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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| care bundle | Active Comparator | will be subjected to a bundle of care of four elements |
|
| best-evidenced practice | Active Comparator | will be guided according to the best-evidenced performance consisting of three elements |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| guidance | Procedure | either follow the care bundle or the best evidence practice |
|
| Measure | Description | Time Frame |
|---|---|---|
| consumption of ephedrine | The total consumption of ephedrine used to manage the spinal induced hypotension with CS | immediately at the end of the surgery |
| Measure | Description | Time Frame |
|---|---|---|
| consumption of atropine | The total consumption of atropine used to manage the spinal induced hypotension with CS | immediately at the end of the surgery |
| postspinal hypotension | The incidence of postspinal hypotension in CS |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Abdelrhman Alshawadfy | Suez Canal University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Suez Canal University | Ismailia | 2685 | Egypt |
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| ID | Term |
|---|---|
| D007022 | Hypotension |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D003376 | Counseling |
| ID | Term |
|---|---|
| D008605 | Mental Health Services |
| D004191 | Behavioral Disciplines and Activities |
| D003153 | Community Health Services |
| D006296 | Health Services |
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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.
| immediately at the end of the surgery |
| D005159 | Health Care Facilities Workforce and Services |