scholarly journals Premedication with dexmedetomidine to reduce emergence agitation: a randomized controlled trial

2019 ◽  
Author(s):  
Jong Chan Kim ◽  
Jihee Kim ◽  
Hayeon Kwak ◽  
So Woon Ahn
Keyword(s):  
Randomized Controlled Trial ◽  
Bone Fracture ◽  
Closed Reduction ◽  
Controlled Trial ◽  
Nasal Bone ◽  
Control Group ◽  
Emergence Agitation ◽  
Point Scale ◽  
Randomized Controlled ◽  
Scale Scores

Abstract Background: Nasal bone fracture is the most common type of facial fracture, and the high incidence of severe emergence agitation occurring after closed reduction of the nasal bone fracture can be challenging to manage. The purpose of this trial was to evaluate whether pre-operative administration of dexmedetomidine is effective in reducing the incidence and severity of emergence agitation in adults undergoing closed reduction of nasal bone fractures. Methods: In this randomized controlled trial, 90 patients who were scheduled to undergo closed reduction of a nasal bone fracture were prospectively included and were randomly assigned to either the control group (n = 45; 0.9% saline infusion) or the dexmedetomidine group (n = 45; 1 μ/kg over 10 min, pre-operatively). The primary endpoint was Aono's four-point scale scores after anesthesia. The recovery time and numeric rating scale score were assessed as secondary endpoints. Results: Aono's four-point scale scores were lower in the dexmedetomidine group than in the control group (median: 1 [1-1] vs. 1 [1-2], 95% confidence interval of difference: 0.01 to 0.02, P = 0.02). The number, severity, and duration of agitation episodes were significantly lower in the dexmedetomidine group than in the control group. Furthermore, the number of patients exhibiting intraoperative movement was lower in the dexmedetomidine group. Conclusions: Pre-operative administration of dexmedetomidine demonstrated several significant benefits, such as a lower incidence of emergence agitation, reduced agitation severity, and a shorter duration of agitation. Additionally, we observed more stable maintenance of intraoperative anesthesia with less movement during the surgery.

scholarly journals Premedication with dexmedetomidine to reduce emergence agitation: a randomized controlled trial

2019 ◽  
Author(s):  
Jong Chan Kim ◽  
Jihee Kim ◽  
Hayeon Kwak ◽  
So Woon Ahn
Keyword(s):  
Randomized Controlled Trial ◽  
Bone Fracture ◽  
Closed Reduction ◽  
Controlled Trial ◽  
Nasal Bone ◽  
Control Group ◽  
Emergence Agitation ◽  
Point Scale ◽  
Randomized Controlled ◽  
Scale Scores

Abstract Background: Nasal bone fracture is the most common type of facial fracture, and the high incidence of severe emergence agitation occurring after closed reduction of the nasal bone fracture can be challenging to manage. The purpose of this trial was to evaluate whether pre-operative administration of dexmedetomidine is effective in reducing the incidence and severity of emergence agitation in adults undergoing closed reduction of nasal bone fractures. Methods: In this randomized controlled trial, 90 patients who were scheduled to undergo closed reduction of a nasal bone fracture were prospectively included and were randomly assigned to either the control group (n = 45; 0.9% saline infusion) or the dexmedetomidine group (n = 45; 1 μ/kg over 10 min, pre-operatively). The primary endpoint was Aono's four-point scale scores after anesthesia. The recovery time and numeric rating scale score were assessed as secondary endpoints. Results: Aono's four-point scale scores were lower in the dexmedetomidine group than in the control group (median: 1 [1-1] vs. 1 [1-2], 95% confidence interval of difference: 0.01 to 0.02, P = 0.02). The number, severity, and duration of agitation episodes were significantly lower in the dexmedetomidine group than in the control group. Furthermore, the number of patients exhibiting intraoperative movement was lower in the dexmedetomidine group. Conclusions: Pre-operative administration of dexmedetomidine demonstrated several significant benefits, such as a lower incidence of emergence agitation, reduced agitation severity, and a shorter duration of agitation. Additionally, we observed more stable maintenance of intraoperative anesthesia with less movement during the surgery.

