Double-blind Study Research Articles

Effects of Omega-3 Supplementation on the Delayed Onset Muscle Soreness after Cycling High Intensity Interval Training in Overweight or Obese Males

People with overweight or obesity preferred high-intensity interval training (HIIT) due to the time-efficiency and pleasure. However, HIIT leads to delayed onset muscle soreness (DOMS). The present study aimed to investigate the effects of omega-3 supplementation on DOMS, muscle damage, and acute inflammatory markers induced by cycling HIIT in untrained males with overweight or obesity. A randomized, double-blinded study was used in the present study. Twenty-four males with a sedentary lifestyle were randomly assigned to either receive omega-3 (O3) (4 g fish oil) or placebo (Con). Subjects consumed the capsules for 4 weeks and performed cycling HIIT at the 4th week. After 4 weeks-intervention, the omega-3 index of O3 group increased by 52.51% compared to the baseline. All subjects performed HIIT at 4th week. The plasma creatine kinase (CK) level of Con group increased throughout 48h after HIIT. While the CK level of O3 group increased only immediately and 24h after HIIT and decreased at 48h after HIIT. The white blood cell count (WBC) of Con group increased immediately after the HIIT, while O3 group did not show such increase. There was no change of CRP in both groups. O3 group had a higher reduction of calf pain score compared to Con group. O3 group also showed a recovery of leg strength faster than Con group. Omega-3 supplementation for 4 weeks lower increased CK level, reduced calf pain score, and recovery leg strength, DOMS markers after cycling HIIT.

A randomized double-blind pilot study to evaluate the efficacy, safety, and tolerability of intravenous iron versus oral iron for the treatment of restless legs syndrome in patients with iron deficiency anemia.

Restless legs syndrome (RLS) is a neurological disorder that can have a profound effect on sleep and quality of life. Idiopathic RLS is associated with brain iron insufficiency despite normal peripheral iron stores. There is, however, a five- to six-fold increase in prevalence of RLS in patients with iron deficiency anemia (IDA). Several open-label trials have demonstrated symptomatic improvement in RLS following treatment of IDA using oral or intravenous iron supplementation. To date, there have been no randomized double-blind controlled trials of intravenous iron compared with oral iron for the treatment of RLS patients with IDA. In the current study, oral ferrous sulfate and ferumoxytol were compared for efficacy and speed of response for treatment of RLS occurring in patients with IDA. The planned recruitment for this study was 70 patients with RLS and IDA, to be randomly assigned 1:1 to oral or intravenous iron, using double-blind, double-dummy procedures. At Week 6, the primary outcomes of Clinical Global Impression-Improvement score and change from baseline in the International Restless Legs Syndrome Study Group rating scale score were assessed. Due to challenges, performing the clinical trial during the COVID-19 pandemic, final-week data were found missing for 30 patients. As a result, in order to maintain the prespecified statistical analysis, an additional 30 patients were recruited. Both IV and oral iron were associated with a marked improvement in RLS symptoms, with no statistically significant difference between treatment groups. No serious adverse events were observed in either treatment group.

Laparoscopic-Guided Transversus Abdominis Plane (TAP) Block Combined with Port-Site Infiltration (PSI) for Laparoscopic Sleeve Gastrectomy in an ERABS Pathway: A Randomized, Prospective, Double-Blind, Placebo-Controlled Trial.

Patients undergoing laparoscopic sleeve gastrectomy (LSG) commonly experience moderate to severe postoperative pain. We conducted a randomized, prospective double-blind placebo-controlled study to evaluate the analgesic effect of laparoscopic-guided TAP (LG-TAP) block after LSG in a high-volume bariatric center, applying an enhanced recovery after bariatric surgery (ERABS) pathway. One hundred ten patients were randomly allocated to receive LG-TAP block with local anesthetic (LA) or saline solution (placebo), both combined with port-site infiltration with LA (LA-PSI). Primary outcome was pain score measured in post-anesthesia care unit (PACU) and at 6, 12, and 24 h after surgery. Secondary outcomes included postoperative nausea and/or vomiting (PONV), analgesic requirement, time to walking, time to flatus, length of hospital stay (LOS), and surgical complications. No significant differences were observed between LG-TAP and placebo groups in postoperative analgesia, with a median (IQR) NRS of 2 (4.75-0) vs. 2 (5.25-0) in PACU, 5.5 (7-3) vs. 6 (7-4) at 6 h, 2 (6-0) vs. 3 (5.25-1.75) at 12 h, and 2 (3.75-0) vs. 1 (2-0) at 24 h; all p > 0.05. A significant difference was found in PONV in PACU (LG-TAP, 46%; placebo, 25%, p-value, 0.019) and at 6 h postoperatively (LG-TAP, 69%, placebo, 41%, p-value, 0.003). No differences were observed as regards other secondary outcomes. Our results suggest that LG-TAP block is not related to more effective postoperative analgesia compared to placebo when LA-PSI is performed.

