Standard Sedation Research Articles

Ketamine as Rescue Treatment for Difficult-to-Sedate Severe Acute Behavioral Disturbance in the Emergency Department

We investigate the effectiveness and safety of ketamine to sedate patients with severe acute behavioral disturbance who have failed previous attempts at sedation. This was a prospective study of patients given ketamine for sedation who had failed previous sedation attempts. Patients with severe acute behavioral disturbance requiring parenteral sedation were treated with a standardized sedation protocol including droperidol. Demographics, drug dose, observations, and adverse effects wererecorded. The primary outcome was the number of patients who failed to sedate within 120 minutes of ketamine administration or requiring further sedation within 1 hour. Forty-nine patients from 2 hospitals were administered rescue ketamine during 27 months; median age was 37 years (range 20-82 years); 28 were men. Police were involved with 20 patients. Previous sedation included droperidol (10 mg; 1), droperidol (10+10 mg; 33), droperidol (10+10+5 mg; 1), droperidol (10+10+10 mg; 11), and combinations of droperidol and benzodiazepines (2) and midazolam alone (1). The median dose of ketamine was 300 mg (range 50 to 500 mg). Five patients (10%; 95% confidence interval 4% to 23%) were not sedated within 120 minutes or required additional sedation within 1 hour. Four of 5 patients received 200 mg or less. Median time to sedation postketamine was 20 minutes (interquartile range 10 to 30 minutes; 2 to 500 minutes). Three patients (6%) had adverse effects, 2 had vomiting, and a third had a transient oxygen desaturation to 90% after ketamine that responded to oxygen. Ketamine appeared effective and did not cause obvious harm in this small sample and is a potential option for patients who have failed previous attempts at sedation. A dose of 4 to 5 mg/kg is suggested, and doses less than 200 mg are associated with treatment failure.

Room for Quality Improvement in Endoscopist-Directed Sedation: Results from the First Nationwide Survey in Korea.

Background/AimsThis study sought to characterize the current sedation practices of Korean endoscopists in real-world settings.MethodsAll active members of the Korean Society of Gastrointestinal Endoscopy were invited to complete an anonymous 35-item questionnaire.ResultsThe overall response rate was 22.7% (1,332/5,860). Propofol-based sedation was the dominant method used in both elective esophagogastroduodenoscopy (55.6%) and colonoscopy (52.6%). The mean satisfaction score for propofol-based sedation was significantly higher than that for standard sedation in both examinations (all p<0.001). The use of propofol was supervised exclusively by endoscopists (98.6%). Endoscopists practicing in nonacademic settings, gastroenterologists, or endoscopists with <10 years of endoscopic practice were more likely to use propofol than were their counterparts (all p<0.001). In total, 27.3% of all respondents performed sedation practices without having undergone sedation training, and 27.4% did so without any formal sedation protocols. The choice of propofol as the dominant sedation method was the only significant predictor of endoscopist experience with serious sedation-related adverse events (odds ratio, 1.854; 95% confidence interval, 1.414 to 2.432).ConclusionsEndoscopist-directed propofol administration is the predominant sedation method used in Korea. This survey strongly suggests that there is much room for quality improvement regarding sedation training and patient vigilance in endoscopist-directed sedation.

Thoracic Paravertebral Block versus Epidural Anesthesia Combined with Moderate Sedation for Percutaneous Nephrolithotomy

