Sufentanil Infusion vs Sufentanil Bolus

NCT04226495 | Completed Phase 4 Results DMC FDA Drug

• 1 other identifier: 0520-20-FB
• Study Type: interventional
• Target: 65
• Locations: 1 country
• Sites: 1

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.

Conditions

Anesthesia

Outcome Measures

Primary Outcomes (1)

• Time to Extubation

  We will determine if sufentanil infusion administration intra-operatively during routine cardiac surgery will decrease time to extubation from OR stop data collection time point by 60 minutes compared to sufentanil bolus administration.

  Amount of time in minutes from procedure finish to time of extubation, up to 800 minutes.

Secondary Outcomes (1)

• Plasma Concentration

  Lab concentration is drawn when patient arrives to ICU, an average of 1 hour after procedure.

Study Arms (2)

Sufentanil Bolus

ACTIVE COMPARATOR

medication in scheduled doses (bolus)

Drug: Sufentanil Bolus

Sufentanil Infusion

EXPERIMENTAL

medication in a slow trickle (infusion)

Drug: Sufentanil Infusion

Interventions

Sufentanil Infusion DRUG

Intra-operative sufentanil infusion

Also known as: Sufentanil

Sufentanil Infusion

Sufentanil Bolus DRUG

Intra-operative sufentanil bolus

Also known as: Sufentanil

Sufentanil Bolus

Eligibility Criteria

• Age: 19 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Scheduled non-emergency cardiac surgical patients including those with planned procedures of CABG, AVR, and combined CABG and AVR
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Nebraska: lead

Study Sites (1)

University of Nebraska Medical Center

Omaha, Nebraska, 68198, United States

Location

MeSH Terms

Interventions

Sufentanil

Intervention Hierarchy (Ancestors)

Fentanyl; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Jeffrey Songster
• Organization: University of Nebraska Medical Center

jeffrey.songster@unmc.edu

308-520-2847

Study Officials

• Jeffrey C Songster, MD

  University of Nebraska

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 9, 2020
• First Posted: January 13, 2020
• Study Start: October 13, 2020
• Primary Completion: October 28, 2021
• Study Completion: October 28, 2021
• Last Updated: December 11, 2024
• Results First Posted: February 28, 2023

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)