Comparison Between Two Concentration of Hypertonic Saline in Intestinal Obstruction Surgery
NCT ID: NCT03741257
Last Updated: 2018-11-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
50 participants
INTERVENTIONAL
2018-11-01
2020-02-29
Brief Summary
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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).
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
QUADRUPLE
Study Groups
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Group A
Received Hypertonic saline 3% as resuscitation fluid.
Hypertonic saline
resuscitation fluid
Group B
Received Hypertonic saline 1.8% as resuscitation
Hypertonic saline
resuscitation fluid
Interventions
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Hypertonic saline
resuscitation fluid
Eligibility Criteria
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Inclusion Criteria
* ASA≤III
* BMI 25-40kg/m.
Exclusion Criteria
* 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.
20 Years
70 Years
ALL
No
Sponsors
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Cairo University
OTHER
Responsible Party
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Ahmed Mohamed Lotfy
lecturer of anesthesia and intensive care
Locations
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Cairo University Hospitals
Cairo, , Egypt
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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N-55-2018
Identifier Type: -
Identifier Source: org_study_id
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