scholarly journals Premedication with dexmedetomidine to reduce emergence agitation: a randomized controlled trial

2019 ◽  
Author(s):  
Jong Chan Kim ◽  
Jihee Kim ◽  
Hayeon Kwak ◽  
So Woon Ahn
Keyword(s):  
Randomized Controlled Trial ◽  
Bone Fracture ◽  
Closed Reduction ◽  
Controlled Trial ◽  
Nasal Bone ◽  
Control Group ◽  
Emergence Agitation ◽  
Point Scale ◽  
Randomized Controlled ◽  
Number Of Patients

Abstract Background: Nasal bone fracture is the most common type of facial fracture, and the high incidence of severe emergence agitation occurring after closed reduction of the nasal bone fracture can be challenging to manage. The purpose of this trial was to evaluate whether pre-operative administration of dexmedetomidine is effective in reducing the incidence and severity of emergence agitation in adults undergoing closed reduction of nasal bone fractures. Methods: In this randomized controlled trial, 90 patients who were scheduled to undergo closed reduction of a nasal bone fracture were prospectively included and were randomly assigned to either the control group (n = 45; 0.9% saline infusion) or the dexmedetomidine group (n = 45; 1 mcg/kg over 10 minutes, pre-operatively). The primary endpoint was Aono's four-point scale after anesthesia. The recovery time and numeric rating scale score were assessed as secondary endpoints. Results: Aono's four-point scale scores were lower in the dexmedetomidine group than in the control group (median: 1 [1-1] vs. 1 [1-2], 95% comfidence interval of difference: 0.01 to 0.02, P = 0.02). The number, severity, and duration of agitation episodes were significantly lower in the dexmedetomidine group than in the control group. Furthermore, the number of patients exhibiting intraoperative movement was lower in the dexmedetomidine group. Conclusions: Pre-operative administration of dexmedetomidine demonstrated several significant benefits, such as a lower incidence of emergence agitation, reduced agitation severity, and a shorter duration of agitation. Additionally, we observed more stable maintenance of intraoperative anesthesia with less movement during the surgery.

scholarly journals Premedication with dexmedetomidine to reduce emergence agitation: a randomized controlled trial

2019 ◽  
Author(s):  
Jong Chan Kim ◽  
Jihee Kim ◽  
Hayeon Kwak ◽  
So Woon Ahn
Keyword(s):  
Randomized Controlled Trial ◽  
Bone Fracture ◽  
Closed Reduction ◽  
Controlled Trial ◽  
Nasal Bone ◽  
Control Group ◽  
Emergence Agitation ◽  
Point Scale ◽  
Randomized Controlled ◽  
Number Of Patients

Abstract Background Nasal bone fracture is the most common type of facial fracture, and the high incidence of severe emergence agitation occurring after closed reduction of the nasal bone fracture can be challenging to manage. The purpose of this trial was to evaluate whether pre-operative administration of dexmedetomidine is effective in reducing the incidence and severity of emergence agitation in adults undergoing closed reduction of nasal bone fractures. Methods In this randomized controlled trial, 90 patients who were scheduled to undergo closed reduction of a nasal bone fracture were prospectively included and were randomly assigned to either the control group (n = 45; 0.9% saline infusion) or the dexmedetomidine group (n = 45; 1 mcg/kg over 10 minutes, pre-operatively). The primary endpoint was Aono's four-point scale after anesthesia. The recovery time and numeric rating scale score were assessed as secondary endpoints. Results Aono's four-point scale scores were lower in the dexmedetomidine group than in the control group [median (IQR); 1 (1-1) vs. 1 (1-2), 95% CI of difference; 0.01 to 0.02, P = 0.02]. The number, severity, and duration of agitation episodes were significantly lower in the dexmedetomidine group than in the control group. Furthermore, the number of patients exhibiting intraoperative movement was lower in the dexmedetomidine group. Conclusions Pre-operative administration of dexmedetomidine demonstrated several significant benefits, such as a lower incidence of emergence agitation, reduced agitation severity, and a shorter duration of agitation. Additionally, we observed more stable maintenance of intraoperative anesthesia with less movement during the surgery.

