drugset / Trial / NCT03741257

Comparison Between Two Concentration of Hypertonic Saline in Intestinal Obstruction Surgery

NCT03741257

Unknown 50 enrolled Cairo University
RandomizedParallel-groupQuadruple-blindSupportive care

Summary

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).

Timeline

Start
2018-11-01
Primary completion
2019-11
Completion
2020-02

Drugs

EvaluationDrugModalityDoseRoute
Comparator Hypertonic saline Unknown 1.8 %
Comparator Hypertonic saline Unknown 3 %

Indications

No indication recorded.