Comparison of Remimazolam Versus Dexmedetomidine on the Quality of Recovery in Functional Endoscopic Sinus Surgery ： A Randomized Clinical Trial

Abstract

Background: The quality of recovery (QoR) of remimazolam versus dexmedetomidine was compared as measured by QoR-40 scores in functional endoscopic sinus surgery (FESS). Methods: 120 patients (18–65 years) scheduled for FESS were randomly allocated to the group R , group D or group C. Group R received remimazolam 0.075 mg/kg loading, 0.1mg/kg/h infusion.Group D received dexmedetomidine 1.0 µg/kg loading, 0.5 µg/kg/h infusion.Group C received the placebo equal to dexmedetomidine.The primary outcome was QoR-40 scores on the day before surgery and postoperative day 1 (POD1).Secondary outcomes were the time to awareness,the length of stay in the PACU,sedation score upon PACU arrival, pain, postoperative nausea and vomiting (PONV). Adverse effects were recorded. Results: The total QoR-40 scores (median, IQR) on POD1 were decreased less(154.5, 152.0 to159.0) in the groups R and D (155.0, 154.8 to159.3)than in the group C (139.0, 136.8 to142.0) (P=0.000).The time to awareness and the length of stay in the PACU were significantly lower in the groups R and C than in the group D (P=0.000).The level of sedation upon PACU arrival (median, IQR) in the groups R (-2.0, -2.0 to -1.0) and D (-2.0, -3.0 to -2.0) was deeper than in the group C (1.0, 0.0 to 1.0)(P=0.000). Compared to the group C, the pain intensity was reduced inthe groups R and D (P=0.000). The incidence of PONV was lower in the groups R (6,15.0%) and D (8,20.0%) than in the group C (17,42.5%)(P=0.011).15 patients had bradycardia in the group D,while no bradycardia was noted in the groups R and C(P=0.000). Conclusion: Administration of remimazolam could provided a similar QoR to dexmedetomidine. And remimazolam can be a promising option for improving the QoR in FESS. Trial registration: ChiCTR2300076209. (Prospective registered). Initial registration date was 27/9/2023.