypo/hyperthyroidism;
12. atrial and/or ventricular hypertrophy on ECG;
13. cardiomyopathy;
14. valvular disease;
15. cardiac failure or chronic disease;
16. cardiomegaly
17. used medication causing QT interval prolongation.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Bupivacaine	Bupivacaine	We were performed spinal anesthesia sitting position by midline. After confirming the free flow of cerebrospinal fluid, bupivacaine was administered without aspiration.ECG recordings were performed at preoperative, 5, 15, and 30 minutes after initial anesthesia and 30 minutes post-operatively.
Sevoflurane	Sevoflurane	We were performed general anesthesia with sevoflurane. Anesthesia was maintained with 2-3% sevoflurane. ECG recordings were performed at preoperative, 5, 15, and 30 minutes after initial anesthesia and 30 minutes post-operatively.

Primary Outcome Measures

Name	Time	Method
Measurement of perioperative electrocardiogram changes	Preoperative, intraoperative and postoperative 30 min.	Electrocardiography measurements were performed and recorded for patients at preoperative, intraoperative 5th, 15th, 30th minutes and postoperative 30th minutes. Electrocardiogram is assessed change from Baseline at intraoperative and postoperative 30 min. Treatment-Related Adverse Events, cardiac disorder Assessed by CTCAE v4.0