scholarly journals Determination of the median effective dose of dexmedetomidine for the prevention of emergence agitation in geriatric patients undergoing major open surgery with general anesthesia: A prospective, double-blinded, dose-response trial

Author(s):  
weibing wang ◽  
AiJiao Sun ◽  
JingBo Xiao ◽  
JingChun Dong ◽  
Huang Xu ◽  
...  

Abstract BackgroundDexmedetomidine can effectively decrease the incidences of emergence agitation (EA) in adult patients, but there are major side effects related to increased dose of dexmedetomidine. The purpose of this study was to determine of the median effective dose of dexmedetomidine in the prevention of EA among geriatric patients undergoing major open surgery with general anesthesia.MethodsA total of 50 geriatric patients were enrolled in this study. Dexmedetomidine 0.5µg·kg-1·h-1 continuous intravenous infusion was administered to the first patient. The next dose was increased or decreased by 0.05 depending on the response of the previous patient, according to the Dixon up-and-down method. An “effective” or “ineffective” response was determined based on the Riker sedation-agitation score(RSAS), we defined “effective” as RSAS < 5, and “ineffective” as RSAS ≥ 5.ResultsThe ED50 of dexmedetomidine in prevention of EA was 0.30µg·kg-1·h-1 (95% CI, 0.27–0.33) and the predicted ED95 was 0.42µg·kg-1·h-1(95% CI, 0.38–0.51). The incidence of bradycardia was significant increased in group without EA compared to the group with EA (57.1% vs 13.6%, P = 0.002).ConclusionsThe ED50 of dexmedetomidine in prevention of EA was 0.30µg·kg-1·h-1 (95% CI, 0.27–0.33) and the predicted ED95 was 0.42µg·kg-1·h-1 (95% CI, 0.38–0.51). Bradycardia was the main complication.Trial registrationThis study was registered in the Chinese Clinical Trial Registry (Registration number: ChiCTR1900023769) on June 11th, 2019.

Dose-Response ◽  
2021 ◽  
Vol 19 (3) ◽  
pp. 155932582110371
Author(s):  
WeiBing Wang ◽  
Hui Zhou ◽  
AiJiao Sun ◽  
JinBo Xiao ◽  
JingChong Dong ◽  
...  

Dexmedetomidine can effectively decrease the incidences of emergence agitation (EA) in adult patients, but there are major side effects related to increased dose of dexmedetomidine. The purpose of this study was to determine the median effective dose of dexmedetomidine in the prevention of EA among geriatric patients undergoing major open surgery with general anesthesia. A total of 50 geriatric patients were enrolled in this study. Dexmedetomidine 0.5 μg·kg−1·h−1 continuous intravenous infusion was administered to the first patient. The next dose was increased or decreased by .05 depending on the response of the previous patient, according to the Dixon up-and-down method. An “effective” or “ineffective” response was determined based on the Riker sedation-agitation score (RSAS), we defined “effective” as RSAS<5, and “ineffective” as RSAS≥5. The ED50 of dexmedetomidine in prevention of EA was .30 μg·kg−1·h−1 (95% CI, .27–.33) and the predicted ED95 was .42 μg·kg−1·h−1 (95% CI, .38–.51). The incidence of bradycardia was significantly increased in the group without EA compared to the group with EA (57.1% vs 13.6%, P = .002). The ED50 of dexmedetomidine in prevention of EA was .30 μg·kg−1·h−1 (95% CI, .27–.33) and the predicted ED95 was .42 μg·kg−1·h−1 (95% CI, .38–.51). Bradycardia was the main complication.


2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Lijun Niu ◽  
Lihong Chen ◽  
Yanhua Luo ◽  
Wenkao Huang ◽  
Yunsheng Li

Abstract Background The objective of this study was to compare the analgesic potency of oxycodone versus morphine after laparoscopic deep infiltrating endometriosis resection. Methods Fifty patients undergoing laparoscopic deep infiltrating endometriosis resection were randomized to receive oxycodone or morphine intravenous-PCA after surgery. The primary outcome was opioid consumption during the 24 h after surgery. Secondary outcomes included time to first request for analgesia, the number of bolus, pain, sedation, nausea, vomiting, respiratory depression, and bradycardia. The prominent pain that caused patients to press the analgesic device was also recorded. Results Oxycodone consumption (14.42 ± 2.83) was less than morphine consumption (20.14 ± 3.83). Compared with the morphine group, the total number of bolus (78 vs 123) was less and the average time to first request for analgesia (97.27 ± 59.79 vs 142.17 ± 51) was longer in the oxycodone group. The incidence of nausea was higher in the morphine group than in the oxycodone group at 0–2 h (45.45% vs 17.19%), 2–4 h (50% vs 17.19%),12–24 h (40.91% vs 13.04%) and 0–24 h (39.17% vs 19.13%). The overall incidence of vomiting was higher in the morphine group (27.27% vs 13.92%). There was no difference in visual analogue scale score, the incidence of respiratory depression, and bradycardia between groups. Of the three types of pain that prompted patients to request analgesia, the incidence of visceral pain was highest (59.9%, P < 0.01). Conclusion Oxycodone was more potent than morphine for analgesia after laparoscopic endometriosis resection, and oxycodone has fewer side effects than morphine. Name of the registry: Chinese Clinical Trial Registry Trial registration number: ChiCTR1900021870 URL of trial registry record:http://www.chictr.org.cn/edit.aspx?pid=35799&htm=4 Date of registration: 2019/3/13 0:00:00


