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Dopamine and Norepinephrine Infusion With Restricted Hydration

Not Applicable
Completed
Conditions
Renal Function Test, Urine Output, Lactate Level
Interventions
Registration Number
NCT03780686
Lead Sponsor
Ain Shams University
Brief Summary

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

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.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
120
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.
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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.
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Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
NorepinephrineNorepinephrine, dopamineInfusion norepinephrine (3mcg/kg/h) with restricted fluid.
Dopamine and norepinephrine infusionNorepinephrine, dopamineInfusion doppamine (2-5mcg/kg/min) and norepinephrine (3mcg/kg/h) with restricted fluid
Primary Outcome Measures
NameTimeMethod
Changes in renal function testBefore induction of anesthesia and up to 12 hours after.

Measuring creatinine level

Changes in serum lactate levelBefore induction of anesthesia and up to 12 hours after.

Serum lactate level in mmol/l

Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (1)

Ain Shams University

🇪🇬

Cairo, Egypt

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