Objective: To investigate the feasibility of thoracic paravertebral block (TPVB) for percutaneous nephrolithotomy (PCNL) in comparison with epidural anesthesia (EA) combined with moderate sedation. Subjects and Methods: One hundred American Society of Anesthesiologists (ASA) I-II adult patients scheduled for first-stage unilateral PCNL were randomly assigned to receive either TPVB or EA. All patients were given standard sedation and analgesia with propofol and sufentanil. Patient characteristics, surgical outcomes, anesthetic outcomes, and time to first use of a patient-controlled intravenous analgesic (PCIA) device and postoperative consumption of sufentanil in the first 24 h were recorded. Intergroup differences of the parameters were analyzed using an independent t test, Mann-Whitney test, and χ² test as appropriate. Results: Patients who received TPVB consumed more propofol during ureteroscopy (56.2 ± 28.4 vs. 42.9 ± 27.5 mg, p < 0.05) and more sufentanil during ureteroscopy (9.7 ± 4.8 vs. 3.9 ± 2.7 μg, p < 0.05) and during PCNL (7.0 ± 4.3 vs. 1.9 ± 1.8 μg, p < 0.05) than those who received EA. The volume fluids infused in patients who received TPVB was less than in those who received EA (854 ± 362 vs. 1,320 ± 468 ml, p < 0.05). Time to first PCIA use, postoperative 24-hour consumption of sufentanil, and other parameters were comparable between groups. Conclusions: In this study, TPVB was as effective and safe as EA in providing intraoperative anesthesia and postoperative analgesia for PCNL, although more sedatives and analgesics were used during PCNL in patients who received TPVB.

Inhalation sedation with the ‘Anaesthetic Conserving Device’ for patients in intensive care units: A literature review

Background. The Anaesthetic Conserving Device is a modified heat and moisture exchanger that enables the application of inhalation sedation with existing ventilators in intensive care units. The following review describes the advantages of inhalation sedation using the Anaesthetic Conserving Device in comparison to standard intravenous sedation for patients in intensive care units and highlights the technical aspects of its functioning.Methods. The literature search was limited to PubMed, Sage Journals and CINAHL databases, using the terms »anaesthetic conserving device«, »volatile anaesthetic reflection filter«, »AnaConDa« independently and in connection with the terms »sedation« and intensive care unit«. Included are articles published up until December 2014.Results. Use of inhalation sedation with the Anaesthetic Conserving Device enables faster transition to spontaneous breathing and a shorter awakening time than with intravenous sedation. Even short-term inhalation sedation of patients after open heart procedures has a cardioprotective effect and reduces troponin T values. Despite increased concentrations of inorganic fluoride in serum after sevoflurane exposure, no clinical studies to date have shown its nephrotoxic effect, even after long-term (48 h) sedation. The Anaesthetic Conserving Device is accurate in maintaining target values of volatile anaesthetics. However, increased dead space volume was found in several studies, exceeding the internal volume of the Anaesthetic Conserving Device.Conclusion. Results to date show that inhalation sedation with the Anaesthetic Conserving Device may be an effective and safe alternative to existing protocols of intravenous sedation for patients requiring intensive treatment.

Dexmedetomidine versus standard care sedation with propofol or midazolam in intensive care: an economic evaluation.

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).Electronic supplementary materialThe online version of this article (doi:10.1186/s13054-015-0787-y) contains supplementary material, which is available to authorized users.

Resting energy expenditure and substrate oxidation rates correlate to temperature and outcome after cardiac arrest - a prospective observational cohort study.

IntroductionTargeted temperature management improves outcome after cardiopulmonary resuscitation. Reduction of resting energy expenditure might be one mode of action. The aim of this study was to correlate resting energy expenditure and substrate oxidation rates with targeted temperature management at 33°C and outcome in patients after cardiac arrest.MethodsThis prospective, observational cohort study was performed at the department of emergency medicine and a medical intensive care unit of a university hospital. Patients after successful cardiopulmonary resuscitation undergoing targeted temperature management at 33°C for 24 hours with subsequent rewarming to 36°C and standardized sedation, analgesic and paralytic medication were included. Indirect calorimetry was performed five times within 48 h after cardiac arrest. Measurements were correlated to outcome with repeated measures ANOVA, linear and logistic regression analysis.ResultsIn 25 patients resting energy expenditure decreased 20 (18 to 27) % at 33°C compared to 36°C without differences between outcome groups (favourable vs. unfavourable: 25 (21 to 26) vs. 21 (16 to 26); P = 0.5). In contrast to protein oxidation rate (favourable vs. unfavourable: 35 (11 to 68) g/day vs. 39 (7 to 75) g/day, P = 0.8) patients with favourable outcome had a significantly higher fat oxidation rate (139 (104 to 171) g/day vs. 117 (70 to 139) g/day, P <0.05) and a significantly lower glucose oxidation rate (30 (−34 to 88) g/day vs. 77 (19 to 138) g/day; P < 0.05) as compared to patients with unfavourable neurological outcome.ConclusionsTargeted temperature management at 33°C after cardiac arrest reduces resting energy expenditure by 20% compared to 36°C. Glucose and fat oxidation rates differ significantly between patients with favourable and unfavourable neurological outcome.Trial registrationClinicaltrials.gov NCT00500825. Registered 11 July 2007.Electronic supplementary materialThe online version of this article (doi:10.1186/s13054-015-0856-2) contains supplementary material, which is available to authorized users.

