Comparison of the effects of remimazolam and dexmedetomidine on the quality of recovery in functional endoscopic sinus surgery: a randomized clinical trial.

Abstract

Background: Postoperative pain usually occur in patients who have undergone functional endoscopic sinus surgery (FESS). Remimazolam and dexmedetomidine could enhance the quality of recovery (QoR) after surgery. The aim of this study was to compare the effects of remimazolam and dexmedetomidine with respect to the QoR-40 score of patients who have undergone FESS.

Methods: A total of 120 patients (18-65 years) scheduled for FESS were randomly allocated to Group R, Group D or Group C. Group R received 0.075 mg/kg remimazolam loading and 0.1 mg/kg/h infusion. Group D received dexmedetomidine (1.0 µg/kg loading, 0.5 µg/kg/h infusion). Group C received a placebo equal to dexmedetomidine. Anaesthesia was induced with propofol, sufentanil and cisatracurium. Anaesthesia maintenance was performed via target-controlled infusions (TCIs) of propofol and remifentanil. The primary outcome was the QoR-40 score on the day before surgery and postoperative Day 1 (POD1). The secondary outcomes were the time to return to consciousness, length of stay in the PACU, sedation score upon PACU arrival, pain, postoperative nausea and vomiting (PONV) and cumulative consumption of propofol and remifentanil. Adverse effects were recorded.

Results: The total QoR-40 scores (median, IQR) on POD1 decreased less (154.5, 152.0 -159.0) in Groups R and D (155.0, 154.8 -159.3) than in Group C (139.0, 136.8 -142.0) (P < 0.001). The time to return of consciousness and the length of stay in the PACU were significantly shorter in Groups R and C than in Group D (P < 0.001). The level of sedation upon PACU arrival (median, IQR) in Groups R (-2.0, -2.0--1.0) and D (-2.0, -3.0--2.0) was greater than that in Group C (1.0, 0.0 -1.0) (P < 0.001). The cumulative consumption rates of propofol and remifentanil in Groups R and D were lower than that in Group C (P < 0.001). Compared with that in Group C, the pain intensity was lower in Groups R and D (P < 0.001).The number of patients occurring PONV was less in Groups R (3/40) and D (4/40) than in Group C (11/40) (P = 0.024). Fifteen patients had bradycardia in Group D, whereas no bradycardia was noted in Groups R or C (P < 0.001).

Conclusion: Administration of remimazolam could provide a similar QoR to that of dexmedetomidine. In addition, remimazolam may be a promising option for improving the QoR of patients who have undergone FESS.

Trial registration: ChiCTR2300076209. (Prospectively registered). The initial registration date was 27/9/2023.