2020 ◽  
Author(s):  
Yuejiao Song ◽  
Zhihong Xu ◽  
Zhenyi Chen ◽  
Qingwu Liao

Abstract Backgroud: To evaluate the optimal administration time of butorphanol in suppressing sufentanil-induced cough(SIC) during the induction of general anesthesia.Methods:180 patients were randomly divided into 4 equally sized groups: at 5min, 2min and 0min before anesthesia induction, all patients were sequentially injected the drug labeled A/B/C (butorphanol 1mg or normal saline), GI received intravenously drug A/B/C (All were normal saline),GII received intravenously drug A/B/C (A was butorphanol, B and C were saline), GIII received intravenously drug A/B/C (B is butorphanol, A and C were saline), GIV received intravenously drug A/B/C (C is butorphanol,A and B were saline). ALL Patients were then administrated with sufentanil 0.4 µg/kg in 5s after drug C. The incidence and severity of SIC was recorded within 2 minutes after sufentanil injection. MAP, HR, and SpO2 were recorded at T0 (before the administration of any drug),Ta, Tb, Tc (before the injection of drug A/B/C), T1( 2minutes after sufentanil injection) and T2 (1 minutes after endotracheal intubation). Results: The incidences of cough in GII, GIII, and IV were lower than that in GI (0.09, 0.01, and 0 vs 42.2%, P<0.01), while there were no significant differences between GII, GIII, and GIV. The HR of all 4 groups at T2 were significantly higher than their levels at any other time (P<0.05,T2 vs other time), but there’s no significant difference among 4 groups at T2. The MBP of all 4 groups at Ta and Tb were significantly lower than their levels at any other time (P<0.05, Ta and Tb vs other time), but there’s no significant difference among 4 groups at Ta and Tb. At Ta, the SpO2 of GII was significantly lower than GI, GIII and GIV (P<0.05); at Tb, the SpO2 of GII was significantly lower than GI (P<0.05) and GIV (P<0.01); at Tc, the SpO2 of GIII were significantly lower than GIV (P<0.05).Conclusion: Intravenous butorphanol 1 mg could effectively suppress SIC before sufentanil injection. Without waiting time before administering the sufentanil may be feasible in clinical practice, it has the same suppressive effection and has no influence on BP, HR, SpO2 and the total amount of sufentanil. Trial registration: Chinese Clinical Trial Registry with registration number ChiCTR1900024394. Registered 9 July 2019.


2021 ◽  
Author(s):  
Mingli Yan ◽  
Huiru Yin ◽  
Qiuyan Meng ◽  
Shuo Wang ◽  
Yiwen Ding ◽  
...  

BACKGROUND Mild cognitive impairment (MCI) is often a precursor of dementia, and MCI patients develop dementia at a higher rate than healthy older adults. Early detection of cognitive decline at the MCI stage supports better planning of care and interventions. At present, the use of virtual reality (VR) in screening for MCI in older adults is promising, but there is little evidence on the use of virtual supermarkets to screen for MCI. OBJECTIVE The objectives were to validate a VR game-based test, namely, the Virtual Supermarket Program (VSP), for differentiating MCI patients and healthy controls (HCs) and to identify cutoff scores for different age levels. METHODS Subjects were recruited from several nursing homes and communities in Changchun, China. They were divided into an HC group (N = 64) and an MCI group (N = 62). All subjects were administered the VSP and a series of neuropsychological examinations. The study determined the optimal cutoff, discriminating validity, concurrent validity and retest reliability of the VSP. We used the area under the curve (AUC) of the receiver operating characteristic to evaluate the discriminating validity and obtain the optimal cutoff values. Pearson correlation analysis and the intraclass correlation coefficient were used to evaluate the concurrent validity and retest reliability, respectively. RESULTS A cutoff score of 46.4 was optimal for the entire sample, yielding a sensitivity of 85.9% and a specificity of 79.0% for differentiating those with MCI and HCs, and the AUC was 0.870 (95% CI = 0.799~0.924). The median index of VSP score was 51.1, and the score range was 42.6 to 60.0. There was a moderate positive correlation between VSP total score and Mini-Mental State Examination score (r = 0.429, P < .001). There was a strong positive correlation between VSP total score and Montreal Cognitive Assessment score (r = 0.645, P < .001). The retest reliability of the VSP was feasible (r = 0.588, P = .048). CONCLUSIONS The VSP is interesting and feasible for subjects. It shows high sensitivity and specificity for the identification of MCI in older adults, which makes it a promising screening method. The VSP may be generalized to older adults in other countries, although some cultural adaptation may be necessary. Trial Registration: The study was registered in the Chinese Clinical Trial Registry (registration number: ChiCTR2000040074). CLINICALTRIAL Trial Registration: The study was registered in the Chinese Clinical Trial Registry (registration number: ChiCTR2000040074).