Multicomponent Intervention on Improving the Cognitive Ability of Older Adults with Mild Cognitive Impairment: A Pilot Randomized Controlled Trial

ABSTRACT This pilot randomized controlled trial aimed to evaluate the feasibility and potential outcomes of an innovative 16-session multicomponent intervention model to improve cognitive abilities in older adults with mild cognitive impairment (MCI) by promoting healthy lifestyle, cognitive skills, tai chi and mindfulness practices. This study was a multicentre, randomized controlled, two-arm, parallel-group, unblinded trial in Hong Kong. 57 Chinese older adults with MCI recruited from three local elderly centers were randomly assigned to either the control or intervention group. The study results support the feasibility and efficacy of the multicomponent intervention, and recommend future larger-scale randomized control trials.

The effects of hyperbaric oxygen therapy on snake-bite-associated wounds in dogs.

To assess the effect of hyperbaric oxygen therapy (HBOT) on Crotalinae envenomation-induced wound swelling and severity and pain in dogs, and to describe the safety and complications of HBOT. Prospective, randomized, controlled, blinded study (2017-2021). University teaching hospital, private veterinary practice. Thirty-six client-owned dogs presenting within 24hours of a confirmed or suspected naturally occurring Crotalinae snake bite injury were enrolled between 2017 and 2021. In addition to the standard of care treatment, dogs received 2 interventions with either HBOT (n=19) or control (n=16) within 24hours of hospital admission. Dogs receiving HBOT were pressurized over 15 minutes (1psi/min), maintained at a target pressure of 2 atmosphere absolute (ATA) for 30 minutes, and decompressed over 15 minutes. Control dogs received 1 ATA for 1hour. Local wound swelling, wound severity score, and pain score were assessed at admission, before and after each intervention, and at hospital discharge. There was no significant difference in wound swelling (P=0.414), severity score (P=1.000), or pain score (P=0.689) between HBOT and control groups. Pain decreased significantly over time regardless of the study intervention (P<0.001). There were no major adverse effects associated with either study intervention. HBOT did not significantly alter the short-term recovery from Crotalinae envenomation in this study population. However, the study might be underpowered to detect a significant treatment effect.

A randomized phase II trial to examine modified vaccinia Ankara-5T4 vaccine in patients with relapsed asymptomatic ovarian cancer (TRIOC)

BackgroundImmunotherapy directed at 5T4 tumor antigen may delay the need for further chemotherapy. An attenuated modified vaccinia Ankara virus containing the gene encoding for 5T4 (MVA-5T4) was studied in asymptomatic...

Treating refractory obsessive compulsive disorder with cathodal transcranial direct current stimulation over the supplementary motor area: a large multisite randomized sham-controlled double-blind study