The effect of sedation during transoesophageal echocardiography on heart rate variability: a comparison of hypnotic sedation with medical sedation

There is no ideal sedation technique that can be used during transoesophageal echocardiography (TEE), and the data concerning the effects of available sedation techniques on heart rate variability (HRV) are limited. To compare the effects of sedation through hypnotherapy with medical sedation achieved by midazolam on HRV. We recruited 76 patients with an indication of TEE; the age range was 18-83 years. In Group T there were 26 patients who had the procedure under topical pharyngeal anaesthesia, in Group D there were 23 patients who received midazolam, and in Group H there were 27 patients receiving hypnosis. All patients had an IV access; throughout the procedure heart rate, rhythm electrocardiography, and peripheric O2 saturation were monitored with a non-invasive monitor, and blood pressure measurements were taken every 3 min. Rhythm Holter recordings were obtained from all patients and TEE was performed. When time domain parameters for HRV were compared in all three groups, the hypnosis group had significant increases in pNN50 and RMSSD compared to Groups D and T (p < 0.05). As concerns frequency domain parameters, there were no significant differences between groups where low frequency (LF) was decreased in hypnosis group and high frequency (HF) was increased (p > 0.05). However, LF/HF was decreased statistically significantly (p < 0.05) when compared with the midazolam group. Contrary to standard sedation in TEE patients, when hypnosis is used autonomic cardiac tone is modified to a significant extent. Hypnotic sedation achieves this by increasing the parasympathetic activity, decreasing the sympathetic activity, and changing the sympathovagal interaction balance.

Speaking the Same Language: Establishing a Uniform Criteria for Safe Administration of Opioids in the PACU Using Poss

Sedation resulting from opioid-administration is a concern for the Post Anesthesia Care Unit (PACU) nurse. The Joint Commission recommends the use of a standardized sedation assessment tool to reduce the occurrence of opioid induced respiratory depression. The use of the Pasero Opioid-induced Sedation Scale (POSS) is recommended by the American Society for Pain Management Nursing as easy to use with superior measurement of sedation in conjunction with being directly linked to nursing interventions. Our current descriptive sedation assessment is subjective with imprecise meanings that are open to varied interpretation leading to diverse narcotic administrative practices.

Anesthesiologic regimen and intraoperative delirium in deep brain stimulation surgery for Parkinson's disease

BackgroundIn many centers the standard anesthesiological care for deep brain stimulation (DBS) surgery in Parkinson's disease patients is an asleep–awake–asleep procedure. However, sedative drugs and anesthetics can compromise ventilation and hemodynamic stability during the operation and some patients develop a delirious mental state after the initial asleep phase. Further, these drugs interfere with the patient's alertness and cooperativeness, the quality of microelectrode recordings, and the recognition of undesired stimulation effects. In this study, we correlated the incidence of intraoperative delirium with the amount of anesthetics used intraoperatively. MethodsThe anesthesiologic approach is based on continuous presence and care, avoidance of negative suggestions, use of positive suggestions, and utilization of the patient's own resources. Clinical data from the operations were analyzed retrospectively, the occurrence of intraoperative delirium was extracted from patients' charts. The last 16 patients undergoing the standard conscious sedation procedure (group I) were compared to the first 22 (group II) psychologically-guided patients. ResultsThe median amount of propofol decreased from 146mg (group I) to 0mg (group II), remifentanyl from 0.70mg to 0.00mg, respectively (P<0.001 for propofol and remifentanyl). Using the new procedure, 12 of 22 patients (55%) in group II required no anesthetics. Intraoperative delirium was significantly less frequent in group II (P=0.03). ConclusionsThe occurrence of intraoperative delirium correlates with the amount of intraoperative sedative and anesthetic drugs. Sedation and powerful analgesia are not prerequisites for patients' comfort during awake-DBS-surgery.

