Comparison of Morphine and Fentanyl/Midazolam in Intensive Care Unit

May 17, 2012 updated by: EFRAIN RIVEROS, Clínica de Los Andes IPS

Sedation and Analgesia in Intensive Care: Comparison of Morphine and Fentanyl/Midazolam

Hypothesis: Morphine infusion decreases time to mechanical ventilation weaning and extubation, as compared to the combination of fentanyl and midazolam in critically-ill patients.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

90

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Colombia
    • Boyaca
      • Tunja, Boyaca, Colombia, 8
        • Clinica de los Andes IPS

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 76 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Adults admitted to ICU requiring mechanical ventilation Informed consent

Exclusion Criteria:

  • Less than 18 years old
  • Consent denial

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Morphine
Drug: Morphine infusion
Conventional dose
Active Comparator: Fentanyl and Midazolam
Control
Drug: Fentanyl and Midazolam infusion
Conventional dose

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Time from sedation discontinuation to first T-Tube time from sedation
Time Frame: 12-120 hours
12-120 hours

Secondary Outcome Measures

Outcome Measure
Time Frame
Time from sedation discontinuation to extubation time from sedation
Time Frame: 12-180 hours
12-180 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Clínica de Los Andes IPS

Investigators

  • Principal Investigator: Efrain Riveros, Principal investigator, Clinica de los Andes IPS

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2009

Primary Completion (Actual)

February 1, 2012

Study Completion (Actual)

March 1, 2012

Study Registration Dates

First Submitted

April 18, 2012

First Submitted That Met QC Criteria

May 17, 2012

First Posted (Estimate)

May 21, 2012

Study Record Updates

Last Update Posted (Estimate)

May 21, 2012

Last Update Submitted That Met QC Criteria

May 17, 2012

Last Verified

May 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ANDES001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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