Comparison of Propofol-fentanyl and Midazolam-fentanyl for Conscious Sedation

Phase 4

• Conditions: Emergencies
• Interventions: Drug: Midazolam; Drug: Propofol; Drug: Fentanyl

• Registration Number: NCT01749579
• Lead Sponsor: Tehran University of Medical Sciences

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-05
• Status Verified: 2012-12
• Study First Submitted: 2012-12-06
• Study First Submitted QC: 2012-12-11
• Last Update Submitted: 2012-12-11
• Study First Posted: 2012-12-13
• Last Update Posted: 2012-12-13
• Primary Completion: 2013-01
• Study Completion: 2013-02

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Propofol	Fentanyl	The patients will receive propofol for sedation in addition to fentanyl
Midazolam	Midazolam	The patients will receive midazolam for sedation in addition to fentanyl
Midazolam	Fentanyl	The patients will receive midazolam for sedation in addition to fentanyl
Propofol	Propofol	The patients will receive propofol for sedation in addition to fentanyl

Primary Outcome Measures

Name	Time	Method
Recovery time	Within one hour after sedation	Length of time before complete recovery from sedation is achieved

Secondary Outcome Measures

Name	Time	Method
Patients' Pain perception	Within one hour after sedation	Pain perception as measured by verbal numeric rating scale

Trial Locations

Locations (1)

Imam Khomeini Hospital; 🇮🇷 Tehran, Iran, Islamic Republic of