Comparative evaluation of the bispectral index (BIS) and BISpro during propofol anaesthesia

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).

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Oxycodone versus morphine for analgesia after laparoscopic endometriosis resection

BMC Anesthesiology ◽

10.1186/s12871-021-01417-3 ◽

2021 ◽

Vol 21 (1) ◽

Author(s):

Lijun Niu ◽

Lihong Chen ◽

Yanhua Luo ◽

Wenkao Huang ◽

Yunsheng Li

Keyword(s):

Respiratory Depression ◽

Visceral Pain ◽

Deep Infiltrating Endometriosis ◽

Trial Registry ◽

Clinical Trial Registry ◽

Morphine Group ◽

Registration Number ◽

To Receive ◽

Registry Record ◽

Infiltrating Endometriosis

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

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The Optimal Administration Time of Butorphanol in Suppressing Sufentanil-induced Cough: A Single-Center Randomized Double-Blind Trial

10.21203/rs.3.rs-74936/v1 ◽

2020 ◽

Author(s):

Yuejiao Song ◽

Zhihong Xu ◽

Zhenyi Chen ◽

Qingwu Liao

Keyword(s):

Normal Saline ◽

Anesthesia Induction ◽

Double Blind Trial ◽

Trial Registry ◽

Single Center ◽

Clinical Trial Registry ◽

Double Blind ◽

Significant Difference ◽

Administration Time ◽

Registration Number

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.

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Comparative Evaluation of a New Depth of Anesthesia Index in ConView® System and the Bispectral Index during Total Intravenous Anesthesia: A Multicenter Clinical Trial

BioMed Research International ◽

10.1155/2019/1014825 ◽

2019 ◽

Vol 2019 ◽

pp. 1-7

Author(s):

Yang Fu ◽

Tao Xu ◽

Keliang Xie ◽

Wei Wei ◽

Ping Gao ◽

...

Keyword(s):

Clinical Trial ◽

Bispectral Index ◽

Mean Value ◽

Total Intravenous Anesthesia ◽

Depth Of Anesthesia ◽

Clinical Trial Registry ◽

Intravenous Anesthesia ◽

Spectral Edge Frequency ◽

Prediction Probability ◽

Conscious Level

The performance of a new monitor for the depth of anesthesia (DOA), the Depth of Anesthesia Index (Ai) based on sample entropy (SampEn), 95% spectral edge frequency (95%SEF), and burst suppression ratio (BSR) was evaluated compared to Bispectral Index (BIS) during total intravenous anesthesia (TIVA). 144 patients in six medical centers were enrolled. General anesthesia was induced with stepwise-increased target-controlled infusion (TCI) of propofol until loss of consciousness (LOC). During surgery propofol was titrated according to BIS. Both Ai and BIS were recorded. Primary outcomes: the limits of agreement between Ai and BIS were -17.68 and 16.49, which were, respectively, -30.0% and 28.0% of the mean value of BIS. Secondary outcomes: prediction probability (Pk) of BIS and Ai was 0.943 and 0.935 (p=0.102) during LOC and 0.928 and 0.918 (p=0.037) during recovery of consciousness (ROC). And the values of BIS and Ai were 68.19 and 66.44 at 50%LOC, and 76.65 and 78.60 at 50%ROC. A decrease or an increase of Ai was significantly greater than that of BIS when consciousness changes (during LOC: -9.13±10.20 versus -5.83±9.63, p<0.001; during ROC: 10.88±11.51 versus 5.32±7.53, p<0.001). The conclusion is that Ai has similar characteristic of BIS as a DOA monitor and revealed the advantage of SampEn for indicating conscious level. This trial is registered at Chinese Clinical Trial Registry with ChiCTR-IOR-16009471.

