NCT03134677

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
90

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Jul 2014

Typical duration for phase_4

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 23, 2014

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 23, 2016

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 23, 2016

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

March 30, 2017

Completed
1 month until next milestone

First Posted

Study publicly available on registry

May 1, 2017

Completed
Last Updated

May 9, 2017

Status Verified

May 1, 2017

Enrollment Period

2 years

First QC Date

March 30, 2017

Last Update Submit

May 4, 2017

Conditions

Caesarean SectionAnesthesia; Reaction

Keywords

Spinal anesthesiaGeneral anesthesiaP wave dispersion

Outcome Measures

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

    Preoperative, intraoperative and postoperative 30 min.

Study Arms (2)

Bupivacaine

EXPERIMENTAL

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

Sevoflurane

EXPERIMENTAL

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

BupivacaineDRUG

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%
Bupivacaine
SevofluraneDRUG

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
Sevoflurane

Eligibility Criteria

Age20 Years - 40 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility Detailselective cesarean section
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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;
  • +2 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

BupivacaineSevoflurane

Intervention Hierarchy (Ancestors)

AnilidesAmidesOrganic ChemicalsAniline CompoundsAminesMethyl EthersEthersHydrocarbons, FluorinatedHydrocarbons, HalogenatedHydrocarbons

Study Officials

  • Sevtap Hekimoglu Sahin, Professor

    Trakya University Medical Faculty

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Professor

Study Record Dates

First Submitted

March 30, 2017

First Posted

May 1, 2017

Study Start

July 23, 2014

Primary Completion

July 23, 2016

Study Completion

August 23, 2016

Last Updated

May 9, 2017

Record last verified: 2017-05