Opioid-Free Using Ketamine versus Opioid-Sparing Anesthesia during the Intraoperative Period in Video-Assisted Thoracoscopic Surgery: A Randomized Controlled Trial
Abstract
:1. Introduction
2. Materials and Methods
2.1. Study Design
2.2. Patients
2.3. Randomization and Blinding
2.4. Intervention
2.5. Primary Outcome
2.6. Secondary Outcomes
2.7. Sample Size
2.8. Statistical Analysis
3. Results
3.1. Patients
3.2. Primary Outcome
3.3. Secondary Outcomes
3.4. Sensitivity Analysis
4. Discussion
5. Conclusions
Author Contributions
Funding
Institutional Review Board Statement
Informed Consent Statement
Data Availability Statement
Acknowledgments
Conflicts of Interest
References
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OFA Group (n = 45) | OSA Group (n = 46) | |
---|---|---|
Age (year) | 57 ± 7 | 58 ± 6 |
Gender (male/female) | 22/23 | 24/22 |
BMI (kg/m2) | 21.8 ± 2.9 | 22.5 ± 2.6 |
Current smoker | 12 (26.7%) | 8 (17.4%) |
ASA physical status (I and II/III) | 38/7 | 41/5 |
Hypertension | 7 (15.6%) | 11 (23.9%) |
Diabetes mellitus | 5 (11.1%) | 7 (15.2%) |
Operation side (right/left) | 25/20 | 29/17 |
Blood loss (mL) | 95 ± 41 | 102 ± 43 |
Working window size (cm) | 4.6 ± 0.5 | 4.5 ± 0.4 |
Duration of surgery (min) | 172 ± 33 | 164 ± 31 |
OFA Group (n = 45) | OSA Group (n = 46) | Mean Difference (95% CI) | p Value | |
---|---|---|---|---|
Preoperative QoR-40 | ||||
Total | 183.5 ± 12.7 | 180.2 ± 13.7 | 3.4 (−2.2, 8.9) | 0.229 |
Physical comfort | 55.8 ± 3.3 | 55.0 ± 3.4 | 0.8 (−0.6, 2.2) | 0.251 |
Emotional state | 40.7 ± 3.9 | 39.9 ± 4.0 | 0.8 (−0.8, 2.5) | 0.326 |
Physical independence | 21.4 ± 3.3 | 20.7 ± 3.0 | 0.7 (−0.6, 2.0) | 0.286 |
Psychological support | 33.0 ± 2.8 | 32.1 ± 3.1 | 0.9 (−0.3, 2.2) | 0.138 |
Pain | 32.6 ± 2.6 | 32.5 ± 2.6 | 0.1 (−1.0, 1.2) | 0.854 |
QoR-40 on postoperative day 1 | ||||
Total | 164.3 ± 10.8 | 158.7 ± 10.6 | 5.6 (1.1, 10.0) | 0.015 |
Physical comfort | 50.5 ± 4.6 | 47.8 ± 5.1 | 2.7 (0.7, 4.8) | 0.009 |
Emotional state | 35.2 ± 3.4 | 35.4 ± 2.9 | −0.2 (−1.5, 1.1) | 0.772 |
Physical independence | 17.7 ± 3.3 | 17.6 ± 3.2 | 0.1 (−1.2, 1.5) | 0.830 |
Psychological support | 31.4 ± 3.2 | 30.7 ± 2.8 | 0.6 (−0.6, 1.9) | 0.332 |
Pain | 29.5 ± 3.4 | 27.2 ± 3.8 | 2.2 (0.7, 3.8) | 0.004 |
QoR-40 on postoperative day 2 | ||||
Total | 168.1 ± 14.2 | 162.2 ± 13.6 | 6.0 (0.2, 11.8) | 0.044 |
Physical comfort | 50.9 ± 5.0 | 48.3 ± 4.9 | 2.6 (0.6, 4.7) | 0.012 |
Emotional state | 36.0 ± 3.8 | 35.7 ± 3.3 | 0.3 (−1.2, 1.8) | 0.685 |
Physical independence | 19.4 ± 3.7 | 18.3 ± 3.3 | 1.1 (−0.4, 2.6) | 0.142 |
Psychological support | 30.3 ± 4.9 | 28.9 ± 4.8 | 1.4 (−0.6, 3.4) | 0.173 |
Pain | 31.6 ± 3.8 | 31.0 ± 3.6 | 0.5 (−1.0, 2.1) | 0.490 |
OFA Group (n = 45) | OSA Group (n = 46) | Mean Difference or RR (95% CI) | p Value | |
---|---|---|---|---|
Intraoperative | ||||
Duration of anesthesia (min) | 221 ± 38 | 209 ± 32 | 12 (−3, 27) | 0.107 |
Time to eye opening (s) | 438 ± 102 | 306 ± 96 | 132 (91, 173) | <0.001 |
Time to extubation (s) | 492 ± 126 | 342 ± 104 | 150 (102, 198) | <0.001 |
Propofol (mg/kg/h) | 8.4 ± 1.6 | 8.7 ± 1.9 | −0.3 (−1.0, 0.4) | 0.418 |
Ketamine (mg/kg/h) | 0.27 ± 0.02 | - | - | - |
