Effect of Spinal Anesthesia in Elective Cesarean Cases on Frontal QRS Angle in Anemic and Non-Anemic Patients

NCT06434870 | Recruiting

• 1 other identifier: MAIEAH630004
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

The QRS-T angle represents a novel marker of myocardial repolarisation. It is defined as the angle difference between the direction of ventricular depolarisation (QRS wave) and the direction of ventricular repolarisation (T wave). It is an indicator of instability in the electrophysiological properties of the myocardium and is associated with arrhythmias. The frontal QRS-T angle is a straightforward, cost-effective parameter that can be readily obtained from 12-lead electrocardiography. The most prevalent arrhythmias during pregnancy are atrial arrhythmias. However, ventricular tachyarrhythmias are exceedingly rare during pregnancy and may be life-threatening. Caesarean section is one of the most common surgical procedures. General anaesthesia, spinal anaesthesia and epidural anaesthesia can be employed in these patients. Spinal anaesthesia is a frequently employed method in caesarean section operations due to its rapid onset of effect, technical simplicity of application and higher probability of success. In pregnant women, anaemia is defined as a haemoglobin concentration below 11 mg/dL in the first trimester, 11 mg/dL in the second trimester and 10.5 mg/dL in the third trimester.

Conditions

Pregnancy Anemia; Electrocardiography; Anesthesia, Spinal

Outcome Measures

Primary Outcomes (5)

• The measurements to be taken include QRS, frontal QRS, QRS angle and Tp-e interval. (T1)

  preoperatively

• The measurements to be taken include QRS, frontal QRS, QRS angle and Tp-e interval.(T2)

  after spinal anaesthesia

• The measurements to be taken include QRS, frontal QRS, QRS angle and Tp-e interval.(T3)

  5 min after spinal anaesthesia

• The measurements to be taken include QRS, frontal QRS, QRS angle and Tp-e interval.(T4)

  5 min after spinal anaesthesia

• The measurements to be taken include QRS, frontal QRS, QRS angle and Tp-e interval.(T5)

  10 min after spinal anaesthesia

Study Arms (2)

Patients who had undergone Elective Cesarean Surgery with anemia

In pregnant women, haemoglobin values below 11 mg/dL in the first trimester, 11 mg/dL in the second trimester and 10.5 mg/dL in the third trimester indicate anaemia. The group comprised patients with haemoglobin levels below 10.5 mg/dL.

Patients who had undergone Elective Cesarean Surgery without anemia

In pregnant women, haemoglobin values below 11 mg/dL in the first trimester, 11 mg/dL in the second trimester and 10.5 mg/dL in the third trimester indicate anaemia. The group comprised patients with haemoglobin levels above 10.5 mg/dL.

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

The study will include 100 patients aged 18-45 years with an American Society of Anesthesiologists (ASA) II classification who will undergo elective caesarean section.

You may qualify if:

• Aged 18-45 years
• Patients with American Society of Anesthesiologists (ASA) II classification

You may not qualify if:

• Patients with rhythm disorders
• Patients with electrolyte disturbances
• Patients with liver and/or renal failure
• Obese patients (body mass index \> 30)
• Trauma patients
• Cancer patients
• ASA III-IV patients
• Patients who do not wish to participate in the study will be excluded.

Sponsors & Collaborators

• Sanliurfa Mehmet Akif Inan Education and Research Hospital: lead

Study Sites (1)

University of Health Science Turkey Sanliurfa Mehmet Akif Inan Training and Research Hospital

Sanliurfa, 63050, Turkey (Türkiye)

RECRUITING

Central Study Contacts

ahmet kaya

CONTACT

00905327010609; ahmet.kaya@sbu.edu.tr

mahmut alp karahan

CONTACT

00905327808997; mahmutalp_k@yahoo.com

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: assistant professor

Study Record Dates

• First Submitted: May 22, 2024
• First Posted: May 30, 2024
• Study Start: April 20, 2024
• Primary Completion: August 31, 2024
• Study Completion: August 31, 2024
• Last Updated: May 30, 2024

Record last verified: 2024-05

Locations

TU (1)