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Completed

NCT Number: NCT03134677

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

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.

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Key information

Age range

20 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • American Society of Anesthesiologists physical status I-II
  • ages 20-40 years
  • parturient patients

Exclusion criteria

  • spinal cord and peripheral nervous system diseases;
  • hypovolemic and hemorrhagic shock;
  • increased intracranial pressure;
  • severe anemia;
  • systemic infection;
  • scoliosis;
  • congenital spinal anomalies;
  • vertebral colon metastatic lesions;
  • anticoagulant drug use;
  • diabetes mellitus;
  • hypo/hyperthyroidism;
  • atrial and/or ventricular hypertrophy on ECG;
  • cardiomyopathy;
  • valvular disease;
  • cardiac failure or chronic disease;
  • cardiomegaly
  • used medication causing QT interval prolongation.

Treatment and study plan

Bupivacaine

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.

Other names: Marcaine Heavy 0.5%

Sevoflurane

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.

Other names: Sevofluran

Primary outcomes

  1. Measurement of perioperative electrocardiogram changes

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Trakya University

Other

Registry information

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
May 1, 2017
Registry last updated
May 9, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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