Vasopressors for Cerebral Oxygenation
Effect of Phenylephrine or Dopamine Infusion on Cerebral Oxygen Saturation in Thoracic Surgery Patients
1 other identifier
interventional
50
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1
Started Dec 2012
Typical duration for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2012
CompletedFirst Submitted
Initial submission to the registry
November 13, 2013
CompletedFirst Posted
Study publicly available on registry
December 11, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2014
CompletedDecember 11, 2013
December 1, 2013
1.5 years
November 13, 2013
December 6, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Cerebral oximeter reading
at 60 minutes after one lung ventilation
Secondary Outcomes (3)
cardiac output
at 60 minutes after one lung ventilation
incidence of delirium
participants will be followed for the first 48 hours of ICU stay
incidence of acute renal injury
participants will be followed for the first 48 hours of ICU stay
Study Arms (2)
dopamine
EXPERIMENTALdopamine is administered to maintain systolic blood pressure in the range of 80-120% of baseline during operation
phenylephrine
EXPERIMENTALPhenylephrine is administered to maintain systolic blood pressure in the range of 80-120% of baseline during operation
Interventions
Eligibility Criteria
You may qualify if:
- Elective surgery
- American society of anesthesia physical status I-III
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Samsung medical center
Seoul, 135-710, South Korea
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Hyun Joo Ahn
Samsung Medical Center
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate professor
Study Record Dates
First Submitted
November 13, 2013
First Posted
December 11, 2013
Study Start
December 1, 2012
Primary Completion
June 1, 2014
Study Completion
December 1, 2014
Last Updated
December 11, 2013
Record last verified: 2013-12