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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03134677
Other study ID # TUTF-GOKAEK 2014/116
Secondary ID
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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.
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