MedDataX Logo

Sufentanil Infusion vs Sufentanil Bolus

NCT ID: NCT04226495

Last Updated: 2024-12-11

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

65 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-10-13

Study Completion Date

2021-10-28

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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).

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Anesthesia

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Sufentanil Bolus

medication in scheduled doses (bolus)

Group Type ACTIVE_COMPARATOR

Sufentanil Bolus

Intervention Type DRUG

Intra-operative sufentanil bolus

Sufentanil Infusion

medication in a slow trickle (infusion)

Group Type EXPERIMENTAL

Sufentanil Infusion

Intervention Type DRUG

Intra-operative sufentanil infusion

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Sufentanil Infusion

Intra-operative sufentanil infusion

Intervention Type DRUG

Sufentanil Bolus

Intra-operative sufentanil bolus

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Sufentanil Sufentanil

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

19 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University of Nebraska

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Jeffrey C Songster, MD

Role: PRINCIPAL_INVESTIGATOR

University of Nebraska

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

University of Nebraska Medical Center

Omaha, Nebraska, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Provided Documents

Download supplemental materials such as informed consent forms, study protocols, or participant manuals.

Document Type: Study Protocol

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

0520-20-FB

Identifier Type: -

Identifier Source: org_study_id