Sedation of Mechanically Ventilated Critically Ill Patients: Midazolam Versus Dexmedetomidine
The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2010 by Hospital Sao Domingos.
Recruitment status was Recruiting
Recruitment status was Recruiting
Sponsor:
Hospital Sao Domingos
Information provided by:
Hospital Sao Domingos
ClinicalTrials.gov Identifier:
NCT01256866
First received: December 8, 2010
Last updated: NA
Last verified: November 2010
History: No changes posted
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
The aim of this prospective randomized study is to compare the safety and efficacy of two strategies for sedation of critically ill patients submitted to mechanical ventilation: continuous intravenous infusion of dexmedetomidine versus intravenous bolus of midazolam. The two groups will be compared as to the incidence of of delirium, evaluated with the Confusion Assessment Method for ICU (CAM-ICU) and the percentage of time within the target sedation using the Richmond Agitation-Sedation Scale (RAAS).Eligible patients will be 18 years or older intubated and mechanically ventilated for less than 48 hours prior to start of study drug and anticipated ventilation duration of at least 48 hours. Calculated sample size is 146 patients (73 patients in each group)
| Condition | Intervention | Phase |
|---|---|---|
|
Mechanically Ventilated Patients Sedation Dexmedetomidine Midazolam |
Drug: Dexmedetomidine Drug: Midazolam |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Crossover Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Sedation of Mechanically Ventilated Critically Ill Patients: Midazolam Versus Dexmedetomidine |
Resource links provided by NLM:
MedlinePlus related topics:
Delirium
Drug Information available for:
Midazolam hydrochloride
Dexmedetomidine
Dexmedetomidine hydrochloride
U.S. FDA Resources
Further study details as provided by Hospital Sao Domingos:
Primary Outcome Measures:
- Incidence of delirium
Secondary Outcome Measures:
- PERCENTAGE OF TIME WITHIN THE TARGET SEDATION
| Estimated Enrollment: | 146 |
| Study Start Date: | November 2010 |
| Estimated Study Completion Date: | June 2012 |
| Estimated Primary Completion Date: | October 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Active Comparator: DEXMEDETOMIDINE, SEDATION | Drug: Dexmedetomidine |
| Active Comparator: Midazolam, sedation, | Drug: Midazolam |
Eligibility| Ages Eligible for Study: | 18 Years to 75 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Adult mechanically ventilated, critically ill patients
Exclusion Criteria:
- pregnancy or lactation, severe liver disease, hearth rate less than 50, hypotension despite volemic repletion and vasoactive drug
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01256866
Locations
| Brazil | |
| Hospital Sao Domingos | Recruiting |
| Sao Luis, Maranhao, Brazil, 65060-100 | |
| Contact: Jose R Azevedo, MD 55 98 32168110 jrazevedo@elo.com.br | |
| Principal Investigator: Jose R Azevedo, MD | |
| Sub-Investigator: Carla C Oliveira, RN | |
Sponsors and Collaborators
Hospital Sao Domingos
More Information
No publications provided
| Responsible Party: | Ethics Committee, Hospital Sao Domingos |
| ClinicalTrials.gov Identifier: | NCT01256866 History of Changes |
| Other Study ID Numbers: | hsd130947 |
| Study First Received: | December 8, 2010 |
| Last Updated: | December 8, 2010 |
| Health Authority: | Brazil: National Committee of Ethics in Research |
Keywords provided by Hospital Sao Domingos:
|
Dexmedetomidine Midazolam Sedation Mechanical ventilation Critically ill patients |
Additional relevant MeSH terms:
|
Critical Illness Disease Attributes Pathologic Processes Midazolam Dexmedetomidine Adjuvants, Anesthesia Central Nervous System Agents Therapeutic Uses Pharmacologic Actions Anti-Anxiety Agents Tranquilizing Agents Central Nervous System Depressants Physiological Effects of Drugs Psychotropic Drugs Hypnotics and Sedatives |
Anesthetics, Intravenous Anesthetics, General Anesthetics GABA Modulators GABA Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Analgesics, Non-Narcotic Analgesics Sensory System Agents Peripheral Nervous System Agents Adrenergic alpha-2 Receptor Agonists Adrenergic alpha-Agonists Adrenergic Agonists Adrenergic Agents |
ClinicalTrials.gov processed this record on June 18, 2013