Effects of robot-(Morning Walk®) assisted gait training for patients after stroke: a randomized controlled trial

2018 ◽  
Vol 33 (3) ◽  
pp. 516-523 ◽  
Author(s):  
JaYoung Kim ◽  
Dae Yul Kim ◽  
Min Ho Chun ◽  
Seong Woo Kim ◽  
Ha Ra Jeon ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Lower Limb ◽  
Controlled Trial ◽  
Gait Training ◽  
Berg Balance Scale ◽  
Control Group ◽  
Balance Scale ◽  
Randomized Controlled ◽  
Scale Scores ◽  
Conventional Physiotherapy

Objective: To investigate the effects of Morning Walk®–assisted gait training for patients with stroke. Design: Prospective randomized controlled trial. Setting: Three hospital rehabilitation departments (two tertiary and one secondary). Patients: We enrolled 58 patients with hemiparesis following a first-time stroke within the preceding year and with Functional Ambulation Category scores ⩾2. Intervention: The patients were randomly assigned to one of two treatment groups: 30 minutes of training with Morning Walk®, a lower limb rehabilitation robot, plus 1 hour of conventional physiotherapy (Morning Walk® group; n = 28); or 1.5 hour of conventional physiotherapy (control group; n = 30). All received treatment five times per week for three weeks. Main outcome measurements: The primary outcomes were walking ability, assessed using the Functional Ambulation Category scale, and lower limb function, assessed using the Motricity Index-Lower. Secondary outcomes included the 10 Meter Walk Test, Modified Barthel Index, Rivermead Mobility Index, and Berg Balance Scale scores. Results: A total of 10 patients were lost to follow-up, leaving a cohort of 48 for the final analyses. After training, all outcome measures significantly improved in both groups. In Motricity Index-Lower of the affected limb, the Morning Walk® group (∆mean ± SD; 19.68 ± 14.06) showed greater improvement ( p = .034) than the control group (∆mean ± SD; 11.70 ± 10.65). And Berg Balance Scale scores improved more ( p = .047) in the Morning Walk® group (∆mean ± SD; 14.36 ± 9.01) than the control group (∆mean ± SD; 9.65 ± 8.14). Conclusion: Compared with conventional physiotherapy alone, our results suggest that voluntary strength and balance of stroke patients with hemiparesis might be improved with Morning Walk®–assisted gait training combined with conventional physiotherapy.

scholarly journals Comparison of emergence agitation between succinylcholine and rocuronium-sugammadex in adults following closed reduction of a nasal bone fracture: a prospective randomized controlled trial

2019 ◽  
Vol 19 (1) ◽  
Author(s):  
Seok-Jin Lee ◽  
Tae-Yun Sung ◽  
Choon-Kyu Cho
Keyword(s):  
Bone Fracture ◽  
Closed Reduction ◽  
Neuromuscular Block ◽  
Controlled Trial ◽  
Nasal Bone ◽  
Emergence Agitation ◽  
Prospective Randomized Controlled Trial ◽  
Registration Number ◽  
Lactate Levels ◽  
Registration Date

