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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

Page last updated: August 23, 2015

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