Dopamine and Norepinephrine Infusion With Restricted Hydration

Ain Shams University

Status: Completed

Conditions: Renal Function Test, Urine Output, Lactate Level

Treatments: Drug: Norepinephrine, dopamine

Study type: Interventional

Funder types: Other

Identifiers

NCT03780686

ASUH3206/17

Details and patient eligibility

About

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 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.

Enrollment: 120 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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120 participants in 3 patient groups

Dopamine and norepinephrine infusion

Active Comparator group

Description:

Infusion doppamine (2-5mcg/kg/min) and norepinephrine (3mcg/kg/h) with restricted fluid

Treatment:

Drug: Norepinephrine, dopamine

Norepinephrine

Active Comparator group

Description:

Infusion norepinephrine (3mcg/kg/h) with restricted fluid.

Treatment:

Drug: Norepinephrine, dopamine

Standard fluid management

No Intervention group

Description:

Standard fluid managements.