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Randomized Controlled Trial
. 2023 Aug;37(4):511-521.
doi: 10.1007/s00540-023-03193-5. Epub 2023 Apr 13.

Effect of intraoperative remimazolam on postoperative sleep quality in elderly patients after total joint arthroplasty: a randomized control trial

Chun-Mei Deng #  1 , Zhao-Ting Meng #  1 , Jing Yang  2 , Cai-Juan Zhang  3 , Min Lu  2 , Yue-Xin Wang  2 , Dong-Liang Mu  4
Affiliations
Randomized Controlled Trial

Effect of intraoperative remimazolam on postoperative sleep quality in elderly patients after total joint arthroplasty: a randomized control trial

Chun-Mei Deng et al. J Anesth. 2023 Aug.

Abstract

Purpose: To investigate the effect of intraoperative remimazolam sedation on postoperative sleep quality in elderly patients after total joint arthroplasty.

Methods: Between May 15, 2021 and March 26, 2022, 108 elderly patients (age ≥ 65 years) who received total joint arthroplasty under neuraxial anesthesia were randomized into remimazolam group (a loading dose of 0.025-0.1 mg/kg and followed by an infusion rate of 0.1-1.0 mg/kg/h till end of surgery) or routine group (sedation was given on patient's requirement by dexmedetomidine 0.2-0.7 μg/kg/h). Primary outcome was the subjective sleep quality at surgery night which was evaluated by Richards Campbell Sleep Questionnaire (RCSQ). Secondary outcomes included RCSQ scores at postoperative first and second nights and numeric rating scale pain intensity within first 3 days after surgery.

Results: RCSQ score at surgery night was 59 (28, 75) in remimazolam group which was comparable with 53 (28, 67) in routine group (median difference 6, 95% CI - 6 to 16, P = 0.315). After adjustment of confounders, preoperative high Pittsburg sleep quality index was associated worse RCSQ score (P = 0.032), but not remimazolam (P = 0.754). RCSQ score at postoperative first night [69 (56, 85) vs. 70 (54, 80), P = 0.472] and second night [80 (68, 87) vs. 76 (64, 84), P = 0.066] were equivalent between two groups. Safety outcomes were comparable between the two groups.

Conclusions: Intraoperative remimazolam did not significantly improve postoperative sleep quality in elderly patients undergoing total joint arthroplasty. But it is proved to be effective and safe for moderate sedation in these patients.

Clinical trial number and registry url: ChiCTR2000041286 ( www.chictr.org.cn ).

Keywords: Bispectral index; Remimazolam; Sedation; Sleep; Total joint arthroplasty.

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Conflict of interest statement

None.

Figures

Fig. 1
Fig. 1
Flowchart of the trial. ITT, intention-to-treat
Fig. 2
Fig. 2
Richards Campbell Sleep Questionnaire scores distribution between two groups of the first 3 nights after surgery. Horizontal stacked bar graphs show Richards Campbell Sleep Questionnaire score distribution between BIS-guided sedation group and routine care group of A night of the surgery, B first night after surgery and C second night after surgery. Bars are labelled with proportions
See this image and copyright information in PMC

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