Oral Sedation is Non-Inferior to Intravenous Sedation for Cornea and Glaucoma Surgery: A Randomized Controlled Trial

Figures & data

Table 1 Patient Characteristics

	Cornea (n = 70)		p-value	Glaucoma (n = 43)		p-value
	Oral (n = 33)	IV (n = 37)		Oral (n = 24)	IV (n = 19)
Age, years, (mean ± SD)	50.58±18.46	49.49±10.55	0.64	66.88±11.49	65.26±11.57	0.65
Sex, n, % of people			0.94			0.39
Male	22 (66.7%)	25 (67.6%)		12 (50.0%)	12 (63.2%)
Female	11 (33.3%)	12 (32.4%)		12 (50.0%)	7 (36.8%)
BMI (kg/m^2) (mean ± SD)			0.90			0.99
<35 (lower dose)	28 (84.8%)	31 (83.8%)		19 (79.2%)	15 (78.9%)
≥35 (higher dose)	5 (15.2%)	6 (16.2%)		5 (20.8%)	4 (21.1%)
Ethnicity			0.49			0.42
Hispanic/Latino	22 (66.7%)	21 (56.8%)		3 (12.5%)	5 (26.3%)
Non-Hispanic/Latino	11 (33.3%)	15 (40.5%)		18 (75.0%)	13 (68.4%)
Unknown	0 (0.0%)	1 (2.7%)		3 (12.5%)	1 (5.3%)
Race			0.38			0.32
American Indian/Alaskan Native	1 (3.0%)	0 (0.0%)		0 (0.0%)	0 (0.0%)
Asian	0 (0.0%)	0 (0.0%)		1 (4.2%)	0 (0.0%)
Black/African American	7 (21.2%)	12 (32.4%)		16 (66.7%)	11 (57.9%)
Declined	16 (48.5%)	14 (37.8%)		7 (29.2%)	6 (31.6%)
Other	6 (18.2%)	4 (10.8%)		0 (0.0%)	0 (0.0%)
White	3 (9.1%)	7 (18.9%)		0 (0.0%)	2 (10.5%)
Language			0.05*			0.15
English	7 (21.2%)	18 (48.6%)		17 (70.8%)	8 (42.1%)
Spanish	24 (72.7%)	18 (48.6%)		3 (12.5%)	6 (31.6%)
Haitian-Creole	2 (6.1%)	1 (2.7%)		4 (16.7%)	5 (26.3%)
Medical Conditions
Systemic hypertension	11 (33.3%)	11 (29.7%)	0.75	18 (75.0%)	10 (52.6%)	0.13
Tobacco use	5 (15.2%)	4 (10.8%)	0.59	3 (12.5%)	1 (5.3%)	0.42
Hypercholesterolemia	2 (6.1%)	5 (13.5%)	0.30	4 (16.7%)	4 (21.1%)	0.71
Heart disease	2 (6.1%)	3 (8.1%)	0.74	4 (16.7%)	3 (15.8%)	0.94
Diabetes mellitus	7 (21.2%)	8 (21.6%)	0.97	15 (62.5%)	11 (57.9%)	0.76
Hyperlipidemia	5 (15.2%)	7 (18.9%)	0.68	10 (41.7%)	7 (36.8%)	0.75
Asthma/bronchitis/COPD	3 (9.1%)	4 (10.8%)	0.81	3 (12.5%)	3 (15.8%)	0.76
None	15 (45.5%)	15 (40.5%)	0.68	3 (12.5%)	4 (21.1%)	0.45

Note: *statistically significant.

Abbreviations: BMI, body mass index; SD, standard deviation; COPD, chronic obstructive pulmonary disease; n, number of patients who completed data analysis.

Table 2 Surgical Case Types and Operative Times

Case Type	Oral	IV	Surgical Time (Minutes)	Case Time (Minutes)
Cornea
Pterygium (n = 55)	27 (47.4%)	28 (50.0%)	51.62 ± 11.79	33.60 ± 12.33
DMEK (n = 2)	1 (1.8%)	1 (1.8%)	70.00 ± 1.41	47.00 ± 5.66
DMEK with cataract (n =1)	1 (1.8%)	0 (0.0%)	77.00	49.00
DSEK (n = 9)	4 (7.0%)	5 (8.9%)	76.78 ± 12.63	53.67 ± 11.41
Conjunctival/corneal lesion excision (n = 3)	0 (0.0%)	3 (5.4%)	45.00 ± 3.61	29.33 ± 1.15
Glaucoma
Trabeculectomy (n = 2)	1 (1.8%)	1 (1.8%)	84.00 ± 21.21	64.50 ± 10.61
Trabeculectomy with cataract (n = 2)	0 (0.0%)	2 (3.6%)	149.00 ± 8.49	128.00 ± 1.41
Ahmed or Baerveldt implant (n = 16)	10 (17.5%)	6 (10.7%)	93.14 ± 23.78	75.29 ± 20.57
Ahmed or Baerveldt implant with cataract (n = 9)	4 (7.0%)	5 (8.9%)	124.50 ± 21.92	107.00 ± 25.46
ECP with cataract (n = 5)	5 (8.8%)	0 (0.0%)	75.00 ± 13.32	57.20 ± 10.73
iStent with cataract (n = 4)	3 (5.3%)	1 (1.8%)	50.25 ± 12.55	35.75 ± 10.50
Kahook with cataract (n = 5)	1 (1.8%)	4 (7.1%)	51.20 ± 14.96	36.00 ± 12.47

Notes: Surgical time, time between room entry and exit; case time, time between start and end of case.

