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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