Table 3. Adverse Events and Severe Adverse Events.

Events	No. (%)
	Atropine-Propofol Group (n = 83)	Atropine-Atracurium- Sufentanil Group (n = 80)
No. of infants with adverse events	25 (30.1)	28 (35)
Type of adverse events
Hypotension (untreated)	9 (10.8)	1 (1.3)
Hypertension	7 (8.4)	7 (8.8)
Bradycardia <100/min >60 s	1 (1.2)	6 (7.5)
Prolonged hypoxiaa	2 (2.4)	5 (6.3)
Upper airway trauma	4 (4.8)	3 (3.8)
Hypercapnia	3 (3.6)	5 (6.3)
Myoclonia	3 (3.6)	0
Hypocapnia	0	1 (1.3)
Hypothermia	1 (1.2)	0
Laryngospasm	1 (1.2)	0
No. of infants with severe adverse events	9 (10.8)	16 (20.0)
Type of severe adverse events
Death	2 (2.4)b	3 (3.8)c
Thoracic rigidity	3 (3.6)	11 (13.8)
Pneumothorax	2 (2.4)	4 (5.0)
Sepsis	4 (4.8)	1 (1.3)
Digestive tract perforationd	3 (3.6)	1 (1.3)
Hypotension (treated)	2 (2.4)	0
Pulmonary hemorrhage	1 (1.2)	2 (2.5)
Cardiac arrest	1 (1.2)	1 (1.3)
Supraventricular tachycardia	1 (1.2)	0
Pulmonary hypertension	0	1 (1.3)
Aspiration syndrome	0	1 (1.3)
Hyponatremia	1 (1.2)	0

^aNo standardized definition for prolonged hypoxia. These events did not fulfill any of the criteria for being considered severe, namely, causing death, threatening life, causing temporary or permanent disability or incapacity, requiring or extending the hospitalization of a patient.

^bOne patient was included on day 7 of life and died on day 9 due to multiple organ failure with suspected sepsis; 1 patient was included on day 1 of life and died on day 3 due to pulmonary hemorrhage. None of these deaths was attributed to the study drugs.

^cOne patient was included on day 0 of life and died on day 2 due to multiple organ failure without sepsis; 1 patient was included on day 6 of life before surgery and died on day 7 due to postoperative multiple organ failure; 1 patient was included on day 7 of life and died on day 9 due to pulmonary hemorrhage. None of these deaths was attributed to the study drugs.

^dAll perforations occurred in the small bowel; none were in the esophagus.