Table 3 Efficacy outcomesa

From: Effect of a single low-dose esketamine administration during surgical abortion on postoperative sleep disturbance: a randomized controlled trial

Outcome

Placebo group (n = 102)

Esketamine group (n = 102)

Estimated effects (95% CI)b

P value

Primary outcome

Incidence of sleep disturbance on the first night after surgery, No. (%)

73 (71.6)

48 (47.1)

OR, 0.35 (0.20–0.64)

0.0004

Incidence of sleep disturbance on the first night after surgery (per-protocol analysis), No. (%)

73 (73) (n = 100)

48 (47.5) (n = 101)

OR, 0.34 (0.19–0.62)

0.0002

Secondary outcomes

AIS score, median (IQR)c

    

 First night after surgery

6.5 (5–8.25)

5 (5–8)

Median difference, −1 (−1 to 0)

0.0046

 Second night after surgery

7 (5–9)

5 (4–7.25)

Median difference, −1 (−1 to 0)

0.0378

 Third night after surgery

5 (5–9)

5 (4–9)

Median difference, 0 (−1 to 0)

0.0450

 Seventh night after surgery

5 (4–9) (2)h

5 (4–7) (1)h

Median difference, 0 (−1 to 0)

0.1097

HADS-A score, median (IQR)d

    

 Postoperative day 1

9.5 (8–11)

9 (7–11)

Median difference, 0 (−1 to 1)

0.5864

 Postoperative day 2

9.5 (7.75–11)

9 (8–11)

Median difference, 0 (−1 to 0)

0.5046

 Postoperative day 3

10 (8–12)

9.5 (7.75–11)

Median difference, 0 (−1 to 0)

0.2879

 Postoperative day 7

10 (8–11.75)(2)h

10 (7–11)(1)h

Median difference, 0 (−1 to 0)

0.3418

HADS-D score, median (IQR)e

    

 Postoperative day 1

3 (2–3)

3 (2–3)

Median difference, 0(0 to 0)

0.6073

 Postoperative day 2

2.5 (2–3)

3 (2–3)

Median difference, 0(0 to 0)

0.2558

 Postoperative day 3

3 (2–3)

3 (2–3)

Median difference, 0(0 to 0)

0.4363

 Postoperative day 7

3 (2–3)(2)h

3 (2–3)(1)h

Median difference, 0(0 to 0)

0.3008

NRS scoref

    

At rest, median (IQR)

    

 Postoperative hour 1

4 (2.75–5)

3 (2–4)

Median difference, 0 (−1 to 0)

0.0151

 Postoperative day 1

4 (3–4)

3 (2–4)

Median difference, 0 (−1 to 0)

0.0676

 Postoperative day 2

3 (2–3)

2 (2–3)

Median difference, 0 (−1 to 0)

0.0999

 Postoperative day 3

2 (1–2)

2 (1–2)

Median difference, 0 (0 to 0)

0.3328

 Postoperative day 7

1 (0–1)(2)h

1 (0–1)(1)h

Median difference, 0 (0 to 0)

0.53

After movement, median (IQR)

    

 Postoperative hour 1

5 (4–6)

5 (4–5)

Median difference, 0 (−1 to 0)

0.0661

 Postoperative day 1

4 (3–4)

3 (3–4)

Median difference, 0 (−1 to 0)

0.0750

 Postoperative day 2

3 (2–3)

2 (1–3)

Median difference, 0 (−1 to 0)

0.1219

 Postoperative day 3

2 (1.75–2)

2 (1–2)

Median difference, 0 (0 to 0)

0.4332

 Postoperative day 7

1 (0.25–1)(2)h

1 (0–1)(1)h

Median difference, 0 (0 to 0)

0.4121

Postoperative use of acetaminophen, No. (%)

13 (12.8)

6 (5.9)

OR, 2.34 (0.89 to 6.31)

0.0917

QoR15 score on postoperative day 7, median (IQR)g

118 (106–126) (2)h

121 (112–127) (1)h

Median difference, 2 (−1 to 5)

0.2542

  1. AIS Athens Insomnia Scale, ASA American Society of Anesthesiologists, HADS-A Hospital Anxiety and Depression Scale-Anxiety, HADS-D Hospital Anxiety and Depression Scale-Depression, NRS numerical rating scale, OR odds ratio, QoR-15 15-item quality of recovery.
  2. aData presented as median (IQR) were compared using the Mann-Whitney test. Data reported as the number of patients (%) were compared using the Pearson χ2 test or Fisher exact test. All statistical tests used were two-sided.
  3. bCalculated as the esketamine group minus or vs the placebo group.
  4. cScores ranges from 0 to 24 points, with a total score of 6 or above indicating sleep disturbance.
  5. dScores ranges from 0 to 21 points, with a total score of 8 or above indicating anxiety.
  6. eScores ranges from 0 to 21 points, with a total score of 8 or above indicating depression.
  7. fScores ranges from 0 to 10 points, with 0 indicating no pain and 10 indicating the worst pain.
  8. gScores ranges from 0 to 150 points, with 118 or greater points indicating a good postoperative recovery.
  9. hPatients with missing data owing to refused assessment.
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