Comparison of Hemodynamic Parameters Based on the Administration of Remimazolam or Sevoflurane in Patients under General Anesthesia in the Beach Chair Position: A Single-Blinded Randomized Controlled Trial
Abstract
:1. Introduction
2. Materials and Methods
2.1. Study Design, Ethics, and Registry
2.2. Participants
2.3. Outcomes
2.4. Procedures
2.5. Sample Size Calculation
2.6. Statistical Analysis
3. Results
3.1. Study Participants and Patient Characteristics
3.2. Primary Outcomes
3.3. Secondary Outcomes
4. Discussion
5. Conclusions
Supplementary Materials
Author Contributions
Funding
Institutional Review Board Statement
Informed Consent Statement
Data Availability Statement
Acknowledgments
Conflicts of Interest
References
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R Group (n = 39) | S Group (n = 39) | p-Value | |
---|---|---|---|
Age (y) | 60 (48, 69) | 60 (45, 70) | 0.984 |
Sex (male/female) (n) | 25 (64.1%)/ 14 (35.9%) | 24 (61.5%)/ 15 (38.5%) | 1.000 |
BMI (kg/m2) | 25.0 ± 3.1 | 25.1 ± 2.8 | 0.792 |
ASA-PS class (I/II/III) | 10 (25.6%)/ 26 (66.7%)/ 3 (7.7%) | 9 (23.1%)/ 28 (71.8%)/ 2 (5.1%) | 0.849 |
Diabetes mellitus (n) | 6 (15.4%) | 9 (23.1%) | 0.566 |
Dyslipidemia (n) | 13 (33.3%) | 13 (33.3%) | 1.000 |
Smoking (non/ex/current) (n) | 28 (71.8%)/ 5 (12.8%)/ 6 (15.4%) | 26 (68.4%)/ 3 (7.9%)/ 9 (23.7%) | 0.560 |
White blood cell (×103/μL) | 6.08 (5.18, 7.38) | 6.75 (5.56, 8.19) | 0.261 |
Hematocrit (%) | 41.5 ± 3.3 | 41.6 ± 3.3 | 0.905 |
Platelet (×103/μL) | 228 ± 54 | 223 ± 44 | 0.682 |
INR | 0.95 ± 0.06 | 0.95 ± 0.06 | 0.750 |
Bilirubin (mg/dL) | 0.66 (0.47, 0.81) | 0.66 (0.52, 0.80) | 0.738 |
Creatinine (mg/dL) | 0.82 (0.67, 0.91) | 0.80 (0.67, 0.89) | 0.693 |
Type of surgery (n) | 0.971 | ||
Shoulder arthroscopy | 20 (51.28%) | 18 (46.15%) | |
Fixative removal | 6 (15.38%) | 7 (17.95%) | |
ORIF | 5 (12.82%) | 5 (12.82%) | |
Total shoulder arthroplasty | 8 (20.51%) | 9 (23.08%) |
R Group (n = 39) | S Group (n = 39) | p-Value | |
---|---|---|---|
Intraoperative data | |||
Dose of remimazolam | |||
Induction (mg/kg) | 0.12 (0.10, 0.14) | N/A | |
Maintenance (mg/kg/h) | 1.11 (0.93, 1.21) | N/A | |
Dose of propofol (mg/kg) | N/A | 1.60 (1.48, 1.75) | |
Mean sevoflurane (vol%) | N/A | 2.10 (2.00, 2.25) | |
Remifentanil infusion (µg/kg/min) | 0.10 (0.06, 0.14) | 0.08 (0.05. 0.10) | 0.035 * |
Vasopressor administration (n) | 10 (25.6%) | 22 (56.4%) | 0.011 * |
Phenylephrine (µg/kg) † | 2.0 (1.3, 3.8) | 4.2 (1.6, 9.7) | 0.092 |
Ephedrine (mg) † | 0 (0, 0) | 0 (0, 10) | 0.172 |
Antihypertensive administration (n) | 11 (28.2%) | 3 (7.7%) | 0.039 * |
Nicardipine (mg) ‡ | 2.0 (0.9, 2.4) | 0.5 (0.4, 0.8) | 0.117 |
Esmolol (mg/kg) ‡ | 0 (0, 0) | 0 (0, 0) | 0.523 |
