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Vasopressors for Cerebral Oxygenation

Primary Purpose

Hypoxia, Hypotension

Status
Unknown status
Phase
Phase 1
Locations
Korea, Republic of
Study Type
Interventional
Intervention
dopamine
phenylephrine
Sponsored by
Samsung Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hypoxia focused on measuring cerebral oximeter, one lung ventilation, dopamine, phenylephrine

Eligibility Criteria

65 Years - 90 Years (Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Samsung medical centerRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

dopamine

phenylephrine

Arm Description

dopamine is administered to maintain systolic blood pressure in the range of 80-120% of baseline during operation

Phenylephrine is administered to maintain systolic blood pressure in the range of 80-120% of baseline during operation

Outcomes

Primary Outcome Measures

Cerebral oximeter reading

Secondary Outcome Measures

cardiac output
incidence of delirium
incidence of acute renal injury

Full Information

First Posted
November 13, 2013
Last Updated
December 6, 2013
Sponsor
Samsung Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT02009007
Brief Title
Vasopressors for Cerebral Oxygenation
Official Title
Effect of Phenylephrine or Dopamine Infusion on Cerebral Oxygen Saturation in Thoracic Surgery Patients
Study Type
Interventional

2. Study Status

Record Verification Date
December 2013
Overall Recruitment Status
Unknown status
Study Start Date
December 2012 (undefined)
Primary Completion Date
June 2014 (Anticipated)
Study Completion Date
December 2014 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Samsung Medical Center

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypoxia, Hypotension
Keywords
cerebral oximeter, one lung ventilation, dopamine, phenylephrine

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
dopamine
Arm Type
Experimental
Arm Description
dopamine is administered to maintain systolic blood pressure in the range of 80-120% of baseline during operation
Arm Title
phenylephrine
Arm Type
Experimental
Arm Description
Phenylephrine is administered to maintain systolic blood pressure in the range of 80-120% of baseline during operation
Intervention Type
Drug
Intervention Name(s)
dopamine
Intervention Description
continuous infusion during operation
Intervention Type
Drug
Intervention Name(s)
phenylephrine
Intervention Description
continuous infusion of phenylephrine during operation
Primary Outcome Measure Information:
Title
Cerebral oximeter reading
Time Frame
at 60 minutes after one lung ventilation
Secondary Outcome Measure Information:
Title
cardiac output
Time Frame
at 60 minutes after one lung ventilation
Title
incidence of delirium
Time Frame
participants will be followed for the first 48 hours of ICU stay
Title
incidence of acute renal injury
Time Frame
participants will be followed for the first 48 hours of ICU stay

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hyun Joo Ahn
Phone
82-2-3410-0784
Email
hyunjooahn@skku.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hyun Joo Ahn
Organizational Affiliation
Samsung Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Samsung medical center
City
Seoul
ZIP/Postal Code
135-710
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hyun Joo Ahn
Phone
82-2-3410-0784
Email
hyunjooahn@skku.edu

12. IPD Sharing Statement

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Vasopressors for Cerebral Oxygenation

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