Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12617000661370
Ethics application status
Approved
Date submitted
2/03/2017
Date registered
8/05/2017
Date last updated
11/04/2019
Date data sharing statement initially provided
11/04/2019
Date results information initially provided
11/04/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Comparison of the effects of Spinal Anesthesia on QT Dispersion in women electing to undergo Caesarean section.
Scientific title
Comparison of the effects of Spinal Anesthesia on QT Dispersion in women electing to undergo Caesarean section: prospective study.
Secondary ID [1] 291215 0
none
Universal Trial Number (UTN)
U1111-1168-3483
Trial acronym
CESAQTCS
Linked study record

Health condition
Health condition(s) or problem(s) studied:
otherwise healthy parturients planned for cesarean section 302201 0
Condition category
Condition code
Anaesthesiology 301810 301810 0 0
Other anaesthesiology
Reproductive Health and Childbirth 302316 302316 0 0
Childbirth and postnatal care
Surgery 302317 302317 0 0
Other surgery

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
patients will allocate to two group

Group 1: Equal and over 39th gestational age
Group 2: Under 39th gestational age

All patients will be monitored and the basal vital functions (HR, SpO2, NIBP, ECG ) will be recorded with admission into the OR. ECG monitorization will perform and their control ECG records was take.

All patients will placed into a sitting position and spinal anesthesia will be performed with a median approach at a level of L3-L4, with a 25 G Quincke type spinal needle and % 0.5 2.0 ml bupivacaine by anaesthesiologist.

After succesful administration of anesthesia, all patients will be placed into supine position, monitored and administered oxygene via a venturi mask after administration of spinal anesthesia until the completion of surgery in %21 inspirated fraction.
ECG records will take 1 , 5 , and 10 minutes after the block. Bromage scale (BS) scores, heart rate, blood pressure, peripheral oxygen saturation, respiration rate values and sensory block levels with pinprick test will record at minutes 1, 5 and 10 of spinal anesthesia
and every 5 minutes thereafter after the end of surgery. end of surgery will record ECG.

Standard 12 derivation ECG recordings obtained with a paper speed of 25 mm.sec-1 and a defl ection of 10 mm.mV-1 of patients participating in the study will analyze (Nihon Kohden cardiofaxm ). We will calculate heart rate using mean RR time.

Spinal block levels, duration of surgery, APGAR scores, vasopressor consumption will be recorded.
Intervention code [1] 297285 0
Prevention
Intervention code [2] 297915 0
Treatment: Drugs
Comparator / control treatment
patients will allocate to two group

Group 1: Equal and over 39th gestational age
Group 2: Under 39th gestational age


Control group
Active

Outcomes
Primary outcome [1] 301319 0
The examine the effects of spinal anesthesia on QT in different pregnancy week women is the primary goal of the study.
Timepoint [1] 301319 0
ECG monitorization will perform and Pre-operatively ECG records will take. After the block is done ECG records will take every 5 minutes for duration of the procedure until the operation is complete. post-operative 60 minutes, ECG records will take.
Primary outcome [2] 301723 0
The examine the effects of spinal anesthesia on QTc in different pregnancy week women is the primary goal of the study.
Timepoint [2] 301723 0
ECG monitorization will perform and Pre-operatively ECG records will take. After the block is done ECG records will take every 5 minutes for duration of the procedure until the operation is complete. post-operative 60 minutes, ECG records will take.
Primary outcome [3] 301724 0
The examine the effects of spinal anesthesia on QT dispersion in different pregnancy week women is the primary goal of the study.
Timepoint [3] 301724 0
ECG monitorization will perform and Pre-operatively ECG records will take. After the block is done ECG records will take every 5 minutes for duration of the procedure until the operation is complete. post-operative 60 minutes, ECG records will take.
Secondary outcome [1] 332293 0
APGAR scores which will be evaluated in the OR after delivery by a pediatrist.
Timepoint [1] 332293 0
APGAR scores in 1 minute and 5 minutes after delivery

Eligibility
Key inclusion criteria
Forty pregnant women age between greater than or equal to 18 and less than or equal to 45,
height greater than or equal to 1.60 cm, weight between greater than or equal to 60 and less than or equal to 100 kg,
placed in the ASA risk group I-II in their preanesthetic evaluation and scheduled for elective cesarean surgery will included in the study.
Minimum age
18 Years
Maximum age
45 Years
Sex
Females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Exclusion criteria is refusal to participate in the study, the existence of brain tumors, scalded skin syndrome (SSS infection), spinal cord and peripheral nervous system diseases (poliomyelitis, multiple sclerosis, demyelinating diseases), hemorrhagic and hypovolemic shock, severe anemia, increased intracranial pressure, aortic and valvular heart disease, cardiac decompensation, systemic infection (generalized sepsis and bacteremia), local infection (dermal infections in puncture site of spinal needle, etc.), congenital spinal anomalies, scoliosis, post-traumatic vertebral injuries, vertebral colon metastatic lesions, increased abdominal pressure, chronic severe headache, anticoagulant drug use and anatomic diffi culties, electrolyte disturbances diabetes mellitus, hypothyroidism, hyperthyroidism, cardiomyopathy, atrial and/or ventricular hypertrophy on ECG, cardiomegaly, valvular disease, cardiac failure or chronic disease, patients with excessive smoking and alcohol consumption and used medication causing QT interval prolongation.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?

