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NCT Number: NCT04226495

Sufentanil Infusion vs Sufentanil Bolus

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.

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Key information

Conditions

Anesthesia

Age range

19 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

University of Nebraska Medical Center

Omaha, Nebraska, 68198, United States

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Sufentanil Infusion

Drug

Intra-operative sufentanil infusion

Other names: Sufentanil

Sufentanil Bolus

Drug

Intra-operative sufentanil bolus

Other names: Sufentanil

Primary outcomes

  1. Time to Extubation

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

    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.

Secondary outcomes

  1. Plasma Concentration

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

    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.

  2. Oral Morphine Milligram Equivalents

    Time frame: Post-operatively

    Post-operative pain medication dosage in oral morphine milligram equivalents (OMMEs).

  3. Length of ICU Stay

    Time frame: From ICU admission to ICU discharge.

    Duration of post-operative ICU stay in hours.

  4. Length of Hospital Stay

    Time frame: From hospital admission to hospital discharge

    Length of hospitalization from hospital admission to hospital discharge measured in days.

Sponsors and collaborators

Lead sponsor

University of Nebraska

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Jan 13, 2020
Registry last updated
Jun 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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