Clinical trial NCT03681847: Crystalloids Versus Colloids Versus Hypertonic Saline as a Co-load During Spinal Anesthesia.
Official title: Crystalloids Versus Colloids Versus Hypertonic Saline Co-load During Spinal Anesthesia: Which is More Effective
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Spinal Anaesthesia
Keywords: hypertonic saline
colloids
normal saline
Lead sponsor: National Cancer Institute, Egypt
Sponsor class: OTHER
First posted: 2018-09-24
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: Hypotension
timeFrame: 3 hours
Secondary outcomes:
measure: serum sodium level
timeFrame: 3 hours
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Department of Anesthesia and Pain medicine.National Cancer Institute
Study officials:
affiliation: National Cancer Institute- Cairo University
name: Ehab H Shaker, MD
role: PRINCIPAL_INVESTIGATOR
References: