Essamedin M Negm, Ahmed M Gouda, Mohammed El Mowafy Khatab, Essam Mohamed Elsayed Youssef, AnaSimon Alfred Foad Eskandr, Ola Mohammed Fathi, Heba Mohammed Fathi
{"title":"心得安单药治疗与心得安加巴喷丁联合治疗预防中重度创伤性脑损伤后阵发性交感神经亢进：一项随机对照试验","authors":"Essamedin M Negm, Ahmed M Gouda, Mohammed El Mowafy Khatab, Essam Mohamed Elsayed Youssef, AnaSimon Alfred Foad Eskandr, Ola Mohammed Fathi, Heba Mohammed Fathi","doi":"10.1186/s12871-026-03802-2","DOIUrl":null,"url":null,"abstract":"<p><strong>Background: </strong>Paroxysmal sympathetic hyperactivity (PSH) is a serious complication of traumatic brain injury (TBI), characterized by episodic hypertension (HTN), tachycardia, hyperthermia, hyperhidrosis, and dystonia. It is associated with prolonged mechanical ventilation (MV), extended ICU and hospital stays, and worse outcomes. Current guidelines lack prophylactic recommendations.</p><p><strong>Methodology: </strong>This single-center randomized controlled trial (NCT05427474) enrolled 90 adults with moderate-to-severe TBI glasgow coma scale (GCS 3-12). Participants were randomized to: standard care (Group I, n = 30); standard care plus propranolol (40 mg/12 h, Group II, n = 30); or standard care plus propranolol (40 mg/12 h) and gabapentin (100 mg/8 h, Group III, n = 30). The primary endpoint was PSH incidence. Secondary endpoints included ventilator days, ICU and hospital length of stay (LOS), and mortality.</p><p><strong>Results: </strong>PSH incidence was lowest in Group III (10%) vs. Group II (33.3%) and Group I (60%) (p < 0.001). Group II showed the shortest MV duration (5.92 ± 5.15 days) vs. Group III (9.42 ± 6.99 days, p = 0.047) and Group I (12.92 ± 5.98 days, p < 0.001). ICU LOS was shortest in Group II (9.6 ± 5.32 days) vs. Group III (14.69 ± 8.35 days, p = 0.017) and Group I (19.5 ± 8.19 days, p < 0.001). Mortality and GCS improvement did not differ significantly (p > 0.05).</p><p><strong>Conclusion: </strong>Prophylactic propranolol significantly reduces PSH incidence, shortens MV duration, and decreases ICU stay in moderate-to-severe TBI. Although adding gabapentin further reduces PSH, it prolongs recovery time, suggesting a trade-off between efficacy and sedative effects. These findings suggest that propranolol monotherapy is a promising prophylactic strategy, with gabapentin potentially reserved for refractory cases. However, given the study's limitations, these results should be considered hypothesis-generating and warrant confirmation in larger, multicenter trials. Mortality and neurological outcomes were comparable across groups.</p><p><strong>Trial registration: </strong>The trial was prospectively registered at ClinicalTrials.gov (NCT05427474) on June 22, 2022.</p>","PeriodicalId":9190,"journal":{"name":"BMC Anesthesiology","volume":" ","pages":""},"PeriodicalIF":2.6000,"publicationDate":"2026-05-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"Propranolol monotherapy versus combined propranolol-gabapentin for prevention of paroxysmal sympathetic hyperactivity after moderate-severe traumatic brain injury: a randomized controlled trial.\",\"authors\":\"Essamedin M Negm, Ahmed M Gouda, Mohammed El Mowafy Khatab, Essam Mohamed Elsayed Youssef, AnaSimon Alfred Foad Eskandr, Ola Mohammed Fathi, Heba Mohammed Fathi\",\"doi\":\"10.1186/s12871-026-03802-2\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Background: </strong>Paroxysmal sympathetic hyperactivity (PSH) is a serious complication of traumatic brain injury (TBI), characterized by episodic hypertension (HTN), tachycardia, hyperthermia, hyperhidrosis, and dystonia. It is associated with prolonged mechanical ventilation (MV), extended ICU and hospital stays, and worse outcomes. Current guidelines lack prophylactic recommendations.</p><p><strong>Methodology: </strong>This single-center randomized controlled trial (NCT05427474) enrolled 90 adults with moderate-to-severe TBI glasgow coma scale (GCS 3-12). Participants were randomized to: standard care (Group I, n = 30); standard care plus propranolol (40 mg/12 h, Group II, n = 30); or standard care plus propranolol (40 mg/12 h) and gabapentin (100 mg/8 h, Group III, n = 30). The primary endpoint was PSH incidence. Secondary endpoints included ventilator days, ICU and hospital length of stay (LOS), and mortality.