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CompletedNCT03134677Updated May 9, 2017

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

A Phase 4 interventional study of Bupivacaine and Sevoflurane in Caesarean Section and Anesthesia; Reaction, sponsored by Trakya University. Completed. Open to female participants aged 20 Years to 40 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-05-09.

Sponsored by Trakya University · Phase 4, Interventional, and Treatment

From the registry’s dates

  • Registered 2 years 8 months after the study started (first participant enrolled Jul 2014, registered Mar 2017).
Phase
Phase 4
Study type
Interventional
Enrollment
90
Allocation
Randomized
Ages
20 Years to 40 Years
Sex
Female
01

Study 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.

Read the 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.

02

Conditions studied

  • Caesarean Section
  • Anesthesia; Reaction

Keywords

  • Spinal anesthesia
  • General anesthesia
  • P wave dispersion
03

In context

Lead sponsor

Trakya University is the lead sponsor of 150 studies on the registry; 15 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 40 Years
Sexes eligible
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

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.
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
90 participants (actual)

Study arms

  • 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

  • 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

Interventions

  • DrugBupivacaine

    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.

    Also known as: Marcaine Heavy 0.5%

  • DrugSevoflurane

    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.

    Also known as: Sevofluran

06

What researchers measure

Primary outcomes

  1. 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

    Time frame: Preoperative, intraoperative and postoperative 30 min.

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 9, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03134677
Lead sponsor
Trakya University
Responsible party
Sevtap Hekimoglu Sahin (Clinical Professor, Trakya University) — Principal investigator
First posted
May 1, 2017
Start date
Jul 23, 2014
Primary completion
Jul 23, 2016
Completion
Aug 23, 2016
Last update
May 9, 2017

Study contacts

Sevtap Hekimoglu Sahin, Professor
study director · Trakya University Medical Faculty

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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