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      Is it safe to use propofol in the emergency department? A randomized controlled trial to compare propofol and midazolam

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          Abstract

          Background

          This study examined the safety and effectiveness of the procedural sedation analgesia (PSA) technique carried out in the emergency department (ED) of a university hospital over a period of 1 year. The research was done to compare the effectiveness and efficacy of moderate sedation of fentanyl combined with either midazolam or propofol for any brief, intense procedure in the ED setting.

          Aims

          The objectives were to observe the occurrence of adverse events in subjects undergoing PSA for intense and painful procedures in the emergency department and to implement the use of capnography as a method of monitoring the patients when they were under PSA.

          Methods

          Forty patients were selected for this study. They were randomly divided into two equal groups using the computer-generated random permuted blocks of four patients. Twenty patients were grouped together as group A and the remaining 20 patients as group B. Drugs used were single blinded to prevent any bias. Drug A was propofol and fentanyl, while drug B was midazolam and fentanyl. The procedures involved included orthopedic manipulation such as reduction of fractures, reduction of dislocated joints, abscess drainage, wound debridement, laceration wound repair and cardioversion. All of the subjects were monitored for their vital signs and end tidal carbon dioxide level every 10 min till the PSA was completed. The duration of stay in the ED was documented when the subjects had completed the procedure and were released from the department.

          Result

          Of the study population, 75.6% were males. The mean age was 37.8 years (95% CI 33.2, 39.8). None of the patients developed any major complications while under PSA. The vital signs pre-, intra- and post-procedure were not significantly different in either the propofol or mizadolam groups (p value >0.05).

          Conclusion

          This study had proven that there was no difference in adverse event occurrence between the studied drugs during PSA. Propofol can be recommended for use in PSA if the operator is well trained and familiar with the drug.

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          Most cited references29

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          Practice guidelines for sedation and analgesia by non-anesthesiologists.

          (2002)
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            Microstream capnography improves patient monitoring during moderate sedation: a randomized, controlled trial.

            Investigative efforts to improve monitoring during sedation for patients of all ages are part of a national agenda for patient safety. According to the Institute of Medicine, recent technological advances in patient monitoring have contributed to substantially decreased mortality for people receiving general anesthesia in operating room settings. Patient safety has not been similarly targeted for the several million children annually in the United States who receive moderate sedation without endotracheal intubation. Critical event analyses have documented that hypoxemia secondary to depressed respiratory activity is a principal risk factor for near misses and death in this population. Current guidelines for monitoring patient safety during moderate sedation in children call for continuous pulse oximetry and visual assessment, which may not detect alveolar hypoventilation until arterial oxygen desaturation has occurred. Microstream capnography may provide an "early warning system" by generating real-time waveforms of respiratory activity in nonintubated patients. The aim of this study was to determine whether intervention based on capnography indications of alveolar hypoventilation reduces the incidence of arterial oxygen desaturation in nonintubated children receiving moderate sedation for nonsurgical procedures. We included 163 children undergoing 174 elective gastrointestinal procedures with moderate sedation in a pediatric endoscopy unit in a randomized, controlled trial. All of the patients received routine care, including 2-L supplemental oxygen via nasal cannula. Investigators, patients, and endoscopy staff were blinded to additional capnography monitoring. In the intervention arm, trained independent observers signaled to clinical staff if capnograms indicated alveolar hypoventilation for >15 seconds. In the control arm, observers signaled if capnograms indicated alveolar hypoventilation for >60 seconds. Endoscopy nurses responded to signals in both arms by encouraging patients to breathe deeply, even if routine patient monitoring did not indicate a change in respiratory status. Our primary outcome measure was patient arterial oxygen desaturation defined as a pulse oximetry reading of 5 seconds. Secondary outcome measures included documented assessments of abnormal ventilation, termination of the procedure secondary to concerns for patient safety, as well as other more rare adverse events including need for bag-mask ventilation, sedation reversal, or seizures. Children randomly assigned to the intervention arm were significantly less likely to experience arterial oxygen desaturation than children in the control arm. Two study patients had documented adverse events, with no procedures terminated for patient safety concerns. Intervention and control patients did not differ in baseline characteristics. Endoscopy staff documented poor ventilation in 3% of all procedures and no apnea. Capnography indicated alveolar hypoventilation during 56% of procedures and apnea during 24%. We found no change in magnitude or statistical significance of the intervention effect when we adjusted the analysis for age, sedative dose, or other covariates. The results of this controlled effectiveness trial support routine use of microstream capnography to detect alveolar hypoventilation and reduce hypoxemia during procedural sedation in children. In addition, capnography allowed early detection of arterial oxygen desaturation because of alveolar hypoventilation in the presence of supplemental oxygen. The current standard of care for monitoring all patients receiving sedation relies overtly on pulse oximetry, which does not measure ventilation. Most medical societies and regulatory organizations consider moderate sedation to be safe but also acknowledge serious associated risks, including suboptimal ventilation, airway obstruction, apnea, hypoxemia, hypoxia, and cardiopulmonary arrest. The results of this controlled trial suggest that microstream capnography improves the current standard of care for monitoring sedated children by allowing early detection of respiratory compromise, prompting intervention to minimize hypoxemia. Integrating capnography into patient monitoring protocols may ultimately improve the safety of nonintubated patients receiving moderate sedation.
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              The comparison of dexmedetomidine and midazolam used for sedation of patients during upper endoscopy: A prospective, randomized study.

