1.Addendum: Improved postoperative recovery profile in pediatric oral rehabilitation with low-dose dexmedetomidine as an opioid substitute for general anesthesia: a randomized double-blind clinical trial
Naik B NAVEEN ; Manoj Kumar JAISWAL ; Venkata GANESH ; Ajay SINGH ; Shyam Charan MEENA ; Vamsidhar AMBURU ; Shiv Lal SONI
Journal of Dental Anesthesia and Pain Medicine 2023;23(1):53-
2.Comparison of Intraoperative Low-Dose Ketodex and Fentanyl Infusion for Postoperative Analgesia In Spine Surgery: A Prospective Randomized Double-Blind Study
Priya THAPPA ; Nidhi SINGH ; Ankur LUTHRA ; Pruthviraj DESHPANDE ; Rajeev CHAUHAN ; Shyam C. MEENA ; Vishal KUMAR ; Navneet SINGLA
Asian Spine Journal 2023;17(5):894-903
Methods:
The study included 60 patients graded American Society of Anesthesiologists I and II and scheduled for thoracolumbar spine surgery involving >3 vertebral levels. The patients were divided into two groups: group KD (ketodex) and group F (fentanyl). The primary objective was to compare the postoperative analgesic requirements among the groups. The secondary objectives included a comparison of the intraoperative anesthetic requirements, postoperative pain scores, hemodynamic parameters, side effects of the study drugs, and the duration of post-anesthesia care unit stay of both the groups.
Results:
Ketodex use prolonged the mean time to first rescue analgesia (22.00±2.30 hours vs. 11.69±3.02 hours, p <0.001) and reduced the requirement of rescue analgesics in the first 24 hours postoperatively compared to fentanyl use (70.00±8.16 μg vs. 113.31±36.65 μg, p =0.03). The intraoperative requirement of desflurane was comparable between the groups (p >0.05). The postoperative pain scores were significantly lower in the group KD than in group F at most timepoints (p <0.05). Patients in group KD had a shorter post-anesthesia care unit stay than group F did (p <0.001).
Conclusions
Low-dose ketodex could be a safe substitute for fentanyl infusion when employed as an anesthetic adjuvant for patients undergoing thoracolumbar spine surgeries involving >3 vertebral levels to achieve prolonged analgesia without any opioidrelated side effects.
3.No difference in outcomes with 15 mm vs. 20 mm lumen-apposing metal stents for endoscopic ultrasound-guided gastroenterostomy for gastric outlet obstruction: a meta-analysis
Shyam VEDANTAM ; Rahil SHAH ; Sean BHALLA ; Shria KUMAR ; Sunil AMIN
Clinical Endoscopy 2023;56(3):298-307
Background/Aims:
We compared outcomes between use of 15 vs. 20 mm lumen-apposing metal stents (LAMSs) in endoscopic ultrasound-guided gastroenterostomy (EUS-GE) for gastric outlet obstruction.
Methods:
Databases were queried for studies that used LAMS for EUS-GE to relieve gastric outlet obstruction, and a proportional meta-analysis was performed.
Results:
Thirteen studies were included. The 15 mm and 20 mm LAMS had pooled technical success rates of 93.2% (95% confidence interval [CI], 90.5%–95.2%) and 92.1% (95% CI, 68.4%–98.4%), clinical success rates of 88.6% (95% CI, 85.4%–91.1%) and 89.6% (95% CI, 79.0%–95.1%), adverse event rates of 11.4% (95% CI, 8.1%–15.9%) and 14.7% (95% CI, 4.4%–39.1%), and reintervention rates of 10.3% (95% CI, 6.7%–15.4%) and 3.5% (95% CI, 1.6%–7.6%), respectively. Subgroup analysis revealed no significant differences in technical success, clinical success, or adverse event rates. An increased need for reintervention was noted in the 15 mm stent group (pooled odds ratio, 3.59; 95% CI, 1.40–9.18; p=0.008).
Conclusions
No differences were observed in the technical, clinical, or adverse event rates between 15 and 20 mm LAMS use in EUS-GE. An increased need for reintervention is possible when using a 15 mm stent compared to when using a 20 mm stent.
4.Borderzone Infarcts and Recurrent Cerebrovascular Events in Symptomatic Intracranial Arterial Stenosis: A Systematic Review and Meta-Analysis
Saurav DAS ; Liqi SHU ; Rebecca J. MORGAN ; Asghar SHAH ; Fayez H. FAYAD ; Eric D. GOLDSTEIN ; Dalia CHAHIEN ; Benton MAGLINGER ; Satish Kumar BOKKA ; Cory OWENS ; Mehdi ABBASI ; Alexandra KVERNLAND ; James E. SIEGLER ; Brian Mac GRORY ; Thanh N. NGUYEN ; Karen FURIE ; Pooja KHATRI ; Eva MISTRY ; Shyam PRABHAKARAN ; David S. LIEBESKIND ; Jose G. ROMANO ; Adam de HAVENON ; Lina PALAIODIMOU ; Georgios TSIVGOULIS ; Shadi YAGHI
Journal of Stroke 2023;25(2):223-232
Background:
and Purpose Intracranial arterial stenosis (ICAS)-related stroke occurs due to three primary mechanisms with distinct infarct patterns: (1) borderzone infarcts (BZI) due to impaired distal perfusion, (2) territorial infarcts due to distal plaque/thrombus embolization, and (3) plaque progression occluding perforators. The objective of the systematic review is to determine whether BZI secondary to ICAS is associated with a higher risk of recurrent stroke or neurological deterioration.
