The Effects of Different Anesthetic Techniques on QT, Corrected QT (QTc), and P Wave Dispersions in Cesarean Section
May 4, 2017 updated by: Sevtap Hekimoglu Sahin, Trakya University
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
90
Phase
- Phase 4
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
20 years to 40 years (ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Female
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: DOUBLE
Arms and Interventions
Participant Group / 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.
|
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:
|
|
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.
|
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:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
|
Preoperative, intraoperative and postoperative 30 min.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Sevtap Hekimoglu Sahin, Professor, Trakya University Medical Faculty
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
July 23, 2014
Primary Completion (ACTUAL)
July 23, 2016
Study Completion (ACTUAL)
August 23, 2016
Study Registration Dates
First Submitted
March 30, 2017
First Submitted That Met QC Criteria
April 25, 2017
First Posted (ACTUAL)
May 1, 2017
Study Record Updates
Last Update Posted (ACTUAL)
May 9, 2017
Last Update Submitted That Met QC Criteria
May 4, 2017
Last Verified
May 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- TUTF-GOKAEK 2014/116
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
product manufactured in and exported from the U.S.
No
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