Abstract Background Sugammadex allows rapid recovery from rocuronium-induced neuromuscular blockade. Succinylcholine is often used for brief surgeries but is associated with myalgia, headache, histamine release, and increased lactate levels. Thus, we hypothesized that succinylcholine may affect emergence agitation (EA) and compared the effects of succinylcholine and rocuronium-sugammadex on EA in patients undergoing closed reduction of a nasal bone fracture under general anesthesia. Methods Forty-two patients were prospectively enrolled and allocated randomly to the succinylcholine group (group SC) or the rocuronium-sugammadex group (group RS; each n = 21). Neuromuscular block and its reversal were achieved with succinylcholine and normal saline in group SC, whereas rocuronium and sugammadex were administered in group RS. After surgery, the incidence of EA as a primary outcome, the incidence of dangerous EA, and duration of EA as secondary outcomes were compared. Results The incidence of EA was higher in group SC than in group RS (90.5% vs. 47.6%, respectively; relative risk [RR] 4.3; 95% confidence interval [CI] 1.2 to 15.7; P = .006). The incidence of dangerous EA increased in group SC compared to group RS (33.3% vs. 4.8%, respectively; RR 2.1; 95% CI 1.3 to 3.4; P = .045). The duration of agitation was longer in group SC than in group RS [106.5 (65.1) vs. 40.4 (26.0) sec; mean difference 66.1 s; 95% CI 31.0 to 101.1; effect size 1.3; P = .001). Conclusion Succinylcholine increases the incidence, severity, and duration of EA compared to rocuronium-sugammadex in patients undergoing closed reduction of a nasal bone fracture. Trial registration CRiS Registration number KCT0002673. Initial registration date was 31 January 2018 (Retrospectively registered).

scholarly journals Surplus Value of Hip Adduction in Leg-Press Exercise in Patients With Patellofemoral Pain Syndrome: A Randomized Controlled Trial

2009 ◽  
Vol 89 (5) ◽  
pp. 409-418 ◽  
Author(s):  
Chen-Yi Song ◽  
Yeong-Fwu Lin ◽  
Tung-Ching Wei ◽  
Da-Hon Lin ◽  
Tzu-Yu Yen ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Controlled Trial ◽  
Pain Syndrome ◽  
Patellofemoral Pain Syndrome ◽  
Patellofemoral Pain ◽  
Oblique Muscle ◽  
Control Group ◽  
Leg Press ◽  
Randomized Controlled ◽  
Scale Scores

BackgroundA common treatment for patients with patellofemoral pain syndrome (PFPS) is strength (force-generating capacity) training of the vastus medialis oblique muscle (VMO). Hip adduction in conjunction with knee extension is commonly used in clinical practice; however, evidence supporting the efficacy of this exercise is lacking.ObjectiveThe objective of this study was to determine the surplus effect of hip adduction on the VMO.DesignThis study was a randomized controlled trial.SettingThe study was conducted in a kinesiology laboratory.ParticipantsEighty-nine patients with PFPS participated.InterventionParticipants were randomly assigned to 1 of 3 groups: hip adduction combined with leg-press exercise (LPHA group), leg-press exercise only (LP group), or no exercise (control group). Training consisted of 3 weekly sessions for 8 weeks.MeasurementsRatings of worst pain as measured with a 100-mm visual analog scale (VAS-W), Lysholm scale scores, and measurements of VMO morphology (including cross-sectional area [CSA] and volume) were obtained before and after the intervention.ResultsSignificant improvements in VAS-W ratings, Lysholm scale scores, and VMO CSA and volume were observed after the intervention in both exercise groups, but not in the control group. Significantly greater improvements for VAS-W ratings, Lysholm scale scores, and VMO volume were apparent in the LP group compared with the control group. There were no differences between the LP and LPHA groups for any measures.LimitationsOnly the VMO was examined by ultrasonography. The resistance level for hip adduction and the length of intervention period may have been inadequate to induce a training effect.ConclusionsSimilar changes in pain reduction, functional improvement, and VMO hypertrophy were observed in both exercise groups. Incorporating hip adduction with leg-press exercise had no impact on outcome in patients with PFPS.

