Stress During Deep Sedation With Propofol With and Without Alfentanil

NCT ID: NCT00997113

Last Updated: 2014-09-25

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-10-31

Study Completion Date

2012-12-31

Brief Summary

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This is a randomized clinical trial of deep procedural sedation with propofol with and without supplemental alfentanil. Patients will be assessed for total and fractionated serum catecholamines before and after the procedure in addition to usual procedural sedation outcomes parameters to assess the adrenergic effect of propofol sedation without supplemental opioid.

Detailed Description

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Conditions

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Sedation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Propofol

propofol only for deep procedural sedation

Group Type ACTIVE_COMPARATOR

propofol

Intervention Type DRUG

1 mg/kg IV followed by 0.5 mg/kg iv prn sedation

Propofol/alfentanil

Propofol with alfentanil for deep procedural sedation

Group Type ACTIVE_COMPARATOR

propofol

Intervention Type DRUG

1 mg/kg IV followed by 0.5 mg/kg iv prn sedation

alfentanil

Intervention Type DRUG

alfentanil 10 ug/kg immediately prior to propofol dose

Interventions

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propofol

1 mg/kg IV followed by 0.5 mg/kg iv prn sedation

Intervention Type DRUG

alfentanil

alfentanil 10 ug/kg immediately prior to propofol dose

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* patients who will require deep procedural sedation with propofol in the ED

Exclusion Criteria

* age \<18
* intoxication
* unable to provide informed consent
* allergy to propofol or alfentanil
* pregnant
* ASA physical status score \> 2
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hennepin Healthcare Research Institute

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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James R. Miner, MD

Role: PRINCIPAL_INVESTIGATOR

Hennepin Faculty Associates

Locations

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Hennepin County Medical Center

Minneapolis, Minnesota, United States

Site Status

Countries

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United States

References

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Miner JR, Moore JC, Plummer D, Gray RO, Patel S, Ho JD. Randomized clinical trial of the effect of supplemental opioids in procedural sedation with propofol on serum catecholamines. Acad Emerg Med. 2013 Apr;20(4):330-7. doi: 10.1111/acem.12110.

Reference Type RESULT
PMID: 23701339 (View on PubMed)

Other Identifiers

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MMRF093051

Identifier Type: -

Identifier Source: org_study_id

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