Dopamine and Norepinephrine Infusion With Restricted Hydration

Overview

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.

Full Title of Study: “The Effect of Adding Dopamine Infusion to Noradrenaline Infusion Combined With Restrictive Hydration on Renal Function and Tissue Perfusion During Open Abdominal Surgeries”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Diagnostic
    • Masking: Double (Participant, Care Provider)
  • Study Primary Completion Date: November 20, 2018

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.

Interventions

  • Drug: Norepinephrine, dopamine
    • drugs to decrease bleeding

Arms, Groups and Cohorts

  • Active Comparator: Dopamine and norepinephrine infusion
    • Infusion doppamine (2-5mcg/kg/min) and norepinephrine (3mcg/kg/h) with restricted fluid
  • Active Comparator: Norepinephrine
    • Infusion norepinephrine (3mcg/kg/h) with restricted fluid.
  • No Intervention: Standard fluid management
    • Standard fluid managements.

Clinical Trial Outcome Measures

Primary Measures

  • Changes in serum lactate level
    • Time Frame: Before induction of anesthesia and up to 12 hours after.
    • Serum lactate level in mmol/l
  • Changes in renal function test
    • Time Frame: Before induction of anesthesia and up to 12 hours after.
    • Measuring creatinine level

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 75 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Ain Shams University
  • Provider of Information About this Clinical Study
    • Principal Investigator: Ayman Anis Metry, Assistant professor – Ain Shams University

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