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Comparison of Morphine and Fentanyl/Midazolam in Intensive Care Unit

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01602640
First Posted: May 21, 2012
Last Update Posted: May 21, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
EFRAIN RIVEROS, Clínica de Los Andes IPS
  Purpose
Hypothesis: Morphine infusion decreases time to mechanical ventilation weaning and extubation, as compared to the combination of fentanyl and midazolam in critically-ill patients.

Condition Intervention
Respiratory Failure Drug: Morphine infusion Drug: Fentanyl and Midazolam infusion

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Supportive Care
Official Title: Sedation and Analgesia in Intensive Care: Comparison of Morphine and Fentanyl/Midazolam

Resource links provided by NLM:


Further study details as provided by EFRAIN RIVEROS, Clínica de Los Andes IPS:

Primary Outcome Measures:
  • Time from sedation discontinuation to first T-Tube time from sedation [ Time Frame: 12-120 hours ]

Secondary Outcome Measures:
  • Time from sedation discontinuation to extubation time from sedation [ Time Frame: 12-180 hours ]

Enrollment: 90
Study Start Date: January 2009
Study Completion Date: March 2012
Primary Completion Date: February 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Morphine Drug: Morphine infusion
Conventional dose
Active Comparator: Fentanyl and Midazolam
Control
Drug: Fentanyl and Midazolam infusion
Conventional dose

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Adults admitted to ICU requiring mechanical ventilation Informed consent

Exclusion Criteria:

  • Less than 18 years old
  • Consent denial
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01602640


Locations
Colombia
Clinica de los Andes IPS
Tunja, Boyaca, Colombia, 8
Sponsors and Collaborators
Clínica de Los Andes IPS
Investigators
Principal Investigator: Efrain Riveros, Principal investigator Clinica de los Andes IPS
  More Information

Responsible Party: EFRAIN RIVEROS, Principal investigator, Clínica de Los Andes IPS
ClinicalTrials.gov Identifier: NCT01602640     History of Changes
Other Study ID Numbers: ANDES001
First Submitted: April 18, 2012
First Posted: May 21, 2012
Last Update Posted: May 21, 2012
Last Verified: May 2012

Keywords provided by EFRAIN RIVEROS, Clínica de Los Andes IPS:
sedation
critical care
morphine
fentanyl
analgesic based sedation

Additional relevant MeSH terms:
Respiratory Insufficiency
Respiration Disorders
Respiratory Tract Diseases
Morphine
Fentanyl
Midazolam
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Adjuvants, Anesthesia
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Hypnotics and Sedatives
Anti-Anxiety Agents
Tranquilizing Agents
Psychotropic Drugs
GABA Modulators
GABA Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action