              The aim of the present prospective, randomized study was to investigate and compare the safety and efficacy of dexmedetomidine versus midazolam in providing sedation for gastroscopy. A total of 50 adult patients (25 patients receiving dexmedetomidine and 25 patients receiving midazolam), 18 to 60 years of age, and rated I and II on the American Society of Anesthesiologists physical status classification system were included. A brief questionnaire was used to collect demographic data; patients were asked to rate anxiety, satisfaction with care to date and expected discomfort on a visual analogue scale. The following parameters were measured continuously and recorded every minute: heart rate, mean arterial pressure, hemoglobin oxygen saturation and respiratory rate. The two groups were similar with regard to age, body mass index, sex, education, duration of endoscopy, and ethanol or tobacco use. After the procedure, full recovery time, mean arterial pressure, heart rate, respiratory rate and hemoglobin oxygen saturation levels were similar in both groups. Both groups also had low levels of perceived procedural gagging, discomfort and anxiety scores (P > 0.05), and high satisfaction levels (90.1+/-3.0 for dexmedetomidine versus 84.9+/-4.5 for midazolam; P > 0.05). Retching and endoscopist satisfaction were significantly different in patients receiving dexmedetomidine versus those receiving midazolam (88.8+/-6.5 versus 73.5+/-16.4, P < 0.05; and 20.6+/-4.4 versus 45.2+/-6.0; P < 0.001). In the midazolam group, the number of patients who had adverse effects was higher than the dexmedetomidine group (P < 0.05). As a result, dexmedetomidine performed as effectively and safely as midazolam when used as a sedative in upper gastroscopy; it was superior to midazolam with regard to retching, rate of side effects and endoscopist satisfaction. It was concluded that dexmedetomidine may be a good alternative to midazolam to sedate patients for upper endoscopy.
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                Author and article information

                Contributors
                nhliza@hotmail.com,
                Journal
                Int J Emerg Med
                International Journal of Emergency Medicine
                Springer-Verlag (London )
                1865-1372
                1865-1380
                25 March 2010
                25 March 2010
                June 2010
                : 3
                : 2
                : 105-113
                Affiliations
                [1 ]Consultant and Head of Emergency Medicine, PPSP, USM, Kubang Kerian, Malaysia
                [2 ]Department of Emergency and Trauma, Queen Elizabeth Hospital, Kota Kinabalu, Sabah, Malaysia
                [3 ]Department of Emergency Medicine, School of Medical Sciences, USM, Kubang Kerian, 16150 Malaysia
                Article
                162
                10.1007/s12245-010-0162-3
                2885259
                20606819
                d38eef70-fe0b-4bd5-bc9b-13d36f2d113b
                © Springer-Verlag London Ltd 2010
                History
                : 23 September 2009
                : 14 January 2010
                Categories
                Original Research Article
                Custom metadata
                © Springer-Verlag London Ltd 2010

                Emergency medicine & Trauma
                midazolam,procedural sedation analgesia,emergency department,propofol

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