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Prefixed equimolar nitrous oxide and oxygen mixture reduces discomfort during flexible bronchoscopy in adult patients: a randomized, controlled, double-blind trial.

STUDY OBJECTIVES: Flexible bronchoscopy (FB) is an invasive procedure associated with patient discomfort and frequent nose pain. A simple sedation procedure that does not require the intervention of an anesthetist is of interest. The aim of this prospective, randomized, double-blind study was to assess efficiency of nitrous oxide inhalation on the reduction of FB-induced discomfort in adult patients. DESIGN AND SETTINGS: Two hundred six patients were randomized to receive either a prefixed equimolar nitrous oxide/oxygen mixture (N2O) or a prefixed equimolar nitrogen and oxygen mixture (control). The primary outcome was stress as assessed by pulse rate and systemic BP during the procedure. Secondary outcomes were self-assessed pain using a visual analog scale (VAS) and patient satisfaction based on a questionnaire. Adverse events were recorded. RESULTS: A significant increase in BP was observed only in the control group (p = 0.003), while pulse rate values did not differ between the two groups. As assessed by the VAS, pain was lower in the N2O group as compared to placebo (p = 0.02). Nose pain and cough were also significantly reduced by N2O. Adverse events, mostly anxiety, were reported in 10 patients. CONCLUSION: These results indicate that equimolar N2O inhalation is efficient in reducing patient discomfort and may be an alternative to general anesthesia.

Administration, Inhalation↗

Sedating patients for radiologic studies.

Many different practice models for radiology sedation can provide satisfactory patient care. Adherence to recognized safety standards and the training and experience of sedation providers are critical for a successful program. Pediatricians should develop an appreciation of safe practices in the radiologic environment and the requirements related to individual studies and procedures. Sedation needs in radiology are diverse. Imaging procedures such as MRI, CT, and nuclear medicine studies require hypnosis to achieve results without motion artifact. Invasive studies may require the use of analgesic and anxiolytic agents. IR procedures often require the use of multiple agents.

Child↗

General anaesthesia or conscious sedation for painful procedures in childhood cancer: the family's perspective.

BACKGROUND: Until recently, midazolam sedation was routinely used in our institution for bone marrow aspirates and lumbar punctures in children with cancer. It has been perceived by many doctors and nurses as being well tolerated by children and their families. AIM: To compare the efficacy of inhalational general anaesthesia and midazolam sedation for these procedures. METHODS: A total of 96 children with neoplastic disorders, who received either inhalational general anaesthesia with sevoflurane, nitrous oxide, and oxygen (GA) or sedation with oral or nasal midazolam (SED) as part of their routine preparation for procedures were studied. The experiences of these children were examined during their current procedure and during their first ever procedure. Main outcome measures were the degree of physical restraint used on the child, and the levels of distress and pain experienced by the child during the current procedure and during the first procedure. The family's preference for future procedures was also determined. RESULTS: During 102 procedures under GA, restraint was needed on four occasions (4%) when the anaesthetic mask was first applied, minimal pain was reported, and children were reported as distressed about 25% of the time. During 80 SED procedures, restraint was required in 94%, firm restraint was required in 66%, the child could not be restrained in 14%, median pain score was 6 (scale 0 (no pain) to 6 (maximum pain)), and 90% of the parents reported distress in their child. Ninety per cent of families wanted GA for future procedures. Many families reported dissatisfaction with the sedation regime and raised concerns about the restraint used on their child. CONCLUSIONS: This general anaesthetic regime minimised the need for restraint and was associated with low levels of pain and distress. The sedation regime, by contrast, was much less effective. There was a significant disparity between the perceptions of health professionals and those of families with respect to how children coped with painful procedures.

Adolescent↗

Assessing the behavioral effects and abuse potential of propofol bolus injections in healthy volunteers.

