Accessing the efficacy and peri-operative adverse effects of three different hyperbaric bupivacaine 0.5% dosages for spinal anesthesia induction in lower limb orthopedic surgeries: a randomized clinical trial.

BACKGROUND: Spinal anesthesia (SA) is a conventional method for proper nerve block in abdominopelvic and lower extremity surgeries. Compared to general anesthesia, SA has reduced perioperative complications significantly. The hyperbaric type of bupivacaine hydrochloride (HB) induces spinal anesthesia more efficiently with a lower incidence of life-threatening adverse reactions like Perioperative hemodynamic changes and respiratory depression. More investigations are needed to define the best dosage that provides adequate anesthesia while reducing adverse effects for each surgical procedure. METHODS: This double-blinded randomized clinical trial compared the consequences of the (12.5mg,15mg,20mg) dosages of HB-bupivacaine in elective lower limb orthopedic surgery. Using block randomization, we allocated 60 participants to three (n = 20) study groups. Utilizing the same protocol of anesthesia induction, outcome variables assumed and measured as the incidence of the adverse effects (Hypotension, Anxiety, Bradycardia, Nausea and Vomiting(N/V), Hypoventilation, and Decreased o2 saturation), and the requirement for intervention to control the unwanted reaction. Addressing that, outcome variables were measured 10 times perioperatively. One-way ANOVA test, the chi2 test, or repeated measures ANOVA test with the Bonferroni adjustment were utilized as appropriate. RESULTS: We found that the incidence of hypotension (P-value:0.02) and the N/V (P-value < 0.001) are associated with the HB-bupivacaine dosage. Contrary, our findings indicate that the incidence of apnea, bradycardia, and hypoventilation did not exhibit a significant dose-dependent pattern between the groups. Repeated measures analysis revealed significant intergroup differences for Herat rate, systolic, diastolic, and mean arterial pressure (group*time Pvalue < 0.001). The observed differences were more prominent 10-30 min after injection of HB-bupivacaine. The regression model claimed that gender (P-value:0.002) and drug dosage (P-value:0.03) significantly predict the incidence of adverse effects. CONCLUSION: Our results, suggest that the administration of the 12.5mg HB-bupivacaine provides adequate anesthesia while minimizing the risk of adverse events for lower limb orthopedic surgeries lasting up to 180 min. TRIAL REGISTRATION: The study was registered at the Clinical Trial Registry Center (IRCT20160202026328N7), Registered on 2022.01.10.

Effectiveness of the Green Heart Smartphone Application as a Self-Management Intervention for Hypertension and Dyslipidemia: A Randomized Clinical Trial.

BACKGROUND: Cardiovascular disease (CVD) is a major global health concern, the leading cause of death and disability. Thus, preventive interventions targeting modifiable risk factors are essential. Mobile-health technologies have emerged as promising tools for improving prevention by modifying risk factors. We created the "Green Heart" mobile app to help coronary artery disease (CAD) patients control their risk factors. The app has three modules: smoking cessation, dyslipidemia (DLP) control, and blood pressure (BP) management. This study evaluated the app's performance in monitoring hypertension (HTN) and DLP among known CAD cases. METHODS: A randomized controlled trial enrolled 1590 CAD subjects, including 1114 hypertensive patients and 1488 subjects with DLP, and assigned them randomly to paper-based education or application-based groups. RESULTS: Regarding HTN, after 6 months, we finally analyzed 545 and 546 hypertensive patients, assigned to the conventional and app groups, respectively. Patients in the app group were more likely to have their BP managed successfully (88.6% vs. 78.5%; P<0.001). The app group showed higher odds of successful BP management (odds ratio [OR]: 2.13; 95% CI: 1.51 - 3.03). Regarding DLP, we analyzed 728 patients in the conventional and 714 patients in the app group. A higher percentage of patients in the app group (24.8%) had low-density lipoprotein cholesterol (LDL-C) levels less than 70 mg/dL (16.1%; P<0.001). The app group showed higher odds of reducing LDL-C (OR: 1.72; 95% CI: 1.32-2.26). CONCLUSION: We found that using the Green Heart app in the self-monitoring setting significantly improved BP and DLP management across the study population.