Comparison of Propofol-fentanyl and Midazolam-fentanyl fo... | NCT01749579

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

NCT01749579

Sponsor

Tehran University of Medical Sciences

Status

Unknown status

Last Update Posted

Dec 13, 2012Estimated

Enrollment

60Estimated

Phase

Phase 4

Conditions

Emergencies

Interventions

Propofol
Midazolam
Fentanyl

Countries

Iran

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2012

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 2012

Primary Completion Date

Jan 2013Estimated

Completion Date

Feb 2013Estimated

First Submitted Date

Dec 6, 2012

First Submission Date that Met QC Criteria

Dec 11, 2012

First Posted Date

Dec 13, 2012Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 11, 2012

Last Update Posted Date

Dec 13, 2012Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

60Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Propofol	Drug	Propofol 1 mg/kg bolus then 500 microg/kg every 2 minutes until sedation level equivalent to Ramsey 3	Propofol

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

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

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

90 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Mohammad Jalili, MD	Contact	+98(912)5483998		mjalili@tums.ac.ir

Overall Officials

Name	Affiliation	Role
Mohammad Jalili, MD	Tehran University of Medical Sciences	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Imam Khomeini Hospital	Recruiting	Tehran	Tehran Province		Iran

Condition Browse Module

MeSH Terms

ID	Term
D004630	Emergencies

Ancestor Terms

ID	Term
D020969	Disease Attributes
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D015742	Propofol
D008874	Midazolam
D005283	Fentanyl

Ancestor Terms

ID	Term
D010636	Phenols
D001555	Benzene Derivatives
D006841	Hydrocarbons, Aromatic
D006844	Hydrocarbons, Cyclic

Browse Leaves

Not provided

Browse Branches

Not provided