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

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ClinicalTrials.gov Identifier: NCT01749579
Recruitment Status : Unknown
Verified December 2012 by Tehran University of Medical Sciences.
Recruitment status was:  Recruiting
First Posted : December 13, 2012
Last Update Posted : December 13, 2012
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Emergencies Drug: Propofol Drug: Midazolam Drug: Fentanyl Phase 4

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Comparison of Propofol-fentanyl and Midazolam-fentanyl for Conscious Sedation in Painful Procedures
Study Start Date : May 2012
Estimated Primary Completion Date : January 2013
Estimated Study Completion Date : February 2013

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: Propofol
The patients will receive propofol for sedation in addition to fentanyl
Drug: Propofol
Propofol 1 mg/kg bolus then 500 microg/kg every 2 minutes until sedation level equivalent to Ramsey 3
Drug: Fentanyl
Fentanyl 2 microg/kg intravenous stat and every 2 minutes until the end of procedure
Active Comparator: Midazolam
The patients will receive midazolam for sedation in addition to fentanyl
Drug: Midazolam
Midazolam 0.03 mg/Kg stat and then the same dose repeated every 2 minutes until a sedation level of Ramsey 3 is achieved.
Drug: Fentanyl
Fentanyl 2 microg/kg intravenous stat and every 2 minutes until the end of procedure



Primary Outcome Measures :
  1. Recovery time [ Time Frame: Within one hour after sedation ]
    Length of time before complete recovery from sedation is achieved


Secondary Outcome Measures :
  1. Patients' Pain perception [ Time Frame: Within one hour after sedation ]
    Pain perception as measured by verbal numeric rating scale


Other Outcome Measures:
  1. Blood pressure [ Time Frame: Within one hour after sedation ]
  2. Oxygen saturation [ Time Frame: Within one hour after sedation ]


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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01749579


Contacts
Contact: Mohammad Jalili, MD +98(912)5483998 mjalili@tums.ac.ir

Locations
Iran, Islamic Republic of
Imam Khomeini Hospital Recruiting
Tehran, Iran, Islamic Republic of
Sponsors and Collaborators
Tehran University of Medical Sciences
Investigators
Study Chair: Mohammad Jalili, MD Tehran University of Medical Sciences

Responsible Party: Tehran University of Medical Sciences
ClinicalTrials.gov Identifier: NCT01749579     History of Changes
Other Study ID Numbers: 130-2640
First Posted: December 13, 2012    Key Record Dates
Last Update Posted: December 13, 2012
Last Verified: December 2012

Keywords provided by Tehran University of Medical Sciences:
propofol
midazolam
duration of recovery
emergency procedure

Additional relevant MeSH terms:
Emergencies
Disease Attributes
Pathologic Processes
Propofol
Midazolam
Fentanyl
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Analgesics, Opioid
Narcotics
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Adjuvants, Anesthesia
Anti-Anxiety Agents
Tranquilizing Agents
Psychotropic Drugs
GABA Modulators
GABA Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action