Pupillary Reflex Dilation And Pain Index Evaluation During General Anesthesia Using Sufentanil: A Double-Blind Randomized Controlled Trial

Abstract

Aim: In a single-center, double-blind, randomized controlled trial, we evaluated whether pupillometry-controlled use of sufentanil is better than free-choice administration of sufentanil by anesthesiologists. Patients methods: 61 patients undergoing daycare gynecological or abdominal surgery were enrolled. A pupillometry pain index score chart was introduced for administration guidance of sufentanil. Results: The first objective, patient well-being, did not show a significant difference with painkiller usage and health state index at day 1 postoperatively. Second, we experienced difficulty in interpretation of the pupillometry score. Third, opioid usage was higher in the intervention group (20.1 vs 14.8 mcg; p = 0.017). Conclusion: The use of pupillometry and pain index chart for bolus sufentanil with our protocol showed an unwanted higher sufentanil usage without a significant difference in patient wellbeing. (Ethics Committee EC17/28/319 of the University Hospital of Antwerp. Registration at clinicaltrials.govNCT03248908).

Plain language summary

Communication with patients under general anesthesia is impossible. A potential solution is to measure pain. One of seven commercially available options is to use a pupillometer. Automated painful stimuli are given and the dilation of the pupil is measured. We hoped to use this method to better control the dose of the opioid sufentanil. During daycare gynecological and abdominal procedures, we had a 25% higher sufentanil usage in the intervention group. We experienced difficulties in reaching the right pain score in both groups. The well-being of the patients, namely pain and painkiller usage at day 1 after surgery, did not show any significant difference. With our protocol, there is no benefit to controlling the dose of sufentanil by pupillometer measurement.

Keywords: :

• analgesia
• anesthesia
• pain index
• pupillometry
• sufentanil

Supplementary data

To view the supplementary data that accompany this paper please visit the journal website at: www.tandfonline.com/doi/suppl/10.2217/pmt-2022-0027

Author contributions

D Van Vlaenderen, G Hans, S Vera and D Wildemeersch made all substantial contributions to the conception or design of the work, or to or the acquisition, analysis or interpretation of data for the work; and to drafting the work or revising it critically for important intellectual content. All authors gave final approval of the version to be published, and agree to be accountable for all aspects of the work in ensuring that questions related to the accuracy or integrity of any part of the work are appropriately investigated and resolved.

Financial & competing interests disclosure

The authors have no relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript. This includes employment, consultancies, honoraria, stock ownership or options, expert testimony, grants, or patents received or pending, or royalties.

No writing assistance was utilized in the production of this manuscript.

Ethical conduct of research

The authors state that they have obtained appropriate institutional review board approval or have followed the principles outlined in the Declaration of Helsinki for all human or animal experimental investigations. In addition, for investigations involving human subjects, informed consent has been obtained from the participants involved.

Data sharing statement

The authors certify that this manuscript reports original clinical trial data. Individual, de-identified participant data that underlie the results reported in this article (text, tables, figures and appendices) are available from the corresponding author following publication, including the clinical study report and study protocol.