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Comparison of Morphine and Fentanyl/Midazolam in Intensive Care Unit

This study has been completed.
Information provided by (Responsible Party):
EFRAIN RIVEROS, Clínica de Los Andes IPS Identifier:
First received: April 18, 2012
Last updated: May 17, 2012
Last verified: May 2012
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 Blind (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 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
Drug: Fentanyl and Midazolam infusion
Conventional dose


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

Inclusion Criteria:

  • Adults admitted to ICU requiring mechanical ventilation Informed consent

Exclusion Criteria:

  • Less than 18 years old
  • Consent denial
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Please refer to this study by its identifier: NCT01602640

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

Responsible Party: EFRAIN RIVEROS, Principal investigator, Clínica de Los Andes IPS Identifier: NCT01602640     History of Changes
Other Study ID Numbers: ANDES001
Study First Received: April 18, 2012
Last Updated: May 17, 2012

Keywords provided by Clínica de Los Andes IPS:
critical care
analgesic based sedation

Additional relevant MeSH terms:
Respiratory Insufficiency
Respiration Disorders
Respiratory Tract Diseases
Adjuvants, Anesthesia
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Anti-Anxiety Agents
Tranquilizing Agents
Psychotropic Drugs
Anesthetics, Intravenous
Anesthetics, General
GABA Modulators
GABA Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Analgesics, Opioid
Sensory System Agents
Peripheral Nervous System Agents processed this record on May 24, 2017