2021 ◽  
Vol 49 (4) ◽  
pp. 030006052110017
Author(s):  
Zhitao Li ◽  
Jiachun Cai ◽  
Jiexiong Li ◽  
Xianghui Xu ◽  
Limin Zheng

Objective To compare the accuracy, correlation and agreement between the bispectral index (BIS) and BISpro during propofol anaesthesia. Methods The BIS, BISpro, heart rate, target-concentration of propofol and Observer’s Assessment of Alertness and Sedation (OAA/S) score were recorded every 30 s in female patients scheduled for hysteroscopic surgery. Propofol anaesthesia was induced by an initial target-controlled concentration (1.0 μg/ml) followed by a stepwise increase (0.5 μg/ml) until the patient was unresponsive. Spearman’s correlation coefficient and prediction probability were calculated for the association between sedation levels and the above parameters. The ability of investigated parameters to distinguish between OAA/S scores was analysed. Bland–Altman analysis was used to compare the agreement between BIS and BISpro. The BIS and BISpro cut-off values for lost response were also determined. Results Out of 30 patients in total, a high correlation was found between BIS and BISpro, and both correlated well with OAA/S score. Only BIS was able to distinguish all investigated OAA/S states accurately, but the ability to predict OAA/S score 5 to loss of response was comparable between BIS and BISpro. The calculated cut-off values were 68 for BIS and 70 for BISpro. Conclusion BISpro and BIS are reliable monitors of general anaesthesia during sedation. Trial registration number: Chinese Clinical Trial Registry (URL: www.chictr.org.cn ): ChiCTR1900024037 (retrospectively registered).


BMJ Open ◽  
2021 ◽  
Vol 11 (2) ◽  
pp. e043599
Author(s):  
Xiaofan Sun ◽  
Yuanqing Kan ◽  
Lihong Huang ◽  
Zhihui Dong ◽  
Daqiao Guo ◽  
...  

IntroductionThoracic endovascular aortic repair (TEVAR) has gradually become the mainstream therapy for aortic arch pathologies (AAP). Our centre developed the in situ fenestration (ISF) system according to years of clinical experience and technological innovation. This study aims to evaluate the safety and effectiveness of the innovative, self-developed ISF system in TEVAR for AAP.Methods and analysisThe study is a prospective, multicentre and single-arm study. Patients diagnosed with AAPs in five centres on 1 January 2021 will be recruited and general TEVAR with ISF system will be performed. Clinical information and CT angiography images will be collected and recorded. Patients will be followed up for 5 years. Safety and efficacy endpoints are planned to be reported to evaluate this self-developed ISF system.Ethics and disseminationThe study is a registry. We have registered the study on the Chinese Clinical Trial Registry website (http://www.chictr.org.cn/). This study has been approved by the Ethics Committee of Zhongshan Hospital Fudan University (B2020-371) and individual consents will be signed at the time of enrolment. We anticipate that this self-developed ISF system will result in favourable social and economic benefits. Findings will be disseminated in peer-reviewed journals to provide reference for future clinical practice.Trial registration numberChiCTR1900026696.


2019 ◽  
Author(s):  
Huaxin Wang ◽  
Xuan Peng ◽  
Yeda Xiao ◽  
Bo Zhao ◽  
Liying Zhan

