Comparison of the effects of Spinal Anesthesia on QT Dispersion in women electing to undergo Caesarean section.

• Register: ANZCTR
• Last refreshed on: 15 July 2019
• Main ID: ACTRN12617000661370
• Date of registration: 08/05/2017
• Prospective Registration: Yes
• Primary sponsor: Harran University School of Medicine, Research and Training Hospital
• 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.
• Date of first enrolment: 04/09/2017
• Target sample size: 40
• Recruitment status: Completed
• URL: https://anzctr.org.au/ACTRN12617000661370.aspx
• Study type: Interventional
• Study design: Purpose: Treatment; Allocation: Non-randomised trial; Masking: Blinded (masking used);Assignment: Parallel;

Countries of recruitment

Turkey

Contacts

• Name: A/Prof Mahmut Alp Karahan

• Name: A/Prof Mahmut Alp Karahan

Key inclusion & exclusion criteria

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.
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.

Age minimum: 18 Years
Age maximum: 45 Years
Gender: Females

Health Condition(s) or Problem(s) studied

Reproductive Health and Childbirth - Childbirth and postnatal care

Surgery - Other surgery

otherwise healthy parturients planned for cesarean section;
otherwise healthy parturients planned for cesarean section

Anaesthesiology - Other anaesthesiology

Intervention(s)

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.

Primary Outcome(s)

The examine the effects of spinal anesthesia on QT in different pregnancy week women is the primary goal of the study.[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.]

The examine the effects of spinal anesthesia on QT dispersion in different pregnancy week women is the primary goal of the study.[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.]

The examine the effects of spinal anesthesia on QTc in different pregnancy week women is the primary goal of the study.[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(s)

APGAR scores which will be evaluated in the OR after delivery by a pediatrist.
[ APGAR scores in 1 minute and 5 minutes after delivery]

Secondary ID(s)

none

Source(s) of Monetary Support

Harran University

Ethics review

Status: Approved
Approval date:
Contact:

Harran university medical faculty ethics committe

Results

• Results available: Yes
• Date Posted: 11/04/2019
• Date Completed: 08/01/2018