Propofol is a recently introduced intravenous anesthetic agent, commonly administered to surgical patients because it induces anesthesia smoothly (i.e., provides loss of consciousness rapidly and usually with no complications) and is associated with rapid recovery. Propofol has psychoactive effects that could be construed as pleasant, although little abuse liability testing has been done on this agent in humans. Accordingly, we examined various effects of this agent at different subanesthetic doses (0.2-0.6 mg/kg) in order to characterize this drug's abuse potential (for recreational use or potential for diversion). Using a double-blind, randomized, crossover design, healthy normal volunteers (N = 10) were injected intravenously with the drug or with placebo. Before the injection and for up to 1 h afterwards, mood (including drug liking), memory and psychomotor performance were assessed. Propofol impaired memory and psychomotor performance and produced changes in 10 of 20 VAS mood ratings. Although there was variability in self-reported drug liking, some subjects clearly liked the effects of propofol, especially at the two higher doses. At the debriefing interview held after completion of the study, five subjects said if they had to participate in one more session in which they were given a choice between being injected with the highest dose (0.6 mg/kg) or a placebo, they would choose propofol. These preliminary results suggest that this agent may have some potential for abuse/diversion and perhaps stricter accountability procedures should be established for this drug in settings where general anesthesia or conscious sedation procedures are done.

Adult↗

Sedation for children with metachromatic leukodystrophy undergoing MRI.

BACKGROUND: Metachromatic leukodystrophy (MLD) is a lysosomal storage disease with infantile and juvenile onset with a poor prognosis and magnetic resonance imaging (MRI) plays a fundamental role in its diagnosis. Procedural sedation is needed to carry out MRI on children. Very few case reports have been published on anesthesia or sedation for MLD patients. METHODS: We prospectively studied 18 MLD patients undergoing sedation for brain MRI. Twenty consecutive similar-aged ASA I children undergoing MRI during the same time span for suspected seizures and exhibiting no MRI brain alteration healthy (HLT) patients were also studied for comparison. In patients up to 3 years of age (T_MLD and T_HLT groups), sedation was induced with thiopental 5 mg x kg(-1) i.v. and further 2.5 mg x kg(-1) i.v. rescue boluses were given if the sedation level was inadequate. In patients over 3 years of age (P_MLD and P_HLT groups), sedation was induced with propofol 1-1.5 mg x kg(-1) i.v. and maintained with 0.1-0.15 mg x kg(-1) x min(-1) continuous i.v. infusion, which was increased if the sedation level was inadequate. We recorded complications, if any, caused by sedation (hypoxia, vomiting, bradycardia, other major arrhythmias, convulsions, MRI artifact movements with increasing sedation, prolonged recovery). RESULTS: No sedation complications occurred. The mean dose of thiopental required to warrant patient immobility was 0.227 +/- 0.053 mg x kg(-1) x min(-1) of procedure in T_MLD patients and 0.119 +/- 0.061 mg x kg(-1) x min(-1) of procedure in T_HLT patients (difference not significant). The mean dose of propofol required for immobility was 0.119 +/- 0.054 mg x kg(-1) x min(-1) of procedure in T_MLD patients and 0.115 +/- 0.043 mg x kg(-1) x min(-1) of procedure in T_HLT patients (difference not significant). CONCLUSIONS: Our protocol for sedation in the MRI setting proved safe and effective in children with MLD, who do not require different doses of sedatives compared with healthy children.

Anesthesia↗

Does interpleural bupivacaine blockade reduce arterial hypoxemia and pain in endoscopic retrograde cholangiopancreatography? A prospective randomized trial.

BACKGROUND AND STUDY AIMS: Interpleural blockade with bupivacaine has been used in operations and for the treatment of pain with promising results. Endoscopy may be followed by serious complications associated with the use of intravenous drugs. Drug-induced hypoxemia has an important role in the pathophysiology. PATIENTS AND METHODS: A randomized study to assess whether interpleural bupivacaine blockade compared with a standard procedure reduced the risk of hypoxemia and the need of medication in patients undergoing endoscopic retrograde cholangiopancreatography (ERCP). Other variables studied were its acceptability to patients and morbidity. RESULTS: Ninety patients were included. Interpleural blockade (n = 43) was followed by minor complications. The blockade itself induced mild hypoxemia in four patients (9%). Overall, eight patients (27%) developed hypoxemia. There were correlations between age, drugs given and hypoxemia in the total series and in the two study groups individually. During ERCP eight (19%) in the blockade group and 16 (34%) in the standard procedure group developed hypoxemia. During the recovery period the opposite pattern was observed: (26%) compared with four (9%) (p = 0.05). Drug requirements did not differ. Procedure-related discomfort did not differ. More patients in the blockade group would prefer another sedative procedure. CONCLUSIONS: Interpleural bupivacaine blockade did not contribute to patients' comfort or safety during ERCP.

