Stress During Deep Sedation With Propofol With and Without Alfentanil

Hennepin Healthcare

Status and phase: Completed; Phase 4

Conditions: Sedation

Treatments: Drug: propofol; Drug: alfentanil

Study type: Interventional

Funder types: Other

Identifiers

NCT00997113

MMRF093051

Details and patient eligibility

About

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.

Enrollment: 20 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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20 participants in 2 patient groups

Propofol

Active Comparator group

Description:

propofol only for deep procedural sedation

Treatment:

Drug: propofol

Propofol/alfentanil

Active Comparator group

Description:

Propofol with alfentanil for deep procedural sedation

Treatment:

Drug: alfentanil

Drug: propofol