Abstract Background: The role of intraoperative intravenous lidocaine infusion has been previously evaluated for pain relief, inflammatory response, and post-operative recovery, including in endoscopic surgery. The present study is a randomized double-blinded trial in which we evaluated whether intravenous lidocaine infusion would reduce postoperative pain, propofol requirement and remifentanil consumption in patients undergoing hysteroscopy surgery. Methods: Eighty-five patients scheduled to undergo elective operative hysteroscopy surgery under general anesthesia were randomized into two groups. Group L included patients who received an intravenous lidocaine bolus 1.5mg/kg over 3 min followed by a continuous infusion at the rate of 2 mg/kg/h until surgery completed, and Group C received 0.9% normal saline solution at an equivalent rate. The depth of anesthesia was monitored using the Narcotrend, which was based on measurement of the patient’s cerebral electrical activity. Primary outcome of the study was postoperative hypogastric pain evaluating by visual analogue scale (VAS). Secondary outcomes include propofol requirement and remifentanil requirement. Results: VAS score of Group L was significantly lower than Group C at postoperative 0.5 h, 4 h, respectively (P < 0.05), while no obvious difference was found at postoperative 24 h. There was no difference between groups in propofol requirement, but Group L required less dosage of remifentanil than Group C (P < 0.05). Moreover, the incidence of throat pain was significantly lower in Group L. No adverse events associated with lidocaine was discovered. Conclusions: Administration of intravenous lidocaine infusion as an adjuvant alleviated short-term postoperative hypogastric pain and throat pain, and reduced remifentanil requirement in patients undergoing operative hysteroscopy surgery. Trial registration: Chinese Clinical Trial Registry (chictr.org.cn) with registration number ChiCTR1800016857. Keywords: Lidocaine, hysteroscopic surgery, remifentanil, propofol


Author(s):  
Angelika Batta ◽  
Raj Khirasaria ◽  
Vinod Kapoor ◽  
Deepansh Varshney

AbstractObjectivesWith the emergence of Novel corona virus, hunt for finding a preventive and therapeutic treatment options has already begun at a rapid pace with faster clinical development programs. The present study was carried out to give an insight of therapeutic interventional trials registered under clinical trial registry of India (CTRI) for COVID-19 pandemic.MethodsAll trials registered under CTRI were evaluated using keyword “COVID” from its inception till 9th June 2020. Out of which, therapeutic interventional studies were chosen for further analysis. Following information was collected for each trial: type of therapeutic intervention (preventive/therapeutic), treatment given, no. of centers (single center/multicentric), type of institution (government/private), study design (randomized/single-blinded/double-blinded) and sponsors (Government/private). Microsoft Office Excel 2007 was used for tabulation and analysis.ResultsThe search yielded total of 205 trials, out of which, 127 (62%) trials were interventional trials. Out of these, 71 (56%) were AYUSH interventions, 36 (28.3%) tested drugs, 9 (7%) tested a nondrug intervention, rest were nutraceuticals and vaccines. About 66 (56%) were therapeutic trials. Majority were single-centered trials, i.e. 87 (73.7%). Trials were government funded in 57 (48.3%) studies. Majority were randomized controlled trials, i.e. 67 (56.8%). AYUSH preparations included AYUSH-64, Arsenic Album, SamshamaniVati etc.ConclusionsThe number of therapeutic interventional clinical trials was fair in India. A clear-cut need exists for an increase in both quantity and quality of clinical trials for COVID-19. Drug repurposing approach in all systems of medicine can facilitate prompt clinical decisions at lower costs than de novo drug development.


Open Heart ◽  
2021 ◽  
Vol 8 (1) ◽  
pp. e001495
Author(s):  
Francesco Bianco ◽  
Massimo Colaneri ◽  
Valentina Bucciarelli ◽  
Francesca Chiara Surace ◽  
Federica Valentina Iezzi ◽  
...  

AimsWe sought to determine the diagnostic performance, clinical profiles and outcomes of anomalous aortic origin of coronary arteries (AAOCA) using a standardised echocardiographic approach in young adults and athletes.MethodsIn 2015–2019, we screened 5998 outpatients (age 16 years (Q1–Q3: 11, 36)), referred for routine echocardiography, using four specific echocardiographic windows: parasternal short/long axis and apical 4/5-chambers view. Coronary CT confirmed AAOCA. For the performance analysis, 300 coronary-CT scans were available; two independent and double-blinded physicians retrospectively reviewed echocardiographic images.ResultsA total of 47 AAOCA was diagnosed; the overall prevalence was 0.0078%. Over 5 years, we found a significant increment of AAOCA diagnostic rate (P for trend=0.002). Syncope (n=17/47) and palpitations (n=6/47) were prevalent symptoms. All patients suspended sports activity at the diagnosis. Twenty-seven patients underwent surgery, while 20 underwent a conservative medical treatment. All patients are alive at a median follow-up of 3±1.6 years; only surgical repairs restarted their activity. Our method showed better sensitivity than traditional short-axis evaluation: 93% vs 83%, p=0.0030 (AUC 0.96 (95% CI 0.92, 0.99) and AUC 0.89 (95% CI 0.83, 0.95), respectively), with a good interobserver agreement (95%, k=0.83, p<0.001).ConclusionsThe application of a standardised echocardiographic approach for AAOCA detection led to a significantly increased rate of identified anomalies. This approach demonstrated higher sensitivity than the traditional echocardiographic assessment. Implementing this protocol in clinical practice may help improve the AAOCA diagnosis in young adults and athletes.Trial registration numberNCT04224090.


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