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

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

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.

Study Overview

• Status: Unknown
• Conditions: Emergencies
• Intervention / Treatment: Drug: Propofol; Drug: Fentanyl; Drug: Midazolam

• Study Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Mohammad Jalili, MD; Phone Number: +98(912)5483998; Email: mjalili@tums.ac.ir

Study Locations

• Iran, Islamic Republic of
  • Tehran, Iran, Islamic Republic of
    • Recruiting
    • Imam Khomeini Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / 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: Fentanyl; Fentanyl 2 microg/kg intravenous stat and every 2 minutes until the end of procedure; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Recovery time	Length of time before complete recovery from sedation is achieved	Within one hour after sedation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patients' Pain perception	Pain perception as measured by verbal numeric rating scale	Within one hour after sedation

Other Outcome Measures

Outcome Measure	Time Frame
Blood pressure	Within one hour after sedation
Oxygen saturation	Within one hour after sedation

Collaborators and Investigators

• Sponsor: Tehran University of Medical Sciences

Study record dates

Study Major Dates

• Study Start: May 1, 2012
• Primary Completion (Anticipated): January 1, 2013
• Study Completion (Anticipated): February 1, 2013

Study Registration Dates

• First Submitted: December 6, 2012
• First Submitted That Met QC Criteria: December 11, 2012
• First Posted (Estimate): December 13, 2012

Study Record Updates

• Last Update Posted (Estimate): December 13, 2012
• Last Update Submitted That Met QC Criteria: December 11, 2012
• Last Verified: December 1, 2012

More Information

Terms related to this study

• Keywords: midazolam; propofol; duration of recovery; emergency procedure
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Emergencies; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Analgesics, Opioid; Narcotics; Tranquilizing Agents; Psychotropic Drugs; Hypnotics and Sedatives; Adjuvants, Anesthesia; Anti-Anxiety Agents; GABA Modulators; GABA Agents; Fentanyl; Midazolam; Propofol
• Other Study ID Numbers: 130-2640

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No