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

Caesarean Section Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03134677
• Other study ID #: TUTF-GOKAEK 2014/116
• Status: Completed
• Phase: Phase 4
• First received: March 30, 2017
• Last updated: May 4, 2017
• Start date: July 23, 2014
• Est. completion date: August 23, 2016

Study information

• Verified date: May 2017
• Source: Trakya University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: August 23, 2016
• Est. primary completion date: July 23, 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 20 Years to 40 Years

Eligibility

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.

Related Conditions & MeSH terms

• Anesthesia; Reaction
• Caesarean Section

Intervention

Drug:
• Bupivacaine
2 ml of hyperbaric bupivacaine (0.5%) was given intrathecally to patients in a sitting position by midline attempt between the L3 and L4 intervertebral space.ECG recordings were performed at preoperative, 5, 15, and 30 minutes after initial anesthesia and 30 minutes post-operatively.
• Sevoflurane
General 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Trakya University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Measurement of perioperative electrocardiogram changes	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	Preoperative, intraoperative and postoperative 30 min.