NCT04226495

Sufentanil Infusion vs Sufentanil Bolus

Sufentanil Infusion vs Sufentanil Bolus and Time to Extubation During Routine Cardiac Surgery

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 65 (actual)
• Sponsor: University of Nebraska · Academic / Other
• Sex: All
• Age: 19 Years – 80 Years
• Healthy volunteers: Accepted

Summary

Randomized single blind controlled clinical trial to test the benefit of sufentanil infusion over bolus dosing to reduce time to extubation and reduced length of ICU stay.

Detailed description

This study will compare Sufentanil bolus vs infusion and analyze which has a faster extubation time in participants who undergo routine cardiac surgery. The hypothesis is that routine cardiac surgery patients receiving sufentanil infusion will have a lower sufentanil concentration at the end of surgery and have a shorter time to extubation than participants receiving sufentanil bolus dosing even with similar total doses of sufentanil. The intervention will be Sufentanil infusion during surgery and evaluations will include Sufentanil blood concentrations, ICU and hospital length of stay and re-intubation rate. We will follow up with the participants through their ICU stay (primary objective) and hospital length of stay (secondary objective).

Conditions

• Anesthesia

Interventions

Type	Name	Description
DRUG	Sufentanil Infusion	Intra-operative sufentanil infusion
DRUG	Sufentanil Bolus	Intra-operative sufentanil bolus

Timeline

• Start date: 2020-10-13
• Primary completion: 2021-10-28
• Completion: 2021-10-28
• First posted: 2020-01-13
• Last updated: 2024-12-11
• Results posted: 2023-02-28

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study