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Local Anesthesia Versus Local Anesthesia and Conscious Sedation for Inguinal Hernioplasty: Protocol of a Randomized Controlled Trial.

ABSTRACT: BACKGROUND:Conscious sedation is regularly used in ambulatory surgery to improve patient outcomes, in particular patient satisfaction. Reports suggest that the addition of conscious sedation to local anesthesia for inguinal hernioplasty is safe and effective in improving patient satisfaction. No previous randomized controlled trial has assessed the benefit of conscious sedation in this regard. OBJECTIVE:To determine whether the addition of conscious sedation to local anesthesia improves patient satisfaction with inguinal hernioplasty. METHODS:This trial is designed as a single-center, randomized, placebo-controlled, blinded trial of 148 patients. Adult patients diagnosed with a reducible, unilateral inguinal hernia eligible for hernioplasty using local anesthesia will be recruited. The intervention will be the use of intravenous midazolam for conscious sedation. Normal saline will be used as placebo in the control group. The primary outcome will be patient satisfaction, measured using the validated Iowa Satisfaction with Anesthesia Scale. Secondary outcomes will include intra- and postoperative pain, operative time, volumes of sedative agent and local anesthetic used, time to discharge, early and late complications, and postoperative functional status. RESULTS:To date, 171 patients have been recruited. Surgery has been performed on 149 patients, meeting the sample size requirements. Follow-up assessments are still ongoing. Trial completion is expected in August 2017. CONCLUSIONS:This randomized controlled trial is the first to assess the effectiveness of conscious sedation in improving patient satisfaction with inguinal hernioplasty using local anesthesia. If the results demonstrate improved patient satisfaction with conscious sedation, this would support routine incorporation of conscious sedation in local inguinal hernioplasty and potentially influence national and international hernia surgery guidelines. TRIAL REGISTRATION:Clinicaltrials.gov NCT02444260; https://clinicaltrials.gov/ct2/show/NCT02444260 (Archived by WebCite at http://www.webcitation.org/6no8Dprp4).

SUBMITTER: Leake PA

PROVIDER: S-EPMC5320391 | biostudies-literature | 2017 Feb

REPOSITORIES: biostudies-literature

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Local Anesthesia Versus Local Anesthesia and Conscious Sedation for Inguinal Hernioplasty: Protocol of a Randomized Controlled Trial.

Leake Pierre-Anthony PA Toppin Patrick J PJ Reid Marvin M Plummer Joseph M JM Roberts Patrick O PO Harding-Goldson Hyacinth H McFarlane Michael E ME

JMIR research protocols 20170207 2

<h4>Background</h4>Conscious sedation is regularly used in ambulatory surgery to improve patient outcomes, in particular patient satisfaction. Reports suggest that the addition of conscious sedation to local anesthesia for inguinal hernioplasty is safe and effective in improving patient satisfaction. No previous randomized controlled trial has assessed the benefit of conscious sedation in this regard.<h4>Objective</h4>To determine whether the addition of conscious sedation to local anesthesia im ...[more]

PMID: 28174148

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Project description:Breast lumpectomy is usually performed under general or local anesthesia. To the best of our knowledge, whether conscious sedation with intranasal dexmedetomidine and local anesthesia is an effective anesthetic technique has not been studied. Thus, the present study aimed to investigate the effectiveness of conscious sedation with intranasal dexmedetomidine combined with local anesthesia in breast lumpectomy, and to identify its optimal dose. A prospective randomized, double-blinded, placebo-controlled, single-center study was designed, and patients undergoing breast lumpectomies were recruited based on the inclusion and exclusion criteria. All patients were randomly allocated to four groups: i) Local anesthesia with 0.9% intranasal saline (placebo); local anesthesia with ii) 1 µg.kg-1; iii) 1.5 µg.kg-1; or iv) 2 µg.kg-1 intranasal dexmedetomidine. The sedation status, pain relief, vital signs, adverse events, and satisfaction of patient and surgeon were recorded. Patients in the three dexmedetomidine groups were significantly more sedated and experienced less pain compared with the placebo group 45 min after intranasal dexmedetomidine administration and during 30 min in the post-anesthesia care unit. Patients in the 1.5 µg.kg-1 group were more sedated compared with the 1 µg.kg-1 group (without reaching statistical significance), whereas the 1.5 µg.kg-1 group exhibited a similar level of sedation 45 min after intranasal dexmedetomidine administration compared with the 2 µg.kg-1 group. In addition, patients in the 1 and 1.5 µg.kg-1 group experienced no adverse hemodynamic effects. Patient and surgeon satisfaction were greater in the 1.5 µg.kg-1 group compared with the 1 and 2 µg.kg-1 groups. Taken together, the results of the present study suggested that conscious sedation with intranasal dexmedetomidine and local anesthesia may be an effective anesthetic for breast lumpectomy surgery, and that the optimal dose for intranasal dexmedetomidine administration may be 1.5 µg.kg-1, as it resulted in good sedation and patient satisfaction without adverse effects.

