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SedationPhase 4NCT00409344

Dexmedetomidine for Postoperative Sedation in Patients Undergoing Repair of Thoracoabdominal Aortic Aneurysms

A Phase 4 study testing Dexmedetomidine and Normal Saline in people with Sedation and Respiration, Artificial, run by Massachusetts General Hospital at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

The primary objective of this study is to test the hypothesis that time on the ventilator and ICU length of stay will be shorter in TAA patients given postoperative sedation with dexmedetomidine compared to those given standard sedation. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Sedation, Respiration, Artificial, Length of Stay
What is being tested?
Dexmedetomidine and Normal Saline
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
0 participants
Where
1 siteUnited States
Study dates
Jan 2007to Jan 2008
Phase
Phase 4
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • All Patients over age 18 undergoing non-emergent repair of type I-III TAA

Who cannot join

  • Pregnancy
  • Patients with hepatic impairment (increase of ALT or AST three times normal)
  • Patient taking clonidine or tricyclic antidepressants.
  • Patients taking opioids or benzodiazepines chronically (> 2 doses a day for > 1 month)
  • Patients with second or third degree heart block without a pacer
  • Patients undergoing emergency repair of TAA
  • Intraoperative cardiac arrest
  • Intraoperative massive blood loss (>10 l)

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Massachusetts General Hospital

    Boston, Massachusetts, 02114

Other trials in United States

About this study

Official title: Phase 4 Study of Dexmedetomidine for Postoperative Sedation in Patients Undergoing Repair of Thoracoabdominal Aortic Aneurysms

The primary objective of this study is to test the hypothesis that time on the ventilator and ICU length of stay will be shorter in TAA patients given postoperative sedation with dexmedetomidine compared to those given standard sedation. Secondary endpoints are: requirement for sedatives vasoactive drugs incidence of postoperative delirium and cost analysis.

Read the detailed description

Repair of thoraco-abdominal aortic aneurysms (TAA) is mostly performed in specialized centers. These centers report an operative mortality around 10%. In an analysis of 337 consecutive TAA, Cambria et al reported pulmonary (44%), cardiac, (13.8 %) renal (13.5%) and postoperative spinal cord deficit as prominent complications. Due to the extent of the surgery and the high risk of complications, all these patients require post- operative care in the Intensive Care Unit (ICU). In 2003, the operation was performed in approximately 40 patients at the Massachusetts General Hospital (MGH). The median length of stay in the ICU was 7 days (range 2-55) All patients required postoperative mechanical ventilation for greater than 48 h. During this period, a continuous intravenous infusion of propofol is normally used for sedation. Pain relief is provided by a continuous intravenous infusion of hydromorphone. This combination of sedation and analgesia is widely used at MGH and other institutions. Although very effective, it may cause respiratory depression and a deep sedative state, which may result in a prolonged requirement for mechanical ventilation. Lighter or more controllable sedation appears to be beneficial in this regard: daily wake up of intubated and sedated ICU patients decreases days on the ventilator and length of stay in the ICU.

Dexmedetomidine is a highly specific α2 agonist with prominent central nervous system (CNS) and cardiovascular effects It is FDA-approved as a postoperative sedative-hypnotic agent for intensive care patients for use up to 24 hours. The drug has hypnotic, sedative, analgesic and anxiolytic actions, and it tends to cause a mild decrease in blood pressure and heart rate. Patients or healthy volunteers sedated with dexmedetomidine alone are easily arousable and have no apparent respiratory depression. Dexmedetomidine has synergistic hypnotic and analgesic interactions with virtually all CNS depressants tested. It significantly decreases sedative and opioid requirements during and after major surgical procedures.Other potentially beneficial effects that are not as well-documented include bronchodilation and the ability to induce a more 'physiologic' sleep than other hypnotics commonly used in the ICU. Dexmedetomidine sedation may also be associated with a lower incidence of delirium.

Patients recovering from TAA surgery routinely require substantial ICU resources. If dexmedetomidine decreases the opioid and sedative requirement in these patients, it may potentially decrease the average number of days spent on the ventilator and in the ICU.

Being tested
Dexmedetomidine, Normal Saline
Keywords
Thoracoabdominal Aortic Aneurysm, Dexmedetomidine, Mechanical ventilation
Medical subject headings
Respiratory Aspiration, Aortic Aneurysm, Thoracoabdominal

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • DexmedetomidineDrug

    Also called No other names have been specified

    A continuous infusion of dexmedetomidine will be started at a dose of 0.8mcg/kg/hr. This will continue for no longer than 24 hours. Four hours post extubation the study drug wii be discontinued using a standard tapering protocol: 0.6mcg/kg/hr for 4 hours then 0.4mcg/kg/hr for 4 hours, then 0.2 mcg/kg/hr for 4 hours and then 0.1mcg/kg/hr for 4 hours and then turned off.

  • Normal SalineOther

    Also called No other names have been specified

    Normal Saline will be given as the placebo and will administered at 0.8mcg/kg/hr

Study groups in NCT00409344
Study groupRoleWhat they receive
1Placebo comparatorNormal Saline
Receives: Other: Normal Saline
DexmedetomidineActive comparatorDexmedetomidine is a highly specific a2 agonist with prominent central nervous system and cardiovascular effects. A postoperative sedative-hypnotic agent for intensive care patients for use up to 24 hours.
Receives: Drug: Dexmedetomidine; Other: Normal Saline

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Time to a Successful Spontaneous Breathing Trial.

    Did not achieve this primary outcome due to no enrollment of participants. Unable to measure this outcome.

    Measured: 1/1/2008

  2. Intensive Care Unit Length of Stay

    The number of days each patient was in the Intensive Care Unit. Unable to measure this outcome due to no enrollment of participnats.

    Measured: 1/1/2008

Secondary outcomes (5)
  1. Secondary Endpoints Include:Amount of Sedative and Opiates Given

    Did not achieve this outcome due to no enrollment of participants

    Measured: 1/1/2008

  2. Time to Extubation

    Did not achieve this outcome due to no enrollment of participants

    Measured: 1/1/2008

  3. Amount of Vasoactive Substances Used to Achieve Hemodynamic Stability

    Did not achieve this outcome due to no enrollment of participants, unable to measure this outcome

    Measured: 1/1/2008

  4. Pharmaco-economics

    Did not achieve this outcome due to no enrollment of participants

    Measured: 1/1/2008

  5. Incidence of Delirium; Number of Shifts During Which Delirium Was Diagnosed

    Did not achieve this outcome due to no enrollment of participants. Was unable to measure this outcome.

    Measured: 1/1/2008

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Dec 2006 (estimated)
  2. Study startJan 2007
  3. Primary completionJan 2008
  4. Study completionJan 2008

Why it stopped: Surgical approach changed therefore subject enrollment not possible.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Single group
Masking
Double blind
Who is masked
Participant, Care provider
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00409344
Sponsor's protocol ID
2006-P-001827
Other IDs
IND:74068
Status last verified
Sep 2009
First submitted
7 Dec 2006
Last updated
22 Sep 2009
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Dexmedetomidine and Normal Saline in people with Sedation and Respiration, Artificial, run by Massachusetts General Hospital at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 22 Sep 2009. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 16 Sep 2009). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Time to a Successful Spontaneous Breathing Trial. (time frame: 1/1/2008). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Sep 2009.

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