OC-049 A prospective comparison of safety and tolerability of propofol versus standard sedation for double balloon enteroscopy–time for a push forward?

Introduction Double balloon enteroscopy (DBE) is routinely performed with moderate sedation in the UK. However, in comparison to standard endoscopy, DBE is complex and takes longer, therefore deep sedation with propofol could improve tolerability and feasibility of the test. Method All patients undergoing DBE between March13 and October14 were prospectively enrolled. DBE was performed either with administration of sedation with fentanyl and midazolam or with anaesthetist-assisted deep sedation with propofol, the decision being made on the basis of patients’ clinical history and expected length of the test. Data from patients receiving propofol were compared to those from patients receiving standard sedation during the same period. Patients were asked to fill in a questionnaire regarding their expectations before the test and their satisfaction afterwards. Anxiety, pain and discomfort were assessed by means of validated numeric rating scales (NRS, range 0–10). Data on comorbidities, previous surgery and hospital anxiety and depression scores (HADS) were also collected. The procedural characteristics of DBE were assessed. Results Twenty-one DBE (18 oral, 3 anal, 33% male) were performed with the aid of propofol infusion and 67 (54 oral, 13 anal, 51% male) with standard sedation. Mean age was 48 ± 14.3 in the propofol group and 58.6 ± 15.9 in the sedation group (p = 0.012). There were no other differences in demographics, comorbidities or HADS scores between the groups. The indications for DBE included obscure gastrointestinal bleeding (n = 45), Peutz-Jeghers syndrome (9) and suspected Crohn’s disease (20), small bowel tumour (10) or celiac complication (2). The mean dose of propofol administered was 1123 ± 483 mg. The mean doses of midazolam and fentanyl were 6 ± 3 mg and 118 ± 54 mcg respectively. No differences were observed in terms of diagnostic yield (52% vs 57%, p = ns) and therapeutic yield (33% both groups). Patients in the propofol group reported lower scores of pain (median score 0, IQR 0–0.5 vs 3, IQR 0–6, p Conclusion The use of propofol for DBE has a good safety profile and better patient tolerability and satisfaction in comparison with moderate sedation. It is associated with a high diagnostic and therapeutic yield. Its use should be recommended when the procedure is expected to be longer and technically challenging. Disclosure of interest None Declared.

