Fluid Coloading and the Incidence of Hypotension

Complications; Cesarean Section Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01741610
• Other study ID #: HZLTNS97
• Status: Completed
• Phase: Phase 4
• First received: November 15, 2012
• Last updated: January 14, 2014
• Start date: October 2008
• Est. completion date: June 2012

Study information

• Verified date: January 2014
• Source: Cukurova University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Turkey: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: June 2012
• Est. primary completion date: August 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 19 Years to 46 Years

Eligibility

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.

Study Design

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

Related Conditions & MeSH terms

• Anesthesia; Adverse Effect, Spinal and Epidural
• Complications; Cesarean Section
• Hypotension
• Other Fluid Overload

Intervention

Biological:
• Cristalloid and colloid coloading
Cristalloid coloading (Group L) Colloid coloading (Group C) No coloading (Group E)Placebo Comparator

Locations

Country	Name	City	State
Turkey	Hakki Unlugenc	Adana

Sponsors (1)

Lead Sponsor	Collaborator
Cukurova University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rapid fluid administration and the incidence of hypotension induced by spinal anaesthesia and ephedrine requirement: the effect of crystalloid versus colloid coloading	The primary study endpoint was the ephedrine requirement (incidence of hypotension).	Four Years	Yes

External Links

•   Cukurova University