Sufentanil Infusion vs Sufentanil Bolus

Anesthesia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04226495
• Other study ID #: 0520-20-FB
• Status: Completed
• Phase: Phase 4
• Start date: October 13, 2020
• Est. completion date: October 28, 2021

Study information

• Verified date: September 2023
• Source: University of Nebraska
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 64
• Est. completion date: October 28, 2021
• Est. primary completion date: October 28, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 19 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Anesthesia

Intervention

Drug:
• Sufentanil Infusion
Intra-operative sufentanil infusion
• Sufentanil Bolus
Intra-operative sufentanil bolus

Locations

Country	Name	City	State
United States	University of Nebraska Medical Center	Omaha	Nebraska

Sponsors (1)

Lead Sponsor	Collaborator
University of Nebraska

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Plasma Concentration	We will determine if sufentanil infusion administration intra-operatively during routine cardiac surgery will result in a lower plasma concentration of sufentanil at time of arrival to ICU and if the plasma concentration correlates with time to extubation.	Lab concentration is drawn when patient arrives to ICU, an average of 1 hour after procedure.