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Comparison of Morphine and Fentanyl/Midazolam in Intensive Care Unit

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
EFRAIN RIVEROS, Clínica de Los Andes IPS
ClinicalTrials.gov Identifier:
NCT01602640
First received: April 18, 2012
Last updated: May 17, 2012
Last verified: May 2012
History of Changes
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Supportive Care
Official Title: Sedation and Analgesia in Intensive Care: Comparison of Morphine and Fentanyl/Midazolam

Resource links provided by NLM:

U.S. FDA Resources

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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Time from sedation discontinuation to extubation time from sedation [ Time Frame: 12-180 hours ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: EFRAIN RIVEROS, Principal investigator, Clínica de Los Andes IPS
ClinicalTrials.gov Identifier: NCT01602640     History of Changes
Other Study ID Numbers: ANDES001
Study First Received: April 18, 2012
Last Updated: May 17, 2012
Health Authority: Colombia: Institutional Review Board

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

Additional relevant MeSH terms:
Respiratory Insufficiency
Respiration Disorders
Respiratory Tract Diseases
Midazolam
Fentanyl
Morphine
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
Narcotics
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Analgesics, Opioid

ClinicalTrials.gov processed this record on May 19, 2013