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

NCT ID: NCT03134677

Last Updated: 2017-05-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 90 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-07-23
• Study Completion Date: 2016-08-23

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.

Conditions

Caesarean Section; Anesthesia; Reaction

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: EXPERIMENTAL

Bupivacaine

Intervention Type: DRUG

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

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.

Group Type: EXPERIMENTAL

Sevoflurane

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: DRUG

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.

Intervention Type: DRUG

Other Intervention Names

Marcaine Heavy 0.5%; Sevofluran

Eligibility Criteria

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.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Trakya University

OTHER

Sponsor Role: lead

Responsible Party

Sevtap Hekimoglu Sahin

Clinical Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Sevtap Hekimoglu Sahin, Professor

Role: STUDY_DIRECTOR

Trakya University Medical Faculty

Other Identifiers

TUTF-GOKAEK 2014/116

Identifier Type: -

Identifier Source: org_study_id