Sedative administration (n) | 2 (5.1%) | 0 | 0.474 |
Hypotension after BCP (n) | 7 (17.9%) | 16 (41.0%) | 0.047 * |
Fluid administration (mL/kg/h) | 2.4 (1.9, 3.1) | 2.1 (1.6, 2.8) | 0.202 |
Estimated blood loss (mL) | 50 (30, 70) | 30 (30, 50) | 0.329 |
Surgical time (min) | 65 (45, 80) | 65 (40, 85) | 0.984 |
Postoperative data | |||
Extubation time (s) ¶ | 210 (159, 264) | 322 (198, 458) | 0.001 * |
Aldrete score ≥ 9 at PACU (min) | 30 (30, 39) | 30 (30, 35) | 0.892 |
Acute kidney injury (n) | 1 (2.6%) | 0 | 1.000 |
PONV (n) | 7 (17.9%) | 7 (17.9%) | 1.000 |
PPC (n) | 0 | 1 (2.6%) | 1.000 |
Hospital length of stay (d) | 2 (2, 3) | 2 (2, 4) | 0.294 |
Univariable | Multivariable | |||
---|---|---|---|---|
OR [95% CI] | p-Value | OR [95% CI] | p-Value | |
Age | 1.02 [0.98–1.05] | 0.349 | 1.02 [0.97–1.07] | 0.435 |
Female | 2.44 [0.90–6.73] | 0.080 | 1.55 [0.42–5.75] | 0.505 |
ASA-PS | ||||
I | Reference | |||
II | 0.66 [0.22–2.06] | 0.460 | ||
III | 0.43 [0.02–3.68] | 0.486 | ||
Body mass index | 1.02 [0.86–1.21] | 0.820 | 1.03 [0.83–1.28] | 0.811 |
Diabetes mellitus | 1.25 [0.35–4.06] | 0.717 | ||
Dyslipidemia | 1.10 [0.38–3.02] | 0.861 | 0.73 [0.19–2.57] | 0.636 |
Sevoflurane group | 3.18 [1.16–9.45] | 0.029 * | 3.88 [1.28–13.32] | 0.021 * |
Baseline systolic BP | 1.03 [1.00–1.07] | 0.027 * | 1.04 [1.00–1.07] | 0.037 * |
Baseline heart rate | 1.03 [0.99–1.07] | 0.189 | 1.02 [0.98–1.07] | 0.405 |
Baseline PVi | 0.96 [0.88–1.06] | 0.429 |
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Lee, S.; Seo, J.; Kim, D.Y.; Lee, Y.; Kang, H.Y.; Choi, J.-H.; Kim, Y.; Kim, M.K.; You, A.H. Comparison of Hemodynamic Parameters Based on the Administration of Remimazolam or Sevoflurane in Patients under General Anesthesia in the Beach Chair Position: A Single-Blinded Randomized Controlled Trial. J. Clin. Med. 2024, 13, 2364. https://doi.org/10.3390/jcm13082364
Lee S, Seo J, Kim DY, Lee Y, Kang HY, Choi J-H, Kim Y, Kim MK, You AH. Comparison of Hemodynamic Parameters Based on the Administration of Remimazolam or Sevoflurane in Patients under General Anesthesia in the Beach Chair Position: A Single-Blinded Randomized Controlled Trial. Journal of Clinical Medicine. 2024; 13(8):2364. https://doi.org/10.3390/jcm13082364
Chicago/Turabian StyleLee, Sangho, Jimung Seo, Doh Yoon Kim, YoungYun Lee, Hee Yong Kang, Jeong-Hyun Choi, Youngsoon Kim, Mi Kyeong Kim, and Ann Hee You. 2024. "Comparison of Hemodynamic Parameters Based on the Administration of Remimazolam or Sevoflurane in Patients under General Anesthesia in the Beach Chair Position: A Single-Blinded Randomized Controlled Trial" Journal of Clinical Medicine 13, no. 8: 2364. https://doi.org/10.3390/jcm13082364