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TerminatedNCT00409344Updated Sep 22, 2009Results posted

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

A Phase 4 interventional study of Dexmedetomidine and Normal Saline in Sedation, Respiration, Artificial and Length of Stay, sponsored by Massachusetts General Hospital. Terminated at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2009-09-22.

Sponsored by Massachusetts General Hospital · Phase 4, Interventional, and Treatment

Why this study was terminated
Surgical approach changed therefore subject enrollment not possible.
Phase
Phase 4
Study type
Interventional
Enrollment
0
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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. 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.

02

Conditions studied

  • Sedation
  • Respiration, Artificial
  • Length of Stay

Keywords

  • Thoracoabdominal Aortic Aneurysm
  • Dexmedetomidine
  • Mechanical ventilation
03

In context

Aneurysm

960 studies on the registry are indexed under Aneurysm; 175 are open to participants now.

Browse Aneurysm studies →

Lead sponsor

Massachusetts General Hospital is the lead sponsor of 2,536 studies on the registry; 446 are open to participants now.

Of its 214 completed or terminated interventional studies of FDA-regulated products, 161 (75%) have results posted.

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

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • 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)
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Single group
Masking
Double (Participant, Care provider)
Enrollment
0 participants (actual)

Study arms

  • Placebo comparator
    1

    Normal Saline

    Other: Normal Saline

  • Active comparator
    Dexmedetomidine

    Dexmedetomidine 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.

    Drug: Dexmedetomidine · Other: Normal Saline

Interventions

  • DrugDexmedetomidine

    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.

    Also known as: No other names have been specified

  • OtherNormal Saline

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

    Also known as: No other names have been specified

06

What researchers measure

Primary outcomes

  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.

    Time frame: 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.

    Time frame: 1/1/2008

Secondary outcomes

  1. Secondary Endpoints Include:Amount of Sedative and Opiates Given

    Did not achieve this outcome due to no enrollment of participants

    Time frame: 1/1/2008

  2. Time to Extubation

    Did not achieve this outcome due to no enrollment of participants

    Time frame: 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

    Time frame: 1/1/2008

  4. Pharmaco-economics

    Did not achieve this outcome due to no enrollment of participants

    Time frame: 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.

    Time frame: 1/1/2008

07

Results

Posted Sep 16, 2009
Limitations and caveats
Unable to enroll participants into the study

Participant flow

Recruitment period 10/10/2006 to 1/1/2008 from a surgical intensive care unit in a tertiary hospital.

Participant flow — Overall Study
MilestoneSalineDexmedetomidine
Started00
Completed00
Not completed00
Withdrew: No enrollment00

Outcome measures

PrimaryTime to a Successful Spontaneous Breathing Trial.

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

Time frame:
1/1/2008
Reported as:
Number · hours

No measurements were reported for this outcome.

SecondarySecondary Endpoints Include:Amount of Sedative and Opiates Given

Did not achieve this outcome due to no enrollment of participants

Time frame:
1/1/2008
Reported as:
Number · milligram of sedative an opiate

No measurements were reported for this outcome.

SecondaryTime to Extubation

Did not achieve this outcome due to no enrollment of participants

Time frame:
1/1/2008
Reported as:
Number · hours

No measurements were reported for this outcome.

SecondaryAmount of Vasoactive Substances Used to Achieve Hemodynamic Stability

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

Time frame:
1/1/2008
Reported as:
Number · participants

No measurements were reported for this outcome.

SecondaryPharmaco-economics

Did not achieve this outcome due to no enrollment of participants

Time frame:
1/1/2008
Reported as:
Number · participants

No measurements were reported for this outcome.

SecondaryIncidence 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.

Time frame:
1/1/2008
Reported as:
Number · participants

No measurements were reported for this outcome.

PrimaryIntensive 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.

Time frame:
1/1/2008
Reported as:
Number · Days

No measurements were reported for this outcome.

Adverse events

Adverse event summary by group
GroupDeathsSeriousOther
Saline———
Dexmedetomidine———

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)SalineDexmedetomidineTotal
<=18 years000
Between 18 and 65 years000
>=65 years000
Sex: Female, Male
Sex: Female, Male(Participants)SalineDexmedetomidineTotal
Female000
Male000
08

Study locations

1 site
  • Massachusetts General Hospital
    Boston, Massachusetts 02114, United States
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 22, 2009, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00409344
Lead sponsor
Massachusetts General Hospital
Collaborators
Hospira, now a wholly owned subsidiary of Pfizer
First posted
Dec 8, 2006
Start date
Jan 2007
Primary completion
Jan 2008
Completion
Jan 2008
Results posted
Sep 16, 2009
Last update
Sep 22, 2009

Study contacts

Ulrich Schmidt, MD,PhD
principal investigator · Massachusetts General Hospital

Oversight

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

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