Dexmedetomidine Versus Midazolam for Facilitating Extubation

NCT00744380 | Completed Results

• 1 other identifier: 08-0570
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this randomized, double-blind study is to evaluate the utility, safety, and cost of transitioning benzodiazepine sedation to dexmedetomidine in medical or surgical intensive care unit (ICU) patients requiring sedation when tracheal extubation is nearing. Fifty medical or surgical ICU patients requiring sedation with existing benzodiazepine therapy and qualifying for daily awakenings will be randomized in a double-blind manner to receive additional midazolam or dexmedetomidine.

Conditions

Critical Illness

Keywords

Analgesia; Mechanical ventilation

Outcome Measures

Primary Outcomes (1)

• Time From Study Drug Initiation to Tracheal Extubation

  Duration of ICU stay, for up to 24 weeks

Secondary Outcomes (7)

• Cumulative Doses of Conventional Sedatives and Analgesics

  Duration of ICU stay, for up to 24 weeks

• The Quality of Sedation (Assessed by the Riker Sedation-Agitation Score) and Analgesia (Assessed by the Pain Assessment Behavioral Score)

  Duration of ICU stay, for up to 24 weeks

• Sedation-related Adverse Effects

  Duration of ICU stay, up to 24 weeks

• ICU Experiences by Administering ICU Stressful Experiences Questionnaire (ICU-SEQ)

  Duration of hospital stay, up to 24 weeks

• Duration of Study Drug Administration

  Duration of ICU stay, up to 24 weeks

Study Arms (2)

Midazolam

ACTIVE COMPARATOR

Midazolam infusion of 1 mg/hour (final infusion concentration of 0.5 mg/mL) and adjusted by 1 mg/hour by the bedside nurse as needed for the desired level of sedation (Riker sedation-agitation score of 3 - 4) as other sedatives are down titrated. Daily awakenings are used.

Drug: Midazolam

Dexmedetomidine

EXPERIMENTAL

Dexmedetomidine 0.15 µg/kg per hour (final infusion concentration of 0.075 µg/kg per mL) and adjusted by 0.15 µg/kg per hour by the bedside nurse as needed for the desired level of sedation (Riker sedation-agitation score of 3 - 4)as other sedatives are down titrated. Daily awakenings are used.

Drug: Dexmedetomidine

Interventions

Midazolam DRUG

Midazolam infusion of 1 mg/hour (final infusion concentration of 0.5 mg/mL) and adjusted by 1 mg/hour by the bedside nurse as needed for the desired level of sedation (Riker sedation-agitation score of 3 - 4)

Also known as: Versed

Midazolam

Dexmedetomidine DRUG

Dexmedetomidine 0.15 µg/kg per hour (final infusion concentration of 0.075 µg/kg per mL) and adjusted by 0.15 µg/kg per hour by the bedside nurse as needed for the desired level of sedation (Riker sedation-agitation score of 3 - 4)

Also known as: Precedex

Dexmedetomidine

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients requiring mechanical ventilation in the medical or surgical ICUs.
• Currently receiving lorazepam or midazolam by continuous infusion for the purpose of sedation therapy.
• Sedation in these ICUs is provided using an ICU-wide order form that preferentially uses either lorazepam or midazolam with the infusion rate titrated by the bedside nurse to the desired Riker sedation-agitation score(s). Continuous analgesia is provided with fentanyl only with the infusion rate titrated by the bedside nurse to PABS ≤ 3 .
• Anticipated duration of continuous sedation \> 12 hours with the level of sedation expected to be maintained at Riker sedation-agitation score(s) of 3 - 4.
• Patients qualifying for daily awakenings as determined by all of the following:
• fraction of inspired oxygen (FiO2) ≤ 70% or
• positive end expiratory pressure (PEEP) ≤ 14 cmH2O,
• hemodynamically stable, and
• NOT receiving pharmacologic neuromuscular blockade.
• Informed consent and HIPAA authorization within 24 hours of qualifying for daily awakenings.

You may not qualify if:

• Patients \< 18 years of age or \> 85 years of age.
• Patients receiving intermittent or "as needed" administration of lorazepam or midazolam.
• Patients receiving lorazepam or midazolam for purposes other than sedation (e.g. seizure control).
• Patients receiving epidural administration of medication(s).
• Patients with Childs-Pugh class C liver disease.
• Comatose patients by metabolic or neurologic affectation.
• Patients with active myocardial ischemia or second- or third-degree heart block.
• Moribund state with planned withdrawal of life support.
• Patients with known or suspected severe adverse reactions to midazolam (or any other benzodiazepine) or dexmedetomidine (or clonidine).
• Patients with alcohol abuse within six months of study eligibility.
• Pregnant females or females suspected of being pregnant.

Sponsors & Collaborators

• University of Colorado, Denver: lead
• Hospira, now a wholly owned subsidiary of Pfizer: collaborator

Study Sites (1)

University of Colorado Hospital

Aurora, Colorado, 80010, United States

Location

Related Publications (1)

• MacLaren R, Preslaski CR, Mueller SW, Kiser TH, Fish DN, Lavelle JC, Malkoski SP. A randomized, double-blind pilot study of dexmedetomidine versus midazolam for intensive care unit sedation: patient recall of their experiences and short-term psychological outcomes. J Intensive Care Med. 2015 Mar;30(3):167-75. doi: 10.1177/0885066613510874. Epub 2013 Nov 12.

  PMID: 24227448 DERIVED

MeSH Terms

Conditions

Critical Illness; Agnosia

Interventions

Midazolam; Dexmedetomidine

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring

Results Point of Contact

• Title: Robert MacLaren
• Organization: University of Colorado

rob.maclaren@ucdenver.edu

303 724-2622

Study Officials

• Robert MacLaren, PharmD

  University of Colorado Skaggs School of Pharmacy and Pharmaceutical Sciences

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 28, 2008
• First Posted: September 1, 2008
• Study Start: August 1, 2008
• Primary Completion: October 1, 2012
• Study Completion: October 1, 2012
• Last Updated: September 28, 2016
• Results First Posted: September 28, 2016

Record last verified: 2016-08

Data Sharing

• IPD Sharing: Will share

Locations

US (1)