Comparison of Morphine and Fentanyl/Midazolam in Intensive Care Unit

Respiratory Failure Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01602640
• Other study ID #: ANDES001
• Status: Completed
• Phase: N/A
• First received: April 18, 2012
• Last updated: May 17, 2012
• Start date: January 2009
• Est. completion date: March 2012

Study information

• Verified date: May 2012
• Source: Clínica de Los Andes IPS
• Contact: n/a
• Is FDA regulated: No
• Health authority: Colombia: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: March 2012
• Est. primary completion date: February 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• Adults admitted to ICU requiring mechanical ventilation Informed consent

Exclusion Criteria:

• Less than 18 years old

• Consent denial

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Respiratory Failure
• Respiratory Insufficiency

Intervention

Drug:
• Morphine infusion
Conventional dose
• Fentanyl and Midazolam infusion
Conventional dose

Locations

Country	Name	City	State
Colombia	Clinica de los Andes IPS	Tunja	Boyaca

Sponsors (1)

Lead Sponsor	Collaborator
Clínica de Los Andes IPS

Country where clinical trial is conducted

Colombia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time from sedation discontinuation to first T-Tube time from sedation		12-120 hours	No
Secondary	Time from sedation discontinuation to extubation time from sedation		12-180 hours	No