Peregrine System™ Infusion Catheter for Perivascular Renal Denervation1

Peregrine System™ Infusion Catheter for Perivascular Renal Denervation1

PTU-028 Peroral cholangioscopy – experience with conscious sedation

<h3>Introduction</h3> Per-oral Cholangioscopy (POC) offers the facility for direct visualisation of bile ducts, targeted biopsy and interventional techniques including Electro Hydro lithotripsy (EHL). Procedure completion time is often longer than conventional Endoscopic Retrograde Cholangio-Pancreatography (ERCP), patients often require high doses of standard sedation or general anaesthesia. We present our data where POC is performed under conscious sedation. <h3>Method</h3> Retrospective analysis was performed for all POC cases between January 2013 –December 2014. Definitions and endpoints were as used by Kalaitzakis <i><i>et al</i></i>.¹Procedural success was defined as direct visualisation of the lesion enabling tissue sampling. Adequacy of tissue samples were analysed against the final Multidisciplinary meeting (MDM) decision-detailing both benign and malignant diagnosis. <h3>Results</h3> 47 cases of POC were performed in 43 patients. Median age was 63 years (IQR 22–86 years). 31 cases were performed for non stone-related disease (28 for indeterminate lesions 3 for other reasons). 16 patients underwent POC for choledocholithiasis, 9 of which had EHL. All patients had conscious sedation during POC. Median midazolam dose was 7 mg (IQR 5–11 mg), fentanyl 150 mcg (IQR 50–225 mcg). Buscopan was used in 42 cases (range 20–60 mg) and glucagon (1 mg) in 6 cases. Lowest oxygen saturations recorded were 95% (range 95–99%). Where a score of 1 represented maximum discomfort and 5 least, worst comfort score recorded was 3 for a single case. There were 4 failed procedures, 1 due to patient related factors and 3 due to equipment failure. Median procedure time was 86 min (IQR 34–114 min) for non-EHL and 92 min (IQR 76–132 min) for EHL cases. Procedural success was established in in 42 (89%) cases with positive visualisation of the target lesion. For non-stone related disease, 27 were successful (87%). For suspected malignancy, POC performance was again comparable with published data (sensitivity 70%, specificity 93%, positive predictive value 88%, negative predictive value 81%), when compared against the final MDT decision. Overall complication rate was comparable with other published data (6.3%). Over sedation requiring reversal was not encountered in the study. <h3>Conclusion</h3> Diagnostic results and complication rates, in our study, were comparable with published UK outcomes. Our practice demonstrates that POC can be performed under conscious sedation without compromising patient safety, test tolerance or efficacy. <h3>Disclosure of interest</h3> None Declared. <h3>Reference</h3> Kalaitzakis E, Webster GJ, Oppong KW, Kallis Y, Vlavianos P, Huggett M, <i>et al</i>. Diagnostic and therapeutic utility of single-operator peroral cholangioscopy for indeterminate biliary lesions and bile duct stones. Eur J Gastroenterol Hepatol. 2012;24(6):656–64

Target Controlled Infusion for non-anaesthesiologist propofol sedation during gastrointestinal endoscopy: The first double blind randomized controlled trial

BackgroundTarget Controlled Infusion is a sophisticated tool for providing optimal sedation regimen avoiding under or oversedation in gastrointestinal endoscopy. AimsTo compare standard moderate sedation vs. non-anaesthesiologist-administered propofol sedation during gastrointestinal endoscopy. MethodsRandomized controlled trial of 70 consecutive colonoscopies and 70 consecutive esophagogastroduodenoscopies (EGD). Standard group (n=70), received fentanyl (1μg/kg)+midazolam (0.03–0.04mg/kg) or midazolam only; propofol group (n=70), received fentanyl (1μg/kg)+propofol Target Controlled Infusion (1.2–1.6μg/ml) or propofol Target Controlled Infusion only. Discharge time, endoscopist satisfaction and patient satisfaction were recorded in all endoscopies. ResultsColonoscopy: discharge time was significantly shorter in the propofol than the standard group (1.1±0.3 vs. 5±10.2min, respectively; P=0.03). Endoscopist satisfaction was significantly higher (98.3±11.4/100 vs. 87.2±12/100; P=0.001); patient satisfaction was significantly higher (95±9.3/100 vs. 85.5±14.4/100; P=0.002) in the propofol compared to the standard group.EGD: discharge time was not significantly different in the propofol and standard groups (1.1±0.7 vs. 3.9±9.2min, respectively; P=0.146). Endoscopist satisfaction was significantly higher (92.7±14.3/100 vs. 82.8±21.2/100; P=0.03); patient satisfaction was significantly higher (93.8±18.2/100 vs. 76.5±25.2/100; P=0.003). In the propofol group 94.3% of patients vs. 71.4% of patients in standard group asked to receive the same sedation in the future (P=0.021). ConclusionTarget Controlled Infusion is a promising method for non-anaesthesiologist-administered propofol sedation.

