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

Sponsor
Trakya University (Other)
Overall Status
Completed
CT.gov ID
NCT03134677
Collaborator
(none)
90
Enrollment
2
Arms
25
Actual Duration (Months)

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
Phase 4

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 Design

Study Type:
Interventional
Actual Enrollment :
90 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Treatment
Official Title:
The Effects of Different Anesthetic Techniques on QT, Corrected QT (QTc), and P Wave Dispersions in Cesarean Section
Actual Study Start Date :
Jul 23, 2014
Actual Primary Completion Date :
Jul 23, 2016
Actual Study Completion Date :
Aug 23, 2016

Arms and Interventions

Arm Intervention/Treatment
Experimental: 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.

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.
Other Names:
  • Marcaine Heavy 0.5%

    		•
    Experimental: 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.

    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.
    Other Names:
  • Sevofluran

    		•

    Outcome Measures

    Primary Outcome Measures

    1. 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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    20 Years to 40 Years
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    Yes
    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.

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Trakya University

    Investigators

    • Study Director: Sevtap Hekimoglu Sahin, Professor, Trakya University Medical Faculty

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Sevtap Hekimoglu Sahin, Clinical Professor, Trakya University
    ClinicalTrials.gov Identifier:
    NCT03134677
    Other Study ID Numbers:
    • TUTF-GOKAEK 2014/116
    First Posted:
    May 1, 2017
    Last Update Posted:
    May 9, 2017
    Last Verified:
    May 1, 2017
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Product Manufactured in and Exported from the U.S.:
    No
    Keywords provided by Sevtap Hekimoglu Sahin, Clinical Professor, Trakya University
    Spinal anesthesia
    General anesthesia
    P wave dispersion
    Additional relevant MeSH terms:
    Bupivacaine
    Sevoflurane

    Study Results

    No Results Posted as of May 9, 2017