Sufentanil Infusion vs Sufentanil Bolus

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

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.

Study Overview

• Status: Completed
• Conditions: Anesthesia
• Intervention / Treatment: Drug: Sufentanil Bolus; Drug: Sufentanil Infusion

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).

• Study Type: Interventional
• Enrollment (Actual): 64
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Nebraska
    • Omaha, Nebraska, United States, 68198
      • University of Nebraska Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Sufentanil Bolus; medication in scheduled doses (bolus)	Drug: Sufentanil Bolus; Intra-operative sufentanil bolus; Other Names: Sufentanil
Experimental: Sufentanil Infusion; medication in a slow trickle (infusion)	Drug: Sufentanil Infusion; Intra-operative sufentanil infusion; Other Names: Sufentanil

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.

Collaborators and Investigators

• Sponsor: University of Nebraska
• Investigators: Principal Investigator: Jeffrey C Songster, MD, University of Nebraska

Study record dates

Study Major Dates

• Study Start (Actual): October 13, 2020
• Primary Completion (Actual): October 28, 2021
• Study Completion (Actual): October 28, 2021

Study Registration Dates

• First Submitted: January 9, 2020
• First Submitted That Met QC Criteria: January 10, 2020
• First Posted (Actual): January 13, 2020

Study Record Updates

• Last Update Posted (Actual): October 4, 2023
• Last Update Submitted That Met QC Criteria: September 26, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Analgesics, Opioid; Narcotics; Adjuvants, Anesthesia; Sufentanil; Dsuvia
• Other Study ID Numbers: 0520-20-FB

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No