Abbreviations: DMEK, Descemet Membrane Endothelial Keratoplasty; DSEK, Descemet Stripping Endothelial Keratoplasty; ECP, Endoscopic cyclophotocoagulation.

Table 3 Rates of Supplemental IV Anesthesia by Local or Regional Anesthesia Type

Procedure Type Local or Regional Anesthesia	Oral Supplemental IV Anesthesia?		IV Supplemental IV Anesthesia?
	Yes	No	Yes	No
Pterygium (n = 55)
Topical Only	1 (50%)	1 (50%)	1 (100%)	0 (0%)
Subconjunctival	1 (25%)	3 (75%)	0	6 (100%)
Intracameral	0	0	0	0
Block	2 (10%)	19 (90%)	3 (14%)	18 (86%)
TOTAL	4 (15%)	23 (85%)	4 (14%)	24 (86%)
Ahmed or Baerveldt implant ± cataract (n = 25)
Topical Only	0	0	1 (100%)	0
Subconjunctival	1 (100%)	0	0	1 (100%)
Intracameral	0	0	0	0
Block	4 (31%)	9 (69%)	5 (56%)	4 (44%)
TOTAL	5 (36%)	9 (69%)	6 (55%)	5 (45%)
DMEK or DSEK ± cataract (n = 12)
Topical Only	0	0	0	0
Subconjunctival	0	0	0	0
Intracameral	0	1 (100%)	0	0
Block	2 (40%)	3 (60%)	1 (20%)	5 (80%)
TOTAL	2 (33%)	4 (67%)	1 (17%)	5 (83%)
ECP with cataract (n = 5)
Topical Only	2 (100%)	0	0	0
Subconjunctival	0	0	0	0
Intracameral	0	3 (100%)	0	0
Block	0	0	0	0
TOTAL	2 (40%)	3 (60%)	0	0
Kahook with cataract (n = 5)
Topical Only	0	1 (100%)	0	1 (100%)
Subconjunctival	0	0	0	0
Intracameral	0	0	0	3 (100%)
Block	0	0	0	0
TOTAL	0	1 (100%)	0	4 (100%)
Trabeculectomy ± cataract (n = 4)
Topical Only	0	0	0	0
Subconjunctival	0	0	0	1 (100%)
Intracameral	0	0	0	0
Block	0	1 (100%)	0	2 (100%)
TOTAL	0	1 (100%)	0	3 (100%)
iStent with cataract (n = 4)
Topical Only	0	3 (100%)	0	1 (100%)
Subconjunctival	0	0	0	0
Intracameral	0	0	0	0
Block	0	0	0	0
TOTAL	0	3	0	1
Conjunctival/corneal lesion excision (n = 3)
Topical Only	0	0	0	0
Subconjunctival	0	0	0	0
Intracameral	0	0	0	0
Block	0	0	0	3 (100%)
TOTAL	0	0	0	3 (100%)
All surgeries combined (n = 113)
Topical Only	3 (37.5%)	5 (62.5%)	2 (50%)	2 (50%)
Subconjunctival	2 (40%)	3 (60%)	0	8 (100%)
Intracameral	0	4 (100%)	0	3 (100%)
Block	8 (20%)	32 (80%)	9 (22%)	32 (78%)
TOTAL	13 (23%)	44 (77%)	11 (20%)	45 (80%)

Abbreviations: DMEK, Descemet Membrane Endothelial Keratoplasty; DSEK, Descemet Stripping Endothelial Keratoplasty; ECP, endoscopic cyclophotocoagulation.

Table 4 Intra-Operative Complications and Adverse Events

	Cornea (n = 70)		p-value	Glaucoma (n = 43)		p-value
	Oral (n = 33)	IV (n = 37)		Oral (n = 24)	IV (n = 19)
Intra-operative Complications			0.34			0.56
Hyphema	0 (0.0%)	0 (0.0%)		1 (2.3%)	0 (0.0%)
Floppy Iris Syndrome	0 (0.0%)	0 (0.0%)		1 (2.3%)	0 (0.0%)
Headache	0 (0.0%)	1 (1.4%)		0 (0.0%)	0 (0.0%)
Hypertension	0 (0.0%)	0 (0.0%)		0 (0.0%)	2 (4.7%)
Cardiac arrythmia	0 (0.0%)	0 (0.0%)		1 (2.3%)	0 (0.0%)
Other	0 (0.0%)	0 (0.0%)		1 (2.3%)	0 (0.0%)
Adverse Events			0.12			0.45
Dizziness	0 (0.0%)	1 (1.4%)		0 (0.0%)	0 (0.0%)
Pain	1 (1.4%)	2 (2.9%)		1 (2.3%)	2 (4.7%)
Elevated Blood Pressure	0 (0.0%)	0 (0.0%)		0 (0.0%)	1 (2.3%)
Elevated Heart Rate	0 (0.0%)	0 (0.0%)		0 (0.0%)	1 (2.3%)
Nausea	0 (0.0%)	1 (1.4%)		0 (0.0%)	1 (2.3%)
Headache	0 (0.0%)	2 (2.9%)		1 (2.3%)	1 (2.3%)
Back Pain	0 (0.0%)	2 (2.9%)		0 (0.0%)	0 (0.0%)
Vomiting	0 (0.0%)	1 (1.4%)		0 (0.0%)	0 (0.0%)
Chest Pain	0 (0.0%)	1 (1.4%)		0 (0.0%)	0 (0.0%)
Irritation From Sutures	0 (0.0%)	0 (0.0%)		0 (0.0%)	1 (2.3%)
Itchiness Around Eye	0 (0.0%)	1 (1.4%)		0 (0.0%)	0 (0.0%)