BackgroundThe present study evaluated the therapeutic efficacy and tolerability of 10 transcranial direct current stimulation (tDCS) sessions in treatment-resistance obsessive-compulsive disorder (OCD) patients using a multisite double-blind sham-controlled design.MethodsEighty treatment-resistance outpatients suffering from obsessive-compulsive disorder were randomized to receive either active or sham transcranial direct current stimulation. The cathode was positioned over the supplementary motor area and the anode over the right supraorbital area. Patients were evaluated at baseline, end of treatment (day 14), one-month follow-up (day 45), and three-month follow-up (day 105) on the Yale-Brown Obsessive Compulsive Scale.ResultsAlthough a significant interaction between time and treatment was observed, the primary endpoint—measuring the change in Yale-Brown obsessive compulsive scale scores after two weeks—was not achieved. Conversely, the secondary endpoint, which concerned the change in Yale-Brown obsessive compulsive scale scores after three months, was successfully met. It is important to note, however, that there were no significant differences in the percentage of responders and remitters at any of the post-treatment assessments. This suggests that the treatment may not have had a clinically relevant impact. Patients well received the transcranial direct current stimulation treatment, indicating its good tolerability.ConclusionThis is the largest controlled trial using transcranial direct current stimulation in treatment-resistance obsessive-compulsive disorder patients. Our results indicate the importance of studying the placebo effect in transcranial direct current stimulation and the necessity to consider a long follow-up time to best evaluate the effects of the intervention.Clinical trial registrationClinicalTrials.gov, identifier NCT03304600.

The effects of grape seed extract supplementation on cardiovascular risk factors, liver enzymes and hepatic steatosis in patients with non-alcoholic fatty liver disease: a randomised, double-blind, placebo-controlled study.

Despite the high antioxidant potential of grape seed extract (GSE), very limited studies have investigated its effect on non-alcoholic fatty liver disease (NAFLD). Therefore, this study was conducted with the aim of investigating the effect of GSE on metabolic factors, blood pressure and steatosis severity in patients with NAFLD. In this double-blind randomized clinical trial study, 50 NAFLD patients were divided into two groups of 25 participants who were treated with 520mg/day of GSE or the placebo group for 2 months. The parameters of glycemic, lipid profile, blood pressure and steatohepatitis were measured before and after the intervention. The GSE group had an average age of 43.52 ± 8.12 years with 15 women and 10 men, while the placebo group had an average age of 44.88 ± 10.14 years with 11 women and 14 men. After 2 months of intervention with GSE, it was observed that insulin, HOMA-IR, TC, TG, LDL-c, ALT, AST, AST/ALT, SBP, DBP and MAP decreased and QUICKi and HDL-c increased significantly (p-value for all < 0.05). Also, before and after adjustment based on baseline, the average changes indicated that the levels of insulin, HOMA-IR, TC, TG, LDL-c, SBP, DBP, MAP in the GSE group decreased more than in the control group (p for all < 0.05). Furthermore, the changes in HDL-c were significantly higher in the GSE group (p < 0.05). The between-groups analysis showed a significant decrease in the HOMA-β and AST before and after adjustment based on baseline levels (p < 0.05). Moreover, the changes in QUICKi after adjustment based on baseline levels were higher in the GSE group than in the control group. Also, between-groups analysis showed that the severity of hepatic steatosis was reduced in the intervention group compared to the placebo group (P = 0.002). It seems that GSE can be considered one of the appropriate strategies for controlling insulin resistance, hyperlipidemia, hypertension and hepatic steatosis in NAFLD patients. The clinical trial was registered in the Iranian Clinical Trial Registration Center (IRCT20190731044392N1). https://irct.behdasht.gov.ir/trial/61413 . (The registration date: 30/03/2022).

Randomized, Multicenter Study to Assess the Effects of Different Doses of Sildenafil on Mortality in Adults With Pulmonary Arterial Hypertension.

