Ruting Liao, Zhijian Zhou, Xuan Wang, Huiying Shao
{"title":"拔管前使用异丙酚对儿童扁桃体和腺样体切除术患者呼吸不良事件的影响:一项随机对照试验。","authors":"Ruting Liao, Zhijian Zhou, Xuan Wang, Huiying Shao","doi":"10.12968/hmed.2024.0431","DOIUrl":null,"url":null,"abstract":"<p><p><b>Aims/Background</b> Perioperative respiratory adverse events (PRAEs) are common in pediatric anesthesia, especially in otolaryngology procedures. In this randomized controlled trial, we investigated the impact of administering propofol before extubation on PRAEs in pediatric patients undergoing tonsillectomy and adenoidectomy. <b>Methods</b> We enrolled children aged 3 to 8 years old, of American Society of Anesthesiologists (ASA) classes I to III, scheduled for tonsillectomy, and randomly divided them into propofol and control groups. The subjects in the propofol group received multiple small doses of propofol (0.5 mg/kg per dose, total 1-2 mg/kg) until the patient resumed regular spontaneous breathing and exhibited no bodily movements. The subjects in the control group received 0.15 mL/kg of saline. The primary outcome was the rate of PRAEs, such as laryngospasm, bronchospasm, breath-holding spell, severe coughing, desaturation, and airway obstruction, post-extubation. The secondary outcomes were the extubation time, pre-extubation Richmond Agitation-Sedation Scale (RASS) score, end-tidal sevoflurane concentration at extubation, incidence of postoperative agitation, time to consciousness, and Face, Legs, Activity, Cry, and Consolability (FLACC) pain score in the recovery room. Results were reported with risk ratios (RR) and their 95% confidence intervals (CI), as well as the <i>p</i>-values indicating statistical significance. <b>Results</b> A total of 239 patients were included, including 119 in the propofol group and 120 in the control group. Our findings indicated no significant difference in the rate of PRAEs between the two groups (5.9% vs 10.8%, RR: 0.54, 95% CI: 0.23 to 1.31, <i>p</i> = 0.17). However, the propofol group showed a notable decrease in moderate to severe coughs (13.4% vs 60.0%, RR: 0.22, 95% CI: 0.14 to 0.36, <i>p</i> < 0.001) and postoperative agitation (4.2% vs 60.8%, RR: 0.07, 95% CI: 0.03 to 0.17, <i>p</i> < 0.001). <b>Conclusion</b> This trial demonstrated that while administering repeated small doses of propofol before extubation does not significantly reduce respiratory adverse events in children undergoing tonsillectomy and adenoidectomy, it does significantly reduce the incidence of severe coughing, improving postoperative recovery and clinical outcomes. Moreover, propofol helps reduce postoperative agitation, enhancing the safety and effectiveness of postoperative care, and maintaining its valuable clinical role in postoperative management. <b>Clinical Trial Registration</b> ClinicalTrials.gov (NCT05769842).</p>","PeriodicalId":9256,"journal":{"name":"British journal of hospital medicine","volume":"85 11","pages":"1-15"},"PeriodicalIF":1.0000,"publicationDate":"2024-11-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"Impact of Propofol Administered before Extubation on Respiratory Adverse Events in Pediatric Patients Undergoing Tonsillectomy and Adenoidectomy: A Randomized Controlled Trial.\",\"authors\":\"Ruting Liao, Zhijian Zhou, Xuan Wang, Huiying Shao\",\"doi\":\"10.12968/hmed.2024.0431\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><p><b>Aims/Background</b> Perioperative respiratory adverse events (PRAEs) are common in pediatric anesthesia, especially in otolaryngology procedures. In this randomized controlled trial, we investigated the impact of administering propofol before extubation on PRAEs in pediatric patients undergoing tonsillectomy and adenoidectomy. <b>Methods</b> We enrolled children aged 3 to 8 years old, of American Society of Anesthesiologists (ASA) classes I to III, scheduled for tonsillectomy, and randomly divided them into propofol and control groups. The subjects in the propofol group received multiple small doses of propofol (0.5 mg/kg per dose, total 1-2 mg/kg) until the patient resumed regular spontaneous breathing and exhibited no bodily movements. The subjects in the control group received 0.15 mL/kg of saline. The primary outcome was the rate of PRAEs, such as laryngospasm, bronchospasm, breath-holding spell, severe coughing, desaturation, and airway obstruction, post-extubation. The secondary outcomes were the extubation time, pre-extubation Richmond Agitation-Sedation Scale (RASS) score, end-tidal sevoflurane concentration at extubation, incidence of postoperative agitation, time to consciousness, and Face, Legs, Activity, Cry, and Consolability (FLACC) pain score in the recovery room. Results were reported with risk ratios (RR) and their 95% confidence intervals (CI), as well as the <i>p</i>-values indicating statistical significance. <b>Results</b> A total of 239 patients were included, including 119 in the propofol group and 120 in the control group. Our findings indicated no significant difference in the rate of PRAEs between the two groups (5.9% vs 10.8%, RR: 0.54, 95% CI: 0.23 to 1.31, <i>p</i> = 0.17). However, the propofol group showed a notable decrease in moderate to severe coughs (13.4% vs 60.0%, RR: 0.22, 95% CI: 0.14 to 0.36, <i>p</i> < 0.001) and postoperative agitation (4.2% vs 60.8%, RR: 0.07, 95% CI: 0.03 to 0.17, <i>p</i> < 0.001). <b>Conclusion</b> This trial demonstrated that while administering repeated small doses of propofol before extubation does not significantly reduce respiratory adverse events in children undergoing tonsillectomy and adenoidectomy, it does significantly reduce the incidence of severe coughing, improving postoperative recovery and clinical outcomes. Moreover, propofol helps reduce postoperative agitation, enhancing the safety and effectiveness of postoperative care, and maintaining its valuable clinical role in postoperative management. <b>Clinical Trial Registration</b> ClinicalTrials.gov (NCT05769842).</p>\",\"PeriodicalId\":9256,\"journal\":{\"name\":\"British journal of hospital medicine\",\"volume\":\"85 11\",\"pages\":\"1-15\"},\"PeriodicalIF\":1.0000,\"publicationDate\":\"2024-11-30\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"British journal of hospital medicine\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://doi.org/10.12968/hmed.2024.0431\",\"RegionNum\":4,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"2024/11/18 0:00:00\",\"PubModel\":\"Epub\",\"JCR\":\"Q3\",\"JCRName\":\"MEDICINE, GENERAL & INTERNAL\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"British journal of hospital medicine","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.12968/hmed.2024.0431","RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"2024/11/18 0:00:00","PubModel":"Epub","JCR":"Q3","JCRName":"MEDICINE, GENERAL & INTERNAL","Score":null,"Total":0}
引用次数: 0
摘要
目的/背景围手术期呼吸不良事件(PRAEs)在小儿麻醉中很常见,特别是在耳鼻喉科手术中。在这项随机对照试验中,我们研究了拔管前给药异丙酚对接受扁桃体切除术和腺样体切除术的儿科患者PRAEs的影响。方法选取美国麻醉医师学会(ASA) I ~ III级3 ~ 8岁拟行扁桃体切除术的患儿,随机分为异丙酚组和对照组。异丙酚组给予多次小剂量异丙酚(每剂量0.5 mg/kg,总剂量1 ~ 2 mg/kg),直至患者恢复正常自主呼吸,无身体运动。对照组给予生理盐水0.15 mL/kg。主要终点为拔管后PRAEs的发生率,如喉痉挛、支气管痉挛、屏气、严重咳嗽、去饱和和气道阻塞。次要结果为拔管时间、拔管前Richmond躁动镇静量表(RASS)评分、拔管时七氟醚末浓度、术后躁动发生率、苏醒时间、恢复室面部、腿部、活动、哭泣和安慰(FLACC)疼痛评分。结果以风险比(RR)及其95%置信区间(CI)报告,p值表示有统计学意义。结果共纳入239例患者,其中异丙酚组119例,对照组120例。我们的研究结果显示,两组间PRAEs发生率无显著差异(5.9% vs 10.8%, RR: 0.54, 95% CI: 0.23 ~ 1.31, p = 0.17)。然而,异丙酚组在中度至重度咳嗽(13.4% vs 60.0%, RR: 0.22, 95% CI: 0.14 ~ 0.36, p < 0.001)和术后躁动(4.2% vs 60.8%, RR: 0.07, 95% CI: 0.03 ~ 0.17, p < 0.001)方面有显著降低。结论拔管前反复小剂量异丙酚不能显著降低扁桃体和腺样体切除术患儿呼吸系统不良事件,但能显著降低严重咳嗽发生率,改善术后恢复和临床预后。此外,异丙酚有助于减少术后躁动,提高术后护理的安全性和有效性,并保持其在术后管理中的宝贵临床作用。临床试验注册:ClinicalTrials.gov (NCT05769842)。
Impact of Propofol Administered before Extubation on Respiratory Adverse Events in Pediatric Patients Undergoing Tonsillectomy and Adenoidectomy: A Randomized Controlled Trial.
Aims/Background Perioperative respiratory adverse events (PRAEs) are common in pediatric anesthesia, especially in otolaryngology procedures. In this randomized controlled trial, we investigated the impact of administering propofol before extubation on PRAEs in pediatric patients undergoing tonsillectomy and adenoidectomy. Methods We enrolled children aged 3 to 8 years old, of American Society of Anesthesiologists (ASA) classes I to III, scheduled for tonsillectomy, and randomly divided them into propofol and control groups. The subjects in the propofol group received multiple small doses of propofol (0.5 mg/kg per dose, total 1-2 mg/kg) until the patient resumed regular spontaneous breathing and exhibited no bodily movements. The subjects in the control group received 0.15 mL/kg of saline. The primary outcome was the rate of PRAEs, such as laryngospasm, bronchospasm, breath-holding spell, severe coughing, desaturation, and airway obstruction, post-extubation. The secondary outcomes were the extubation time, pre-extubation Richmond Agitation-Sedation Scale (RASS) score, end-tidal sevoflurane concentration at extubation, incidence of postoperative agitation, time to consciousness, and Face, Legs, Activity, Cry, and Consolability (FLACC) pain score in the recovery room. Results were reported with risk ratios (RR) and their 95% confidence intervals (CI), as well as the p-values indicating statistical significance. Results A total of 239 patients were included, including 119 in the propofol group and 120 in the control group. Our findings indicated no significant difference in the rate of PRAEs between the two groups (5.9% vs 10.8%, RR: 0.54, 95% CI: 0.23 to 1.31, p = 0.17). However, the propofol group showed a notable decrease in moderate to severe coughs (13.4% vs 60.0%, RR: 0.22, 95% CI: 0.14 to 0.36, p < 0.001) and postoperative agitation (4.2% vs 60.8%, RR: 0.07, 95% CI: 0.03 to 0.17, p < 0.001). Conclusion This trial demonstrated that while administering repeated small doses of propofol before extubation does not significantly reduce respiratory adverse events in children undergoing tonsillectomy and adenoidectomy, it does significantly reduce the incidence of severe coughing, improving postoperative recovery and clinical outcomes. Moreover, propofol helps reduce postoperative agitation, enhancing the safety and effectiveness of postoperative care, and maintaining its valuable clinical role in postoperative management. Clinical Trial Registration ClinicalTrials.gov (NCT05769842).
期刊介绍:
British Journal of Hospital Medicine was established in 1966, and is still true to its origins: a monthly, peer-reviewed, multidisciplinary review journal for hospital doctors and doctors in training.
The journal publishes an authoritative mix of clinical reviews, education and training updates, quality improvement projects and case reports, and book reviews from recognized leaders in the profession. The Core Training for Doctors section provides clinical information in an easily accessible format for doctors in training.
British Journal of Hospital Medicine is an invaluable resource for hospital doctors at all stages of their career.
The journal is indexed on Medline, CINAHL, the Sociedad Iberoamericana de Información Científica and Scopus.