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

This study is currently recruiting participants.
Verified December 2012 by Tehran University of Medical Sciences
Sponsor:
Information provided by (Responsible Party):
Tehran University of Medical Sciences
ClinicalTrials.gov Identifier:
NCT01749579
First received: December 6, 2012
Last updated: December 11, 2012
Last verified: December 2012
History of Changes
  Purpose

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 Intervention Phase
Emergencies
 Drug: Propofol
Drug: Midazolam
Drug: Fentanyl
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Comparison of Propofol-fentanyl and Midazolam-fentanyl for Conscious Sedation in Painful Procedures

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Tehran University of Medical Sciences:

Primary Outcome Measures:
  • Recovery time [ Time Frame: Within one hour after sedation ] [ Designated as safety issue: No ]
    Length of time before complete recovery from sedation is achieved


Secondary Outcome Measures:
  • Patients' Pain perception [ Time Frame: Within one hour after sedation ] [ Designated as safety issue: No ]
    Pain perception as measured by verbal numeric rating scale


Other Outcome Measures:
  • Blood pressure [ Time Frame: Within one hour after sedation ] [ Designated as safety issue: Yes ]
  • Oxygen saturation [ Time Frame: Within one hour after sedation ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 60
Study Start Date: May 2012
Estimated Study Completion Date: February 2013
Estimated Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

Responsible Party: Tehran University of Medical Sciences
ClinicalTrials.gov Identifier: NCT01749579     History of Changes
Other Study ID Numbers: 130-2640
Study First Received: December 6, 2012
Last Updated: December 11, 2012
Health Authority: Iran: Ethics Committee

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

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

ClinicalTrials.gov processed this record on May 19, 2013