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Fluid Coloading and the Incidence of Hypotension

Information source: Cukurova University
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Complications; Cesarean Section; Anesthesia; Adverse Effect, Spinal and Epidural; Other Fluid Overload

Intervention: Cristalloid and colloid coloading (Biological)

Phase: Phase 4

Status: Completed

Sponsored by: Cukurova University

Official(s) and/or principal investigator(s):
Hakki Unlugenc, Prof Dr, Study Chair, Affiliation: Cukurova University

Summary

This study was conducted to evaluate the effects of rapid crystalloid (Lactated Ringer's solution) or colloid (hydroxyethyl starch; HES) cohydration with a second intravenous access line on the incidence of hypotension and ephedrine requirement during spinal anaesthesia for caesarean section.

Clinical Details

Official title: Rapid Fluid Administration and the Incidence of Hypotension Induced by Spinal Anaesthesia and Ephedrine Requirement: the Effect of Crystalloid Versus Colloid Coloading

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Primary outcome: Rapid fluid administration and the incidence of hypotension induced by spinal anaesthesia and ephedrine requirement: the effect of crystalloid versus colloid coloading

Detailed description: Background: Spinal anaesthesia for caesarean delivery is often associated with hypotension. This study was conducted to evaluate the effects of rapid crystalloid (Lactated Ringer's solution) or colloid (hydroxyethyl starch; HES) cohydration with a second intravenous access line on the incidence of hypotension and ephedrine requirement during spinal anaesthesia for caesarean section. Methods: We studied 90 women with uncomplicated pregnancies undergoing elective caesarean section under spinal anaesthesia. Intravenous access was established in all with two peripheral intravenous lines, the first being used for the baseline volume infusion. Immediately after induction of spinal anaesthesia, Lactated Ringer's solution (Group L) or HES (Group C) infusions were started at the maximal possible rate via the second line in groups L and C respectively. The third group (Group E) patients received lactated Ringer's solution at a 'keep vein open' rate to maintain the double-blind nature. The incidence of hypotension, ephedrine requirements, total amount of volume and side effects were recorded.

Eligibility

Minimum age: 19 Years. Maximum age: 46 Years. Gender(s): Female.

Criteria:

Inclusion Criteria:

- elective caesarean section under spinal anaesthesia

Exclusion Criteria:

- Significant coexisting disease such as; pre-eclampsia and hepato-renal disease,

- Pregnancy preinduced hypertension,

- Being in active labour or requiring emergency caesarean section,

- Any contraindication to regional anaesthesia such as local infection or bleeding

disorders.

Locations and Contacts

Hakki Unlugenc, Adana 01330, Turkey
Additional Information

Cukurova University

Starting date: October 2008
Last updated: January 14, 2014

Page last updated: August 20, 2015

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