Pupillary Reflex Dilation And Pain Index Evaluation During General Anesthesia Using Sufentanil: A Double-Blind Randomized Controlled Trial

Figures & data

Table 1. Pupillometry pain index score.

Maximum intensity (mA)	PPI score	Stop stimulation
10	9	Dilation ≥13% stimulating 10 mA
20	8	Dilation ≥13% stimulating 20 mA
30	7	Dilation ≥13% stimulating 30 mA
40	6	Dilation ≥13% stimulating 40 mA
50	5	Dilation ≥13% stimulating 50 mA
60	4	Dilation ≥13% during first stimulation 60 mA
60	3	Dilation ≥13% during second stimulation 60 mA
60 (5% < pupil dilatation <13%)	2	Dilation ≥13% during third stimulation 60 mA
60 (pupil dilatation ≤5%)	1	Fourth stimulation 60 mA

Note: when pupil dilatation was more than 20%, the resulting score was PPI score + 1.

PPI: Pupillometry pain index.

Figure 1. Flowchart: administration of sufentanil.

CBW: Corrected body weight; PPI: Pupillometry pain index.

Figure 2. CONSORT flow diagram.

CONSORT: Consolidated Standards of Reporting Trials.

Table 2. End measurements.

Total	Sufentanil flowchart	Sufentanil control	p-value	Test
n = 60	n = 29	n = 31
End baseline	2.1 (0.29)	2.0 (0.31)	0.666	T
End PRDA	0.30 (0.138)	0.33 (0.172)	0.915	M
End VAR	14 (5.8)	16 (8.9)	0.898	M
End Int (mA)	60 (10)	50 (20)	0.430	M
End PPI (median)	5 (5)	5 (5)	0.510	M
End SBP	100 (15.0)	104 (18.1)	0.387	T
End HR	63 (14.2)	61 (10.3)	0.658	T
End Neurowave	44 (10.0)	43.2 (11.2)	0.806	T
End PPI 1/2 vs ≥3			0.969	C
PPI 1 or 2	9 (31.0%)	8 (25.8%)
PPI ≥3	20 (69.0%)	23 (74.2%)

C: Pearson χ-square test; HR: Heart rate; Int: Intensity; M: Mann–Whitney U test; PPI: Pupillometry pain index; PRDA: Pupil reflex dilation amplitude; SBP: Systolic blood pressure; T: t-test; VAR: Variation.

Table 3. Two-way analysis of variance pupil baseline diameter and pupillometry pain index.

	Sufentanil flowchart	Sufentanil control
Baseline T0	4.1 (3.7–4.4)	4.2 (3.9–4.5)
Baseline T1	2.0 (1.9–2.1)	2.1 (2.0–2.2)
Baseline T2	2.2 (2.0–2.4)	2.2 (2.1–2.4)
Baseline TEnd	2.1 (2.0–2.2)	2.0 (1.9–2.1)
PPI T0	7.5 (6.5–8.4)	6.7 (5.8–7.6)
PPI T1	6.2 (5.4–7.1)	6.1 (5.3–6.9)
PPI T2	4.8 (3.8–5.8)	5.0 (4.1–6.0)
PPI TEnd	4.4 (3.5–5.3)	4.9 (4.0–5.7)

All tests: two-way analysis of variance.

PPI: Pupillometry pain index.

Table 4. Post-anesthesia care unit.

	Sufentanil flowchart	Sufentanil control	p-value	test
Time recovery in minutes (median) (number of answers)	52:00 (14:00) (n = 23)	40:00 (14:30) (n = 25)	0.025	M
Aldrete score: arrival (median) (number of answers)	8 (2.0) (n = 24)	8 (1.0) (n = 29)	0.147	M
Aldrete score: departure (median) (number of answers)	10 (0.5) (n = 23)	10 (0.0) (n = 27)	NA	M
PONV (percentage) (number of answers)	0 (0%) (n = 25)	0 (0%) (n = 30)	>0.999	C
Supplemental oxygen (percentage) (number of answers)	4 (16%) (n = 25)	6 (20%) (n = 30)	0.741	C
Painkiller received (percentage) (number of answers)	2 (12%) (n = 25)	3 (10%) (n = 30)	>0.999	C

C: Pearson χ-square test; M: Mann–Whitney U test; NA: Not applicable; PONV: Post-operative nausea and vomiting.

Table 5. Online questionnaire: day 1 results.

Total	Sufentanil flowchart	Sufentanil control	p-value	Test
n = 61
Medtracking (median) (number of answers)	15 (7.1) (n = 25)	14 (5.6) (n = 28)	0.759	M
NRS pain (median) (number of answers)	2 (4) (n = 13)	1 (4) (n = 11)	0.249	M
NRS activity (median) (number of answers)	5 (4) (n = 13)	5 (2) (n = 11)	0.804	M
NRS sleep (median) (number of answers)	7 (3) (n = 13)	6 (6) (n = 11)	0.429	M
Nausea (%) (number of answers)	3 (23%) (n = 13)	0 (0%) (n = 11)	0.223	C
Vomiting (%) (number of answers)	2 (15%) (n = 13)	0 (0%) (n = 12)	0.480	C
Health State Index (median) (number of answers)	0.66 (0.279) (n = 16)	0.70 (0.252) (n = 23)	0.464	M
EQ-VAS score (median) (number of answers)	56 (29) (n = 16)	70 (40) (n = 23)	0.247	M

C: Pearson χ-square test; EQ-VAS: European Quality of Life Visual Analog Scale; M: Mann–Whitney U test; NRS: Numeric rating scale.

Data sharing statement

The authors certify that this manuscript reports original clinical trial data. Individual, de-identified participant data that underlie the results reported in this article (text, tables, figures and appendices) are available from the corresponding author following publication, including the clinical study report and study protocol.