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

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

Status
Terminated
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00409344
Enrollment
0
Registered
2006-12-08
Start date
2007-01-31
Completion date
2008-01-31
Last updated
2009-09-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Length of Stay, Respiration, Artificial, Sedation

Keywords

Thoracoabdominal Aortic Aneurysm, Dexmedetomidine, Mechanical ventilation

Brief 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.

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.

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.

OTHERNormal Saline

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

Sponsors

Hospira, now a wholly owned subsidiary of Pfizer
CollaboratorINDUSTRY
Massachusetts General Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Caregiver)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

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

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)

Design outcomes

Primary

MeasureTime frameDescription
Time to a Successful Spontaneous Breathing Trial.1/1/2008Did not achieve this primary outcome due to no enrollment of participants. Unable to measure this outcome.
Intensive Care Unit Length of Stay1/1/2008The number of days each patient was in the Intensive Care Unit. Unable to measure this outcome due to no enrollment of participnats.

Secondary

MeasureTime frameDescription
Amount of Vasoactive Substances Used to Achieve Hemodynamic Stability1/1/2008Did not achieve this outcome due to no enrollment of participants, unable to measure this outcome
Secondary Endpoints Include:Amount of Sedative and Opiates Given1/1/2008Did not achieve this outcome due to no enrollment of participants
Incidence of Delirium; Number of Shifts During Which Delirium Was Diagnosed1/1/2008Did not achieve this outcome due to no enrollment of participants. Was unable to measure this outcome.
Pharmaco-economics1/1/2008Did not achieve this outcome due to no enrollment of participants
Time to Extubation1/1/2008Did not achieve this outcome due to no enrollment of participants

Countries

United States

Participant flow

Recruitment details

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

Pre-assignment details

Unable to enroll participants due to hepatic impairment and many patients taking tricyclic antidepressants.

Participants by arm

ArmCount
Saline
This group will recive saline
0
Dexmedetomidine
This group will receive dexmedetomidine
0
Total0

Withdrawals & dropouts

PeriodReasonFG000FG001
Overall Studyno enrollment00

Baseline characteristics

CharacteristicSalineDexmedetomidineTotal
Age, Categorical
<=18 years
0 Participants0 Participants0 Participants
Age, Categorical
>=65 years
0 Participants0 Participants0 Participants
Age, Categorical
Between 18 and 65 years
0 Participants0 Participants0 Participants
Sex: Female, Male
Female
0 Participants0 Participants0 Participants
Sex: Female, Male
Male
0 Participants0 Participants0 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
— / —— / —
other
Total, other adverse events
— / —— / —
serious
Total, serious adverse events
— / —— / —

Outcome results

Primary

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

Primary

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

Secondary

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

Secondary

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

Secondary

Pharmaco-economics

Did not achieve this outcome due to no enrollment of participants

Time frame: 1/1/2008

Secondary

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

Secondary

Time to Extubation

Did not achieve this outcome due to no enrollment of participants

Time frame: 1/1/2008

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026