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

NCT00409344 | Terminated Phase 4 Results DMC

• 2 other identifiers: 2006-P-001827IND:74068
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Sedation; Respiration, Artificial; Length of Stay

Keywords

Thoracoabdominal Aortic Aneurysm; Dexmedetomidine; Mechanical ventilation

Outcome Measures

Primary Outcomes (2)

• Time to a Successful Spontaneous Breathing Trial.

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

  1/1/2008

• 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.

  1/1/2008

Secondary Outcomes (5)

• Secondary Endpoints Include:Amount of Sedative and Opiates Given

  1/1/2008

• Time to Extubation

  1/1/2008

• Amount of Vasoactive Substances Used to Achieve Hemodynamic Stability

  1/1/2008

• Pharmaco-economics

  1/1/2008

• Incidence of Delirium; Number of Shifts During Which Delirium Was Diagnosed

  1/1/2008

Study Arms (2)

1

PLACEBO COMPARATOR

Normal Saline

Other: Normal Saline

Dexmedetomidine

ACTIVE COMPARATOR

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

Dexmedetomidine DRUG

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

Dexmedetomidine

Normal Saline OTHER

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

1; Dexmedetomidine

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Massachusetts General Hospital: lead
• Hospira, now a wholly owned subsidiary of Pfizer: collaborator

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

MeSH Terms

Conditions

Respiratory Aspiration; Aortic Aneurysm, Thoracoabdominal

Interventions

Dexmedetomidine; Saline Solution

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Aortic Aneurysm, Abdominal; Aortic Aneurysm; Aneurysm; Vascular Diseases; Cardiovascular Diseases; Aortic Diseases

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Limitations and Caveats

Unable to enroll participants into the study

Results Point of Contact

• Title: Ulrich Schmidt, MD PhD
• Organization: Massachusetts General Hospital

uschmidt@partners.org

617-724-6490

Study Officials

• Ulrich Schmidt, MD,PhD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: December 7, 2006
• First Posted: December 8, 2006
• Study Start: January 1, 2007
• Primary Completion: January 1, 2008
• Study Completion: January 1, 2008
• Last Updated: September 22, 2009
• Results First Posted: September 16, 2009

Record last verified: 2009-09

Locations

US (1)