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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03681847
Other study ID # Ehab-Walaa.Hypertonic
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date February 28, 2018
Est. completion date August 30, 2018

Study information

Verified date September 2018
Source National Cancer Institute, Egypt
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 120
Est. completion date August 30, 2018
Est. primary completion date August 30, 2018
Accepts healthy volunteers No
Gender All
Age group 18 Years to 65 Years
Eligibility 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


Related Conditions & MeSH terms


Intervention

Procedure:
Normal saline
normal saline 0.9% 15 ml/kg over 15-20 minutes.
hydroxyethyl starch
hydroxyethyl starch 130/0.4 in 0.9 % sodium chloride 5 ml/kg over 15-20 minutes.
Hypertonic saline
hypertonic saline 3% (7ml/kg) over 15-20 minutes.

Locations

Country Name City State
Egypt Department of Anesthesia and Pain medicine.National Cancer Institute Cairo

Sponsors (1)

Lead Sponsor Collaborator
National Cancer Institute, Egypt

Country where clinical trial is conducted

Egypt, 

Outcome

Type Measure Description Time frame Safety issue
Primary Hypotension The development of hypotension 3 hours
Secondary serum sodium level measurement of serum sodium level 3 hours
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