Remifentanil (μg/kg/min) | - | 0.12 ± 0.05 | - | - |
Hemodynamic disturbance | 13 (28.9%) | 22 (47.8%) | 0.6 (0.3, 1.0) | 0.063 |
Intraoperative awareness | 0 (0.0%) | 0 (0.0%) | - | >0.999 |
0–1 h after surgery | ||||
PACU duration (min) | 47 ± 6 | 39 ± 8 | 8 (5, 11) | <0.001 |
VAS | 4.2 ± 2.3 | 6.2 ± 2.1 | −2.0 (−2.9, −1.1) | <0.001 |
PCA consumption (mL) | 1.5 ± 1.1 | 2.3 ± 1.2 | −0.8 (−1.3, −0.3) | 0.001 |
Any postoperative opioid 1 | 22 (48.9%) | 31 (67.4%) | 0.7 (0.5, 1.0) | 0.073 |
Rescue opioid 2 | 16 (35.6%) | 30 (65.2%) | 0.5 (0.3, 0.8) | 0.004 |
Nausea and vomiting | 2 (4.4%) | 9 (19.6%) | 0.2 (0.1, 0.9) | 0.049 |
Shivering | 4 (8.9%) | 13 (28.3%) | 0.3 (0.1, 0.8) | 0.030 |
Psychosis | 0 (0.0%) | 0 (0.0%) | - | >0.999 |
1–4 h after surgery | ||||
VAS | 3.4 ± 1.8 | 4.6 ± 1.9 | −1.2 (−2.0, −0.4) | 0.003 |
PCA consumption (mL) | 4.7 ± 2.6 | 6.5 ± 2.7 | −1.8 (−2.9, −0.7) | 0.002 |
Any postoperative opioid 1 | 25 (55.6%) | 32 (69.6%) | 0.8 (0.6, 1.1) | 0.167 |
Rescue opioid 2 | 2 (4.4%) | 5 (10.9%) | 0.4 (0.1, 1.7) | 0.435 |
Nausea and vomiting | 2 (4.4%) | 4 (8.7%) | 0.5 (0.1, 2.3) | 0.677 |
Shivering | 0 (0.0%) | 2 (4.3%) | 0.0 (0.0, 1.9) | 0.495 |
Psychosis | 0 (0.0%) | 0 (0.0%) | - | >0.999 |
4–24 h after surgery | ||||
VAS | 4.5 ± 2.0 | 5.0 ± 2.3 | −0.5 (−1.4, 0.4) | 0.272 |
PCA consumption (mL) | 14.8 ± 12.3 | 17.7 ± 11.4 | −2.9 (−7.8, 2.0) | 0.246 |
Any postoperative opioid 1 | 45 (100%) | 46 (100%) | 1.0 (0.9, 1.1) | >0.999 |
Rescue opioid 2 | 9 (20.0%) | 13 (28.3%) | 0.7 (0.3, 1.5) | 0.358 |
Nausea and vomiting | 4 (8.9%) | 8 (17.4%) | 0.5 (0.2, 1.5) | 0.354 |
Shivering | 0 (0.0%) | 1 (2.2%) | 0.0 (0.0, 3.9) | >0.999 |
Psychosis | 0 (0.0%) | 0 (0.0%) | - | >0.999 |
24–48 h after surgery | ||||
VAS | 4.3 ± 2.6 | 4.4 ± 2.7 | −0.1 (−1.2, 1.0) | 0.858 |
PCA consumption (mL) | 16.3 ± 10.7 | 20.1 ± 14.3 | −3.8 (−9.1, 1.5) | 0.155 |
Any postoperative opioid 1 | 44 (97.8%) | 43 (93.5%) | 1.0 (0.9, 1.2) | 0.617 |
Rescue opioid 2 | 11 (24.4%) | 12 (26.1%) | 0.9 (0.5, 1.9) | 0.857 |
Nausea and vomiting | 3 (6.7%) | 7 (15.2%) | 0.4 (0.1, 1.5) | 0.316 |
Shivering | 0 (0.0%) | 0 (0.0%) | - | >0.999 |
Psychosis | 0 (0.0%) | 0 (0.0%) | - | >0.999 |
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Choi, H.; Huh, J.; Kim, M.; Moon, S.W.; Kim, K.S.; Hwang, W. Opioid-Free Using Ketamine versus Opioid-Sparing Anesthesia during the Intraoperative Period in Video-Assisted Thoracoscopic Surgery: A Randomized Controlled Trial. J. Pers. Med. 2024, 14, 881. https://doi.org/10.3390/jpm14080881
Choi H, Huh J, Kim M, Moon SW, Kim KS, Hwang W. Opioid-Free Using Ketamine versus Opioid-Sparing Anesthesia during the Intraoperative Period in Video-Assisted Thoracoscopic Surgery: A Randomized Controlled Trial. Journal of Personalized Medicine. 2024; 14(8):881. https://doi.org/10.3390/jpm14080881
Chicago/Turabian StyleChoi, Hoon, Jaewon Huh, Minju Kim, Seok Whan Moon, Kyung Soo Kim, and Wonjung Hwang. 2024. "Opioid-Free Using Ketamine versus Opioid-Sparing Anesthesia during the Intraoperative Period in Video-Assisted Thoracoscopic Surgery: A Randomized Controlled Trial" Journal of Personalized Medicine 14, no. 8: 881. https://doi.org/10.3390/jpm14080881