Sildenafil, approved for pulmonary arterial hypertension (PAH), has a recommended adult dose of 20 mg TID, with a previously approved 5-mg TID dose by the US Food and Drug Administration. Safety concerns arose because of common off-label use of higher doses, particularly after pediatric data linked higher doses to increased mortality. To assess this, the Food and Drug Administration mandated a study evaluating the effects of various sildenafil doses on mortality in adults with PAH. This randomized, double-blind study compared sildenafil at doses of 5, 20, or 80 mg TID in adults with PAH. The primary objective was noninferiority of 80 mg of sildenafil versus 5 mg for all-cause mortality. Secondary end points included time to clinical worsening and change in 6-minute walk distance at 6 months. Interim analyses were planned at 50% and 75% of the anticipated mortality events. Safety and tolerability were assessed in the intention-to-treat population. The study was halted after the first interim analysis, demonstrating noninferiority for 80 mg of sildenafil versus 5 mg. Of 385 patients enrolled across all dose groups, 78 died. The primary analysis showed a hazard ratio of 0.51 (99.7% CI, 0.22-1.21; P<0.001 for noninferiority) for overall survival comparing 80 mg of sildenafil with 5 mg. Time to clinical worsening favored 80 mg of sildenafil compared with 5 mg (hazard ratio, 0.44 [99.7% CI, 0.22-0.89]; P<0.001). Sildenafil at 80 mg improved 6-minute walk distance from baseline at 6 months compared with 5 mg (least square mean change, 18.9 m [95% CI, 2.99-34.86]; P=0.0201). No significant differences were found between 80 mg of sildenafil and 20 mg in mortality, clinical worsening, and 6-minute walk distance. Adverse event-related drug discontinuations were numerically higher with 80 mg of sildenafil. Sildenafil at 80 mg was noninferior to sildenafil at 5 mg when examining all-cause mortality in adults with PAH. Secondary efficacy end points favored 80 mg of sildenafil over 5 mg. On the basis of these findings, the Food and Drug Administration recently revoked the approval of 5 mg of sildenafil for adults with PAH, reinforced 20 mg TID as the recommended dose, and now allows dose titration up to 80 mg TID, if needed. URL: https://www.clinicaltrials.gov; Unique identifier: NCT02060487.

Pharmacists in Trauma: a randomised controlled trial of emergency medicine pharmacists in trauma response teams

BackgroundAnalgesia is an important component for patient well-being, but commonly delayed during trauma resuscitation. The Pharmacists in Trauma trial assessed the effects of integrating pharmacists into trauma response teams to...

A COMPARATIVE STUDY OF CLONIDINE VERSUS FENTANYL FOR INTRAOPERATIVE HEMODYNAMIC STABILITY IN PATIENTS UNDERGOING LAPAROSCOPIC CHOLECYSTECTOMY UNDER GENERAL ANESTHESIA: RANDOMIZED, DOUBLE-BLIND, INTERVENTIONAL STUDY

Objective: Laparoscopic cholecystectomy, though advantageous over traditional surgery, presents hemodynamic challenges due to pneumoperitoneum, systemic CO2 absorption, and patient positioning. Clonidine and Fentanyl are evaluated for their effectiveness in maintaining intraoperative hemodynamic stability, considering their different pharmacological actions. Methods: This randomized, double-blind interventional study involved 72 patients undergoing elective laparoscopic cholecystectomy under general anesthesia. Participants were allocated into two groups, receiving either IV Clonidine or IV Fentanyl. Hemodynamic parameters, including heart rate and blood pressure, were monitored and compared. Results: Clonidine demonstrated superior control over heart rate and blood pressure compared to Fentanyl, with statistically significant differences observed in the intraoperative period and post-intubation, indicating enhanced hemodynamic stability. Conclusion: Clonidine is more effective than Fentanyl in maintaining intraoperative hemodynamic stability in patients undergoing laparoscopic cholecystectomy. This suggests a potential preference for Clonidine as a premedicant in such surgical procedures, highlighting the need for tailored anesthetic techniques.

Efficacy of Lemborexant in Adults ≥ 65 Years of Age with Insomnia Disorder.