Adult↗

Conscious sedation with propofol.

The study was designed to assess the suitability of propofol for conscious sedation. Thirty-one patients undergoing bilateral third molar surgery were randomly given either propofol or midazolam for sedation as an adjunct to local anaesthesia at the first visit, and the alternative at the second visit. Propofol, like midazolam, produced reliable sedation, good operating conditions, stable vital signs and profound amnesia, with minimum intra-operative and post-operative adverse effects. Furthermore, most patients were willing to undergo either sedation procedure again. The advantages of propofol over midazolam were the ease with which the degree of sedation could be altered and the quick recovery. Its disadvantages were pain during injection, increased talkativeness, the extra equipment needed, and cost.

Adolescent↗

Intramuscular neurolysis for spasticity in children.

Intramuscular neutrolysis with phenol has been used for 10 years in the management of spasticity in children. Best results depend on fastidious technique and realistic use of the procedure. Sedation or anesthesia was used in all cases -- 5% phenol in water was used for all procedures. The main indications were spasticity which interfered with function, either actual or potential, or with care. Where uninhibited vestibular or tonic neck reflexes affect muscle tone, or there is dystonia or athetosis, the procedure is less effective than where spasticity alone is present. Duration of relief of spasticity ranged from 1 month to more than 2 years. About one half of the lower extremity muscle treated required tenotomy later. Generally training was required after the procedure to obtain improved function. A representative sample of muscles treated, repeat procedures, and later surgery is discussed. The procedure is recommended for use in the management of spasticity in children as a way of improving function and/or care.

Adolescent↗

General anaesthesia vs sedation for minor gynaecological procedures--a comparative study.

Sedation using combined intravenous midazolam and fentanyl is a popular technique for minor gynaecological procedures. However, it is fraught with inconsistency in efficacy and has a greater tendency to perioperative oxygen desaturation. Fifty female ASA I patients scheduled for minor gynaecological procedures were given intravenous midazolam and fentanyl before surgery started. Intraoperative excessive movement that interfered with surgery and failure to maintain a patient airway were noted. Perioperative oxygen saturation was monitored with the pulse oximeter. In another group of 50 female ASA I patients, intravenous thiopentone was given and anaesthesia maintained with 67% nitrous oxide in 33% oxygen and 0.5% of isoflurane via a face mask. Results showed that 10% of the sedated patients had excessive movements that interfered with surgery, of which 6% needed a general anaesthetic. Twenty-two percent of the sedated patients needed maintenance of airway perioperatively. Perioperative oxygen desaturation was profound in incidence and degree in the sedated patients whereas no patient who received general anaesthesia desaturated. The perioperative incidence of desaturation in the sedated patients was 46%. Intraoperatively, 28% (p < 0.001) of the sedated patients had oxygen saturation in the range of 85 to 90% and 18% of them (p < 0.01) had oxygen saturation of less than 85%. Postoperatively 8% of the sedated patients had oxygen saturation of 85 to 90%. We conclude that general anaesthesia is more efficacious and safer than sedation in patients scheduled for minor gynaecological procedures. The same minimum standard of monitoring applied to general anaesthesia should be used for sedated patients.

Adolescent↗

Clinical practice guideline for emergency department ketamine dissociative sedation in children.

We present an evidence-based clinical practice guideline for the administration of the dissociative agent ketamine for emergency department pediatric procedural sedation and analgesia. Substantial research in recent years has necessitated updates and revisions to the widely disseminated 1990 recommendations. We critically discuss indications, contraindications, personnel requirements, monitoring, dosing, coadministered medications, recovery issues, and future research questions for dissociative sedation.

Age Factors↗

Evaluation of the safety and efficacy of deep sedation for electrophysiology procedures administered in the absence of an anesthetist.

