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

National Cancer Institute, Egypt

Status: Completed

Conditions: Spinal Anaesthesia

Treatments: Procedure: Hypertonic saline; Procedure: hydroxyethyl starch; Procedure: Normal saline

Study type: Interventional

Funder types: Other

Identifiers

NCT03681847

Ehab-Walaa.Hypertonic

Details and patient eligibility

About

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.

Full 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.

Enrollment: 120 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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120 participants in 3 patient groups

normal saline

Active Comparator group

Description:

Patients will receive normal saline 0.9% 15 ml/kg over 15-20 minutes.

Treatment:

Procedure: Normal saline

Hydroxyethyl starch

Active Comparator group

Description:

Patients will receive hydroxyethyl starch 130/0.4 in 0.9 % sodium chloride 5 ml/kg over 15-20 minutes.

Treatment:

Procedure: hydroxyethyl starch

Hypertonic saline

Active Comparator group

Description:

Patients will receive hypertonic saline 3% (7ml/kg) over 15-20 minutes.

Treatment:

Procedure: Hypertonic saline