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Clinical Trials/NCT03681847
NCT03681847CompletedNot Applicable

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

National Cancer Institute, Egypt2 sites in 1 country120 target enrollmentStarted: February 28, 2018Last updated:
Conditions
Interventions

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

Active Comparator

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

Intervention: Normal saline (Procedure)

Hypertonic saline

Active Comparator

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

Intervention: Hypertonic saline (Procedure)

Hydroxyethyl starch

Active Comparator

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

Sponsor
National Cancer Institute, Egypt
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Ehab Hanafy Shaker

lecturer of anesthesia ,critical care and pain medicine

National Cancer Institute, Egypt

Study Sites (2)

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