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.

Study Overview

• Status: Completed
• Conditions: Caesarean Section; Anesthesia; Reaction
• Intervention / Treatment: Drug: Bupivacaine; Drug: Sevoflurane

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

Eligibility Criteria

• Ages Eligible for Study: 20 years to 40 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

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.	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Preoperative, intraoperative and postoperative 30 min.

Collaborators and Investigators

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

Study record dates

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

• Keywords: Spinal anesthesia; General anesthesia; P wave dispersion
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics, General; Anesthetics; Platelet Aggregation Inhibitors; Anesthetics, Local; Anesthetics, Inhalation; Sevoflurane; Bupivacaine
• 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