Comparison of Propofol-fentanyl and Midazolam-fentanyl for Conscious Sedation
Information source: Tehran University of Medical Sciences
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Emergencies
Intervention: Propofol (Drug); Midazolam (Drug); Fentanyl (Drug)
Phase: Phase 4
Status: Recruiting
Sponsored by: Tehran University of Medical Sciences Official(s) and/or principal investigator(s): Mohammad Jalili, MD, Study Chair, Affiliation: Tehran University of Medical Sciences
Overall contact: Mohammad Jalili, MD, Phone: +98(912)5483998, Email: mjalili@tums.ac.ir
Summary
Sixty patients who refer to the emergency ward and need any painful procedure in the ward
are randomized into 2 groups. One group is sedated before the procedure using
propofol-fentanyl and the other with midazolam-fentanyl, with the same depth of sedation.
The two groups will be compared regarding recovery time and other parameters described
below.
Clinical Details
Official title: Comparison of Propofol-fentanyl and Midazolam-fentanyl for Conscious Sedation in Painful Procedures
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Primary outcome: Recovery time
Secondary outcome: Patients' Pain perception
Eligibility
Minimum age: 18 Years.
Maximum age: 90 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- age more than 18
- candidate for a painful procedure
- negative past history of a serious medical condition
- ASA score 0 and 1
Exclusion Criteria:
- deep sedation making the patient unable to answer the questions
- pregnancy
- allergy to drugs
- hemodynamic instability
- failure to consent
Locations and Contacts
Mohammad Jalili, MD, Phone: +98(912)5483998, Email: mjalili@tums.ac.ir
Imam Khomeini Hospital, Tehran, Iran, Islamic Republic of; Recruiting
Additional Information
Starting date: May 2012
Last updated: December 11, 2012
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