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Different Preloads for Prevention of Hypotension in Patients Undergoing Elective CS Under Intrathecal Anesthesia

Crystalloid Versus Crystalloid and Colloid Combination Preload for Prevention of Hypotension in Patients Undergoing Elective Caesarean Section Under Intrathecal Anesthesia

Status
UNKNOWN
Phases
Early Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03465943
Enrollment
60
Registered
2018-03-15
Start date
2018-03-31
Completion date
2019-04-30
Last updated
2018-03-15

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

Conditions

Hypotension Drug-Induced

Brief summary

The aim of this study was to compare between crystalloid versus crystalloid and colloid combination preloads for prevention of hypotension following intrathecal anaesthesia in patients undergoing elective Caesarean section. To examine weather baseline perfusion index could predict the incidence of intrathecal-induced hypotension during Caesarean section.

Detailed description

Intrathecal anesthesia is the most commonly used technique for elective Caesarean section all over the world. One of the most common complications of this technique is hypotension. It's incidence is more than 80% without any prophylactic measures, this hypotension has adverse effects on both mother ( causing nausea and vomiting ) and foetus ( causing acidosis and neurological defects ). This complication can be managed by several ways like fluid therapy, usage of vasopressors or combination between both of them. Among the type of fluids ( crystalloid or colloid ) it's still not known which one of them is better. Crystalloid has a short intravascular half-life because of its rapid distribution into the interstitial space. On the other hand colloid remains longer within the intravascular space. Change in baseline peripheral vascular tone due to pregnancy may affect the degree of such hypotension. The perfusion index ( PI ) derived from a pulse oximeter has been used for assessing peripheral perfusion dynamics due to changes in peripheral vascular tone.

Interventions

DRUGRinger

1L of Ringer's solution as a preload in one group.

500 ml of voluven will be given in combination with 500 ml Ringer's solution as a preload in the other group.

Sponsors

Assiut University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 40 Years
Healthy volunteers
Yes

Inclusion criteria

* Age : 18-40 years * ASA 1&2

Exclusion criteria

* Patients with morbid obesity. * Pre-existing or pregnancy-induced hypertension. * Known cardiovascular or cerebrovascular disease. * Abnormal CTG tracing. * Any other contraindications for intrathecal anaesthesia.

Design outcomes

Primary

MeasureTime frameDescription
Incidence of hypotension1 hourDecrease in systolic blood pressure more than 20% of base line

Secondary

MeasureTime frameDescription
Perfusion index1 hourDerived from pulse oximeter
Heart rate1 hour
Urine output1 hour

Contacts

Primary ContactEssam E. Abd El-Hakeem, PhD
Essam1993@yahoo.com01207159716
Backup ContactNagwa Mostafa Osman, PhD
nagwaosman1962@yahoo.com01006792219

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026