Comparison of Remimazolam versus Sevoflurane on the Postoperative Quality of Recovery in Cervical Spine Surgery: A Prospective Randomized Controlled Double-Blind Trial

Abstract

Purpose

Remimazolam is a newly developed ultra-short-acting benzodiazepine. We compared overall functional recovery, including the postoperative Quality of Recovery-15 (QoR-15) questionnaire scores, between balanced inhalational anesthesia using sevoflurane and total intravenous anesthesia (TIVA) with remimazolam in patients undergoing anterior cervical discectomy and fusion (ACDF).

Patients and Methods

Seventy-two patients were randomized to the remimazolam (group R) or sevoflurane (group S) group. The primary outcome was the total QoR-15 score on postoperative day (POD) 1. We also assessed the total QoR-15 score on POD2, sub-scores of the QoR-15, perioperative parameters, and postoperative recovery profiles. Group-time interaction effects on the QoR-15 and its sub-scores were analyzed using a linear mixed model.

Results

The total QoR-15 score on POD1 (120.2 in group R vs 114.3 in group S, P=0.189) was not statistically different between the groups. There were no significant group-time interaction effects on total QoR-15 scores. Instead, patients in group R showed significantly better sub-scores in psychological and postoperative nausea and vomiting (PONV) items on POD1, as well as a lower degree of PONV, than those in group S. Among the five dimensions of the QoR-15, a significant group-time interaction effect was observed for psychological support. Group R showed significantly less changeability in blood pressure and heart rate with a lower dose of intraoperatively administered vasopressor than group S.

Conclusion

Considering QoR-15, including PONV reduction, and intraoperative hemodynamic stability, remimazolam can be used as the novel and safe anesthetic agent for maintaining general anesthesia instead of sevoflurane in patients undergoing ACDF.

Plain Language Summary

• Compared with balanced anesthesia using sevoflurane, total intravenous anesthesia with remimazolam showed better aspects for psychological support and postoperative nausea/vomiting in the quality of recovery and hemodynamic stability.

• Despite comparable total Quality of Recovery-15 scores, remimazolam-based total intravenous anesthesia could be a secure and suitable choice for patients undergoing cervical spine surgery.

Keywords:

• cervical spine surgery
• quality of recovery
• remimazolam
• sevoflurane
• total intravenous anesthesia

Abbreviations

ACDF, anterior cervical discectomy and fusion; BMI, body mass index; GABA_A, gamma-aminobutyric acid type A; HR, heart rate; MAP, mean arterial pressure; MCID, minimal clinically important difference; NMB, neuromuscular blockade; NRS, numeric rating scale; PONV, postoperative nausea and vomiting; PACU, post-anesthetic care unit; PCA, Patient-controlled analgesia; POD, postoperative day; PSI, patient state index; QoR, Quality of Recovery; SD, standard deviation; TCI, target-controlled infusion; TIVA, total intravenous anesthesia; TOF, train‐of‐four.

Ethics Approval and Informed Consent

This prospective double-blind randomized controlled trial was conducted at a tertiary hospital in accordance with the Declaration of Helsinki 2013. The protocol was approved by the Institutional Review Board (IRB) of Gangnam Severance Hospital (IRB No. 3-2021-0257), Yonsei University Health System (Seoul, Republic of Korea), and registered before patient enrolment at clinicaltrials.gov (Trial Registration Number: NCT05019222).

Data availability

The datasets used or analyzed during the current study are available from the corresponding author upon reasonable request.

Acknowledgments

We thank the Biostatistics Collaboration Unit and Electronic Medical Record Team at Severance Hospital Yonsei University College of Medicine for their contribution to this study.

Disclosure

The authors declare that they have no conflict of interest.

Additional information

Funding

This research received no financial support.