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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.

ABSTRACT: 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.

SUBMITTER: Fu Y

PROVIDER: S-EPMC6425335 | biostudies-literature | 2019

REPOSITORIES: biostudies-literature

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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.

Fu Yang Y Xu Tao T Xie Keliang K Wei Wei W Gao Ping P Nie Huang H Deng Xiaoming X Wang Guolin G Tian Ming M Yan Min M Dong Hailong H Yue Yun Y

BioMed research international 20190304

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 surge ...[more]

PMID: 30949495

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Project description:BackgroundReducing depth of anesthesia and anesthetic exposure may help prevent delirium, but trials have been conflicting. Most studies were conducted under general anesthesia or in cognitively impaired patients. It is unclear whether reducing depth of anesthesia beyond levels consistent with general anesthesia reduces delirium in cognitively intact patients. The authors' objective was to determine whether a bundled approach to reduce anesthetic agent exposure as determined by Bispectral Index (BIS) values (spinal anesthesia with targeted sedation based on BIS values) compared with general anesthesia (masked BIS) reduces delirium.MethodsImportant eligibility criteria for this parallel-arm randomized trial were patients 65 yr or greater undergoing lumbar spine fusion. The intervention group received spinal anesthesia with targeted sedation to BIS greater than 60 to 70. The control group received general anesthesia (masked BIS). The primary outcome was delirium using the Confusion Assessment Method daily through postoperative day 3, with blinded assessment.ResultsThe median age of 217 patients in the analysis was 72 (interquartile range, 69 to 77). The median BIS value in the spinal anesthesia with targeted sedation based on BIS values group was 62 (interquartile range, 53 to 70) and in the general anesthesia with masked BIS values group was 45 (interquartile range, 41 to 50; P < 0.001). Incident delirium was not different in the spinal anesthesia with targeted sedation based on BIS values group (25.2% [28 of 111] vs. the general anesthesia with masked BIS values group (18.9% [20 of 106]; P = 0.259; relative risk, 1.22 [95% CI, 0.85 to 1.76]). In prespecified subgroup analyses, the effect of anesthetic strategy differed according to the Mini-Mental State Examination, but not the Charlson Comorbidity Index or age. Two strokes occurred among patients receiving spinal anesthesia and one death among patients receiving general anesthesia.ConclusionsSpinal anesthesia with targeted sedation based on BIS values compared with general anesthesia with masked BIS values did not reduce delirium after lumbar fusion.Editor’s perspective

Project description:BACKGROUND:It is unknown to what extent hypotension frequently observed following administration of propofol for induction of general anesthesia is caused by overdosing propofol. Unlike clinical signs, electroencephalon-based cerebral monitoring allows to detect and quantify an overdose of hypnotics. Therefore, we tested whether the use of an electroencephalon-based cerebral monitoring will cause less hypotension following induction with propofol. METHODS:Subjects were randomly assigned to a bispectral index (BIS)-guided (target range 40-60) or to a weight-related (2 mg.kg-?1) manual administration of propofol for induction of general anesthesia. The primary endpoint was the incidence of hypotension following the administration of propofol. Secondary endpoints included the degree of hypotension and correlations between BIS and drop in mean arterial pressure (MAP). Incidences were analyzed with Fisher's Exact-test. RESULTS:Of the 240 patients enrolled into this study, 235 predominantly non-geriatric (median 48 years, 25th - 75th percentile 35-61 years) patients without severe concomitant disease (88% American Society of Anesthesiology physical status 1-2) undergoing ear, nose and throat surgery, ophthalmic surgery, and dermatologic surgery were analyzed. Patients who were manually administered propofol guided by BIS (n?=?120) compared to those who were given propofol by weight (n?=?115) did not differ concerning the incidence of hypotension (44% vs. 45%; p?=?0.87). Study groups were also similar regarding the maximal drop in MAP compared to baseline (33% vs. 30%) and the proportion of hypotensive events related to all measurements (17% vs. 19%). Final propofol induction doses in BIS group and NON-BIS group were similar (1.93 mg/kg vs. 2 mg/kg). There was no linear correlation between BIS and the drop in MAP at all times (r?<?0.2 for all) except for a weak one at 6 min (r?=?0.221). CONCLUSION:Results of our study suggest that a BIS-guided compared to a weight-adjusted manual administration of propofol for induction of general anesthesia in non-geriatric patients will not lower the incidence and degree of arterial hypotension. TRIAL REGISTRATION:German Registry of Clinical Trials ( DRKS00010544 ), retrospectively registered on August 4, 2016.

Dataset Information

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

Publications

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

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