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Predictability of preoperative corrected left ventricular-ejection time for hypotension after spinal anesthesia in patients undergoing caesarean section: a single-center prospective diagnostic study

Predictability of preoperative corrected left ventricular-ejection time for hypotension after spinal anesthesia in patients undergoing caesarean section: a single-center prospective diagnostic study

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2400091135
Enrollment
Unknown
Registered
2024-10-21
Start date
2024-11-01
Completion date
Unknown
Last updated
2025-02-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypotension after spinal anesthesia

Interventions

Gold Standard:Hypotension after spinal anesthesia is defined as a decrease in systolic blood pressure of greater than or equal to 25% or the minimum systolic blood pressure is less than or equal to 80
Index test:Corrected left ventricular-ejection time

Sponsors

Beijing Chao-Yang Hospital, Capital Medical University
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 40 Years

Inclusion criteria

Inclusion criteria: 1.Women aged 18 to 40 years. 2.Scheduled for elective caesarean section under combined spinal-epidural anesthesia. 3.ASA (American Society of Anesthesiologists) grade I-ll classification. 4.Singleton pregnancy with gestational age>36 weeks or <= 41 weeks. 5.Willingness to participate in this study and providing the informed consent.

Exclusion criteria

Exclusion criteria: 1.Poor impedance cardiogram (ICG) waveform caused by obvious interference (such as agitation, coughing, shivering, limb shaking). 2.Persistent high blood pressure after entering the operation room (systolic blood pressure>160 mmHg for noninvasive blood pressure after 5 minutes of rest in the operation room). 3.History of cardiovascular and cerebrovascular diseases. 4.Serious obstetric complications, including hypertensive disorders complicating pregnancy (gestational hypertension, preeclampsia, eclampsia, chronic hypertension with preeclampsia, chronic hypertension), placental abruption, pernicious placenta previa, placenta accreta. 5.Obesity (BMI>35kg/m^2) or emaciation (BMI<15 kg/m^2). 6.Contraindications to neuraxial anesthesia. 7.Skin rashes, infections, or ulcers at the site where the electrodes of the chest impedance monitoring device to be attached. 8.Severe aortic insufficiency. 9.Atrial septal defect or ventricular septal defect. 10.Severe aortic sclerosis or post-aortic repair surgery. 11.Aortic aneurysm or aortic dissection. 12.Status post-pacemaker implantation. 13.Height below 120cm or above 230cm. 14.Weight less than 30kg or more than 155kg. 15.History of allergies or other serious adverse reactions to the drugs used in the study. 16.History of allergies to medical tape, electrocardiogram electrodes, and medical skin surface dressings involved in this study.

Design outcomes

Primary

MeasureTime frame
The area under the ROC curve and optimal threshold of corrected left ventricular-ejection time for predicting hypotension after spinal anesthesia in patients undergoing caesarean section;

Secondary

MeasureTime frame
Correlation between the preanesthetic corrected left ventricular-ejection time and the magnitude of decrease in SBP from the baseline;Incidence of hypotension after spinal anesthesia;Incidence of skin allergy with electrode of non-invasive hemodynamic detector;Patient satisfaction 24 hours after surgery;Changes in hemodynamics before and after spinal anesthesia;

Countries

China

Contacts

Public ContactSai-Nan Wang

Beijing Chao-Yang Hospital, Capital Medical University

sunnywsn915@163.com+86 10 85231862

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026