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A comparison of propofol-to-BIS post-operative intensive care sedation by means of target controlled infusion, Bayesian-based and predictive control methods: an observational, open-label pilot study.

ABSTRACT: PURPOSE:We evaluated the feasibility and robustness of three methods for propofol-to-bispectral index (BIS) post-operative intensive care sedation, a manually-adapted target controlled infusion protocol (HUMAN), a computer-controlled predictive control strategy (EPSAC) and a computer-controlled Bayesian rule-based optimized control strategy (BAYES). METHODS:Thirty-six patients undergoing short lasting sedation following cardiac surgery were included to receive propofol to maintain a BIS between 40 and 60. Robustness of control for all groups was analysed using prediction error and spectrographic analysis. RESULTS:Although similar time courses of measured BIS were obtained in all groups, a higher median propofol effect-site concentration (CePROP) was required in the HUMAN group compared to the BAYES and EPSAC groups. The time course analysis of the remifentanil effect-site concentration (CeREMI) revealed a significant increase in CeREMI in the EPSAC group compared to BAYES and HUMAN during the case. Although similar bias and divergence in control was found in all groups, larger control inaccuracy was observed in HUMAN versus EPSAC and BAYES. Spectrographic analysis of the system behavior shows that BAYES covers the largest spectrum of frequencies, followed by EPSAC and HUMAN. CONCLUSIONS:Both computer-based control systems are feasible to be used during ICU sedation with overall tighter control than HUMAN and even with lower required CePROP. EPSAC control required higher CeREMI than BAYES or HUMAN to maintain stable control. Clinical trial number: NCT00735631.

SUBMITTER: Neckebroek M

PROVIDER: S-EPMC6602998 | biostudies-literature | 2019 Aug

REPOSITORIES: biostudies-literature

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A comparison of propofol-to-BIS post-operative intensive care sedation by means of target controlled infusion, Bayesian-based and predictive control methods: an observational, open-label pilot study.

Neckebroek M M Ionescu C M CM van Amsterdam K K De Smet T T De Baets P P Decruyenaere J J De Keyser R R Struys M M R F MMRF

Journal of clinical monitoring and computing 20181011 4

<h4>Purpose</h4>We evaluated the feasibility and robustness of three methods for propofol-to-bispectral index (BIS) post-operative intensive care sedation, a manually-adapted target controlled infusion protocol (HUMAN), a computer-controlled predictive control strategy (EPSAC) and a computer-controlled Bayesian rule-based optimized control strategy (BAYES).<h4>Methods</h4>Thirty-six patients undergoing short lasting sedation following cardiac surgery were included to receive propofol to maintain ...[more]

PMID: 30311073

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Project description:BACKGROUND:Propofol sedation is effective for gastrointestinal endoscopic procedures, but its narrow therapeutic window highlights the importance of identifying an optimal administration technique regarding effectiveness and safety. This study aimed to determine the incidence of significant adverse events in adult patients scheduled for gastrointestinal endoscopy under anaesthetist-performed sedation using propofol target-controlled infusion and determine the existence of associations between these events and potentially related variables. METHODS:This single-centre, retrospective cohort study took place in a tertiary referral university hospital. Medical records of 823 patients (age?>?18?years, American Society of Anesthesiologists physical status classification scores I-III) who had undergone elective gastrointestinal endoscopy under propofol target-controlled infusion sedation during September 2018 were reviewed. Outcomes included hypoxia, hypotension, and bradycardia events, requirement of vasoactive drugs, unplanned tracheal intubation or supraglottic device insertion, and need for advanced cardiac life support. RESULTS:The most frequently encountered adverse event was oxygen desaturation <?95% with an incidence of 22.35%. Vasoactive drug administration, hypotension, and oxygen desaturation <?90% followed, with incidences of 19.2, 12.64, and 9.92%, respectively. Only 0.5% of patients required advanced airway management. Multivariate analysis revealed an association between hypotension events, colonoscopic procedures, and propofol doses (odds ratio: 3.08, 95% confidence interval: 1.43 to 6.61; P?=?0.004 and odds ratio: 1.14, 95% confidence interval: 1.00 to 1.29; P?=?0.046). A strong dose-effect relationship was found between hypoxia and obesity; patients with body mass index ?40 were nine times (odds ratio: 10.22, 95% confidence interval: 2.83 to 36.99) more likely to experience oxygen desaturation <?90% events. CONCLUSIONS:Propofol sedation using target-controlled infusion appears to be a safe and effective anaesthetic technique for gastrointestinal endoscopic procedures with acceptable rates of adverse events and could be more widely adopted in clinical practice.

