Dopamine and Norepinephrine Infusion With Restricted Hydration

Study Overview
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Brief Summary
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This study was designed to assess the effect of adding dopamine infusion in addition to restrictive hydration combined with noradrenaline infusion on intraoperative serum lactate levels as an indicator for tissue hypo perfusion and renal function in comparison to restrictive hydration combined with noradrenaline infusion only and standard hydration during open abdominal surgeries.

Detailed Description
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One hundred and twenty patients were randomly assigned into three groups (dopamine norepinephrine group, restrictive hydration group and liberal hydration group) undergoing open abdominal procedures (radical cystectomy and hemi colectomy). In Restrictive group (n=40): Ringer's solution was infused at a rate of 1 ml.kg.h-1 until the basic part of the surgery (tumor resection) is completed to be followed by 3 ml.kg.h-1 of Ringer's solution until the end of surgery. Noradrenaline infusion (0.07mcg.kg.min-1) was combined with fluids until the end of surgery. In Liberal group (n=40): the conventional fluid replacement was introduced according to maintenance, deficit for the first 3 hours (hours fasting x body weight) and 3rd space loss (estimated between 8-10 ml.kg.h-1). The outcome to be assessed was serial measurements of serum lactate intraoperatively and immediate postoperatively as an index of tissue perfusion, in addition to blood pressure, heart rate and oxygen saturation.

Official Title
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The Effect of Adding Dopamine Infusion to Noradrenaline Infusion Combined With Restrictive Hydration on Renal Function and Tissue Perfusion During Open Abdominal Surgeries

Conditions
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Renal Function Test, Urine Output, Lactate Level

Intervention / Treatment
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* Drug: Norepinephrine, dopamine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: All patients with American Society of Anesthesiologists (ASA) physical status I or II Age range from 18-80 years scheduled to either radical cystectomy or hemicolectomy were contained in the study. Exclusion Criteria: Patients with coagulopathies, Hepatic dysfunction (prothrombin ratio <50%), Renal dysfunction, Congestive heart failure (New York Heart Association scores ≥3), Contraindications for epidural analgesia (e.g. patient refusal, local infection or coagulopathy), and peripheral vascular disease.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Dopamine and norepinephrine infusion<br>Infusion doppamine (2-5mcg/kg/min) and norepinephrine (3mcg/kg/h) with restricted fluid | Drug: Norepinephrine, dopamine<br>* drugs to decrease bleeding<br>|
| Active Comparator: Norepinephrine<br>Infusion norepinephrine (3mcg/kg/h) with restricted fluid. | Drug: Norepinephrine, dopamine<br>* drugs to decrease bleeding<br>|
| No Intervention: Standard fluid management<br>Standard fluid managements. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in serum lactate level | Serum lactate level in mmol/l | Before induction of anesthesia and up to 12 hours after. | 
| Changes in renal function test | Measuring creatinine level | Before induction of anesthesia and up to 12 hours after. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Restrictive hydration,, Dopamine,, Norepinephrine,, Serum lactate,, Standard hydration