Use of Dexmedetomidine to Facilitate Extubation in Surgical ICU Patients Who Failed Previous Weaning Attempts

NCT00464490 | Terminated Results

• 1 other identifier: 0703054
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

Brief Summary

Mechanical ventilation commonly is associated with patient agitation requiring sedation to alleviate discomfort and reduce excessive central respiratory drive. Upon recovery from acute respiratory failure, sedation is reduced to facilitate the withdrawal of ventilatory support. In some patients, abrupt reduction in sedation provokes severe agitation that causes catecholamine release resulting in severe hypertension, tachycardia and tachypnea. This requires increased sedation to bring hemodynamic and respiratory function under control. Dexmedetomidine is an alpha-2 receptor agonist with both sedative and analgesic properties that allows for the reduction in the anesthetic and analgesic requirements in the perioperative setting. In addition to its sedative effects, alpha-2 receptor stimulation in the central nervous system inhibits sympathetic activity and reduces plasma epinephrine and norepinephrine levels, thereby lowering both arterial blood pressure and heart rate. Because alpha-2 receptor stimulation does not cause respiratory depression, dexmedetomidine may facilitate the transition to unassisted breathing in profoundly agitated patients. The investigators will prospectively evaluate dexmedetomidine in 30 patients who could not be extubated because of agitation with hemodynamic instability and tachypnea. The purpose of this study is to test if a larger prospective randomized controlled pilot study can show that dexmedetomidine facilitates weaning and extubation in patients who have failed previous attempts because of agitation and hyperdynamic cardiopulmonary response.

Conditions

Intubation; Difficult; Respiration Disorders

Keywords

Weaning; Extuvation; Dexmedetomidine

Outcome Measures

Primary Outcomes (1)

• Mechanical Ventilation Time

  time from first weaning attempt to successful extubation

Study Arms (2)

Standard Hospital Ventilation Weaning Protocol

NO INTERVENTION

Control. Hospital weaning protocol

Dexmedetomidine for Extubation

EXPERIMENTAL

Dexmedomidine infusion to facilitate extubation

Drug: Dexmedetomidine

Interventions

Dexmedetomidine DRUG

Dexmedetomidine .5mcg/kg/hr-.7mcg/kg/hr 1hour prior to extubation. Dexmedetomidine will be titrated according to blood pressure, RASS and heart rate response and the dose will be lowered only after sedation is discontinued or markedly reduced.

Also known as: Precedex

Dexmedetomidine for Extubation

Eligibility Criteria

• Age: 18 Years - 69 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age less than 70 years old
• Normothermia (36.5 degrees centigrade)
• Normal sinus rhythm
• Hemodynamically stable (systolic blood pressure \[SBP\] \> 110 mmHg)
• Ejection fraction (EF) \> 40%/absence of congestive heart failure (CHF)
• Cardiac index \> 2.5 L/min/m2
• Minimal inotropic support (\< 3 mcg/kg/min dobutamine)
• Adequate coagulation profile
• Adequate urine output (\> 100 ml/hr)
• Primary service and critical care physician agreement

You may not qualify if:

• Prior use of clonidine or alpha-antagonists
• Prior history of intravenous drug abuse (IVDA) or alcohol abuse (ETOH)
• Evidence of heart block
• Difficulty with oxygenation/ventilation
• Renal or hepatic insufficiency
• Pregnant (positive urine or serum pregnancy test upon admission)
• Patient received dexmedetomidine \> 24 hours

Sponsors & Collaborators

• University of California, San Francisco: lead

Study Sites (1)

University of California, San Francisco

San Francisco, California, 94110, United States

Location

MeSH Terms

Conditions

Respiration Disorders

Interventions

Dexmedetomidine

Condition Hierarchy (Ancestors)

Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Limitations and Caveats

Lower than anticipated enrollment due to unwillingness of providers to assign patients to the control group led to smaller-than-planned samples for analysis

Results Point of Contact

• Title: Julin F. Tang, MD, MS
• Organization: University of California San Francisco

tangj@anesthesia.ucsf.edu

415-206-5274

Study Officials

• Julin F Tang, M.D., M.S.

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 19, 2007
• First Posted: April 23, 2007
• Study Start: November 1, 2007
• Primary Completion: May 1, 2012
• Study Completion: December 1, 2012
• Last Updated: October 31, 2014
• Results First Posted: October 31, 2014

Record last verified: 2014-10

Locations

US (1)