</p><p><strong>Results: </strong>PSH incidence was lowest in Group III (10%) vs. Group II (33.3%) and Group I (60%) (p < 0.001). Group II showed the shortest MV duration (5.92 ± 5.15 days) vs. Group III (9.42 ± 6.99 days, p = 0.047) and Group I (12.92 ± 5.98 days, p < 0.001). ICU LOS was shortest in Group II (9.6 ± 5.32 days) vs. Group III (14.69 ± 8.35 days, p = 0.017) and Group I (19.5 ± 8.19 days, p < 0.001). Mortality and GCS improvement did not differ significantly (p > 0.05).</p><p><strong>Conclusion: </strong>Prophylactic propranolol significantly reduces PSH incidence, shortens MV duration, and decreases ICU stay in moderate-to-severe TBI. Although adding gabapentin further reduces PSH, it prolongs recovery time, suggesting a trade-off between efficacy and sedative effects. These findings suggest that propranolol monotherapy is a promising prophylactic strategy, with gabapentin potentially reserved for refractory cases. However, given the study's limitations, these results should be considered hypothesis-generating and warrant confirmation in larger, multicenter trials. Mortality and neurological outcomes were comparable across groups.</p><p><strong>Trial registration: </strong>The trial was prospectively registered at ClinicalTrials.gov (NCT05427474) on June 22, 2022.</p>\",\"PeriodicalId\":9190,\"journal\":{\"name\":\"BMC Anesthesiology\",\"volume\":\" \",\"pages\":\"\"},\"PeriodicalIF\":2.6000,\"publicationDate\":\"2026-05-08\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"BMC Anesthesiology\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://doi.org/10.1186/s12871-026-03802-2\",\"RegionNum\":3,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q2\",\"JCRName\":\"ANESTHESIOLOGY\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"BMC Anesthesiology","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1186/s12871-026-03802-2","RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q2","JCRName":"ANESTHESIOLOGY","Score":null,"Total":0}
Propranolol monotherapy versus combined propranolol-gabapentin for prevention of paroxysmal sympathetic hyperactivity after moderate-severe traumatic brain injury: a randomized controlled trial.
Background: Paroxysmal sympathetic hyperactivity (PSH) is a serious complication of traumatic brain injury (TBI), characterized by episodic hypertension (HTN), tachycardia, hyperthermia, hyperhidrosis, and dystonia. It is associated with prolonged mechanical ventilation (MV), extended ICU and hospital stays, and worse outcomes. Current guidelines lack prophylactic recommendations.
Methodology: This single-center randomized controlled trial (NCT05427474) enrolled 90 adults with moderate-to-severe TBI glasgow coma scale (GCS 3-12). Participants were randomized to: standard care (Group I, n = 30); standard care plus propranolol (40 mg/12 h, Group II, n = 30); or standard care plus propranolol (40 mg/12 h) and gabapentin (100 mg/8 h, Group III, n = 30). The primary endpoint was PSH incidence. Secondary endpoints included ventilator days, ICU and hospital length of stay (LOS), and mortality.
Results: PSH incidence was lowest in Group III (10%) vs. Group II (33.3%) and Group I (60%) (p < 0.001). Group II showed the shortest MV duration (5.92 ± 5.15 days) vs. Group III (9.42 ± 6.99 days, p = 0.047) and Group I (12.92 ± 5.98 days, p < 0.001). ICU LOS was shortest in Group II (9.6 ± 5.32 days) vs. Group III (14.69 ± 8.35 days, p = 0.017) and Group I (19.5 ± 8.19 days, p < 0.001). Mortality and GCS improvement did not differ significantly (p > 0.05).
Conclusion: Prophylactic propranolol significantly reduces PSH incidence, shortens MV duration, and decreases ICU stay in moderate-to-severe TBI. Although adding gabapentin further reduces PSH, it prolongs recovery time, suggesting a trade-off between efficacy and sedative effects. These findings suggest that propranolol monotherapy is a promising prophylactic strategy, with gabapentin potentially reserved for refractory cases. However, given the study's limitations, these results should be considered hypothesis-generating and warrant confirmation in larger, multicenter trials. Mortality and neurological outcomes were comparable across groups.
Trial registration: The trial was prospectively registered at ClinicalTrials.gov (NCT05427474) on June 22, 2022.
期刊介绍：
BMC Anesthesiology is an open access, peer-reviewed journal that considers articles on all aspects of anesthesiology, critical care, perioperative care and pain management, including clinical and experimental research into anesthetic mechanisms, administration and efficacy, technology and monitoring, and associated economic issues.
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