Clinical trial NCT05269537: Changes in Cardiac Output During Cesarean Delivery Under Spinal Anesthesia
Official title: Changes in Cardiac Output During Cesarean Delivery Under Spinal Anesthesia. A Prospective Observational Study Using Transthoracic Echocardiography
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Anesthesia, Spinal
Cesarean Section
Echocardiography
Cardiac Output
Lead sponsor: Mansoura University
Sponsor class: OTHER
First posted: 2022-03-08
Enrollment: 60
Sex: FEMALE
Minimum age (years): 19
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Healthy women with full term, singleton pregnancy presenting for elective cesarean delivery under spinal anesthesia in a tertiary obstetric hospital

Brief summary: Cardiac output will be measured in healthy parturients undergoing cesarean delivery under spinal anesthesia

Detailed description: ASA-II women undergoing cesarean delivery under spinal anesthesia will be included. Cardiac output will be measured using transthoracic echocardiography at 4 time points: Baseline, after 10 minutes of intrathecal injection, after delivery, and after 1 hour of intrathecal injection. Spinal anesthesia will be administered with 2.5 ml bupivacaine 0.5% and fentanyl 15 μg.

Eligibility criteria: Inclusion Criteria:

* American Society of Anesthesiologists physical status II parturients.
* Full term, singleton pregnancy
* Elective cesarean delivery under spinal anesthesia

Exclusion Criteria:

* Height \<150 cm
* Weight \<60 kg
* Body mass index (BMI) \<18.5 or ≥ 35 kg/m²
* Women presenting in labor
* Contraindications to spinal anesthesia: increased intracranial pressure, coagulopathy, or local skin infection
* Hemoglobin \<10 g/dL
* Current administration of vasoactive drugs (e.g., salbutamol, thyroxin)
* Diabetes mellitus, cardiovascular, or renal disease
* Chronic or pregnancy-induced hypertension
* Polyhydramnios
* Women with high risk for postpartum hemorrhage or uterine atony (e.g., placenta accreta spectrum, ≥3 previous cesarean deliveries)

Primary outcomes:
measure: Changes in cardiac output
timeFrame: At baseline, at 10 minutes after intrathecal injection, immediately after delivery, and at 1 hour after intrathecal injection
Secondary outcomes:
measure: Changes in stroke volume
timeFrame: At baseline, at 10 minutes after intrathecal injection, immediately after delivery, and at 1 hour after intrathecal injection
measure: Changes in heart rate
timeFrame: At baseline, at 10 minutes after intrathecal injection, immediately after delivery, and at 1 hour after intrathecal injection
measure: Number of subjects requiring ephedrine
timeFrame: From intrathecal injection to the end of cesarean delivery
measure: Incidence of hypotension
timeFrame: From intrathecal injection to the end of cesarean delivery
measure: Incidence of severe hypotension
timeFrame: From intrathecal injection to the end of cesarean delivery
measure: Incidence of bradycardia
timeFrame: From intrathecal injection to the end of cesarean delivery
measure: Incidence of nausea and/or vomiting
timeFrame: From intrathecal injection to the end of cesarean delivery
measure: Neonatal Apgar scores
timeFrame: At 1 and 5 minutes after delivery
Other outcomes:
Locations:
city: Mansoura
country: Egypt
facility: Department of Anesthesia and Surgical Critical Care, Mansoura University Hospitals
state: Dakahlia
Study officials:
affiliation: Department of Anesthesia and Surgical Critical Care, Mansoura University Hospitals, Mansoura, Egypt
name: Mohamed M Tawfik, MD
role: PRINCIPAL_INVESTIGATOR
References: