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Safety and efficacy of ciprofol vs.propofol for sedation in intensive care unit patients with mechanical ventilation:a multi-center,open label,randomized,phase 2 trial

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Chinese Medical Journal 2022年第9期135卷 1043-1051页

作者： Yongjun Liu Xiangyou Yu Duming Zhu Jun Zeng Qinhan Lin Bin Zang Chuanxi Chen Ning Liu Xiao Liu Wei Gao Xiangdong Guan Department of Critical Care Medicine The First Affiliated HospitalSun Yat-sen UniversityGuangzhou 510080China Department of Critical Care Medicine The First Affiliated Hospital of Xinjiang Medical UniversityUrumqi 830011China Department of Critical Care Medicine Zhongshan HospitalFudan UniversityShanghai 200032China Department of Critical Care Medicine Guangzhou First People's HospitalGuangzhou 510180China Department of Critical Care Medicine Qingyuan People's HospitalThe Sixth Affiliated Hospital of Guangzhou Medical UniversityQingyuan 511518China Department of Critical Care Medicine Shengjing Hospital of China Medical UniversityShenyang 110022China Department of Research and Development Haisco Pharmaceutical Group Co.LtdShanghai 201203China.

Background:Ciprofol(HSK3486;Haisco Pharmaceutical Group Co.,Ltd.,Chengdu,China),developed as a novel 2,6-disubstituted phenol derivative showed similar tolerability and efficacy characteristics as propofol when applicated as continuous intravenous infusion for 12 h maintenance sedation in a previous phase 1 trial.The phase 2 trial was designed to investigate the safety,efficacy,and pharmacokinetic characteristics of ciprofol for sedation of patients undergoing mechanical ventilation.Methods:In this multicenter,open label,randomized,propofol positive-controlled,phase 2 trial,39 Chinese intensive care unit patients receiving mechanical ventilation were enrolled and randomly assigned to a ciprofol or propofol group in a 2:1 ratio.The ciprofol infusion was started with a loading infusion of 0.1-0.2 mg/kg for 0.5-5.0 min,followed by an initial maintenance infusion rate of 0.30 mg·kg^(-1)·h^(-1),which could be adjusted to an infusion rate of 0.06 to 0.80 mg·kg^(-1)·h^(-1),whereas for propofol the loading infusion dose was 0.5-1.0 mg/kg for 0.5-5.0 min,followed by an initial maintenance infusion rate of 1.50 mg·kg^(-1)·h^(-1),which could be adjusted to 0.30-4.00 mg·kg^(-1)·h^(-1)to achieve-2 to+1 Richmond Agitation-sedation Scale sedation within 6-24 h of drug administration.Results:Of the 39 enrolled patients,36 completed the trial.The median(min,max)of the average time to sedation compliance values for ciprofol and propofol were 60.0(52.6,60.0)min and 60.0(55.2,60.0)min,with median difference of 0.00(95%confidence interval:0.00,0.00).In total,29(74.4%)patients comprising 18(69.2%)in the ciprofol and 11(84.6%)in the propofol group experienced 86 treatment emergent adverse events(TEAEs),the majority being of severity grade 1 or 2.Drug-and sedation-related TEAEs were hypotension(7.7%vs.23.1%,P=0.310)and sinus bradycardia(3.8%vs.7.7%,P=1.000)in the ciprofol and propofol groups,respectively.The plasma concentration-time curves for ciprofol and propofol were similar.Conclusions:ciprofol is comparable to propofol with good t

关键词： HSK3486 Ciprofol Propofol sedation Mechanical ventilation

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sedation and analgesia in gastrointestinal endoscopy: What’s new?

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World Journal of Gastroenterology 2010年第20期16卷 2451-2457页

作者： Lorella Fanti Pier Alberto Testoni Division of Gastroenterology and Gastrointestinal Endoscopy Vita-Salute San Raffaele UniversityScientific Institute San Raffaele20132 MilanItaly

Various types of sedation and analgesia technique have been used during gastrointestinal endoscopy procedures.The best methods for analgesia and sedation during gastrointestinal endoscopy are still debated.Providing an adequate regimen of sedation/analgesia might be considered an art,influencing several aspects of endoscopic procedures: the quality of the examination,the patient’s cooperation and the patient’s and physician’s satisfaction with the sedation.The properties of a model sedative agent for endoscopy would include rapid onset and offset of action,analgesic and anxiolytic effects,ease of titration to desired level of sedation,rapid recovery and an excellent safety prof ile.Therefore there is an impulse for development of new approaches to endoscopic sedation.This article provides an update on the methods of sedation today available and future directions in endoscopic sedation.

关键词： Gastrointestinal endoscopy Analgesia sedation Propofol

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Considerations for pediatric burn sedation and analgesia

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Burns & Trauma 2017年第4期5卷 218-228页

作者： Alice Fagin Tina L. Palmieri Arkansas Children's Hospital 1 Children's Way Little Rock AR 72202 USA Shriners Hospitals for Children Northern California and University of California Davis 2425 Stockton Blvd Suite 718 Sacramento CA USA

Burn patients experience anxiety and pain in the course of their injury, treatment, and recovery. Hence, treatment of anxiety and pain is paramount after burn injury. Children, in particular, pose challenges in anxiety and pain management due to their unique physiologic, psychologic, and anatomic status. Burn injuries further complicate pain management and sedation as such injuries can have effects on medication response and elimination. Burn injuries further complicate pain management and sedation as such injuries can have effects on medication response and elimination. The purpose of this review is to describe the challenges associated with management of anxiety, pain, and sedation in burned children and to describe the different options for treatment of anxiety and pain in burned children.

关键词： Pediatric sedation Burns

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Suspected cerebrovascular air embolism during endoscopic esophageal varices ligation under sedation with fatal outcome: A case report

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World Journal of Clinical Cases 2022年第1期10卷 371-380页

作者： Cuo-Mao-Ji Zhang Xiao Wang Department of Anesthesiology West China Hospital of Sichuan UniversityChengdu 610041Sichuan ProvinceChina

BACKGROUND Air embolism is a very rare,yet serious and potentially fatal complication of digestive endoscopic treatment.Air embolism is the result of air directly entering the arteries or veins.However,to recognize neurological dysfunction under sedation can be difficult.Therefore,it is extremely important to identify high-risk groups and take preventive measures.CASE SUMMARY Herein,we report a 74-year-old female patient with esophageal varices who suffered from consciousness disturbance after the third endoscopic ligation of esophageal varices under sedation.Combined with the patient’s imaging examination results and medical history,we highly suspected that the patient had developed paradoxical cerebral air embolism during endoscopic ligation.We learned that the patient died at a later follow-up.In order to be able to identify and prevent the occurrence of air embolism early,we summarize and analyze the risk factors,pathogenesis,clinical manifestations,prevention and treatment options of gastrointestinal endoscopy complicated by cerebral air embolism.CONCLUSION Electroencephalographic monitoring helps to recognize the occurrence of air embolism in time and increase the patient's chance of survival.

关键词： Cerebral infarction Paradoxical air embolism Endoscopic ligation Esophageal variceal sedation Case report

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Intranasal sufentanil combined with intranasal dexmedetomidine: A promising method for non-anesthesiologist sedation during endoscopic ultrasonography

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World Journal of Clinical Cases 2022年第23期10卷 8428-8431页

作者： Yong Wang Zhi-Jun Ge Chao Han Department of Anesthesiology The Affiliated Yixing Hospital of Jiangsu UniversityYixing 214200Jiangsu ProvinceChina School of Medical Jiangsu UniversityZhenjiang 212013Jiangsu ProvinceChina

Intranasal sufentanil combined with intranasal dexmedetomidine exhibited an estimated sedation success probability as high as 94.9%,higher satisfaction scores,and only minor adverse events during endoscopic ultrasonog... 详细信息

关键词： Intranasal Sufentanil Dexmedetomidine sedation Endoscopic Ultrasonography

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Early Goal Directed sedation, a bridge to better clinical outcomes

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Chinese Medical Journal 2014年第10期127卷 1969-1972页

作者： Yahya Shehabi Univ New S Wales Sch Clin Randwick NSW 2301 Australia Monash Univ Fac Med Nursing & Hlth Sci Melbourne Vic 3004 Australia Prince Wales Hosp Randwick NSW 2031 Australia

Critical care has become a central part of modern medicine and an integral essential to improve the outcomes in acute care.The increasing complexity of surgical procedures,severity of co-morbid diseases,life expectancy and societal expectation is likely to escalate the burden and the global need for critical care resources.While millions of patients are ventilated worldwide every year,projections suggest that the number of ventilated patients is expected to rise by 31% over the following decade.1

关键词： sedation early goal directed sedation ventilation critically ill dexmedetomidine

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Effect of oral premedication of midazolam, ketamine, and dexmedetomidine on pediatric sedation and ease of parental separation in anesthesia induction for elective surgery: A randomized clinical trial

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Journal of Acute Disease 2022年第4期11卷 133-139页

作者： Aref Zarei Hesameddin Modir Behnam Mahmoodiyeh Alireza Kamali Farzad Zamani-Barsari Student Research Committee Arak University of Medical SciencesArakIran Anesthesiology Department Arak University of Medical SciencesArakIran Department of ENT Surgery Arak University of Medical SciencesArakIran

Objective:To compare effect of midazolam,dexmedetomidine,and ketamine as oral premedication on pediatric sedation and ease of parental separation anxiety in anesthesia induction.Methods:This multicenter,prospective,randomized,double-blind,clinical trial focused on a pediatric population aged 2-7 years(n=153)with the American Society of AnesthesiologistsⅠ-Ⅱwho required elective surgery.The patients were stratified into three intervention groups:midazolam,ketamine,and dexmedetomidine.Hemodynamic parameters(blood pressure,heart rate,and oxygen saturation)every 5 min until induction of anesthesia along with non-hemodynamic factors,comprised of sedation score before the administration and at the time of being separated from the parents,as well as parental separation anxiety scale,acceptance of anesthesia induction,and side effects were recorded and compared.Results:No statistically significant difference in oxygen saturation,heart rate,blood pressure,duration of surgery,time to achieve an Aldrete score of 9-10,or sedation score was noted in the study groups.More patients in the dexmedetomidine and midazolam groups could better ease parental separation anxiety than the ketamine group(P=0.001).Moreover,fewer patients accept anesthesia induction(P=0.001)and more had side effects in the ketamine group(P=0.047).Conclusions:Our findings indicate that compared to the ketamine group,dexmedetomidine and midazolam are better in easing parental separation anxiety and accepting induction of anesthesia with fewer side effects.Dexmedetomidine and midazolam may be considered better choices.However,the final choice hinges on the patient's specific physical condition and the anesthesiologist's preference.Clinical registarion:This study is registered in the Iranian Registry Clinical Trial center with the clinical trial code of IRCT20211007052693N1.

关键词： Dexmedetomidine Ketamine Midazolam Premedication sedation

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A small-dose naloxone infusion alleviates nausea and sedation without impacting analgesia via intravenous tramadol

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Chinese Medical Journal 2010年第13期123卷 1695-1698页

作者： JIA Dong-lin NI Cheng XU Ting ZHANG Li-ping GUO Xiang-yang Department of Anesthesiology Peking University Third Hospital Beijing 100191 China

Background Early studies showed that naloxone infusion decreases the incidence of morphine-related side effects from intravenous patient-controlled analgesia. This study aimed to determine whether naloxone preserved analgesia while minimizing side effects caused by intravenous tramadol administration. Methods Eighty patients undergoing general anesthesia for cervical vertebrae surgery were randomly divided into four groups. All patients received 1 mg/kg tramadol 30 minutes before the end of surgery, followed by a continuous infusion with 0.3 mg-kg1.h^-1 tramadol with no naloxone （group I, n=20）, 0.05 μg.kg.^-1.h^-1 naloxone （group Ⅱ, n=20）, 0.1 pg.kg^-1.h^-1 naloxone （group Ⅲ, n=-20） and 0.2 μg.kg^-1.h^-1 naloxone （group Ⅳ, n=20）. Visual analog scales （VAS） for pain during rest and cough, nausea five-point scale （NFPS） for nausea and vomiting, and ramsay sedation score （RSS） for sedation were assessed at 2, 6, 12, 24 and 48 hours postoperatively. Analgesia and side effects were evaluated by blinded observers. Results Seventy-eight patients were included in this study. The intravenous tramadol administration provided the satisfied analgesia. There was no significant difference in either resting or coughing VAS scores among naloxone groups and control group. Compared with control group, sedation was less in groups Ⅱ, Ⅲ, and Ⅳ at 6, 12, and 24 hours （P 〈0.05）; nausea was less in groups Ⅱ, Ⅲ and Ⅳ than group I at 2, 6, 12, 24 and 48 hours postoperatively （P 〈0.05）. The incidence of vomiting in the control group was 35% vs. 10% for the highest dose naloxone group （group Ⅳ）（P 〈0.01）. Conclusion A small-dose naloxone infusion could reduce tramadol induced side effects without reversing its analgesic effects.

关键词： tramadol naloxone analgesia nausea sedation

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Prospective, randomized comparison of two supplemental oxygen methods during gastro-scopy with propofol mono-sedation in obese patients

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World Journal of Clinical Cases 2021年第20期9卷 5479-5489页

作者： Liu-Jia-Zi Shao Fang-Xiao Hong Fu-Kun Liu Lei Wan Fu-Shan Xue Department of Anesthesiology Beijing Friendship HospitalCapital Medical UniversityBeijing 100050China

BACKGROUND Hypoxemia is a common complication in obese patients during gastroscopy with sedation.The Wei nasal jet tube(WNJT)is a new special nasopharyngeal airway with the ability to provide supraglottic jet ventilation and oxygen insufflation via its built-in wall channels.The aim of this study was to compare the efficacy and safety of the WNJT vs a nasal cannula for supplemental oxygen during gastroscopy with propofol mono-sedation in obese patients.AIM To compare the efficacy and safety of the WNJT vs a nasal cannula for supplemental oxygen during gastroscopy with propofol mono-sedation in obese patients.METHODS A total of 103 obese patients with a body mass index of 30 kg/m2 or more undergoing elective gastroscopy under propofol mono-sedation were randomly assigned to receive supplemental oxygen at 5 L/min through either a WNJT(WNJT group,n=51)or a nasal cannula(nasal cannula group,n=52).The lowest pulse oxygen saturation(SpO2)and mild and severe hypoxemia during gastroscopy were recorded.The primary outcome was the incidence of hypoxemia.RESULTS The lowest SpO2 during gastroscopy with propofol mono-sedation was significantly increased in the WNJT group compared with the nasal cannula group.The incidence of mild hypoxemia and total incidence of hypoxemia were significantly lower in the WNJT group than in the nasal cannula group.Other than a higher incidence of epistaxis in the WNJT group,the occurrence of adverse events was similar between the devices.While neither device demonstrated a statistically significant difference in satisfaction among patients,the WNJT did result in improved satisfaction among anesthetists and physicians.CONCLUSION During gastroscopy with propofol mono-sedation in obese patients,the WNJT,when compared with a nasal cannula for supplemental oxygen,can significantly reduce the occurrence of hypoxemia and improve both arterial oxygenation and satisfaction among anesthetists and physicians.The use of the WNJT may,however,lead to epistaxis in a few patients.In view of this clinically acc

关键词： Supplemental oxygen Gastroscopy sedation Obese patients

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sedation in gastrointestinal endoscopy: Current issues

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World Journal of Gastroenterology 2013年第4期19卷 463-481页

作者： John K Triantafillidis Emmanuel Merikas Dimitrios Nikolakis Apostolos E Papalois Department of Gastroenterology and Center for Inflammatory Bowel Disease "Saint Panteleimon" General HospitalNikaia12461 HaidariGreece Experimental Research Center ELPEN Pharmaceuticals19009 AthensGreece

Diagnostic and therapeutic endoscopy can successfully be performed by applying moderate(conscious) sedation.Moderate sedation,using midazolam and an opioid,is the standard method of sedation,although propofol is increasingly being used in many countries because the satisfaction of endoscopists with propofol sedation is greater compared with their satisfaction with conventional sedation.Moreover,the use of propofol is currently preferred for the endoscopic sedation of patients with advanced liver disease due to its short biologic half-life and,consequently,its low risk of inducing hepatic encephalopathy.In the future,propofol could become the preferred sedation agent,especially for routine colonoscopy.Midazolam is the benzodiazepine of choice because of its shorter duration of action and better pharmacokinetic profile compared with diazepam.Among opioids,pethidine and fentanyl are the most popular.A number of other substances have been tested in several clinical trials with promising results.Among them,newer opioids,such as remifentanil,enable a faster recovery.The controversy regarding the administration of sedation by an endoscopist or an experienced nurse,as well as the optimal staffing of en-doscopy units,continues to be a matter of discussion.Safe sedation in special clinical circumstances,such as in the cases of obese,pregnant,and elderly individuals,as well as patients with chronic lung,renal or liver disease,requires modification of the dose of the drugs used for sedation.In the great majority of patients,sedation under the supervision of a properly trained endoscopist remains the standard practice worldwide.In this review,an overview of the current knowledge concerning sedation during digestive endoscopy will be provided based on the data in the current literature.

关键词： Gastrointestinal endoscopy Endoscopy sedation Analgesia Digestive system

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