Trial Outcomes & Findings for Sufentanil Infusion vs Sufentanil Bolus (NCT NCT04226495)

Last Updated: 2024-12-11

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

65 participants

Primary outcome timeframe

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

Results posted on

2024-12-11

Participant Flow

Participant milestones

Participant milestones
Measure	Sufentanil Bolus Sufentanil Bolus: Intra-operative sufentanil bolus	Sufentanil Infusion Sufentanil Infusion: Intra-operative sufentanil infusion
Overall Study STARTED	32	33
Overall Study COMPLETED	26	26
Overall Study NOT COMPLETED	6	7

Reasons for withdrawal

Reasons for withdrawal
Measure	Sufentanil Bolus Sufentanil Bolus: Intra-operative sufentanil bolus	Sufentanil Infusion Sufentanil Infusion: Intra-operative sufentanil infusion
Overall Study Withdrawal by Subject	3	3
Overall Study PI discretion	3	4

Baseline Characteristics

Sufentanil Infusion vs Sufentanil Bolus

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Sufentanil Bolus n=32 Participants Sufentanil Bolus: Intra-operative sufentanil bolus	Sufentanil Infusion n=33 Participants Sufentanil Infusion: Intra-operative sufentanil infusion	Total n=65 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	17 Participants n=5 Participants	18 Participants n=7 Participants	35 Participants n=5 Participants
Age, Categorical >=65 years	15 Participants n=5 Participants	15 Participants n=7 Participants	30 Participants n=5 Participants
Age, Continuous	64.9 years STANDARD_DEVIATION 8.4 • n=5 Participants	63.3 years STANDARD_DEVIATION 8.9 • n=7 Participants	64.1 years STANDARD_DEVIATION 8.7 • n=5 Participants
Sex: Female, Male Female	6 Participants n=5 Participants	5 Participants n=7 Participants	11 Participants n=5 Participants
Sex: Female, Male Male	26 Participants n=5 Participants	28 Participants n=7 Participants	54 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	32 Participants n=5 Participants	32 Participants n=7 Participants	64 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	32 participants n=5 Participants	33 participants n=7 Participants	65 participants n=5 Participants

PRIMARY outcome

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

Population: The participant number represent the number of participant whom made it to this portion of the study.

Outcome measures

Outcome measures
Measure	Sufentanil Bolus n=26 Participants Sufentanil Bolus: Intra-operative sufentanil bolus	Sufentanil Infusion n=26 Participants Sufentanil Infusion: Intra-operative sufentanil infusion
Time to Extubation	230.5 Minutes Interval 52.0 to 794.0	242.4 Minutes Interval 58.0 to 691.0

SECONDARY outcome

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

Population: Lab concentration was measured on arrival to ICU. Not all subjects had this lab available, thus the inconsistency of numbers from the participant flow module.

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.

Outcome measures

Outcome measures
Measure	Sufentanil Bolus n=22 Participants Sufentanil Bolus: Intra-operative sufentanil bolus	Sufentanil Infusion n=20 Participants Sufentanil Infusion: Intra-operative sufentanil infusion
Plasma Concentration	2.8 ng/mL Standard Deviation 0.5	2.8 ng/mL Standard Deviation 0.5

Adverse Events

Sufentanil Bolus

Serious events: 1 serious events

Other events: 4 other events

Deaths: 0 deaths

Sufentanil Infusion

Serious events: 1 serious events

Other events: 5 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Sufentanil Bolus n=31 participants at risk Sufentanil Bolus: Intra-operative sufentanil bolus	Sufentanil Infusion n=33 participants at risk Sufentanil Infusion: Intra-operative sufentanil infusion
Vascular disorders Acute left MCA stroke	3.2% 1/31 • Number of events 1 • Procedure end time to discharge from hospital, an average of 4 days. AEs and SAEs will be captured on a source document page. AEs and SAEs will be reported to the PI within 24 hrs of notice of occurrence. AEs and SAEs will be reviewed by PI for severity and relationship. Any reportable AEs will be reported to the IRB within 5 business days, and SAEs will be reported to Institutional Review Board within 24 hrs of PI becoming aware of occurrence. PI will determined what follow up is needed for each event.	0.00% 0/33 • Procedure end time to discharge from hospital, an average of 4 days. AEs and SAEs will be captured on a source document page. AEs and SAEs will be reported to the PI within 24 hrs of notice of occurrence. AEs and SAEs will be reviewed by PI for severity and relationship. Any reportable AEs will be reported to the IRB within 5 business days, and SAEs will be reported to Institutional Review Board within 24 hrs of PI becoming aware of occurrence. PI will determined what follow up is needed for each event.
Cardiac disorders Emergent OR procedure	0.00% 0/31 • Procedure end time to discharge from hospital, an average of 4 days. AEs and SAEs will be captured on a source document page. AEs and SAEs will be reported to the PI within 24 hrs of notice of occurrence. AEs and SAEs will be reviewed by PI for severity and relationship. Any reportable AEs will be reported to the IRB within 5 business days, and SAEs will be reported to Institutional Review Board within 24 hrs of PI becoming aware of occurrence. PI will determined what follow up is needed for each event.	3.0% 1/33 • Number of events 1 • Procedure end time to discharge from hospital, an average of 4 days. AEs and SAEs will be captured on a source document page. AEs and SAEs will be reported to the PI within 24 hrs of notice of occurrence. AEs and SAEs will be reviewed by PI for severity and relationship. Any reportable AEs will be reported to the IRB within 5 business days, and SAEs will be reported to Institutional Review Board within 24 hrs of PI becoming aware of occurrence. PI will determined what follow up is needed for each event.

Other adverse events

Other adverse events
Measure	Sufentanil Bolus n=31 participants at risk Sufentanil Bolus: Intra-operative sufentanil bolus	Sufentanil Infusion n=33 participants at risk Sufentanil Infusion: Intra-operative sufentanil infusion
Cardiac disorders Hypotension	12.9% 4/31 • Number of events 4 • Procedure end time to discharge from hospital, an average of 4 days. AEs and SAEs will be captured on a source document page. AEs and SAEs will be reported to the PI within 24 hrs of notice of occurrence. AEs and SAEs will be reviewed by PI for severity and relationship. Any reportable AEs will be reported to the IRB within 5 business days, and SAEs will be reported to Institutional Review Board within 24 hrs of PI becoming aware of occurrence. PI will determined what follow up is needed for each event.	15.2% 5/33 • Number of events 5 • Procedure end time to discharge from hospital, an average of 4 days. AEs and SAEs will be captured on a source document page. AEs and SAEs will be reported to the PI within 24 hrs of notice of occurrence. AEs and SAEs will be reviewed by PI for severity and relationship. Any reportable AEs will be reported to the IRB within 5 business days, and SAEs will be reported to Institutional Review Board within 24 hrs of PI becoming aware of occurrence. PI will determined what follow up is needed for each event.

Additional Information

Jeffrey Songster

University of Nebraska Medical Center

Phone: 308-520-2847

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place