deltatrials
Completed OBSERVATIONAL NCT00494598

The Pharmacokinetics of Opioids and Sedative/Hypnotics During Selective Cerebral Perfusion

Sponsor: Columbia University

Interventions Sufentanil
Updated 10 times since 2017 Last updated: Jul 31, 2013 Started: Mar 31, 2007 Completion: Jun 30, 2007
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

This observational or N/A phase trial investigates Aortic Aneurysm and is currently completed. Columbia University leads this study, which shows 10 recorded versions since 2007 — indicating substantial longitudinal coverage. The change history captured here reflects the iterative nature of clinical trial conduct.

Study Description(click to expand)

The purpose of this study is to understand the disposition of sufentanil, midazolam and morphine when the drugs are introduced into the arterial circulation of the brain. Patients undergoing surgery on the ascending aorta or aortic arch often require cessation of blood flow to the organs of the body, while maintaining some degree of blood flow to the brain. In order to achieve organ protection during the circulatory arrest phase of surgery, the body is cooled to a core temperature of 28°C. Various techniques including deep hypothermic circulatory arrest, retrograde cerebral perfusion through the superior vena cava, and partial or bilateral antegrade selective cerebral perfusion have been proposed as means to protect the brain from ischemic injury during surgery on the aortic arch. At our institution selective cerebral perfusion has found success for major aortic surgery. This technique was devised and first employed by DeBakey and associates, to protect the brain during aortic arch surgery with bilateral carotid perfusion \[1\]. Selective cerebral perfusion requires the surgical construction and placement of a Dacron graft onto the right axillary artery that when connected to a cardiopulmonary bypass machine it will provide 10 ml/kg/min antegrade flow for brain perfusion \[2\]. Cerebral cooling will...

The purpose of this study is to understand the disposition of sufentanil, midazolam and morphine when the drugs are introduced into the arterial circulation of the brain. Patients undergoing surgery on the ascending aorta or aortic arch often require cessation of blood flow to the organs of the body, while maintaining some degree of blood flow to the brain. In order to achieve organ protection during the circulatory arrest phase of surgery, the body is cooled to a core temperature of 28°C. Various techniques including deep hypothermic circulatory arrest, retrograde cerebral perfusion through the superior vena cava, and partial or bilateral antegrade selective cerebral perfusion have been proposed as means to protect the brain from ischemic injury during surgery on the aortic arch. At our institution selective cerebral perfusion has found success for major aortic surgery. This technique was devised and first employed by DeBakey and associates, to protect the brain during aortic arch surgery with bilateral carotid perfusion \[1\]. Selective cerebral perfusion requires the surgical construction and placement of a Dacron graft onto the right axillary artery that when connected to a cardiopulmonary bypass machine it will provide 10 ml/kg/min antegrade flow for brain perfusion \[2\]. Cerebral cooling will also decrease the oxygen demand of the brain. In such a way brain ischemia may be minimized. The nature of major aortic arch surgery requires independent cerebral circulation or selective cerebral perfusion for a finite period of time. The cardiopulmonary bypass machine is allowed to perfuse the brain indirectly by serial flow through the right axillary artery to the innominate artery and finally to the right carotid artery. Any anesthetic drug that is introduced into the cardiopulmonary bypass circuit will be delivered the same way. We will take advantage of this independent circuit to safely deliver anesthetic drugs to the brain via the right carotid artery during surgery.

A prior study that enrolled 6 patients has shown that the anesthetic administration is safe and feasible. Patients had no problems related to anesthesia or surgery. All patients left the hospital in stable condition.

Status Flow

~Jan 2017 – ~Aug 2017 · 7 months · monthly snapshotCompleted~Aug 2017 – ~Apr 2018 · 8 months · monthly snapshotCompleted~Apr 2018 – ~May 2018 · 30 days · monthly snapshotCompleted~May 2018 – ~Jun 2018 · 31 days · monthly snapshotCompleted~Jun 2018 – ~Nov 2020 · 29 months · monthly snapshotCompleted~Nov 2020 – ~Jan 2021 · 2 months · monthly snapshotCompleted~Jan 2021 – ~Dec 2021 · 11 months · monthly snapshotCompleted~Dec 2021 – ~Jul 2024 · 31 months · monthly snapshotCompleted~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshotCompleted~Sep 2024 – present · 19 months · monthly snapshotCompleted

Change History

10 versions recorded
  1. Sep 2024 — Present [monthly]

    Completed

  2. Jul 2024 — Sep 2024 [monthly]

    Completed

  3. Dec 2021 — Jul 2024 [monthly]

    Completed

  4. Jan 2021 — Dec 2021 [monthly]

    Completed

  5. Nov 2020 — Jan 2021 [monthly]

    Completed

Show 5 earlier versions
  1. Jun 2018 — Nov 2020 [monthly]

    Completed

  2. May 2018 — Jun 2018 [monthly]

    Completed

  3. Apr 2018 — May 2018 [monthly]

    Completed

    Phase: PHASE4None

  4. Aug 2017 — Apr 2018 [monthly]

    Completed PHASE4

  5. Jan 2017 — Aug 2017 [monthly]

    Completed PHASE4

    First recorded

Mar 2007

Trial started

Per CT.gov start date — pre-dates our first snapshot

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:
  • Columbia University
Data source: Columbia University

For direct contact, visit the study record on ClinicalTrials.gov .

Study Locations