UNLABELLED: Several procedures performed in the electrophysiology laboratory (EP lab) require surgical manipulation and are lengthy. Patients undergoing such procedures usually receive general anesthesia or deep sedation administered by an anesthesiologist. In 536 consecutive procedures performed in the EP lab, we assessed the safety and efficacy of deep sedation administered under the direction of an electrophysiologist and in the absence of an anesthetist. Patients were monitored with pulse oximetry, noninvasive blood pressure recordings, and continuous ECGs. The level of consciousness and vital signs were evaluated at 5-minute intervals. Deep sedation was induced in 260 patients using midazolam, phenergan, and meperidine, then maintained with intermittent dosing of meperidine at the following mean doses: midazolam 0.031 +/- 0.024 mg/kg; phenergan 0.314 +/- 0.179 mg/kg; and meperidine 0.391 +/- 0.167 mg/kg per hour. In the remaining 276 patients, deep sedation was induced with midazolam and fentanyl and maintained with a continuous infusion of fentanyl at a mean dose of 2.054 +/- 1.43 micrograms/kg per hour. Fourteen patients experienced a transient reduction in oxygen saturation that was readily reversed following administration of naloxone. An additional 11 patients desaturated secondary to partial airway obstruction, which resolved after repositioning the head and neck. Fourteen patients experienced hypotension with fentanyl. All but one returned to baseline blood pressures following an infusion of normal saline. No patient required intubation and no death occurred. Only three patients had recollection of periprocedure events. No patient remembered experiencing pain with the procedure. Hospital stays were not prolonged as a result of the sedation used. IN CONCLUSION: (1) deep sedation during EP procedures can be administered safely under the guidance of the electrophysiologist without an anesthetist present; (2) the drugs used should be readily reversible in case of respiratory depression; and (3) this approach may reduce the overall cost of the procedures in the EP lab, maintaining adequate patient comfort.

Adjuvants, Anesthesia↗

Ketamine sedation for pediatric procedures: Part 1, A prospective series.

Emergency physicians frequently perform painful but necessary procedures on frightened children. We conducted a prospective, uncontrolled clinical trial of ketamine sedation (4 mg/kg IM) to facilitate a variety of procedures in 108 children aged 14 months to 13 years. Acceptable conditions were achieved with a single injection in 97% of the patients, and adjunctive restraint or local anesthesia was not required in 86%. Full sedation was produced within five minutes in 83%. Mean duration from injection to dischargeable recovery was 82 minutes (range, 30 to 175 minutes). One 18-month-old child vomited shortly after injection and experienced transient laryngospasm with cyanosis; intubation was not required, and there were no adverse sequelae. Airway patency and independent respirations were fully maintained in all other patients; no hemodynamic instability occurred at any time. There were no other clinically significant complications. Emesis well into the recovery phase was noted in 6% of the patients. Nightmares were not observed. Response from parents and physicians was strongly positive. Ketamine can be effectively used by emergency physicians to facilitate procedural sedation, yet equipment and expertise for advanced airway management are mandatory due to the rare occurrence of laryngospasm.

Adolescent↗

Ventilation, ventilatory carbon dioxide and hormonal response during halothane anaesthesia and surgery in children after midazolam premedication.

In 14 intubated, spontaneously breathing children with body weight (bw) ranging from 8.3 to 25.6 kg, the influence of midazolam 0.1 mg kg-1 i.m. (group M0.1, n = 7) and 0.2 mg kg-1 i.m. (group M0.2, n = 7) as premedication, on sedation, ventilation, ventilatory response to carbon dioxide and hormonal stress response was studied in connection with minor surgical procedures during halothane anaesthesia. The concentrations of catecholamines, ACTH and cortisol were measured immediately after induction, during undisturbed anaesthesia, during surgery and 15 min after the end of the surgical procedure. Sedation was better and plasma catecholamine concentrations during undisturbed anaesthesia were less in children receiving the larger dose of midazolam. During surgery and in recovery there were no differences in hormone concentrations. In recovery, the concentrations of all hormones were significantly greater compared with during undisturbed anaesthesia. During surgery, VE and respiratory rate were somewhat lower in group M0.2 while E' CO2 was similar. A dose dependent depression of the response to carbon dioxide was found. However, clinically, the ventilatory response to carbon dioxide after surgery was considered to be adequate in both groups.

