Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624000596505
Ethics application status
Approved
Date submitted
19/10/2023
Date registered
9/05/2024
Date last updated
9/05/2024
Date data sharing statement initially provided
9/05/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
The Effects of Anesthetizing the Lower Waist with an Injection in the Waist on the Waves in the Heart Strip in Pregnant Women Who Are Planned for Non-Urgent Caesarean Section or Overdue
Scientific title
Comparison of the Effects of spinal anesthesia on Frontal QRS-T angle in term and postterm pregnancies planned for elective cesarean section: a prospective study
Secondary ID [1] 310813 0
none
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
pregnancy 331803 0
Rhythm change in ECG with spinal anesthesia 331805 0
Condition category
Condition code
Anaesthesiology 328544 328544 0 0
Anaesthetics
Anaesthesiology 328545 328545 0 0
Other anaesthesiology
Reproductive Health and Childbirth 328546 328546 0 0
Normal pregnancy
Cardiovascular 328547 328547 0 0
Normal development and function of the cardiovascular system

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
SUMMARY OF THE METHOD
Patients will be divided into two groups of 40 based on gestational age. Group A (those who are at 42 weeks of gestation and above) Group B (those who are less than 42 weeks of gestation)
After obtaining informed consent from the patients, venous access will be established with an 18 G peripheral vein cannula and standard monitoring (ECG, SpO2, NIBP) will be applied to the patients who will be taken to the operation room. Basal systolic arterial pressure (SAP) and heart rate (HR) will be recorded. The first ECG will be done in the operating room before the procedures are performed by surgical nurse. Both groups will receive volume replacement with 10 ml/kg 0.9% isotonic NaCl for 30 minutes before anesthesia. The second ECG recording will be performed. The patients will be placed in a sitting position and the puncture site will be disinfected with 10% povidone-iodine antiseptic solution. After sterile draping, 2.5 ml hyperbaric bupivacaine will be administered by reaching the subarachnoid space with a 25 G Quincke spinal needle from the L3-L4 or L4-L5 space administered by registered anaesthesist. Following the application, patients will be placed on their back.
In all cases, a 12-lead ECG recording will be taken while resting in the supine position after resting for at least 10 minutes, with a paper speed of 25 mm per second, a height of 10 mm/Mv and a filter range of 0.16-100 Hz. In ECG evaluation, QT and Tp-e interval measurements will be calculated with the help of magnifying glasses. ECGs will be measured before the operation (T1), after spinal anesthesia (T2), at the 5th minute after spinal anesthesia (T3), at the 10th minute after spinal anesthesia (T4) and at the 30th minute after spinal anesthesia (T5).
Intervention code [1] 327223 0
Diagnosis / Prognosis
Comparator / control treatment
who are less than 42 weeks of gestation
Control group
Active

Outcomes
Primary outcome [1] 336368 0
Effects of Spinal Anesthesia on Frontal QRS-T Angle
Timepoint [1] 336368 0
before the operation (T1), immediately after spinal anesthesia (T2), at the 5th minute after spinal anesthesia (T3), at the 10th minute after spinal anesthesia (T4) and at the 30th minute after spinal anesthesia (T5)
Secondary outcome [1] 428048 0
nil
Timepoint [1] 428048 0
nil

Eligibility
Key inclusion criteria
80 patients aged between 18 and 45 who will undergo elective cesarean section with ASA II will be included in the study.
Minimum age
18 Years
Maximum age
45 Years
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients with contraindications for neuraxial anesthesia, injection site infection, severe hypovolemia, increased intracranial pressure, coagulopathy or bleeding diathesis, known local anesthetic allergy, severe mitral and/or aortic stenosis, abnormal serum electrolyte levels, heart rate-corrected QT (QTc). duration > 440 ms, drug abuse affecting QTc interval duration, family history of long QT syndrome, unstable angina pectoris, chronic obstructive pulmonary disease, ejection fraction <40%, severe heart failure, severe atrioventricular block, an arrhythmia disorder other than coronary sinus rhythm , liver and kidney disease, anemia, muscle-nerve disease and obesity were excluded from the study. Additionally, patients who underwent permanent battery placement and refused to participate in the study will also be excluded.

Study design
Purpose
Duration
Selection
Timing
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
15/05/2024
Actual
Date of last participant enrolment
Anticipated
15/05/2024
Actual
Date of last data collection
Anticipated
20/05/2024
Actual
Sample size
Target
80
Accrual to date
Final
Recruitment outside Australia
Country [1] 25908 0
Turkey
State/province [1] 25908 0
sanliurfa

Funding & Sponsors
Funding source category [1] 316210 0
Self funded/Unfunded
Name [1] 316210 0
Ahmet Kaya
Country [1] 316210 0
Turkey
Primary sponsor type
Individual
Name
Ahmet Kaya
Address
UNIVERSITY OF HEALTH SCIENCE TURKEY SANLIURFA MEHMET AKIF INAN TRAINING AND RESEARCH HOSPITAL
Country
Turkey
Secondary sponsor category [1] 317077 0
None
Name [1] 317077 0
Address [1] 317077 0
Country [1] 317077 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 314009 0
harran university clinical research ethics committee
Ethics committee address [1] 314009 0
Ethics committee country [1] 314009 0
Turkey
Date submitted for ethics approval [1] 314009 0
Approval date [1] 314009 0
07/08/2023
Ethics approval number [1] 314009 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 130106 0
Dr ahmet kaya
Address 130106 0
university of health science turkey sanliurfa mehmet akif inan training and research hospital, Esentepe Str. 32 A, 63040 Haliliye/Sanliurfa
Country 130106 0
Turkey
Phone 130106 0
+905327010609
Fax 130106 0
Email 130106 0
[email protected]
Contact person for public queries
Name 130107 0
ahmet kaya
Address 130107 0
university of health science turkey sanliurfa mehmet akif inan training and research hospital, Esentepe Str. 32 A, 63040 Haliliye/Sanliurfa
Country 130107 0
Turkey
Phone 130107 0
+905327010609
Fax 130107 0
Email 130107 0
[email protected]
Contact person for scientific queries
Name 130108 0
ahmet kaya
Address 130108 0
university of health science turkey sanliurfa mehmet akif inan training and research hospital, Esentepe Str. 32 A, 63040 Haliliye/Sanliurfa
Country 130108 0
Turkey
Phone 130108 0
+905327010609
Fax 130108 0
Email 130108 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
Yes
Will there be any conditions when requesting access to individual participant data?
Persons/groups eligible to request access:
• only researchers who provide a methodologically sound proposal

Conditions for requesting access:
• -

What individual participant data might be shared?
• individual participant data underlying published results only

What types of analyses could be done with individual participant data?
• only to achieve the aims in the approved proposal

When can requests for individual participant data be made (start and end dates)?
From:
Immediately following publication, no end date

To:
-

Where can requests to access individual participant data be made, or data be obtained directly?
• access subject to approvals by Principal Investigator (email:[email protected])

Are there extra considerations when requesting access to individual participant data?
No


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
20691Ethical approval    Study-related document.pdf



Results publications and other study-related documents

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

Documents added automatically
No additional documents have been identified.