Monitoring Sedation in Patients Receiving Opioids for Pain Management

Excessive sedation precedes opioid-induced respiratory depression. An evidence-based practice project standardized systematic sedation monitoring by nurses using an opioid sedation scale and respiratory assessment when opioids are administered for pain management. Nurses were educated and documentation updated. Nurses demonstrated increased ability to identify at-risk patients (3.2 pre-implementation; 3.6 post-implementation; 1-4 Likert scale) and reported understanding the tool to assess for oversedation (2.6 pre-implementation; 3.2 post-implementation). Documentation compliance improved, and patient safety was maintained.

Sevoflurane in acute myocardial infarction: A pilot randomized study

Experimental evidence suggests that the inhalational anesthetic sevoflurane has a cardioprotective effect. Our objective was to determine if sedation with sevoflurane will reduce infarct size in patients with acute myocardial infarction (MI) who are treated with primary percutaneous coronary intervention (PCI). We randomized 50 patients presenting with a first acute ST-elevation MI treated by primary PCI within 6 hours from symptom onset to sedation with sevoflurane inhalation or standard sedation (control). Coronary flow at the end of PCI was assessed by corrected Thrombolysis In Myocardial Infarction frame count. Myocardial reperfusion was assessed by ST-segment resolution 60 minutes post-PCI. Infarct size was assessed by release of creatinine kinase (CK) and troponin T. There was no difference in the primary end point: troponin T or CK release adjusted to the area at risk, between groups. However, among patients with anterior MI, there was a trend toward lower CK (P = .05) and nonsignificant decrease in troponin (P = .11) levels in the sevoflurane group. Corrected Thrombolysis In Myocardial Infarction frame count was 12.3 ± 1.5 in the sevoflurane group and 15.6 ± 9.1 in the control group (P = .16). There was more ST resolution in patients treated by sevoflurane 80.7% ± 25.8% versus 56.6% ± 35.7% (P = .01). Sevoflurane had no significant adverse effect during administration. Sevoflurane administration during primary PCI did not reduce infarct size. There was a trend toward a reduction in infarct size among patients with anterior MI. Sevoflurane administration was associated with improvement in ST-segment resolution.

High dose droperidol and QT prolongation: analysis of continuous 12‐lead recordings

AimsTo investigate the QT interval after high dose droperidol using continuous 12-lead Holter recordings.MethodsThis was a prospective study of patients given droperidol with a continuous Holter recording. Patients were recruited from the DORM II study which included patients with aggression presenting to the emergency department. Patients initially received 10 mg droperidol as part of a standardized sedation protocol. An additional 10 mg dose was given after 15 min if required and further doses at the clinical toxicologist's discretion. Continuous 12-lead Holter recordings were obtained for 2–24 h utilizing high resolution digital recordings with automated QT interval measurement. Electrocardiograms were extracted hourly from Holter recordings. The QT interval was plotted against heart rate (HR) on the QT nomogram to determine if it was abnormal. QTcF (Fridericia's HR correction) was calculated and >500 ms was defined as abnormal.ResultsForty-six patients had Holter recordings after 10–40 mg droperidol and 316 QT–HR pairs were included. There were 32 abnormal QT measurements in four patients, three given 10 mg and one 20 mg. In three of the four patients QTcF >500 ms but only in one taking methadone was the timing of QTcF >500 ms consistent with droperidol dosing. Of the three other patients, one took amphetamines, one still had QT prolongation 24 h after droperidol and one took a lamotrigine overdose. No patient given >30 mg had a prolonged QT. There were no arrhythmias.ConclusionQT prolongation was observed with high dose droperidol. However, there was little evidence supporting droperidol being the cause and QT prolongation was more likely due to pre-existing conditions or other drugs.