The people administering the treatment/s

Intervention assignment
Parallel
Other design features
Phase
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
4/09/2017
Date of last participant enrolment
Anticipated
17/05/2017
Actual
2/10/2017
Date of last data collection
Anticipated
19/05/2017
Actual
8/01/2018
Sample size
Target
40
Accrual to date
Final
40
Recruitment outside Australia
Country [1] 8703 0
Turkey
State/province [1] 8703 0
sanliurfa

Funding & Sponsors
Funding source category [1] 295663 0
University
Name [1] 295663 0
Harran University
Country [1] 295663 0
Turkey
Primary sponsor type
Hospital
Name
Harran University School of Medicine, Research and Training Hospital
Address
Harran University School of Medicine, Research and Training Hospital
Osmanbey Campus
Sanliurfa-Mardin Karayolu Uzeri 18.Km
Sanliurfa/Turkey
Country
Turkey
Secondary sponsor category [1] 294509 0
None
Name [1] 294509 0
Address [1] 294509 0
Country [1] 294509 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 296979 0
Harran university medical faculty ethics committe
Ethics committee address [1] 296979 0
Ethics committee country [1] 296979 0
Turkey
Date submitted for ethics approval [1] 296979 0
Approval date [1] 296979 0
09/02/2017
Ethics approval number [1] 296979 0

Summary
Brief summary
The principal cardiovascular changes in pregnancy are increased sympathetic
hyperactivity and systemic vascular resistance. Blood volume, heart rate, venous pressure in the lower extremity, and heart rate increase.In addition, peripheral resistance and pulmonary vascular resistance and blood pressure can be reduced. As the gestation week progresses It also affects the heart conduction system and makes patients more susceptible to arrhythmia.

Regional anesthesia in cesarean surgeries has the advantages of allowing the mother to be awake during delivery and not neeeding airway manipulation, keeping mother’s airway reflexes, decreasing blood loss, reducing the risk of druginduced fetal depression, and carrying the need for analgesia over to the postoperative stage. But Neuroaxial blockade, such as spinal anesthesia, has been shown to modulate the effects of the stress response and sympathetic overactivity in pregnancy .

The QT interval, a marker of ventricular repolarization is diagnosed when this value is more than 440 ms . A prolonged QT interval can cause serious cardiac rhythm problems such as
ventricular tachydysrhythmias.

Therefore, We aimed to investigate the effects of Spine Anesthesia on QT Dispersion in patients with different gestational weeks who were scheduled for elective cesarean section.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 72606 0
A/Prof Mahmut Alp Karahan
Address 72606 0
Harran University School of Medicine, Research and Training Hospital
Osmanbey Campus
Sanliurfa-Mardin Karayolu Uzeri 18.Km
Sanliurfa/Turkey
Country 72606 0
Turkey
Phone 72606 0
+905327808997
Fax 72606 0
Email 72606 0
mahmutalp_k@yahoo.com
Contact person for public queries
Name 72607 0
A/Prof Mahmut Alp Karahan
Address 72607 0
Harran University School of Medicine, Research and Training Hospital
Osmanbey Campus
Sanliurfa-Mardin Karayolu Uzeri 18.Km
Sanliurfa/Turkey
Country 72607 0
Turkey
Phone 72607 0
+905327808997
Fax 72607 0
Email 72607 0
mahmutalp_k@yahoo.com
Contact person for scientific queries
Name 72608 0
A/Prof Mahmut Alp Karahan
Address 72608 0
Harran University School of Medicine, Research and Training Hospital
Osmanbey Campus
Sanliurfa-Mardin Karayolu Uzeri 18.Km
Sanliurfa/Turkey
Country 72608 0
Turkey
Phone 72608 0
+905327808997
Fax 72608 0
Email 72608 0
mahmutalp_k@yahoo.com

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
Dimensions AIThe relationship between gestational week and QT dispersion in cesarean section patients undergoing spinal anaesthesia: A prospective study2021https://doi.org/10.1111/ijcp.14154
N.B. These documents automatically identified may not have been verified by the study sponsor.