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Table 4 Primary and Secondary Outcomes

From: Dexmedetomidine for prevention of postoperative pulmonary complications in patients after oral and maxillofacial surgery with fibular free flap reconstruction:a prospective, double-blind, randomized, placebo-controlled trial

Outcome

Dexmedetomidine group

Placebo group

Relative risk

P value

(n = 80)

(n = 80)

(95% CI)

Primary outcome, No. (%)

 Overall incidence of PPCs

18 (22.5)

32(40.0)

0.563 (0.346–0.916)

0.017

 Respiratory infection

14 (17.5)

19 (23.8)

0.737 (0.398–1.356)

0.329

 Respiratory failure

3 (3.8)

7 (8.8)

0.429 (0.115–1.599)

0.191

 Pleural effusion

0 (0)

2 (2.5)

0.155

 Atelectasis

1 (1.3)

5 (6.3)

0.200 (0.024–1.674)

0.096

 Pneumothorax

0 (0)

0 (0)

 Bronchospasm

0 (0)

1 (1.3)

0.316

 Aspiration pneumonitis

0 (0)

0 (0)

 Pulmonary edema

1 (1.3)

2 (2.5)

0.500(0.046–5.404)

0.560

 Pulmonary embolism

1 (1.3)

1 (1.3)

1.000 (0.064–15.712)

1.000

 Acute respiratory distress syndrome

1 (1.3)

0 (0)

0.316

Secondary outcome, No. (%)

 The time to first diagnosis of PPCs a

4 (2, 5)

3 (2, 5)

0.928

The number of PPCs b

 0.00

62 (77.5)

48 (60.0)

 1.00

15 (18.8)

27 (33.8)

0.541 (0.314–0.933)

0.023

 2.00

3 (3.8)

5 (6.3)

0.489 (0.123–1.954)

0.300

postoperative extrapulmonary complications c

 Delirium

1 (1.3)

4 (5.0)

0.250 (0.029–2.188)

0.173

 Anemia d

3 (3.8)

2 (2.5)

1.500 (0.258–8.737)

0.650

 Extrapulmonary infection

2 (2.5)

4 (5.0)

0.500(0.094–2.653)

0.405

 Need secondary surgery e

4 (5.0)

6 (7.5)

0.667 (0.196–2.273)

0.514

Adverse events

 Bradycardia f

2 (2.5)

2 (2.5)

1

 Hypotension g

2 (2.5)

3 (3.8)

0.667 (0.114–3.883)

0.650

 Length of stay in hospital after surgery, median (IQR), day

9 (8, 11)

10 (9, 11)

0.036

30-day all-cause mortality

0(0.0)

0(0.0)

1

  1. Abbreviations: PPCs Postoperative pulmonary complications
  2. a Indicated the time from end of surgery to first diagnosis of PPCs within 7 days after surgery
  3. b Indicated the number of diagnosed individual PPCs within 7 days after surgery
  4. c Defined as complications other than PPCs that occur during operation and within 7 days after surgery, and require therapeutic intervention
  5. d Defined as hemoglobin less than 9 g/dL
  6. e Included hematoma or vascular crisis exploration within 7 days after surgery
  7. f Defined as heart rate less than 50 beats/min or a decrease of more than 20% from baseline
  8. g Defined as systolic blood pressure less than 90 mmHg or a decrease of more than 20% from baseline