Pharmacologic treatments are available to treat insomnia, a common and burdensome sleep disorder, but may be contraindicated in older adults who are prone to side effects from sleep-promoting drugs. These analyses of sleep diary data from Study E2006-G000-303 (Study 303) investigated the benefits of lemborexant 5mg (LEM5) and 10mg (LEM10) in the subgroup age ≥ 65years with insomnia. Study 303, a 12-month, double-blind study of LEM5 and LEM10 in adults (age ≥ 18years) with insomnia disorder (sleep onset and/or maintenance difficulties) assessed subject-reported (subjective) sleep-onset latency (sSOL), sleep efficiency (sSE), wake after sleep onset (sWASO), and total sleep time (sTST). Morning sleepiness/alertness, insomnia severity (Insomnia Severity Index [ISI]), fatigue (Fatigue Severity Scale [FSS]), perceptions of sleep-related medication effects (Patient Global Impression-Insomnia [PGI-I] questionnaire), and safety were also evaluated. In this subgroup of older adults (≥ 65years; n = 262), there were significantly larger changes from baseline for sSOL, sSE, sTST, and sWASO with LEM5 and LEM10 versus placebo through month 6 (except sWASO month 1), indicating improvement; these improvements were sustained through month 12. Subject-reported increases in morning alertness were significantly greater with one or both LEM doses versus placebo through month 6 and sustained through month 12. There were significantly larger ISI total and daytime functioning score decreases (improvement) from baseline with LEM versus placebo at months 1, 3, and 6 (total score: both doses; daytime functioning: LEM5 month 1 and both doses months 3 and 6) and decreases from baseline FSS at months 1 and 3 (LEM5) and month 6 (both doses), sustained to month 12. Compared with placebo, more subjects reported that LEM (both doses) positively impacted ability to sleep, time to fall asleep, and TST through month 6, sustained to month 12, with no rebound after drug withdrawal. LEM was well tolerated to month 12; mild somnolence was the most common treatment-emergent adverse event. Improvements in subject-reported efficacy in LEM-treated adults age ≥ 65years with insomnia were observed as early as the first week of treatment and sustained through end of month 12. LEM was well tolerated. ClinicalTrials.gov identifier NCT02952820: E2006-G000-303; Study 303; SUNRISE-2 (First posted: October 2016); EudraCT 2015-001463-39 (First posted: November 2016).

Monitored anesthesia care: Dexmedetomidine-ketamine versus dexmedetomidine-propofol combination during burr-hole surgery for chronic subdural hematoma: A randomized trial

Background and Aim: Selecting the ideal drug combination for effective monitored anesthesia care to keep patients comfortable and safe during evacuation of chronic subdural hematoma is a challenge. Our hypothesis was that the combination of dexmedetomidine with ketamine might provide safer monitored anesthesia care keeping airway patency and stable hemodynamics in comparison to dexmedetomidine-propofol combination during burr-hole surgery for evacuating chronic subdural hematoma in high-risk patients.Methods: A total of 56 paticipants were allocated into two groups in this randomized prospective double-blind study by a computer-generated randomization table. DK group (n = 28): Patients were given a mix of ketamine (1 mg/kg) and dexmedetomidine (1 µg/kg) diluted in 10 ml of saline solution infused over 10 min as an intravenous bolus dose. This was followed by a continuous infusion of 0.5 µg/kg/h dexmedetomidine with 0.5 mg/kg/h ketamine. DP group (n = 28): Patients were given a mix of propofol (0.5 mg/kg) and dexmedetomidine (1 µg/kg) diluted in 10 ml of saline solution infused over 10 min as an intravenous bolus dose. This was followed by a continuous infusion of 0.5 µg/kg/h dexmedetomidine with 0.5 mg/kg/h propofol. The infused solutions were in two separate syringe pumps. The target was to achieve a modified Observer's Assessment of Alertness and Sedation score (OAA/S) of 3, and the infusion was stopped by finishing the skin suture.Results: The onset of sedation using OAA/S was significantly longer in the DK group (413.21 ± 49.18 s.) compared to (297.21 ± 37.68 s.) in the DP group. The number of participants with an airway obstruction score of 1 and 2 was significantly higher in the DK group compared to the DP group; however, those with a score of 3 were significantly higher in the DP group. The total number of patients needing intraoperative fentanyl was comparable between groups. The number of patients who developed intraoperative hypotension, bradycardia, bradypnea, and hypoxemia was significantly higher in the DP group compared to the DK group (p < 0.05). There was an improvement in postoperative Markwalder's Neurological Grading Scale (MNG) scores compared to preoperatively in both the DK and DP groups. The recovery time was significantly longer in the DK group (8.75 ± 1.17 min) compared to (5.73 ± 0.75 min) in the DP group, with comparable surgeon satisfaction.Conclusions: Combining dexmedetomidine with ketamine is safer than dexmedetomidine with propofol for effective monitored anesthesia care in high-risk patients undergoing burr-hole surgery for evacuating chronic subdural hematoma.Institutional Review Board approval (ref: 6434/25-10-2020).ClinicalTrials.gov (ref: NCT04621526, the date of registration: 9-11-2020).

