Kengo Imai1, Tatsuya Morita2, Naosuke Yokomichi2, Takashi Kawaguchi3, Hiroyuki Kohara4, Takashi Yamaguchi5, Ayako Kikuchi6, Takuya Odagiri7, Yuki Sumazaki Watanabe8, Rena Kamura9, Isseki Maeda10, Natsuki Kawashima11, Satoko Ito12, Mika Baba13, Yosuke Matsuda14, Kiyofumi Oya15, Keisuke Kaneishi16, Yusuke Hiratsuka17, Akemi Shirado Naito18, Masanori Mori2. 1. Seirei Hospice, Seirei Mikatahara General Hospital (K.I.), Hamamatsu, Japan. Electronic address: k.imai@sis.seirei.or.jp. 2. Division of Palliative and Supportive Care (T.M., N.Y., M.M.), Seirei Mikatahara General Hospital, Hamamatsu, Japan. 3. Department of Practical Pharmacy (T.K.), Tokyo University of Pharmacy and Life Sciences, Tokyo, Japan. 4. Department of Internal Medicine (H.K.), Hatsukaichi Memorial Hospital, Hatsukaichi, Japan. 5. Division of Palliative Care (T.Y.), Konan Medical Center, Kobe, Japan. 6. Department of Oncology and Palliative Medicine (A.K.), Mitsubishi Kyoto Hospital, Kyoto, Japan. 7. Komaki City Hospital (T.O.), Palliative Care, Komaki, Japan. 8. Department of Palliative Medicine (Y.S.W.), National Cancer Center Hospital East, Kashiwa, Japan. 9. Hospice (R.K.), Yodogawa Christian Hospital, Osaka, Japan. 10. Department of Palliative Care (I.M.), Senri-Chuo Hospital, Toyonaka, Japan. 11. Department of Palliative Medicine (N.K.), Tsukuba Medical Center Hospital, Tsukuba, Japan. 12. Hospice (S.I.), The Japan Baptist Hospital, Kyoto, Japan. 13. Department of Palliative Medicine (M.B.), Suita Tokushukai Hospital, Suita, Japan. 14. Palliative Care Department (Y.M.), St. Luke's International Hospital, Tokyo, Japan. 15. Transitional and Palliative Care (K.O.), Aso Iizuka Hospital, Iizuka, Japan. 16. Department of Palliative Care Unit (K.K.), JCHO Tokyo Shinjuku Medical Center, Tokyo, Japan. 17. Department of Palliative Medicine (Y.H.), Tohoku University School of Medicine, Sendai, Japan. 18. Department of Palliative Care (A.S.N.), Miyazaki Medical Association Hospital, Miyazaki, Japan.
Abstract
PURPOSE: To investigate the efficacy of two types of palliative sedation: proportional and deep sedation, defined by sedation protocols. METHODS: From a multicenter prospective observational study, we analyzed the data of those patients who received the continuous infusion of midazolam according to the sedation protocol. The primary endpoint was goal achievement at 4 hours: in proportional sedation, symptom relief (Integrated Palliative care Outcome Scale: IPOS ≤ 1) and absence of agitation (modified Richmond Agitation-Sedation Scale: RASS ≤ 0); in deep sedation, the achievement of deep sedation (RASS ≤ -4). Secondary endpoints included deep sedation as a result of proportional sedation, communication capacity (Communication Capacity Scale item 4 ≤ 2), IPOS and RASS scores, and adverse events. RESULTS: A total of 81 patients from 14 palliative care units were analyzed: proportional sedation (n = 64) and deep sedation (n = 17). At 4 hours, the goal was achieved in 77% (n = 49; 95% confidence interval: 66-87) with proportional sedation; and 88% (n = 15; 71-100) with deep sedation. Deep sedation was necessary in 45% of those who received proportional sedation. Communication capacity was maintained in 34% with proportional sedation and 10% with deep sedation. IPOS decreased from 3.5 to 0.9 with proportional sedation, and 3.5 to 0.4 with deep sedation; RASS decreased from +0.3 to -2.6, and +0.4 to -4.2, respectively. Fatal events related to the treatment occurred in 2% (n = 1) with proportional and none with deep sedation. CONCLUSION: Proportional sedation achieved satisfactory symptom relief while maintaining some patients' consciousness, and deep sedation achieved good symptom relief while the majority of patients lost consciousness.
PURPOSE: To investigate the efficacy of two types of palliative sedation: proportional and deep sedation, defined by sedation protocols. METHODS: From a multicenter prospective observational study, we analyzed the data of those patients who received the continuous infusion of midazolam according to the sedation protocol. The primary endpoint was goal achievement at 4 hours: in proportional sedation, symptom relief (Integrated Palliative care Outcome Scale: IPOS ≤ 1) and absence of agitation (modified Richmond Agitation-Sedation Scale: RASS ≤ 0); in deep sedation, the achievement of deep sedation (RASS ≤ -4). Secondary endpoints included deep sedation as a result of proportional sedation, communication capacity (Communication Capacity Scale item 4 ≤ 2), IPOS and RASS scores, and adverse events. RESULTS: A total of 81 patients from 14 palliative care units were analyzed: proportional sedation (n = 64) and deep sedation (n = 17). At 4 hours, the goal was achieved in 77% (n = 49; 95% confidence interval: 66-87) with proportional sedation; and 88% (n = 15; 71-100) with deep sedation. Deep sedation was necessary in 45% of those who received proportional sedation. Communication capacity was maintained in 34% with proportional sedation and 10% with deep sedation. IPOS decreased from 3.5 to 0.9 with proportional sedation, and 3.5 to 0.4 with deep sedation; RASS decreased from +0.3 to -2.6, and +0.4 to -4.2, respectively. Fatal events related to the treatment occurred in 2% (n = 1) with proportional and none with deep sedation. CONCLUSION: Proportional sedation achieved satisfactory symptom relief while maintaining some patients' consciousness, and deep sedation achieved good symptom relief while the majority of patients lost consciousness.