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Comparison of bispectral index and patient state index during sevoflurane anesthesia in children: a prospective observational study

10.21203/rs.3.rs-53378/v2 ◽

2020 ◽

Author(s):

Sang-Hwan Ji ◽

Young-Eun Jang ◽

Eun-Hee Kim ◽

Ji-Hyun Lee ◽

Jin-Tae Kim ◽

...

Keyword(s):

Bispectral Index ◽

Prospective Observational Study ◽

Pediatric Population ◽

Sevoflurane Anesthesia ◽

Trial Registry ◽

Confidential Interval ◽

Prediction Probability ◽

Patient State ◽

State Index ◽

Patient State Index

Abstract Background: Cortical electroencephalography (EEG)-based devices are used to monitor the depth of anesthesia. In this study, we compared the values of bispectral index (BIS) and patient state index (PSI) during sevoflurane anesthesia in children. The ability/accuracy of BIS and PSI to predict the maintenance and recovery state of anesthesia was evaluated based on prediction probability (Pk) values and the secondary outcomes were agreement and correlation of two monitors.Methods: Fifty children (3-12 years old) were enrolled and the patients received sevoflurane anesthesia with remifentanil. Before the induction of anesthesia, BIS and PSI sensors were simultaneously placed on the forehead, and data were collected until the end of anesthesia. Maintenance state was defined as the period following intubation until the cessation of sevoflurane, while recovery state was defined as the period following the cessation of sevoflurane until awake. The prediction probability (Pk), agreement or correlation of BIS and PSI in different anesthesia state were calculated.Results: Anesthesia reduced mean BIS and PSI values. Pk of BIS (95% Confidential Interval (CI) [0.78-0.91])) and PSI (95% CI [0.82-0.91]) for anesthesia were 0.85 and 0.87, respectively. Agreement was 0.79 for recovery state and 0.73 for maintenance state.Conclusions: Pk values were comparable for BIS and PSI. Agreement between BIS and PSI measurements in the same state was relatively good. Therefore, these monitors are appropriate for monitoring for different state of anesthesia in pediatric population.Trial Registry Number: Clinical Trials.gov NCT03792334.

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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

10.21203/rs.3.rs-152373/v1 ◽

2021 ◽

Author(s):

weibing wang ◽

AiJiao Sun ◽

JingBo Xiao ◽

JingChun Dong ◽

Huang Xu ◽

...

Keyword(s):

Effective Dose ◽

Open Surgery ◽

Geriatric Patients ◽

Trial Registry ◽

Emergence Agitation ◽

Clinical Trial Registry ◽

Registration Number ◽

Double Blinded ◽

Response Trial

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.

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Virtual Supermarket Program for the Screening of Mild Cognitive Impairment in Older Adults: Feasibility Study (Preprint)

10.2196/preprints.30919 ◽

2021 ◽

Author(s):

Mingli Yan ◽

Huiru Yin ◽

Qiuyan Meng ◽

Shuo Wang ◽

Yiwen Ding ◽

...

Keyword(s):

Older Adults ◽

Clinical Trial ◽

Cognitive Impairment ◽

Mild Cognitive Impairment ◽

Concurrent Validity ◽

Trial Registry ◽

Clinical Trial Registry ◽

Optimal Cutoff ◽

Retest Reliability ◽

Registration Number

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).

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Evaluation for the safety and effectiveness of the in situ fenestration system in TEVAR for aortic arch pathologies: protocol for a prospective, multicentre and single-arm study

BMJ Open ◽

10.1136/bmjopen-2020-043599 ◽

2021 ◽

Vol 11 (2) ◽

pp. e043599

Author(s):

Xiaofan Sun ◽

Yuanqing Kan ◽

Lihong Huang ◽

Zhihui Dong ◽

Daqiao Guo ◽

...

Keyword(s):

Aortic Arch ◽

Clinical Information ◽

Ethics Committee ◽

Economic Benefits ◽

Thoracic Endovascular Aortic Repair ◽

Trial Registry ◽

Clinical Trial Registry ◽

Future Clinical Practice ◽

Registration Number

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.