Dexmedetomidine Versus Fentanyl on Time to Extubation in Patients with Morbid Obesity Undergoing Laparoscopic Sleeve Gastrectomy

Background: Sleeve gastrectomy (SG) is an effective method for managing obesity. While opioids are used for their hemodynamic stability and their ability to reduce intraoperative stress, they also have reported side effects. Dexmedetomidine (DEX), an α2 adrenergic receptor agonist, is noted for its analgesic and anesthetic-sparing effects, leading to a higher quality of recovery. Objectives: The study aims to compare the effects of fentanyl and dexmedetomidine (DEX) on the recovery of morbidly obese patients following laparoscopic sleeve gastrectomy (SG). Methods: This randomized, double-blind study involved 64 patients, equally divided into two groups. The Dexmedetomidine group (Group D) received an intravenous (IV) loading dose of dexmedetomidine (1 μg/kg) over 15 minutes before anesthesia induction, followed by a 10 ml saline 0.9% infusion over 60 seconds during induction. Post-intubation, dexmedetomidine was administered at 0.5 μg/kg/h. The Fentanyl group (Group F) received a volume-matched saline 0.9% IV over 15 minutes pre-induction and fentanyl (1 μg/kg) diluted in 10 ml saline 0.9% IV over 60 seconds during induction. After intubation, a continuous fentanyl infusion was maintained at a rate of 1 μg/kg/hr. Results: Extubation time was significantly shorter in the Dexmedetomidine group (Group D) at 8.25 ± 2.7 minutes compared to the Fentanyl group (Group F) at 10.47 ± 2.17 minutes, with a P value of 0.001. Intraoperative heart rate and mean arterial blood pressure were also significantly lower in Group D than in Group F. Visual analogue scale (VAS) pain scores were significantly lower in Group D compared to Group F upon arrival at the post-anesthesia care unit and at 2 hours postoperatively (P-value &lt; 0.05). Additionally, the morphine dose consumed in the first 12 hours after surgery was significantly lower in Group D (5.75 ± 2.20 mg) compared to Group F (8 ± 2.38 mg), with a P-value of 0.001. Conclusions: For morbidly obese patients undergoing laparoscopic sleeve gastrectomy, dexmedetomidine (DEX) proves to be an effective anesthetic choice. It not only reduces extubation time but also lowers early postoperative visual analogue scale (VAS) pain scores and opioid consumption within the first 12 hours following surgery.

Immediate cardiopulmonary responses to consecutive pulmonary embolism: a randomized, controlled, experimental study

BackgroundAcute pulmonary embolism (PE) induces ventilation-perfusion mismatch and hypoxia and increases pulmonary pressure and right ventricular (RV) afterload, entailing potentially fatal RV failure within a short timeframe. Cardiopulmonary factors may respond differently to increased clot burden. We aimed to elucidate immediate cardiopulmonary responses during successive PE episodes in a porcine model.MethodsThis was a randomized, controlled, blinded study of repeated measurements. Twelve pigs were randomly assigned to receive sham procedures or consecutive PEs every 15 min until doubling of mean pulmonary pressure. Cardiopulmonary assessments were conducted at 1, 2, 5, and 13 min after each PE using pressure-volume loops, invasive pressures, and arterial and mixed venous blood gas analyses. ANOVA and mixed-model statistical analyses were applied.ResultsPulmonary pressures increased after the initial PE administration (p < 0.0001), with a higher pulmonary pressure change compared to pressure change observed after the following PEs. Conversely, RV arterial elastance and pulmonary vascular resistance was not increased after the first PE, but after three PEs an increase was observed (p = 0.0103 and p = 0.0015, respectively). RV dilatation occurred following initial PEs, while RV ejection fraction declined after the third PE (p = 0.004). RV coupling exhibited a decreasing trend from the first PE (p = 0.095), despite increased mechanical work (p = 0.003). Ventilatory variables displayed more incremental changes with successive PEs.ConclusionIn an experimental model of consecutive PE, RV afterload elevation and dysfunction manifested after the third PE, in contrast to pulmonary pressure that increased after the first PE. Ventilatory variables exhibited a more direct association with clot burden.

