Hypertonic Saline 3% Compared to Hypertonic Saline 1.8% for Fluid Management of Intestinal Obstruction Surgery
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Cairo University
- Enrollment
- 50
- Locations
- 1
- Primary Endpoint
- Total volume of infused fluids
Study Overview
Brief 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).
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 20 Years to 70 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Age: 20-70 years old
- •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.
Arms & Interventions
Group A
Received Hypertonic saline 3% as resuscitation fluid.
Intervention: Hypertonic saline (Drug)
Group B
Received Hypertonic saline 1.8% as resuscitation
Intervention: Hypertonic saline (Drug)
Outcomes
Primary Outcomes
Total volume of infused fluids
Time Frame: 24 hours
the total volume of fluids given to subjects intraoperatively and postoperatively
Secondary Outcomes
- surgical complications rate(4 days)
Investigators
Ahmed Mohamed Lotfy
lecturer of anesthesia and intensive care
Cairo University