Comparison Between Two Concentration of Hypertonic Saline in Intestinal Obstruction Surgery

Study Overview
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Brief Summary
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Background and Rationale : Perioperative fluid management is a challenging issue in surgical care especially in a procedure specific model. Recently hypertonic saline (HS) has the advantage of using the patient's own total body water by drawing interstitial space. Although it still controversial whether HS is associated with benefits in specific patient populations, particularly with respect to site of lesion and illness severity; these data provide insight into therapeutic modalities to curtail ileus formation. Objectives : Measurement of total volume of fluid infused, the need of inotropic or vasopressor to maintain adequate hemodynamic parameters with assessment of electrolyte disturbances and S.lactate The incidence rate of surgical complications; infection and anastomotic dehiscence Study population & Sample size : There were no previous trials comparing the two studied groups of the current trial. We expected a small standardized effect size of 0.2. Based on this effect size, 25 subjects will be needed to elicit the difference between the two groups at an alpha level of 0.05 and power of 0.9 (Whitehead et al; 2016).

Official Title
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Hypertonic Saline 3% Compared to Hypertonic Saline 1.8% for Fluid Management of Intestinal Obstruction Surgery

Conditions
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Intestinal Obstruction Fluid Management With Hypertonic Saline

Intervention / Treatment
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* Drug: Hypertonic saline


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age: 20-70 years old ASA≤III BMI 25-40kg/m. Exclusion Criteria: Severe CVS diseases (EF<50%) Severe pulmonary diseases (Pulmonary function test ≤ 50% of predicted) Neurological disorders; Psychological diseases, demyelinating lesions, Parkinsonism, motor or sensory disorders. Pregnancy. Severe chronic renal disease (s. Creatinine> 2gm/dl or patients on dialysis). Severe hepatic impairment (Child & Pugh classification class C). Acid-base and electrolytes disturbances.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Group A<br>Received Hypertonic saline 3% as resuscitation fluid. | Drug: Hypertonic saline<br>* resuscitation fluid<br>|
| Active Comparator: Group B<br>Received Hypertonic saline 1.8% as resuscitation | Drug: Hypertonic saline<br>* resuscitation fluid<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total volume of infused fluids | the total volume of fluids given to subjects intraoperatively and postoperatively | 24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| surgical complications rate | the rate of surgical complications i.e leakage and wound dehisence | 4 days |