Crystalloids Versus Colloids Versus Hypertonic Saline as a Co-load During Spinal Anesthesia.

Spinal Anaesthesia Clinical Trial

Official title:

Crystalloids Versus Colloids Versus Hypertonic Saline Co-load During Spinal Anesthesia: Which is More Effective

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03681847
• Other study ID #: Ehab-Walaa.Hypertonic
• Status: Completed
• Phase: N/A
• Start date: February 28, 2018
• Est. completion date: August 30, 2018

Study information

• Verified date: September 2018
• Source: National Cancer Institute, Egypt
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Spinal anesthesia is commonly accompanied by hypotension due to vasodilation that follows sympathetic blockade and decreased systemic vascular resistance. Prevention of hypotension is usually achieved through administration of fluids and vasopressors .There is an ongoing debate concerning both the proper fluid timing, pre-load against co-load and fluid type crystalloids against colloids .This study aims at comparing the effectiveness of co-loading of crystalloids versus colloids versus hypertonic saline 3% in preventing hypotension induced by spinal anesthesia.

Description:

Spinal anesthesia is commonly accompanied by hypotension due to vasodilation that follows sympathetic blockade and decreased systemic vascular resistance. Prevention of hypotension is usually achieved through administration of fluids and vasopressors . Fluids are either administrated before initiation of spinal anesthesia which is defined as fluid pre-loading or at time of initiation of spinal anesthesia which is defined as fluid co-loading .There is an ongoing debate concerning both the proper fluid timing, pre-load against co-load and fluid type crystalloids against colloids. Fluid preloading with colloids appears to have superior effect on that of crystalloids as the later shows a shorter intravascular half-life. While both colloid and crystalloid co-loading show comparable results .Although crystalloid preloading has been the traditional regimen for long time, it failed to reduce the incidence of hypotension. This is because crystalloids rapidly distribute out of the intravascular compartment to the interstitial space. Superiority of fluid co-loading might be explained by decrease of the extravascular crystalloid redistribution secondary to the simultaneous vasodilatation response to sympathetic block.This study aims at comparing the effectiveness of co-loading of crystalloids versus colloids versus hypertonic saline 3% in preventing hypotension induced by spinal anesthesia.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: August 30, 2018
• Est. primary completion date: August 30, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Age 18-65 years

• ASA II-III

• Elective lower abdominal surgeries

Exclusion Criteria:

• Coagulation defects

• Abnormal kidney or liver functions

• Local infection at site of injection

• Uncontrolled hypertension

• Bone metastases

• Cardiac disease

• Elevated serum sodium level > 145 mEq/L

Related Conditions & MeSH terms

• Spinal Anaesthesia

Intervention

Procedure:
• Normal saline
normal saline 0.9% 15 ml/kg over 15-20 minutes.
• hydroxyethyl starch
hydroxyethyl starch 130/0.4 in 0.9 % sodium chloride 5 ml/kg over 15-20 minutes.
• Hypertonic saline
hypertonic saline 3% (7ml/kg) over 15-20 minutes.

Locations

Country	Name	City	State
Egypt	Department of Anesthesia and Pain medicine.National Cancer Institute	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
National Cancer Institute, Egypt

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hypotension	The development of hypotension	3 hours
Secondary	serum sodium level	measurement of serum sodium level	3 hours

External Links

•   Colloid versus Crystallid Co-load with Spinal Anesthesia during Emergent Cesarean Section and Their Effect on Hemodynamic Changes.Lotfy ME; Moustafa AM; Elham M.E, et al. J Am Sci 2014;10(11):158-163]