Project description:BACKGROUND:Two common methods of treating pediatric dental patients with severe early childhood caries (S-ECC) are general anesthesia (GA) and conscious sedation (CS). We sought to first evaluate the cost-effectiveness of treating S-ECC with GA versus CS and then compare the cost-effectiveness at 2 time points: 2011 and 2015. METHODS:We used a decision tree model to produce 2-y estimates of costs and outcomes from the Medicaid perspective. The model cohort consisted of healthy 3-y-olds with S-ECC in need of a theoretical set of dental treatments to be performed under either a single GA visit or 3 CS visits. Outcomes were measured in caries-free months. Costs were evaluated in 2015 US dollars. Costs, probabilities, and outcomes were estimated from published data, expert opinion, and Medicaid billing at an academic health center. One-way and probabilistic sensitivity analyses were performed. RESULTS:As compared with CS, GA resulted in 4 additional caries-free months per child. The cost of a caries-free month for GA versus CS rose from $596 in 2011 to $881 in 2015. These findings were sensitive to loss to follow-up for subsequent CS visits and total cost of GA. CONCLUSIONS:Comprehensive S-ECC treatment had better outcomes when performed under GA versus CS. However, GA was not cost saving when compared with CS. While the cost of dental treatment increased for both GA and CS from 2011 to 2015, the cost rose faster for GA. These results have important implications due to the increasing cost to Medicaid insurance and the rising number of young children being treated for S-ECC under GA. KNOWLEDGE TRANSFER STATEMENT:Medicaid policy makers can use the results of this study to evaluate the cost-effectiveness of dental treatment for young children with S-ECC at 2 time points: 2011 and 2015. Compared with CS, GA resulted in a longer amount of time during which children were free from dental caries but at a higher cost. The cost difference rose from 2011 to 2015.

Project description:Background Endovascular therapy is the standard of care for severe acute ischemic stroke caused by large-vessel occlusion in the anterior circulation, but there is uncertainty regarding the optimal anesthetic approach during this therapy. Meta-analyses of observational studies suggest that general anesthesia increases morbidity and mortality compared with conscious sedation. We performed a systematic review and meta-analysis of randomized clinical trials to examine the effect of anesthetic strategy during endovascular treatment for acute ischemic stroke. Methods and Results Systematic review and meta-analysis according to PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) guidelines has been registered with the PROSPERO (International Prospective Register of Ongoing Systematic Reviews) ( CRD 42018103684). Medline, EMBASE, and CENTRAL databases were searched through August 1, 2018. Meta-analyses were conducted using a random-effects model to pool odds ratio with corresponding 95% CI . The primary outcome was 90-day functional independence (modified Rankin Scale 0-2). In the results, 3 trials with a total of 368 patients were selected. Among patients with ischemic stroke undergoing endovascular therapy, general anesthesia was significantly associated with higher odds of functional independence (odds ratio 1.87, 95% CI 1.15-3.03, I2=17%) and successful recanalization (odds ratio 1.94, 95% CI 1.13-3.3) compared with conscious sedation. However, general anesthesia was associated with a higher risk of 20% mean arterial pressure decrease (odds ratio 10.76, 95% CI 5.25-22.07). There were no significant differences in death, symptomatic intracranial hemorrhage, anesthesiologic complication, intensive care unit length of stay, pneumonia, and interventional complication. Conclusions Moderate-quality evidence suggests that general anesthesia results in significantly higher rates of functional independence than conscious sedation in patients with ischemic stroke undergoing endovascular therapy. Large randomized clinical trials are required to confirm the benefit.