Comparison of channelled with non-channelled blade of King Vision videolaryngoscope for orotracheal intubation in patients undergoing emergency surgery: A randomised double blind study

BackgroundPatients undergoing emergency surgery can have both anatomical and physiological difficult airways. There being no consensus on the best strategy to secure such airways, hence the present study evaluated the clinical performance of the two blades of King Vision™ Videolaryngoscope (KVVL). MethodsThis prospective double blind study was done on fifty two patients of 18–80 years aged posted for emergency surgery under general anaesthesia (GA). Patients were randomly assigned to channelled (CH) and non-channelled (NC) group for intubation. The primary outcome was time to tracheal intubation with CH and NC blades. The secondary outcomes among the two groups noted were ease of videolaryngoscope (VL) blade insertion, time to optimal laryngeal view, fremantle score, number of intubation attempts, any manoeuver required to intubate and complications. Haemodynamic parameters were noted before induction, during preoxygenation before laryngoscopy and 5 min after endotracheal intubation. ResultsSignificant shorter time to intubation was noted in NC group (18s) compared with CH group (25s). The NC blade was easier to insert and the time to optimal laryngeal view was also shorter with NC group (7s) as compared to CH group (10s). Fremantle score was comparable among the two groups. Endotracheal tube (ETT) impingment on arytenoids was more common with NC blade. For intubation with CH blade, anticlockwise rotation of ETT was frequently required. ConclusionThe NC blade of KVVL was easier to introduce and resulted in faster intubation, thus favouring its use in patients undergoing emergency surgery under GA. The CH blade of KVVL required anticlockwise rotation to facilitate intubation.

In the article “Double blind randomized placebocontrolled study of the efficacy and safety of proroxan in the complex therapy of generalized anxiety disorder”

In the article “Double blind randomized placebocontrolled study of the efficacy and safety of proroxan in the complex therapy of generalized anxiety disorder”

Long-Term Effect of Home Blood Pressure Self-Monitoring Plus Medication Self-Titration for Patients With Hypertension

Patient empowerment through pharmacologic self-management is a common strategy for some chronic diseases such as diabetes, but it is rarely used for controlling blood pressure (BP). Several trials have shown its potential for reducing BP in the short term, but evidence in the longer term is scarce. To evaluate the longer-term effectiveness of BP self-monitoring plus self-titration of antihypertensive medication vs usual care for patients with poorly controlled hypertension, with passive follow-up and primary-care nursing involvement. The ADAMPA (Impact of Self-Monitoring of Blood Pressure and Self-Titration of Medication in the Control of Hypertension) study was a randomized, unblinded clinical trial with 2 parallel arms conducted in Valencia, Spain. Included participants were patients 40 years or older, with systolic BP (SBP) over 145 mm Hg and/or diastolic BP (DBP) over 90 mm Hg, recruited from July 21, 2017, to June 30, 2018 (study completion, August 25, 2020). Statistical analysis was conducted on an intention-to-treat basis from August 2022 to February 2024. Participants were randomized 1:1 to usual care vs an individualized, prearranged plan based on BP self-monitoring plus medication self-titration. The main outome was the adjusted mean difference (AMD) in SBP between groups at 24 months of follow-up. Secondary outcomes were the AMD in DBP between groups at 24 months of follow-up, proportion of patients reaching the BP target (SBP <140 mm Hg and DBP <90 mm Hg), change in behaviors, quality of life, health service use, and adverse events. Among 312 patients included in main trial, data on BP measurements at 24 months were available for 219 patients (111 in the intervention group and 108 in the control group). The mean (SD) age was 64.3 (10.1) years, and 120 patients (54.8%) were female; the mean (SD) SBP was 155.6 (13.1) mm Hg, and the mean (SD) diastolic BP was 90.8 (7.7) mm Hg. The median follow-up was 23.8 months (IQR, 19.8-24.5 months). The AMD in SBP at the end of follow-up was -3.4 mm Hg (95% CI, -4.7 to -2.1 mm Hg; P < .001), and the AMD in DBP was -2.5 mm Hg (95% CI, -3.5 to -1.6 mm Hg; P < .001). Subgroup analysis for the main outcome showed consistent results. Sensitivity analyses confirmed the robustness of the main findings. No differences were observed between groups in behaviors, quality of life, use of health services, or adverse events. In this secondary analysis of a randomized clinical trial, BP self-monitoring plus self-titration of antihypertensive medication based on an individualized prearranged plan used in primary care reduced BP in the longer term with passive follow-up compared with usual care, without increasing health care use or adverse events. These results suggest that simple, inexpensive, and easy-to-implement self-management interventions have the potential to improve the long-term control of hypertension in routine clinical practice. ClinicalTrials.gov Identifier: NCT03242785.