Project description:Objective: Compare the duration of mechanical ventilation between patients receiving sedation with continuous infusions of propofol alone or combination with the use of dexmedetomidine and propofol. Design: Retrospective, propensity matched (1:1) cohort study, employing eight variables chosen a priori for matching. Timing of exposure to dexmedetomidine initiation was incorporated into a matching algorithm. Setting: Level 1, university-based, 32-bed, adult, mixed trauma and surgical intensive care unit (SICU). Continuous sedation was delivered according to a protocol methodology with daily sedation vacation and spontaneous breathing trials. Choice of sedation agent was physician directed. Patients: Between 2010 and 2014, 149 SICU patients receiving mechanical ventilation for >24 h received dexmedetomidine with propofol. Propensity matching resulted in 143 pair cohorts. Interventions: Dexmedetomidine with propofol or propofol alone. Measurements and Main Results: There was no statistical difference in SICU length of stay (LOS), with a median absolute difference of 5.3 h for propofol alone group (p = 0.43). The SICU mortality was not statistically different (RR = 1.002, p = 0.88). Examining a 14-day period post-treatment with dexmedetomidine, on any given day (excluding days 1 and 14), dexmedetomidine with propofol-treated patients had a 0.5% to 22.5% greater likelihood of being delirious (CAM-ICU positive). In addition, dexmedetomidine with propofol-treated patients had a 4.5% to 18.8% higher likelihood of being above the target sedation score (more agitated) compared to propofol-alone patients. Conclusions: In this propensity matched cohort study, adjunct use of dexmedetomidine to propofol did not show a statistically significant reduction with respect to mechanical ventilation (MV) duration, SICU LOS, or SICU mortality, despite a trend toward receiving fewer hours of propofol. There was no evidence that dexmedetomidine with propofol improved sedation scores or reduced delirium.

Project description:IntroductionDexmedetomidine was shown in two European randomized double-blind double-dummy trials (PRODEX and MIDEX) to be non-inferior to propofol and midazolam in maintaining target sedation levels in mechanically ventilated intensive care unit (ICU) patients. Additionally, dexmedetomidine shortened the time to extubation versus both standard sedatives, suggesting that it may reduce ICU resource needs and thus lower ICU costs. Considering resource utilization data from these two trials, we performed a secondary, cost-minimization analysis assessing the economics of dexmedetomidine versus standard care sedation.MethodsThe total ICU costs associated with each study sedative were calculated on the basis of total study sedative consumption and the number of days patients remained intubated, required non-invasive ventilation, or required ICU care without mechanical ventilation. The daily unit costs for these three consecutive ICU periods were set to decline toward discharge, reflecting the observed reduction in mean daily Therapeutic Intervention Scoring System (TISS) points between the periods. A number of additional sensitivity analyses were performed, including one in which the total ICU costs were based on the cumulative sum of daily TISS points over the ICU period, and two further scenarios, with declining direct variable daily costs only.ResultsBased on pooled data from both trials, sedation with dexmedetomidine resulted in lower total ICU costs than using the standard sedatives, with a difference of €2,656 in the median (interquartile range) total ICU costs-€11,864 (€7,070 to €23,457) versus €14,520 (€7,871 to €26,254)-and €1,649 in the mean total ICU costs. The median (mean) total ICU costs with dexmedetomidine compared with those of propofol or midazolam were €1,292 (€747) and €3,573 (€2,536) lower, respectively. The result was robust, indicating lower costs with dexmedetomidine in all sensitivity analyses, including those in which only direct variable ICU costs were considered. The likelihood of dexmedetomidine resulting in lower total ICU costs compared with pooled standard care was 91.0% (72.4% versus propofol and 98.0% versus midazolam).ConclusionsFrom an economic point of view, dexmedetomidine appears to be a preferable option compared with standard sedatives for providing light to moderate ICU sedation exceeding 24 hours. The savings potential results primarily from shorter time to extubation.Trial registrationClinicalTrials.gov NCT00479661 (PRODEX), NCT00481312 (MIDEX).

