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Status unknownNCT02009007Updated Dec 11, 2013

Vasopressors for Cerebral Oxygenation

A Phase 1 interventional study of dopamine and phenylephrine in Hypoxia and Hypotension, sponsored by Samsung Medical Center. Status unknown at 1 site in Korea, Republic of. Open to participants aged 65 Years to 90 Years. Per ClinicalTrials.gov, last updated 2013-12-11.

Sponsored by Samsung Medical Center · Phase 1, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Dec 2013), so the status shown — last known as Recruiting — may be out of date.
Phase
Phase 1
Study type
Interventional
Enrollment
50
Allocation
Randomized
Ages
65 Years to 90 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Hypoxia
  • Hypotension

Keywords

  • cerebral oximeter
  • one lung ventilation
  • dopamine
  • phenylephrine
03

In context

Hypotension

1,003 studies on the registry are indexed under Hypotension; 173 are open to participants now.

This study's planned enrollment of 50 is below the median of 80 across 675 interventional studies indexed under Hypotension.

Browse Hypotension studies →

Lead sponsor

Samsung Medical Center is the lead sponsor of 980 studies on the registry; 146 are open to participants now.

Of its 7 completed or terminated interventional studies of FDA-regulated products, 1 (14%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
65 Years to 90 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Elective surgery
  • American society of anesthesia physical status I-III

Exclusion criteria

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
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
50 participants (estimated)

Study arms

  • Experimental
    dopamine

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

    Drug: dopamine

  • Experimental
    phenylephrine

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

    Drug: phenylephrine

Interventions

  • Drugdopamine

    continuous infusion during operation

  • Drugphenylephrine

    continuous infusion of phenylephrine during operation

06

What researchers measure

Primary outcomes

  1. Cerebral oximeter reading

    Time frame: at 60 minutes after one lung ventilation

Secondary outcomes

  1. cardiac output

    Time frame: at 60 minutes after one lung ventilation

  2. incidence of delirium

    Time frame: participants will be followed for the first 48 hours of ICU stay

  3. incidence of acute renal injury

    Time frame: participants will be followed for the first 48 hours of ICU stay

07

Study locations

1 of 1 sites recruiting
  • Samsung medical center
    Seoul, 135-710, Korea, Republic of
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 11, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02009007
Lead sponsor
Samsung Medical Center
Responsible party
Hyun Joo Ahn (Associate professor, Samsung Medical Center) — Principal investigator
First posted
Dec 11, 2013
Start date
Dec 2012
Primary completion
Jun 2014 (estimated)
Completion
Dec 2014 (estimated)
Last update
Dec 11, 2013

Study contacts

Hyun Joo Ahn
Contact
hyunjooahn@skku.edu
82-2-3410-0784
Hyun Joo Ahn
principal investigator · Samsung Medical Center

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Dec 2013. You cannot join it, but the record below documents what was studied.

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