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

Emergencies research study

What is the primary objective of this study?

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.

Who is eligible to participate?

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

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Emergencies

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

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

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

Drug:FentanylFentanyl 2 microg/kg intravenous stat and every 2 minutes until the end of procedure

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

PropofolThe patients will receive propofol for sedation in addition to fentanyl

MidazolamThe patients will receive midazolam for sedation in addition to fentanyl

Study Status

Unknown status

Start Date: May 2012

Completed Date: February 2013

Phase: Phase 4

Type: Interventional

Design:

Primary Outcome: Recovery time

Secondary Outcome: Patients' Pain perception

Study sponsors, principal investigator, and references

Principal Investigator: Mohammad Jalili, MD

Lead Sponsor: Tehran University of Medical Sciences

Collaborator:

More information:https://clinicaltrials.gov/show/NCT01749579

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