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Application of intravenous lidocaine in patients undergoing operative hysteroscopy: a randomized, double-blind, controlled study

10.21203/rs.2.181/v1 ◽

2019 ◽

Author(s):

Huaxin Wang ◽

Xuan Peng ◽

Yeda Xiao ◽

Bo Zhao ◽

Liying Zhan

Keyword(s):

Controlled Study ◽

Intravenous Lidocaine ◽

Clinical Trial Registry ◽

Double Blind ◽

Operative Hysteroscopy ◽

Throat Pain ◽

Hysteroscopic Surgery ◽

Registration Number ◽

Operative Recovery ◽

Double Blinded

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

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Therapeutic clinical trials to combat COVID-19 pandemic in India: analysis from trial registry

Journal of Basic and Clinical Physiology and Pharmacology ◽

10.1515/jbcpp-2020-0208 ◽

2020 ◽

Vol 0 (0) ◽

Author(s):

Angelika Batta ◽

Raj Khirasaria ◽

Vinod Kapoor ◽

Deepansh Varshney

Keyword(s):

Clinical Trials ◽

De Novo ◽

Treatment Options ◽

Drug Repurposing ◽

Trial Registry ◽

Therapeutic Treatment ◽

Clinical Trial Registry ◽

Clear Cut ◽

Therapeutic Trials ◽

Microsoft Office

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.

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Primary success of electrical cardioversion for new-onset atrial fibrillation and its association with clinical course in non-cardiac critically ill patients: sub-analysis of a multicenter observational study

Journal of Intensive Care ◽

10.1186/s40560-021-00562-8 ◽

2021 ◽

Vol 9 (1) ◽

Author(s):

Nozomu Shima ◽

Kyohei Miyamoto ◽

Seiya Kato ◽

Takuo Yoshida ◽

Shigehiko Uchino ◽

...

Keyword(s):

Atrial Fibrillation ◽

Clinical Trial ◽

Sinus Rhythm ◽

Trial Registry ◽

Clinical Trial Registry ◽

Icu Discharge ◽

Primary Success ◽

Success Group ◽

Onset Atrial Fibrillation ◽

New Onset

Abstract Background Electrical cardioversion (ECV) is widely used to restore sinus rhythm in critically ill adult patients with atrial fibrillation, although its prognostic value is uncertain. This study aims to elucidate the clinical meaning of successful ECV. Methods This is a sub-analysis of the AFTER-ICU study, a multicenter prospective study with a cohort of 423 adult non-cardiac patients with new-onset atrial fibrillation (AF). Patients that underwent ECV within 7 days after initial onset of AF were included in the sub-analysis. We compared intensive care unit (ICU) and overall hospital mortality, survival time within 30 days, cardiac rhythm at ICU discharge, and the length of ICU and overall hospital stay between patients whose sinus rhythm was restored immediately after the first ECV session (primary success group) and those in whom it was not restored (unsuccessful group). To find the factors related to the primary success of ECV, we also compared patient characteristics, the delivered energy, and pretreatment. Results Sixty-five patients received ECV and were included in this study. Although 35 patients (54%) had primary success, recurrence of AF occurred in 24 of these patients (69%). At ICU discharge, three patients still had AF in the unsuccessful group, but no patients in the primary success group still had AF. ICU mortality was 34% in the primary success group and 17% in the unsuccessful group (P = 0.10). Survival time within 30 days did not differ between the groups. Delivered energy and pretreatment were not associated with primary success of ECV. Conclusions The primary success rate of ECV for new-onset AF in adult non-cardiac ICU population was low, and even if it succeeded, the subsequent recurrence rate was high. Primary success of ECV did not affect the rate of mortality. Pretreatment and delivered energy were not associated with the primary success of ECV. Trial registration UMIN clinical trial registry, the Japanese clinical trial registry (registration number: UMIN000026401, March 31, 2017).

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