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

Not Applicable

Completed

• Conditions: Spinal Anaesthesia
• Interventions: Procedure: Normal saline; Procedure: hydroxyethyl starch; Procedure: Hypertonic saline

• Registration Number: NCT03681847
• Lead Sponsor: National Cancer Institute, Egypt

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 Timeline

• Study Start: 2018-02-28
• Primary Completion: 2018-08-30
• Study Completion: 2018-08-30
• Status Verified: 2018-09
• Study First Submitted: 2018-09-19
• Study First Submitted QC: 2018-09-20
• Last Update Submitted: 2018-09-20
• Study First Posted: 2018-09-24
• Last Update Posted: 2018-09-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
normal saline	Normal saline	Patients will receive normal saline 0.9% 15 ml/kg over 15-20 minutes.
Hydroxyethyl starch	hydroxyethyl starch	Patients will receive hydroxyethyl starch 130/0.4 in 0.9 % sodium chloride 5 ml/kg over 15-20 minutes.
Hypertonic saline	Hypertonic saline	Patients will receive hypertonic saline 3% (7ml/kg) over 15-20 minutes.

Primary Outcome Measures

Name	Time	Method
Hypotension	3 hours	The development of hypotension

Secondary Outcome Measures

Name	Time	Method
serum sodium level	3 hours	measurement of serum sodium level

Trial Locations

Locations (1)

Department of Anesthesia and Pain medicine.National Cancer Institute; 🇪🇬 Cairo, Egypt