Vasopressors for Cerebral Oxygenation
Information source: Samsung Medical Center
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Hypoxia; Hypotension
Intervention: dopamine (Drug); phenylephrine (Drug)
Phase: Phase 1
Status: Recruiting
Sponsored by: Samsung Medical Center Official(s) and/or principal investigator(s): Hyun Joo Ahn, Principal Investigator, Affiliation: Samsung Medical Center
Overall contact: Hyun Joo Ahn, Phone: 82-2-3410-0784, Email: hyunjooahn@skku.edu
Summary
Liberal fluid administration is one of risk factors of developing acute lung injury (ALI) in
thoracic surgery. Therefore, the investigators try to restrain fluid administration, and in
the case of intraoperative hypotension, the investigators often administer vasoactive agents
or inotropes. One lung ventilation (OLV) which is routinely employed for thoracic surgery
decrease arterial oxygenation and oxygen delivery to brain can be also decreased. In this
study, the investigators compared dopamine and phenylephrine in respect to maintaining
cerebral oxygen saturation in major thoracic surgery. The investigators hypothesis is that
dopamine is better than phenylephrine to maintain cerebral oxygen saturation in thoracic
surgery.
Clinical Details
Official title: Effect of Phenylephrine or Dopamine Infusion on Cerebral Oxygen Saturation in Thoracic Surgery Patients
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Primary outcome: Cerebral oximeter reading
Secondary outcome: cardiac outputincidence of delirium incidence of acute renal injury
Detailed description:
A 'restrictive' intraoperative fluid regimen, avoiding hypovolaemia but limiting infusion to
the minimum necessary reduced major complications after complex surgery. This restrictive
fluid regimen is especially relevant in thoracic surgery since acute lung injury is known to
be related to large amount of fluid administration during operation to treat hypotension.
One study suggests that, for every 500-mL increase in perioperative fluids, there is an odds
ratio of 1. 17 for developing ALI after lung resection. Slinger suggested that fluid should
be restricted just to the point of maintaining urine output of 0. 5 mL/kg/h, and vasopressors
may be used if tissue perfusion is inadequate. Therefore, restriction of fluid
administration and treatment of hypotension which is not caused by major hemorrhage with
vasoactive agents could be a basic concept in thoracic anesthesia.
Patients who undergoing lung resection surgery usually receive one lung ventilation (OLV).
Decrease of systemic oxygenation occurs during OLV due to intrapulmonary shunt. During OLV,
significant decrease in cerebral oxygenation (SctO2) is also known to occur and low SctO2 is
related to postoperative complications.
Because the endpoint of hemodynamic optimization is to improve oxygen delivery to major
organs, understanding how the administration of vasoactive agents affects cerebral perfusion
and oxygenation, the most important organ in the body is of major clinical relevance.
Recently published studies show that near-infrared spectroscopy (NIRS)-guided brain
protection protocols might lead to reduced neurocognitive complications and improved
postoperative outcomes.
However, there have been no data on which agent between dopamine and phenylephrine, the most
commonly used aged during operation against hypotension, is better in maintaining cerebral
oxygen saturation during thoracic surgery. Therefore, the investigators try to compare
dopamine and phenylephrine continuous infusion in respect to maintaining SctO2 in major
thoracic surgery.
In addition, acute kidney injury (AKI) develops in around 6% of patients after lung
resection surgery and AKI is related to poor prognosis and prolonged duration of hospital
admission. Therefore, the investigators also tried to find which agent is better to maintain
urinary output during operation and reduce postoperative AKI. The investigators also found
there is difference in postoperative delirium incidence between dopamine and phenylephrine
continuous infusion.
The primary aims of the study were (i) to investigate the effect of phenylephrine and
dopamine continuous infusion on cerebral SctO2 (ii) to identify the hemodynamic variables
[mean blood pressure, cardiac output, heart rate (HR), stroke volume (SV)] which are
responsible for the changes in cerebral SctO2 induced by phenylephrine and dopamine
treatments.
Eligibility
Minimum age: 65 Years.
Maximum age: 90 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Elective surgery
- American society of anesthesia physical status I-III
Exclusion Criteria:
- Symptomatic cardiovascular disease
- Poorly controlled hypertension (systolic arterial pressure ≥160 mm Hg)
- Cerebrovascular disease
- Poorly controlled diabetes mellitus (blood glucose ≥200 mg/dl)
- Diuretics or antidepressant use before operation
- Renal insufficiency (creatinine>1. 5 mg/dl)
- Cerebral infarction
- Documented coagulopathy
Locations and Contacts
Hyun Joo Ahn, Phone: 82-2-3410-0784, Email: hyunjooahn@skku.edu
Samsung medical center, Seoul 135-710, Korea, Republic of; Recruiting Hyun Joo Ahn, Phone: 82-2-3410-0784, Email: hyunjooahn@skku.edu
Additional Information
Starting date: December 2012
Last updated: December 6, 2013
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