Midazolam with meperidine and dexmedetomidine vs. midazolam with meperidine for sedation during ERCP: prospective, randomized, double-blinded trial

The combination of midazolam and opioid has been widely used as a standard sedative regimen for endoscopic retrograde cholangiopancreatography (ERCP). Following recent evidence that dexmedetomidine may exert a synergistic effect in combination with midazolam, this study compared the sedative effect and adverse events of midazolam - meperidine - dexmedetomidine (MMD) and midazolam - meperidine during ERCP. A total of 110 patients who were scheduled for ERCP were prospectively enrolled and randomly assigned, in a double-blind manner, to the MMD (n = 53) or midazolam - meperidine (n = 57) groups. Each patient received an intravenous (IV) bolus dose of midazolam and meperidine (0.06 mg/kg and 50 mg, 30 % reduction and 25 mg for patients aged ≥ 65 years, respectively). To this dose, a continuous IV infusion of dexmedetomidine (1 μg/kg/h; MMD group) or the same volume of normal saline (midazolam - meperidine group) was added. The sedation level (Ramsay Sedation Scale [RSS]) as well as hemodynamic and respiratory changes were assessed. Adequate sedation (RSS ≥ 3) was maintained during ERCP in 75.5 % and 36.8 % of the MMD and midazolam - meperidine group, respectively (P < 0.001). RSS scores were significantly higher in the MMD group (P < 0.001). Intraoperative bispectral index scores were significantly lower in the MMD group (P < 0.001) than in the midazolam - meperidine group. Lower additional (P = 0.001) and total (P = 0.003) doses of midazolam were required in the MMD group. Patients in the MMD group showed lower pain scores (P < 0.001) and higher satisfaction scores (P < 0.001). Desaturation occurred more frequently in the midazolam - meperidine group (11 vs. 1; P = 0.003). The addition of dexmedetomidine to the midazolam - meperidine regimen provided better sedative efficacy and a superior safety profile during ERCP compared with a midazolam - meperidine regimen.This trial was registered at ClinicalTrials.gov Identifier (NCT01404689).

Endoscopic sedation: from training to performance.

Adequate sedation and analgesia are considered essential requirements to relieve patient discomfort and pain and ultimately to improve the outcomes of modern gastrointestinal endoscopic procedures. The willingness of patients to undergo sedation during endoscopy has increased steadily in recent years and standard sedation practices are needed for both patient safety and successful procedural outcomes. Therefore, regular training and education of healthcare providers is warranted. However, training curricula and guidelines for endoscopic sedation may have conflicts according to varying legal frameworks and/or social security systems of each country, and well-recognized endoscopic sedation training systems are not currently available in all endoscopy units. Although European and American curricula for endoscopic sedation have been extensively developed, general curricula and guidelines for each country and institution are also needed. In this review, an overview of recent curricula and guidelines for training and basic performance of endoscopic sedation is presented based on the current literature.