Project description:Target-controlled infusion (TCI) provides precise pharmacokinetic control of propofol concentration in the effect-site (Ce), eg. brain. This pilot study aims to evaluate the feasibility and optimal TCI regimen for flexible bronchoscopy (FB) sedation.After alfentanil bolus, initial induction Ce of propofol was targeted at 2 ?g/ml. Patients were randomized into three titration groups (i.e., by 0.5, 0.2 and 0.1 ?g/ml, respectively) to maintain stable sedation levels and vital signs. Adverse events, frequency of adjustments, drug doses, and induction and recovery times were recorded.The study was closed early due to significantly severe hypoxemia events (oxyhemoglobin saturation <70%) in the group titrated at 0.5 ?g/ml. Forty-nine, 49 and 46 patients were enrolled into the 3 respective groups before study closure. The proportion of patients with hypoxemia events differed significantly between groups (67.3 vs. 46.9 vs. 41.3%, p?=?0.027). Hypotension events, induction and recovery time and propofol doses were not different. The Ce of induction differed significantly between groups (2.4±0.5 vs. 2.1±0.4 vs. 2.1±0.3 ?g/ml, p?=?0.005) and the Ce of procedures was higher at 0.5 ?g/ml titration (2.4±0.5 vs. 2.1±0.4 vs. 2.2±0.3 ?g/ml, p?=?0.006). The adjustment frequency tended to be higher for titration at 0.1 ?g/ml but was not statistically significant (2 (0?6) vs. 3 (0?6) vs. 3 (0?11)). Subgroup analysis revealed 14% of all patients required no further adjustment during the whole sedation. Comparing patients requiring at least one adjustment with those who did not, they were observed to have a shorter induction time (87.6±34.9 vs. 226.9±147.9 sec, p<0.001), a smaller induction dose and Ce (32.5±4.1 vs. 56.8±22.7 mg, p<0.001; 1.76±0.17 vs. 2.28 ±0.41, p<0.001, respectively), and less hypoxemia and hypotension (15.8 vs.56.9%, p?=?0.001; 0 vs. 24.1%, p?=?0.008, respectively).Titration at 0.5 ?g/ml is risky for FB sedation. A subgroup of patients required no more TCI adjustment with fewer complications. Further studies are warranted to determine the optimal regimen of TCI for FB sedation.ClinicalTrials.gov NCT01101477.

Project description:BackgroundCiprofol (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.MethodsIn 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.ResultsOf 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.Conclusionsciprofol is comparable to propofol with good tolerance and efficacy for sedation of Chinese intensive care unit patients undergoing mechanical ventilation in the present study setting.Trial registrationClinicalTrials.gov, NCT04147416.

Project description:BackgroundFearful and anxious patients who find dental treatment intolerable without sedative and analgesic support may benefit from moderate sedation. Target controlled infusion (TCI) pumps are superior to bolus injection in maintaining low plasma and effect-site concentration variability, resulting in stable, steady-state drug concentrations. We evaluated the safety and efficacy of moderate sedation with remifentanil and propofol using TCI pumps in non-hospital dental settings.MethodsA prospective chart review was conducted on 101 patients sedated with propofol and remifentanil using TCI pumps. The charts were completed at two oral surgeons and one general dentist's office over 6 months. Hypoxia, hypotension, bradycardia, and over-sedation were considered adverse events and were collected using Tracking and Reporting Outcomes of Procedural Sedation (TROOPS). Furthermore, patient recovery time, sedation length, drug dose, and patient satisfaction questionnaires were used to measure sedation effectiveness.ResultsOf the 101 reviewed sedation charts, 54 were of men, and 47 were of women. The mean age of the patients was 40.5 ±18.7 years, and their mean BMI was 25.6 ± 4.4. The patients did not experience hypoxia, bradycardia, and hypotension during the 4694 min of sedation. The average minimum Mean Arterial Pressure (MAP) and heartbeats were 75.1 mmHg and 60.4 bpm, respectively. 98% of patients agreed that the sedation technique met their needs in reducing their anxiety, and 99% agreed that they were satisfied with the sedation 24 hours later. The average sedation time was 46.9 ± 55.6 min, and the average recovery time was 12.4 ± 4.4 min. Remifentanil and propofol had mean initial effect-site concentration doses of 0.96 µ/ml and 1.0 ng/ml respectively. The overall total amount of drug administered was significantly higher in longer sedation procedures compared to shorter ones, while the infusion rate decreased as the procedural stimulus decreased.ConclusionAccording to the results of this study, no patients experienced adverse events during sedation, and all patients were kept at a moderate sedation level for a wide range of sedation times and differing procedures. The results showed that TCI pumps are safe and effective for administering propofol and remifentanil for moderate sedation in dentistry.

Dataset Information

A comparison of propofol-to-BIS post-operative intensive care sedation by means of target controlled infusion, Bayesian-based and predictive control methods: an observational, open-label pilot study.

Publications

A comparison of propofol-to-BIS post-operative intensive care sedation by means of target controlled infusion, Bayesian-based and predictive control methods: an observational, open-label pilot study.

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