Crystalloids Versus Colloids Versus Hypertonic Saline Co-load During Spinal Anesthesia: Which is More Effective
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 120
- Locations
- 2
- Primary Endpoint
- Hypotension
Study Overview
Brief 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.
Detailed 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
normal saline
Patients will receive normal saline 0.9% 15 ml/kg over 15-20 minutes.
Intervention: Normal saline (Procedure)
Hypertonic saline
Patients will receive hypertonic saline 3% (7ml/kg) over 15-20 minutes.
Intervention: Hypertonic saline (Procedure)
Hydroxyethyl starch
Patients will receive hydroxyethyl starch 130/0.4 in 0.9 % sodium chloride 5 ml/kg over 15-20 minutes.
Intervention: hydroxyethyl starch (Procedure)
Outcomes
Primary Outcomes
Hypotension
Time Frame: 3 hours
The development of hypotension
Secondary Outcomes
- serum sodium level(3 hours)
Investigators
Ehab Hanafy Shaker
lecturer of anesthesia ,critical care and pain medicine
National Cancer Institute, Egypt
