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

Tehran University of Medical Sciences

Status and phase: Unknown; Phase 4

Conditions: Emergencies

Treatments: Drug: Propofol; Drug: Fentanyl; Drug: Midazolam

Study type: Interventional

Funder types: Other

Identifiers

NCT01749579

130-2640

Details and patient eligibility

About

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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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60 participants in 2 patient groups

Propofol

Experimental group

Description:

The patients will receive propofol for sedation in addition to fentanyl

Treatment:

Drug: Propofol

Drug: Fentanyl

Midazolam

Active Comparator group

Description:

The patients will receive midazolam for sedation in addition to fentanyl

Treatment:

Drug: Midazolam

Drug: Fentanyl