Project description:BackgroundThe impact of anesthesia strategy on the outcomes of acute ischemic stroke (AIS) patients undergoing endovascular treatment is currently controversy. Thus, we performed this meta-analysis to compare the differences of clinical and angiographic outcomes between general anesthesia (GA) and conscious sedation (CS).MethodsA literature search in PubMed, Embase, and Web of Knowledge databases through February 2019 was conducted for related records on GA and CS of AIS undergoing endovascular treatment. The results of the studies were pooled and meta-analyzed with fixed- or random-effect model based on heterogeneity test in total and subgroup analyses.ResultsTwenty-three studies including 6703 patients were analyzed in this meta-analysis. We found that patients in the GA group have lower odds of favorable functional outcome (mRS scores ≤2) compared with the CS group (odds ratio [OR] = 0.62, 95% confidence interval [CI]: 0.49-0.77), and higher risk of mortality (OR = 1.68, 95% CI: 1.49-1.90), pneumonia (OR = 1.78, 95% CI: 1.40-2.26), symptomatic intracranial hemorrhage (OR = 1.64, 95% CI: 1.13-2.37). However, no significant differences were seen between the groups in the rate of recanalization (OR = 1.07, 95% CI: 0.89-1.28), vessel dissection or perforation (OR = 1.00, 95% CI: 0.98-1.03) and asymptomatic intracranial hemorrhage (OR = 1.19, 95% CI: 0.96-1.47). While in the RCT subgroup analysis, we found patients in the GA group does not show lower rate of favorable functional outcome compared with the CS group (OR = 1.84, 95% CI: 1.17-2.89). And there was no significant difference in the rate of mortality between GA and CS groups during RCT subgroup analysis (OR = 0.74, 95% CI: 0.43-1.27).ConclusionsAIS patients performed endovascular treatment under GA compared with CS was associated with worse functional outcome and increased rate of mortality, but differences in worsened outcomes do not exist when one looks into the GA vs. CS RCTs. Moreover, these findings are mainly based on the retrospective studies and additional multi-center randomized controlled trials to definitively address these issues is warranted.

Project description:IntroductionIschemic cerebrovascular disease (ICVD) is a serious health problem in which brain tissue suffers from hypoxic damage due to obstruction in cerebral vessels. Mechanical thrombectomy is a commonly used method in the treatment of these patients. However, the effects of local anesthesia (LA) and conscious sedation (CS) during thrombectomy are still unclear. We evaluated whether there was a relationship between the two anesthesia regimens in terms of 90-day modified Rankin Scale (mRS) scores.MethodsIn this study, a retrospective observational study was conducted to evaluate the effects of LA and CS used during mechanical thrombectomy in four comprehensive stroke centers among ICVD patients. Patients were divided into the LA group and the CS group. Statistical analysis was performed before and after 1:1 matching under propensity score matching (PSM) analysis. The primary outcome measure was an mRS score of 0-2 at 90 days. Secondary outcomes were procedure times, recanalization rates, symptomatic and asymptomatic hemorrhage rates, and procedural complications.ResultsA total of 193 patients (118 patients with LA and 75 patients with CS) were included in the final analysis before PSM. After 1:1 PSM, 98 patients-49 patients from each group-were included in the study. There was no difference in clinical outcomes between the LA- and CS-applied groups (p = 0.543). When blood pressure (BP) values at follow-up after endovascular treatment (EVT) were compared, the lowest systolic and lowest diastolic BP were found to be lower in the CS group (p = 0.001 and p = 0.009). There was no significant difference between the two groups in terms of recanalization rates, symptomatic intracranial hemorrhage (sICH) rates, 90-day mRS, and procedure-related complication rates (p = 0.617, p = 0.274, p = 0.543, and p = 1.000).ConclusionThis study did not reveal the superiority of CS applied during EVT on 90-day mRS, sICH, recanalization rates, or procedural complications. However, the risk of developing hypotension during the CS application was found to be high.

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Local Anesthesia Versus Local Anesthesia and Conscious Sedation for Inguinal Hernioplasty: Protocol of a Randomized Controlled Trial.

Publications

Local Anesthesia Versus Local Anesthesia and Conscious Sedation for Inguinal Hernioplasty: Protocol of a Randomized Controlled Trial.

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