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Feasibility of bispectral index-guided propofol infusion for flexible bronchoscopy sedation: a randomized controlled trial.

ABSTRACT: There are safety issues associated with propofol use for flexible bronchoscopy (FB). The bispectral index (BIS) correlates well with the level of consciousness. The aim of this study was to show that BIS-guided propofol infusion is safe and may provide better sedation, benefiting the patients and bronchoscopists.After administering alfentanil bolus, 500 patients were randomized to either propofol infusion titrated to a BIS level of 65-75 (study group) or incremental midazolam bolus based on clinical judgment to achieve moderate sedation. The primary endpoint was safety, while the secondary endpoints were recovery time, patient tolerance, and cooperation.The proportion of patients with hypoxemia or hypotensive events were not different in the 2 groups (study vs. control groups: 39.9% vs. 35.7%, p?=?0.340; 7.4% vs. 4.4%, p?=?0.159, respectively). The mean lowest blood pressure was lower in the study group. Logistic regression revealed male gender, higher American Society of Anesthesiologists physical status, and electrocautery were associated with hypoxemia, whereas lower propofol dose for induction was associated with hypotension in the study group. The study group had better global tolerance (p<0.001), less procedural interference by movement or cough (13.6% vs. 36.1%, p<0.001; 30.0% vs. 44.2%, p?=?0.001, respectively), and shorter time to orientation and ambulation (11.7±10.2 min vs. 29.7±26.8 min, p<0.001; 30.0±18.2 min vs. 55.7±40.6 min, p<0.001, respectively) compared to the control group.BIS-guided propofol infusion combined with alfentanil for FB sedation provides excellent patient tolerance, with fast recovery and less procedure interference.ClinicalTrials. gov NCT00789815.

SUBMITTER: Lo YL

PROVIDER: S-EPMC3223212 | biostudies-literature | 2011

REPOSITORIES: biostudies-literature

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Feasibility of bispectral index-guided propofol infusion for flexible bronchoscopy sedation: a randomized controlled trial.

Lo Yu-Lun YL Lin Ting-Yu TY Fang Yueh-Fu YF Wang Tsai-Yu TY Chen Hao-Cheng HC Chou Chun-Liang CL Chung Fu-Tsai FT Kuo Chih-Hsi CH Feng Po-Hao PH Liu Chien-Ying CY Kuo Han-Pin HP

PloS one 20111123 11

<h4>Objectives</h4>There are safety issues associated with propofol use for flexible bronchoscopy (FB). The bispectral index (BIS) correlates well with the level of consciousness. The aim of this study was to show that BIS-guided propofol infusion is safe and may provide better sedation, benefiting the patients and bronchoscopists.<h4>Methods</h4>After administering alfentanil bolus, 500 patients were randomized to either propofol infusion titrated to a BIS level of 65-75 (study group) or increm ...[more]

PMID: 22132138

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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:BACKGROUND:Obstructive sleep apnea (OSA) is characterized by repetitive episodes of complete or partial obstruction of the upper airways during sleep. Conscious sedation for flexible bronchoscopy (FB) places patients in a sleep-like condition. We hypothesize that oxygen desaturation during flexible bronchoscopy may help to detect undiagnosed sleep apnea. METHODS:Single-centre, investigator-initiated and driven study including consecutive patients undergoing FB for clinical indication. Patients completed the Epworth Sleepiness Scale (ESS), Lausanne NoSAS score, STOP-BANG questionnaire and the Berlin questionnaire and underwent polygraphy within 7 days of FB. FB was performed under conscious sedation with propofol. Oxygen desaturation during bronchoscopy was measured with continuous monitoring of peripheral oxygen saturation with ixTrend (ixellence GmbH, Germany). RESULTS:145 patients were included in the study, 62% were male, and the average age was 65.8?±?1.1 years. The vast majority of patients (n?=?131, 90%) proved to fulfill OSA criteria based on polygraphy results: 52/131 patients (40%) had mild sleep apnea, 49/131 patients (37%) moderate sleep apnea and 30/131 patients (23%) severe sleep apnea. Patients with no oxygen desaturation had a significantly lower apnea-hypopnea index than patients with oxygen desaturation during bronchoscopy (AHI 11.94/h vs 21.02/h, p?=?0.011). This association remained significant when adjusting for the duration of bronchoscopy and propofol dose (p?=?0.023; 95% CI 1.382; 18.243) but did not hold when also adjusting for age and BMI. CONCLUSION:The severity of sleep apnea was associated to oxygen desaturation during flexible bronchoscopy under conscious sedation. Patients with oxygen desaturation during bronchoscopy might be considered for sleep apnea screening. TRIAL REGISTRATION:The Study was approved by the Ethics Committee northwest/central Switzerland, EKNZ (EK 16/13) and was carried out according to the Declaration of Helsinki and Good Clinical Practice guidelines. Due to its observational character, the study did not require registration at a clinical trial registry.

Project description:BackgroundProcedural sedation is a core skill of the emergency physician. Bolus administration of propofol is widely utilised in UK emergency departments to provide procedural sedation. Bolus administration of propofol, titrated to an endpoint of sedation, has a rapid effect but can easily result in apnoea and loss of airway patency. The use of a target-controlled infusion of propofol allows for controlled titration to an effect site concentration and may reduce the rate of adverse incidents. Target-controlled infusion of propofol is not currently used in emergency departments.The primary aim of this feasibility study is to ensure that propofol target-controlled infusion (TCI) is acceptable to the patient and that recruitment rates are adequate to power a randomised controlled trial comparing propofol target-controlled infusion versus bolus administration.MethodsThis study will recruit in four emergency departments in Scotland, UK. Patients aged 18-65 years with anterior shoulder dislocation, weighing ≥ 50 kg and fasted ≥ 90 min, will be screened. Recruited patients will undergo emergency reduction of a dislocated shoulder facilitated by procedural sedation utilising TCI of propofol.The widespread adoption of TCI propofol by emergency departments will require evidence that it is safe, potentially effective, patient centred and a timely method of providing procedural sedation. The primary endpoint will be acceptability measured by patient satisfaction. The secondary endpoints will include incidence and severity of adverse events, number of shoulder reduction attempts, nursing opinion of patient experience, patient's reported pain score and time from commencement of TCI propofol sedation to desired sedation level.The study will be open for recruitment from April 2017 to December 2018.DiscussionIf the study demonstrates patient acceptability with adequate recruitment, we will be in a position to determine the feasibility of progression to a randomised controlled clinical trial of TCI compared to bolus administration of propofol.Trial registrationClinicalTrials.gov Identifier: NCT03442803. Registered retrospectively on 22 February 2018.

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: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

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Feasibility of bispectral index-guided propofol infusion for flexible bronchoscopy sedation: a randomized controlled trial.

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Feasibility of bispectral index-guided propofol infusion for flexible bronchoscopy sedation: a randomized controlled trial.

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