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

NCT01749579 | Unknown Phase 4 DMC

• 1 other identifier: 130-2640
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Emergencies

Keywords

propofol; midazolam; duration of recovery; emergency procedure

Outcome Measures

Primary Outcomes (1)

• Recovery time

  Length of time before complete recovery from sedation is achieved

  Within one hour after sedation

Secondary Outcomes (1)

• Patients' Pain perception

  Within one hour after sedation

Other Outcomes (2)

• Blood pressure

  Within one hour after sedation

• Oxygen saturation

  Within one hour after sedation

Study Arms (2)

Propofol

EXPERIMENTAL

The patients will receive propofol for sedation in addition to fentanyl

Drug: Propofol; Drug: Fentanyl

Midazolam

ACTIVE COMPARATOR

The patients will receive midazolam for sedation in addition to fentanyl

Drug: Midazolam; Drug: Fentanyl

Interventions

Propofol DRUG

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

Propofol

Midazolam DRUG

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

Midazolam

Fentanyl DRUG

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

Midazolam; Propofol

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• age more than 18
• candidate for a painful procedure
• negative past history of a serious medical condition
• ASA score 0 and 1

You may not qualify if:

• deep sedation making the patient unable to answer the questions
• pregnancy
• allergy to drugs
• hemodynamic instability
• failure to consent

Sponsors & Collaborators

• Tehran University of Medical Sciences: lead

Study Sites (1)

Imam Khomeini Hospital

Tehran, Tehran Province, Iran

RECRUITING

MeSH Terms

Conditions

Emergencies

Interventions

Propofol; Midazolam; Fentanyl

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Piperidines; Heterocyclic Compounds, 1-Ring

Study Officials

• Mohammad Jalili, MD

  Tehran University of Medical Sciences

  STUDY CHAIR

Central Study Contacts

Mohammad Jalili, MD

CONTACT

+98(912)5483998; mjalili@tums.ac.ir

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 6, 2012
• First Posted: December 13, 2012
• Study Start: May 1, 2012
• Primary Completion: January 1, 2013
• Study Completion: February 1, 2013
• Last Updated: December 13, 2012

Record last verified: 2012-12

Locations

IR (1)