NCT04226495

Sufentanil Infusion vs Sufentanil Bolus

Completed Phase 4 Results posted Last updated 11 December 2024

What this trial tests

Phase 4 trial testing Sufentanil Infusion in Anesthesia in 65 participants. Completed in 28 October 2021.

Timeline

13 October 2020

Primary endpoint
28 October 2021

28 October 2021

Quick facts

Lead sponsor	University of Nebraska
Phase	Phase 4
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	treatment
Enrollment	65
Start date	13 October 2020
Primary completion	28 October 2021
Estimated completion	28 October 2021
Sites	1 location across United States

Drugs / interventions tested

• Sufentanil Infusion — full drug profile →
• Sufentanil Bolus — full drug profile →

Conditions studied

• Anesthesia — all drugs for Anesthesia →

Sponsor

University of Nebraska

Who can join

Adults 19 to 80, any sex, with Anesthesia. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Time to Extubation Primary · 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.

Group	Value	95% CI
Sufentanil Bolus	230.5	52 – 794
Sufentanil Infusion	242.4	58 – 691

Plasma Concentration Secondary · 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.

Group	Value	95% CI
Sufentanil Bolus	2.8	± 0.5
Sufentanil Infusion	2.8	± 0.5

Adverse events — posted to ClinicalTrials.gov

Time frame: Procedure end time to discharge from hospital, an average of 4 days.. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Sufentanil Bolus

Serious: 1/31 (3%)

Deaths: 0/31

Sufentanil Infusion

Serious: 1/33 (3%)

Deaths: 0/33

Serious adverse events (2 terms)

Reaction	System	Sufentanil Bolus	Sufentanil Infusion
Acute left MCA stroke	Vascular disorders	—	—
Emergent OR procedure	Cardiac disorders	—	—

Other adverse events (1 terms — click to expand)

Reaction	System	Sufentanil Bolus	Sufentanil Infusion
Hypotension	Cardiac disorders	—	—

Most-reported serious reactions: Acute left MCA stroke, Emergent OR procedure.

Data from ClinicalTrials.gov NCT04226495 adverse events section.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.