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

Comparison of Propofol-fentanyl and Midazolam-fentanyl for Conscious Sedation in Painful Procedures

Status
UNKNOWN
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01749579
Enrollment
60
Registered
2012-12-13
Start date
2012-05-31
Completion date
2013-02-28
Last updated
2012-12-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Emergencies

Keywords

propofol, midazolam, duration of recovery, emergency procedure

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.

Interventions

DRUGPropofol

Propofol 1 mg/kg bolus then 500 microg/kg every 2 minutes until sedation level equivalent to Ramsey 3

DRUGMidazolam

Midazolam 0.03 mg/Kg stat and then the same dose repeated every 2 minutes until a sedation level of Ramsey 3 is achieved.

DRUGFentanyl

Fentanyl 2 microg/kg intravenous stat and every 2 minutes until the end of procedure

Sponsors

Tehran University of Medical Sciences
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Recovery timeWithin one hour after sedationLength of time before complete recovery from sedation is achieved

Secondary

MeasureTime frameDescription
Patients' Pain perceptionWithin one hour after sedationPain perception as measured by verbal numeric rating scale

Other

MeasureTime frame
Blood pressureWithin one hour after sedation
Oxygen saturationWithin one hour after sedation

Countries

Iran

Contacts

Primary ContactMohammad Jalili, MD
mjalili@tums.ac.ir+98(912)5483998

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026