Evaluation of a collaborative protocolized approach by community pharmacies and general medical practitioners for an Australian minor ailments scheme: study protocol for a cluster-randomized controlled trial (Preprint)

2019 ◽  
Author(s):  
Sarah Dineen-Griffin ◽  
Victoria Garcia Cardenas ◽  
Kylie Williams ◽  
Shalom Isaac Benrimoj
Keyword(s):  
Randomized Controlled Trial ◽  
Usual Care ◽  
Controlled Trial ◽  
Self Care ◽  
Cluster Randomized Controlled Trial ◽  
Control Group ◽  
Community Pharmacies ◽  
Randomized Controlled ◽  
Minor Ailments ◽  
Cluster Randomized

BACKGROUND Internationally, governments have been investing in supporting pharmacists to take on an expanded role to support self-care for health system efficiency. There is consistent evidence that minor ailment schemes (MAS) promote efficiencies within the healthcare system. The cost savings and health outcomes demonstrated in the UK and Canada opens up new opportunities for pharmacists to effect sustainable changes through MAS delivery in Australia. OBJECTIVE This trial is evaluating the clinical, economic and humanistic impact of an Australian minor ailments service (AMAS), compared with usual pharmacy care in a cluster-randomized controlled trial in Western Sydney, Australia. METHODS The cluster-randomized controlled trial design has an intervention and a control group, comparing individuals receiving a structured intervention with those receiving usual care for specific common ailments. Participants will be community pharmacies, general practices and patients located in Western Sydney Primary Health Network region. 30 community pharmacies will be randomly assigned to either intervention or control group. Each will recruit 24 patients seeking, aged 18 years or older, presenting to the pharmacy in person with a symptom-based or product-based request for one of the following ailments (reflux, cough, common cold, headache (tension or migraine), primary dysmenorrhoea and low back pain). Intervention pharmacists will deliver protocolized care to patients using clinical treatment pathways with agreed referral points and collaborative systems boosting clinician-pharmacist communication. Patients recruited in control pharmacies will receive usual care. The co-primary outcomes are rates of appropriate use of nonprescription medicines and rates of appropriate medical referral. Secondary outcomes include self-reported symptom resolution, time to resolution of symptoms, health services resource utilization and EQ VAS. Differences in the primary outcomes between groups will be analyzed at the individual patient level accounting for correlation within clusters with generalized estimating equations. The economic impact of the model will be evaluated by cost analysis compared with usual care. RESULTS The study began in July 2018. At the time of submission, 30 community pharmacies have been recruited. Pharmacists from the 15 intervention pharmacies have been trained. 27 general practices have consented. Pharmacy patient recruitment began in August 2018 and is ongoing and monthly targets are being met. Recruitment will be completed March 31st, 2019. CONCLUSIONS This study may demonstrate the utilization and efficacy of a protocolized intervention to manage minor ailments in the community, and will assess the clinical, economic and humanistic impact of this intervention in Australian pharmacy practice. Pharmacists supporting patient self-care and self-medication may contribute greater efficiency of healthcare resources and integration of self-care in the health system. The proposed model and developed educational content may form the basis of a MAS national service, with protocolized care for common ailments using a robust framework for management and referral. CLINICALTRIAL Registered with Australian New Zealand Clinical Trials Registry (ANZCTR) and allocated the ACTRN: ACTRN12618000286246. Registered on 23 February 2018.

Effectiveness of a web-based medication adherence tool with patient centered communication: Results of a clustered randomized controlled trial (Preprint)

2019 ◽  
Author(s):  
Jan van Lieshout ◽  
Joyca Lacroix ◽  
Aart van Halteren ◽  
Martina Teichert
Keyword(s):  
Randomized Controlled Trial ◽  
Medication Adherence ◽  
Controlled Trial ◽  
Intervention Group ◽  
Control Group ◽  
Community Pharmacies ◽  
Web Based ◽  
Randomized Controlled ◽  
Tailored Interventions ◽  
Increased Risk

