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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01741610
Other study ID # HZLTNS97
Secondary ID
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


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
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