Sufentanil Infusion vs Sufentanil Bolus

Overview

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.

Full Title of Study: “Sufentanil Infusion vs Sufentanil Bolus and Time to Extubation During Routine Cardiac Surgery”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Single (Participant)
  • Study Primary Completion Date: February 1, 2022

Interventions

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

Arms, Groups and Cohorts

  • Active Comparator: Sufentanil Bolus
  • Experimental: Sufentanil Infusion

Clinical Trial Outcome Measures

Primary Measures

  • Time to extubation
    • Time Frame: 60 minutes
    • We will determine if sufentanil infusion administration intra-operatively during routine cardiac surgery will decrease time to extubation.

Secondary Measures

  • Plasma concentration
    • Time Frame: intra-operative
    • 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.

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 19 Years

Maximum Age: 80 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • University of Nebraska
  • Provider of Information About this Clinical Study
    • Principal Investigator: Jeffrey Songster MD, Principal Investigator – University of Nebraska
  • Overall Contact(s)
    • Jeffrey Songster, MD, 402-559-4455, jeffrey.songster@unmc.edu

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