The Effect of Sufentanil Administration via Bolus or Infusion on Time-to-Extubation in Cardiac Surgery: A Prospective, Randomized Clinical Trial

Abstract

Background Intraoperative opioid administration for cardiac surgery varies greatly, with most of this variability arising from anesthesiologist and institutional practices. Anesthesiologists administer intraoperative opioids via intermittent boluses and continuous infusions. Real-world data have shown infusion administration to be a strong determinant of high intraoperative opioid exposure, but whether bolus or infusion administration of sufentanil affects post-operative outcomes is unknown.

Methods We conducted a prospective, randomized, single-blind controlled trial to compare the impact of intraoperative intermittent bolus administration versus continuous infusion of sufentanil on time to extubation in adult patients undergoing nonemergent cardiac surgery with cardiopulmonary bypass at a single tertiary referral university hospital in the United States.

Results The primary endpoint was the time from operating room departure to extubation in the intensive care unit. The study was terminated early for futility after an interim analysis of 50 subjects. The infusion group received statistically higher doses of intraoperative opioid. The per-protocol analysis found no statistical difference in time to extubation between the bolus group (median 2.9 hours) and infusion group (median 2.6 hours). Secondary outcomes, including post-operative pain scores, opioid consumption, ICU length of stay, and hospital stay, and adverse event rates were comparable between groups.

Conclusions Intraoperative administration of sufentanil via bolus or infusion results in similar time to extubation and recovery metrics. Since continuous infusions are a strong predictor of higher total intraoperative opioid doses, protocols emphasizing administration via intermittent boluses may reduce opioid exposure without compromising recovery.

Question Does the method of intraoperative sufentanil administration, either by intermittent bolus or infusion, affect weaning from mechanical ventilation in the intensive care unit after cardiac surgery?

Findings The method of sufentanil administration did not affect time to extubation after cardiac surgery, but the infusion group received significantly higher intraoperative opioid doses compared to the intermittent bolus group.

Meaning Intermittent opioid bolus administration may reduce intraoperative opioid dosage without negatively impacting recovery after cardiac surgery.

Competing Interest Statement

The authors have declared no competing interest.

Clinical Trial

NCT04226495

Funding Statement

This study was funded by the Department of Anesthesiology at the University of Nebraska Medical Center.

Author Declarations

I confirm all relevant ethical guidelines have been followed, and any necessary IRB and/or ethics committee approvals have been obtained.

Yes

The details of the IRB/oversight body that provided approval or exemption for the research described are given below:

The Institutional Review Board of the University of Nebraska Medical Center gave ethical approval for this work.

I confirm that all necessary patient/participant consent has been obtained and the appropriate institutional forms have been archived, and that any patient/participant/sample identifiers included were not known to anyone (e.g., hospital staff, patients or participants themselves) outside the research group so cannot be used to identify individuals.

Yes

I understand that all clinical trials and any other prospective interventional studies must be registered with an ICMJE-approved registry, such as ClinicalTrials.gov. I confirm that any such study reported in the manuscript has been registered and the trial registration ID is provided (note: if posting a prospective study registered retrospectively, please provide a statement in the trial ID field explaining why the study was not registered in advance).

Yes

I have followed all appropriate research reporting guidelines, such as any relevant EQUATOR Network research reporting checklist(s) and other pertinent material, if applicable.

Yes

Data Availability

All data produced in the present study are available upon reasonable request to the authors.

Comments (0)

No login
gif