Sufentanil Infusion vs Sufentanil Bolus

Sponsor

University of Nebraska (Other)

Overall Status

Completed

CT.gov ID

NCT04226495

Collaborator

(none)

Enrollment

Location

Arms

12.5

Actual Duration (Months)

5.2

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Anesthesia	Drug: Sufentanil Infusion Drug: Sufentanil Bolus	Phase 4

Study Design

Study Type:

Interventional

Actual Enrollment :

65 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Participant)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Oct 13, 2020

Actual Primary Completion Date :

Oct 28, 2021

Actual Study Completion Date :

Oct 28, 2021

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Sufentanil Bolus	Drug: Sufentanil Bolus Intra-operative sufentanil bolus
Experimental: Sufentanil Infusion	Drug: Sufentanil Infusion Intra-operative sufentanil infusion Other Names: Sufentanil

Arm

Intervention/Treatment

Active Comparator: Sufentanil Bolus

Drug: Sufentanil Bolus

Intra-operative sufentanil bolus

Experimental: Sufentanil Infusion

Drug: Sufentanil Infusion

Intra-operative sufentanil infusion

Other Names:

Sufentanil

Outcome Measures

Primary Outcome Measures

Time to extubation [60 minutes]
Sufentanil infusion administration intra-operatively during routine cardiac surgery decreases time to extubation.

Secondary Outcome Measures

Plasma concentration [intra-operative]
Sufentanil infusion administration intra-operatively during routine cardiac surgery results in a lower plasma concentration of sufentanil at time of arrival to ICU.

Eligibility Criteria

Criteria

Ages Eligible for Study:

19 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

Scheduled non-emergency cardiac surgical patients including those with planned procedures of CABG, AVR, and combined CABG and AVR
19 to 80 years old
Planned pre-operative anesthesia screening visit and/or preoperative surgical clinic visit.
Inpatient subject that is scheduled (greater than 24hrs in advance) for a non-emergency cardiac surgical case

Exclusion Criteria:

Sufentanil allergy
EF less than or equal to 30%
Moderate or severe right ventricular dysfunction,
Moderate pulmonary dysfunction, to include patients with at home 02 and/or daily bronchodilator therapy.
End Stage Renal Disease on Dialysis
Chronic Kidney Disease with GFR <30
Sternotomy Re-do
Emergency surgery
Greater than 4 units of RBCs or FFP combined
Mechanical circulatory support post-operatively such as ECMO, IABP, Impella
Not eligible for rapid wean extubation protocol
Requires infusion of sedative medication required during ICU admission
Greater than or equal to 15 minute ICU hold within PACU

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Nebraska Medical Center	Omaha	Nebraska	United States	68198

Sponsors and Collaborators

University of Nebraska

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Jeffrey Songster MD, Principal Investigator, University of Nebraska

ClinicalTrials.gov Identifier:

NCT04226495

Other Study ID Numbers:

520-20-FB

First Posted:

Jan 13, 2020

Last Update Posted:

Apr 14, 2022

Last Verified:

Apr 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Additional relevant MeSH terms:

Sufentanil

Dsuvia

Study Results

No Results Posted as of Apr 14, 2022