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Table 2 Study outcomes

From: Efficacy and safety of remimazolam tosilate versus propofol in patients undergoing day surgery: a prospective randomized controlled trial

Perioperative Details

RT

(Arm A, n = 38)

RT + flumazenil

(Arm B, n = 38)

Propofol

(Arm C, n = 38)

P value

Arm A vs. Arm C

Arm B vs. Arm C

Arm A vs. Arm B

Primary endpoint

       

 Induction time (s)

50.0(45.0-55.8)

49.5(43.8–60.0)

51.0(41.0-60.3)

0.437

   

 Time to fully alert (min)

17.6(12.9–24.1)

12.3(11.6–13.0)

12.3(9.4–16.4)

< 0.001

< 0.001

0.949

< 0.001

Secondary endpoints

       

 Success rate of anesthesia

37(97.4)

37(97.4)

37(97.4)

1.000

   

 LMA insertion time (s)

129.0(120.0-139.0)

125.0(119.0-140.0)

140.0(118.5–155.0)

0.820

   

 Time to eye opening (min)

16.8(11.4–22.4)

11.3(11.1–12.2)

10.2(7.8–15.5)

< 0.001

< 0.001

0.570

0.001

 Time to LMA extraction (min)

17.2(12.2–22.8)

11.7(11.3–12.5)

11.2(8.2–16.1)

< 0.001

< 0.001

0.712

0.001

 Time to the third consecutive Aldrete score ≥ 9 (min)

49.0(43.5–52.0)

33.5(28.0-37.3)

33.0(30.0-35.8)

< 0.001

< 0.001

0.664

< 0.001

 Delirium at PACU

0

0

0

1.000

   

 BIS

       

  Baseline

89.0(86.0–94.0)

93.0(89.5–95.0)

94.0(88.0–96.0)

0.216

   

  LoC

70.0(62.0–74.0)

66.5(62.8–76.0)

55.5(48.0-66.3)

0.002

0.002

0.002

0.969

  LMA insertion

63.5(58.0-71.3)

67.0(62.3–74.0)

51.0(43.0–60.0)

< 0.001

< 0.001

< 0.001

0.212

  LMA extraction

86.0(82.3–87.0)

87.0(84.0-89.3)

87.0(87.0–90.0)

0.009

0.002

0.246

0.078

  Exiting operating room

86.0(83.3–87.8)

87(84.0–91.0)

87.0(85.5–90.5)

0.034

0.005

0.618

0.050

 N BIS values during anesthesia maintenance

      

  BIS > 60

37(97.4)

35(92.1)

16(42.1)

< 0.001

< 0.001

< 0.001

0.615

  BIS<40

3(7.9)

2(5.3)

11(28.9)

0.005

0.018

0.006

1.000

  % time BIS > 60 during anesthesia maintenance (%)

80.0 (53.4–89.7)

73.6 (50.0-90.5)

0.0 (0.0-39.7)

< 0.001

< 0.001

< 0.001

0.954

  RT dose (mg)

49.2(22.5–69.0)

36.0(28.0-75.2)

 

0.941

   

  Sufentanil (µg)

14.8(11.9–20.0)

15.0(12.6–19.5)

14.9(13.0–20.0)

0.805

   

  Remifentanil (µg)

250.0(121.45–340.0)

140.4(98.0-320.0)

140.0(100.0-261.0)

0.301

   

  Vasopressors

12(31.6)

12(31.6)

27(71.1)

< 0.001

0.001

0.001

1.000

  Ephedrine (mg)

0.0(0.0–0.0)

0.0(0.0–0.0)

6.0(0.0–6.0)

< 0.001

0.001

< 0.001

0.847

  Phenylephrine (mg)

0.0(0.0–0.0)

0.0(0.0–0.0)

0.0(0.0-0.1)

0.048

0.015

0.209

0.219

  1. Data are presented as median (interquartile range) or numbers (percentages), as appropriate
  2. Abbreviations: BIS, bispectral index; IQR, interquartile range; LMA, laryngeal mask airway; LoC, loss of consciousness; N BIS values, number of patients with corresponding BIS values; PACU, postanesthesia care unit; RT, remimazolam tosilate; % time BIS > 60 during anesthesia maintenance, the percentage of time with BIS values > 60 in the whole anesthesia maintenance period
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BMC Anesthesiology

ISSN: 1471-2253

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