Adrenocorticotropic Hormone↗

Propofol infusion during regional anesthesia: sedative, amnestic, and anxiolytic properties.

We examined the plasma concentrations and resultant clinical effects produced by four different propofol bolus infusion regimens in 98 healthy males undergoing elective urologic procedures under regional anesthesia. Patients were randomly assigned to one of four propofol dosage groups. In Groups 1-4, loading doses of propofol equal to 0.2, 0.4, 0.5, or 0.7 mg/kg intravenously, respectively, were followed by fixed-rate propofol infusions of 0.5, 1, 2, or 4 mg.kg-1.h-1, respectively, during the regional block procedure. Sedation (sleepiness) was assessed independently by the patient and a blinded observer using 100-mm visual analog scales. Intraoperative amnesia was assessed using picture recall. Sedation scores increased in a dose-dependent fashion (13 +/- 19, 21 +/- 19, 45 +/- 28, and 73 +/- 26 mm at 30 min in Groups 1-4, respectively). Within a given dosage group, sedation scores were stable during the maintenance infusion period. Mean plasma propofol concentrations increased with higher propofol infusion rates (0.16 +/- 0.3, 0.18 +/- 0.1, 0.47 +/- 0.2, and 1.1 +/- 0.8 microgram/mL at 30 min in Groups 1-4, respectively). However, significant variability was observed among individual patient sedation scores and plasma propofol concentrations. Anxiety scores decreased in all four propofol infusion groups during the maintenance period. Hemodynamic variables and hemoglobin oxygen saturation values were similar in all four treatment groups. Recovery from propofol's central effects was rapid after discontinuation of the propofol infusion, and the incidence of side effects was low. Recall of intraoperative events was more commonly observed in the lower-dosage groups (86%, 96%, 58%, and 13% of patients in Groups 1-4, respectively).(ABSTRACT TRUNCATED AT 250 WORDS)

Aged↗

Conscious sedation for endoscopic procedures.

Despite the fact that gastrointestinal endoscopy is a safe procedure, significant complications can occur. According to the literature most complications are related to sedation and compared with perioperative mortality under general anaesthesia, the mortality for this procedure appears high. Strict implementation of existing guidelines is warranted.

Anesthesia, General↗

Sedation for pediatric echocardiography: evaluation of preprocedure fasting guidelines.

In an effort to increase the safety of sedated procedures, there is a recent trend to increase preprocedure fasting times. However, optimal fasting times have never been established for a sedated echocardiogram. We retrospectively analyzed 334 patients divided into 2 groups. Group 1 (140 patients) had fasting times less than 2 hours, whereas group 2 (184 patients) had fasting times more than 2 hours. When the entire population was considered, there was no difference in efficacy between the 2 groups (P =.08). However, in patients younger than 6 months, group 2 had decreased efficacy compared with group 1 (P =.03). There were no major complications in either group. There was no difference in the rate of minor complications between the 2 groups. Our study concludes that longer fasting times are less efficacious in children younger than 6 months, and do not improve safety.

Arrhythmias, Cardiac↗

Sedation for endoscopic procedures: not as simple as it seems.

The Bispectral Index (BIS) is a processed electroencephalogram, which has been evaluated as an automated monitoring technique for patients receiving sedation for endoscopic procedures. BIS monitoring has not been shown to be of significant clinical benefit, but the need for an objective quantitative measure of the depth of sedation in patients undergoing endoscopy remains.

Procedural Sedation↗

[Midazolam--how safe is it in sedation of newborn?].

Since the nineties, while both pain and stress reactions in newborn were revealed, the period of opioid analgesia as well as benzodwuazepin sedation was initiated. Midazolam is the drug which is particularly willingly used in neonatal intensive care units. Although commonly accepted as a safe drug, midazolam produced adverse effects which could make early as well late treatment outcome worse. In this paper the results of pharmacokinetics studies and studies concerning the adverse effects of midazolam among low birth weight newborn are collected and the current opinion of experts dedicates regarding analgetic and sedative procedures in neonatal period are presented. On the basis of the results of the previous studies, it seems reasonable to be more critical of our sedation approach with midazolam and pay more attention to appropriate administration of midazolam in neonatal period.

Cytochrome P-450 CYP3A↗