Safety, tolerability, and pharmacokinetics of a single orally inhaled dose of PUR3100, a dry powder formulation of dihydroergotamine versus intravenous dihydroergotamine: A Phase 1 randomized, double-blind study in healthy adults.

Intravenous dihydroergotamine (DHE) has well-established efficacy for the acute treatment of migraine, but its use is limited by the need for in-hospital administration and the nausea/vomiting associated with a high maximum plasma concentration (Cmax). Inhalation is an alternative to intravenous dosing. The surface area of the lung allows for rapid absorption of a self-administered dose. This study evaluated the safety, tolerability, and systemic pharmacokinetics (PK) of a dry powder formulation (PUR3100) DHE when delivered via inhalation compared to intravenous delivery. In this double-blind, double-dummy Phase 1 study, healthy volunteers (N = 26) were randomized (1:1:1:1) to one of four groups: orally inhaled placebo plus intravenous DHE 1.0 mg or orally inhaled PUR3100 (0.5, 1.0, or 1.5 mg) plus intravenous placebo. Blood samples were drawn pre-dose and at time points post-dose over 48 h. Standard PK and safety parameters were assessed and values for Cmax and area under plasma concentration time curve (AUC) were used to assess comparative exposures of PUR3100 versus intravenous DHE. All doses of PUR3100 were associated with a lower incidence of nausea (21% vs. 86%), vomiting (0% vs. 29%), and headache (16% vs. 57%) compared to intravenous DHE. The PK profile of PUR3100 versus intravenous DHE was characterized by a similar mean time to Cmax (5 vs. 5.5 min), with reduced AUC0-2h (1120-4320 vs. 6340), and a lower Cmax (3620-14,400 vs. 45,000). Compared to intravenous DHE 1.0 mg, the highest nominal PUR3100 dose (1.5 mg), which delivers a fine-particle dose of approximately 0.9 mg to the lungs, had a geometric mean ratio percentage (90% confidence interval [CI]) for Cmax of 32% [17.2, 59.6] and AUC0-inf of 93% (62.9, 138.5), the latter of which was not significantly different. Inhaled PUR3100 is associated with rapid systemic PK within the therapeutic window and an improved safety profile relative to intravenous DHE.

A rapid host-protein test for differentiating bacterial from viral infection: Apollo diagnostic accuracy study.

To determine the diagnostic accuracy of a rapid host-protein test for differentiating bacterial from viral infections in patients who presented to the emergency department (ED) or urgent care center (UCC). This was a prospective multicenter, blinded study. MeMed BV (MMBV), a test based on tumor necrosis factor-related apoptosis-inducing ligand (TRAIL), interferon gamma-inducible protein-10 (IP-10), and C-reactive protein (CRP), was measured using a rapid measurement platform. Patients were enrolled from 9 EDs and 3 UCCs in the United States and Israel. Patients>3 months of age presenting with fever and clinical suspicion of acute infection were considered eligible. MMBV results were not provided to the treating clinician. MMBV results (bacterial/viral/equivocal) were compared against a reference standard method for classification of infection etiology determined by expert panel adjudication. Experts were blinded to MMBV results. They were provided with comprehensive patient data, including laboratory, microbiological, radiological and follow-up. Of 563 adults and children enrolled, 476 comprised the study population (314 adults, 162 children). The predominant clinical syndrome was respiratory tract infection (60.5% upper, 11.3% lower). MMBV demonstrated sensitivity of 90.0% (95% confidence interval [CI]: 80.3-99.7), specificity of 92.8% (90.0%-95.5%), and negative predictive value of 98.8% (96.8%-99.6%) for bacterial infections. Only 7.2% of cases yielded equivocal MMBV scores. Area under the curve for MMBV was 0.95 (0.90-0.99). MMBV had a high sensitivity and specificity relative to reference standard for differentiating bacterial from viral infections. Future implementation of MMBV for patients with suspected acute infections could potentially aid with appropriate antibiotic decision-making.