BACKGROUND Growing numbers of people use medication for chronic conditions; non-adherence is common, leading to poor disease control. A newly developed web-based tool to identify an increased risk for non-adherence with related potential individual barriers might facilitate tailored interventions and improve adherence. OBJECTIVE To assess the effectiveness of the newly developed tool to improve medication adherence. METHODS A cluster randomized controlled trial assessed the effectiveness of this adherence tool in patients initiating cardiovascular or oral blood glucose lowering medication. Participants were included in community pharmacies. They completed an online questionnaire comprising an assessments of their risk for medication non-adherence and subsequently of barriers to adherence. In pharmacies belonging to the intervention group, individual barriers displayed in a graphical profile on a tablet were discussed by pharmacists and patients at high non-adherence risk in face to face meetings and shared with their general practitioners and practice nurses. Tailored interventions were initiated by the healthcare providers. Barriers of control patients were not presented or discussed and these patients received usual care. The primary outcome was the difference in medication adherence at 8 months follow-up between patients with an increased non-adherence risk from intervention and control group, calculated from dispensing data. RESULTS Data from 492 participants in 15 community pharmacies were available for analyses (intervention 253, 7 pharmacies; control 239, 8 pharmacies). The intervention had no effect on medication adherence (-0.01; 95%CI -0.59 – 0.57; P= .96), neither in the post hoc per protocol analysis (0.19; 95%CI -0.50 – 0.89; P=.58). CONCLUSIONS This study showed no effectiveness of a risk stratification and tailored intervention addressing personal barriers for medication adherence. Various potential explanations for lack of effect were identified. These explanations relate for instance to high medication adherence in the control group, study power and fidelity. Process evaluation should elicit possible improvements and inform the redesign of intervention and implementation. CLINICALTRIAL The Netherlands National Trial Register: NTR5186. Date: May 18, 2015 (http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=5186)

scholarly journals Effect of leg wrapping technique on prevention of spinal induced hypotension and fetal acidosis during cesarean section: Randomized controlled trial

2019 ◽  
Vol 10 (2) ◽  
pp. 70
Author(s):  
Samah Nasser Abd El-Aziz El-Shora ◽  
Amina Mohamed Rashad El-Nemer
Keyword(s):  
Randomized Controlled Trial ◽  
Cesarean Section ◽  
Controlled Trial ◽  
Intervention Group ◽  
Cost Effective ◽  
Control Group ◽  
Induced Hypotension ◽  
Randomized Controlled ◽  
Significant Difference ◽  
Wrapping Technique

Background and aim: Hypotension during cesarean section (CS) under spinal anesthesia has been a subject of scientific study for more than 50 years and the search for the most effective strategy to achieve hemodynamic stability remains challenging. Aim: The study was carried out to apply leg wrapping technique for the prevention of spinal-induced hypotension (SIH) during CS.Methods: Randomized Controlled Trial design was utilized at cesarean delivery operating room Mansoura General Hospital in El-Mansoura City during the period from May 2018 to November 2018. A purposive sample of 88 pregnant women, assigned randomly to an intervention group (n = 44) in which their legs wrapped with elastic crepe bandage and control group (n = 44) in which no wrapping was done. Data collected for maternal, neonatal hemodynamic and signs of hypotension, the feasibility of application and cost analysis.Results: There was a statistically significant difference in the incidence of SIH and Ephedrine use among both groups (18.20% in leg wrapping group whereas 75% in control group). In addition, neonatal acidosis and NICU admission were less among leg wrapping group (11.40%, 9.10% respectively). Economically, leg wrapping technique was cost effective compared to the cost of the hospital regimen for treating SIH and admission to (NICU).Conclusion and recommendations: Leg wrapping technique was cost effective and an efficient method for decreasing SIH, neonatal acidosis and Ephedrine administration. It is recommended to apply leg wrapping technique in maternal hospitals' protocol of care for decreasing SIH during CS.

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