Cesarean Section Complications, Hypotension
Conditions
Brief summary
Cesarean Section (CS) is a common obstetric surgery that can be performed by both general or regional anaesthetic techniques. Hypotension is the most common complication of spinal anaesthesia, its incidence varying from 70% to 80 %, if severe, it can result in serious perinatal adverse outcomes, such as maternal nausea and vomiting, fetal acidosis and may be an important contributory factor for maternal death related to regional anaesthesia.
Detailed description
A variety of methods have been used for the prevention of post-spinal hypotension which includes the use of intravenous fluid, vasopressors, and physical methods such as table tilt, leg binders, and compression devices. However, a single technique is ineffective and a combination of interventions is suggested. A care bundle is a group of three to five evidence-based interventions that, when performed together, have a better outcome than if performed individually. A care bundle consists of a group of (usually) between three and five evidence-based interventions. These are related to a particular condition or event for patient care. Care bundles are well known in the field of intensive care medicine such as Ventilator-Associated Pneumonia (VAP) care bundle, sepsis care bundle, and Central Line-Associated Bloodstream Infection (CLABSI) care bundle. To our knowledge, till now, no one has investigated a special care bundle in the field of anaesthesia. In this work, we will investigate the safety and efficacy of a special care bundle in controlling spinal induced hypotension.
Interventions
PROCEDUREguidance
either follow the care bundle or the best evidence practice
Sponsors
Suez Canal University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)
Masking description
patients will be randomly allocated by a computer software program (www. Randmizer.org) and allocation sequence will be done by opaque closed envelope. Data will be collected by a separate anesthesiologist not sharing in the study and blinded to the technique being used.
Eligibility
Sex/Gender
FEMALE
Age
21 Years to 40 Years
Healthy volunteers
No
Inclusion criteria
* Age more than 21 years old and less than 40 years. * Patients are ASA I (American Society of Anesthesiology physical status Grade I) = (normal healthy patients) or ASA II (American Society of Anesthesiologists physical status Grade II) = (patients with mild systemic disease and no functional limitations). * None laboring, at term with singleton uncomplicated pregnancies. * Delivery under spinal anesthesia, with height 150 to 180 cm * Body mass index of at most 40 kg/m2.
Exclusion criteria
* Parturient with peri-partum disorders as DM, HTN, cardiac diseases, bronchial asthma or bleeding disorders * Obesity: BMI \>40 * Any known allergy to local anesthetic drugs or ondansetron. * Apparent anatomical abnormalities or infections in the back region. * Bleeding disorders e.g., thrombocytopenia, high INR, high PT in the chronic liver or impaired kidney). * Refusal to participate in the study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| consumption of ephedrine | immediately at the end of the surgery | The total consumption of ephedrine used to manage the spinal induced hypotension with CS |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| consumption of atropine | immediately at the end of the surgery | The total consumption of atropine used to manage the spinal induced hypotension with CS |
| postspinal hypotension | immediately at the end of the surgery | The incidence of postspinal hypotension in CS |
Countries
Egypt
Outcome results
None listed