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Introduction: Early Goal-Directed Sedation (EGDS) represents the administration of a sedative regimen soon after initiation of ventilation to maintain targeted light sedation through frequent sedative titration, awakening and monitoring of sedation depth. The impact of sedative choice on EGDS and the external validity of EGDS remains unclear. Our objectives is to 1)Test the feasibility of achieving EGDS with dexmedetomidine (DEX) compared with standard sedatives chosen by treating clinician, propofol and/or midazolam (CnS) and 2) test the feasibility of delivering EGDS in Malaysian ICUs. Methods: A Prospective randomized controlled pilot trial conducted in 10 tertiary, regional and rural ICUs. After obtaining institutional ethics approval, critically ill adult expected to be mechanically ventilated and needing intravenous sedation > 24 hours were included. Exclusions included acute global or regional brain injury, suspected prolonged weakness and imminent death. EGDS was delivered to all patients with adequate analgesia following randomization. Light sedation (RASS -2 to +1) was targeted in all patients throughout the study period. Subjects were randomized to receive EGDS with DEX as a primary sedative starting at 1 mcg/kg/hr or sedative agents CnS as chosen by treating clinician. Propofol rescue in EGDS+DEX was permitted. Primary outcome was number of RASS in target (-2 to +1) in the first 48 hrs following intubation. Feasibility outcome was time to randomization. Efficacy outcome was dose and duration of rescue sedatives and opioids given. RASS was measured every 2-4 hours and CAM-ICU measured daily (during light sedation). Results: Sixty subjects were randomized, 30 in each group. Mean ±SD age was (48 ± 19 vs 52 ± 17), APACHEII (18 ± 8 vs 20 ± 6) in EGDS+DEX vs EGDS+CnS respectively. Median [IQR] time to randomization was 5.5 [2.4-11.5] vs 7.6 [3.3-11.8] hours following initiation of mechanical ventilation. Midazolam was given on 7/151(4.6%) and propofol on 6/151(4.0%) study days in the EGDS-DEX group. Fentanyl was used in comparable proportion in both groups 19(63.3%) vs 21(70%) while morphine to significantly more patients in EGDS+CnS vs EGDS+DEX 14(46.6%) vs 4(13.3%), P=0.006. The number of RASS (-2 to +1) in the first 48 hours in the EGDS+DEX 115/127(91%) vs 93(137)68% P=0.001 in the EGDS-CnS. Comparable proportion of patients 29% vs 33% had one or more positive CAM-ICU with significant trend to lower days with positive CAM-ICU 10(7%) vs 24(13%) P=0.06, lower physical restraint use 6(20%) vs 14(46.6%) P=0.03 in the EGDS+DEX vs EGDS+CnS respectively. The median [IQR] time to extubation was 53[39-78] vs 65[46-141] hrs P=0.09, ICU stay 3[1.9-2.5] vs 4[3-8] days P=0.09, Hospital stay 9[6-12] vs 13[7.5-14.5] days P=0.07 with comparable proportion of patients received vasopressors 52% vs 54% and 16% vs 15% dialysis in the EGDS+DEX vs EGDS+CnV respectively throughout the study period. Conclusions: Early Goal-Directed Sedation delivered shortly after initiation of ventilation achieved significantly more light sedation targets with a dexmedetomidine based algorithm than with standard sedatives. EGDS+DEX reduced early deep sedation, use of physical restraints with a trend to lower delirium days, ventilation time, ICU and hospital stay. EGDS+DEX, administered in the context of randomized trial, delivered effective sedation with minimal need for rescue sedation and reduced overall opioid use. The administration of EGDS in Malaysian ICUs was safe and feasible. This data supports the validity of EGDS in non Australian ICUs for inclusion in future large scale clinical trial.

Entropy correlates with Richmond Agitation Sedation Scale in mechanically ventilated critically ill patients

Sedation is routinely used in intensive care units. However due to absence of objective scoring systems like Bispectral Index and entropy our ability to regulate the degree of sedation is limited. This deficiency is further highlighted by the fact that agitation scores used in intensive care units (ICU) have no role in paralyzed patients. The present study compares entropy as a sedation scoring modality with Richmond Agitation Sedation Scale (RASS) in mechanically ventilated, critically ill patients in an ICU. Twenty-seven, mechanically ventilated, critically ill patients of either sex, 16-65 years of age, were studied over a period of 24 h. They received a standard sedation regimen consisting of a bolus dose of propofol 0.5 mg/kg and fentanyl 1 lg/kg followed by infusions of propofol and fentanyl ranging from 1.5 to 5 mg/kg/h and 0.5 to 2.0 lg/kg/h, respectively. Clinically relevant values of RASS for optimal ICU sedation (between 0 and -3) in non-paralyzed patients were compared to corresponding entropy values, to find if any significant correlation exists between the two. These entropy measurements were obtained using the Datex-Ohmeda-M-EntropyTM module. This module is presently not approved by Food and Drug Administration (FDA) for monitoring sedation in ICU. A total of 527 readings were obtained. There was a statistically significant correlation between the state entropy (SE) and RASS [Spearman's rho/rs = 0.334, p\0.0001]; response entropy (RE) and RASS [Spearman's rho/rs = 0.341, p\0.0001]). For adequate sedation as judged by a RASS value of 0 to -3, the mean SE was 57.86 ± 16.50 and RE was 67.75 ± 15.65. The present study illustrates that entropy correlates with RASS (between scores 0 and -3) when assessing the level of sedation in mechanically ventilated critically ill patients.