The Hip Fracture Surgery in Elderly Patients (HIPELD) study: protocol for a randomized, multicenter controlled trial evaluating the effect of xenon on postoperative delirium in older patients undergoing hip fracture surgery

Table 1 Study evaluations

	Visit 0^a(selection)	Visit 1^b (GA)	Visit 2^a(3 h post GA)	Visit 3^a(day 1)		Visit 4^a (day 2)		Visit 5^a (day 3)		Visit 6^a (day 4)		Visit 7^a (day 5 to D)		Visit 8^a (study end)
				A	B	A	B	A	B	A	B	A	B
Signed informed consent	X
Selection criteria	X
Demographic data	X
Vital signs	X	X	X	X		X		X		X		X
Medical and surgical history	X
Concomitant diseases	X
Concomitant medication	X	X	X	X	X	X	X	X	X	X	X	X	X	X
MMSE evaluation	X
Randomization			X
General anesthesia			X
Blood sample	X			X		X		X		X		According to investigator’s judgment
CAM evaluation	X		X	X	X	X	X	X	X	X	X	X	X
Pain VAS evaluation	X	X	X	X		X		X		X
Verbal Rating Scale for Nausea		X	X	X
SOFA	X			X		X		X		X		According to investigator’s judgment
Recovery parameters		X
Adverse events		X	X	X	X	X	X	X	X	X	X	X	X	X

A represents 10:00 am ± 30 minutes; B represents 6:00 pm ± 30 minutes; day 5 to D is post-surgery day 5 until discharge from hospital (or at maximum 28 days post surgery), or withdrawal from the study.
^aPhysician 1; ^bPhysician 2.
CAM = Confusion Assessment Method; GA = general anesthesia; MMSE = Mini-Mental State Examination; SOFA = Sequential Organ Failure Assessment; VAS = visual analog scale.

ISSN: 1745-6215