Methods:
As part of this registered systematic review (CRD42021265230), a comprehensive search was performed to identify relevant papers and conference abstracts (with ≥20 patients) reporting initial infarct patterns and recurrence rates in patients with symptomatic ICAS. Subgroup analyses were performed for studies including any BZI versus isolated BZI and those excluding posterior circulation stroke. The study outcome included neurological deterioration or recurrent stroke during follow-up. For all outcome events, corresponding risk ratios (RRs) and 95% confidence intervals (95% CI) were calculated.
Results:
A literature search yielded 4,478 records with 32 selected during the title/abstract triage for full text; 11 met inclusion criteria and 8 studies were included in the analysis (n=1,219 patients; 341 with BZI). The meta-analysis demonstrated that the RR of outcome in the BZI group compared to the no BZI group was 2.10 (95% CI 1.52–2.90). Limiting the analysis to studies including any BZI, the RR was 2.10 (95% CI 1.38–3.18). For isolated BZI, RR was 2.59 (95% CI 1.24–5.41). RR was 2.96 (95% CI 1.71–5.12) for studies only including anterior circulation stroke patients.
Conclusion
This systematic review and meta-analysis suggests that the presence of BZI secondary to ICAS may be an imaging biomarker that predicts neurological deterioration and/or stroke recurrence.
5.Guillain-Barré syndrome associated with SARS-CoV-2 vaccination: how is it different? a systematic review and individual participant data meta-analysis
Yerasu Muralidhar REDDY ; Jagarlapudi MK MURTHY ; Syed OSMAN ; Shyam Kumar JAISWAL ; Abhinay Kumar GATTU ; Lalitha PIDAPARTHI ; Santosh Kumar BOORGU ; Roshan CHAVAN ; Bharadwaj RAMAKRISHNAN ; Sreekanth Reddy YEDUGURI
Clinical and Experimental Vaccine Research 2023;12(2):143-155
Purpose:
An association between Guillain-Barré syndrome (GBS) and severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) vaccination has been reported. We aimed to summarize the clinical features of GBS associated with SARS-CoV-2 vaccination and determine the contrasting features from coronavirus disease-19 (COVID-19) associated GBS and GBS following other causes.
Materials and Methods:
We performed PubMed search for articles published between 1 December 2020 and 27 January 2022 using search terms related to “SARS-CoV-2 vaccination” and “GBS”. Reference searching of the eligible studies was performed. Sociodemographic and vaccination data, clinical and laboratory features, and outcomes were extracted. We compared these findings with post-COVID-19 GBS and International GBS Outcome Study (IGOS) (GBS from other causes) cohorts.
Results:
We included 100 patients in the analysis. Mean age was 56.88 years, and 53% were males. Six-eight received non-replicating virus vector and 30 took messenger RNA (mRNA) vaccines. The median interval between the vaccination and the GBS onset was 11 days. Limb weakness, facial palsy, sensory symptoms, dysautonomia, and respiratory insufficiency were seen in 78.65%, 53.3%, 77.4%, 23.5%, and 25%, respectively. The commonest clinical and electrodiagnostic subtype were sensory-motor variant (68%) and acute inflammatory demyelinating polyneuropathy (61.4%), respectively. And 43.9% had poor outcome (GBS outcome score ≥3). Pain was common with virus vector than mRNA vaccine, and the latter had severe disease at presentation (Hughes grade ≥3). Sensory phenomenon and facial weakness were common in vaccination cohort than post-COVID-19 and IGOS.
Conclusion
There are distinct differences between GBS associated with SARS-CoV-2 vaccination and GBS due to other causes. Facial weakness and sensory symptoms were commonly seen in the former and outcomes poor.
6.Improved postoperative recovery profile in pediatric oral rehabilitation with low-dose dexmedetomidine as an opioid substitute for general anesthesia:a randomized double-blind clinical trial
Naik B NAVEEN ; Manoj Kumar JAISWAL ; Venkata GANESH ; Ajay SINGH ; Shyam Charan MEENA ; Vamsidhar AMBURU ; Shiv Lal SONI
Journal of Dental Anesthesia and Pain Medicine 2022;22(5):357-367
Background:
Low-dose dexmedetomidine may be a suitable alternative to opioids for pediatric ambulatory procedures under general anesthesia (GA). However, the recovery profile remains unclear. Herein, we aimed to evaluate the effects of low-dose dexmedetomidine on the recovery profile of children.
Methods:
Seventy-two children undergoing ambulatory oral rehabilitation under GA were randomly and equally distributed into two groups (D and F). Group D received an infusion of dexmedetomidine 0.25 μg/kg for 4 min for induction, followed by maintenance of 0.4 μg/kg/h. Group F received an infusion of fentanyl 1 μg/kg over 4 min for induction, followed by maintenance at 1 μg/kg/h. The primary outcome was the extubation time. The secondary outcomes were awakening time, end-tidal sevoflurane (ET-Sevo) requirement, change in hemodynamic parameters, Richmond Agitation–Sedation Scale (RASS), Children's Hospital of Eastern Ontario pain scale (CHEOPS) score, length of PACU stay, and incidence of adverse events.
Results:
Statistically significant differences were observed in the recovery profile between the groups: the median time for extubation was 3.65 (3.44–6.2) vs. 6.25 (4.21–7) minutes in groups D vs. F (P=0.001), respectively, while the corresponding awakening times were 19 (18.75–21) and 22.5 (22–24) minutes, respectively (P < 0.001).The mean ET-Sevo was low in group D (1.1 vs. 1.2; P < 0.001). The heart rate was significantly low across all time points in group D, without resulting in bradycardia. The median RASS and CHEOPS scores were also significantly lower in group D. No significant differences were observed in the mean arterial pressure, incidence of adverse events, or length of PACU stay.
Conclusion
Low-dose dexmedetomidine was more effective than fentanyl as an opioid substitute at providing a better recovery profile in pediatric ambulatory oral rehabilitation under GA. Dexmedetomidine also significantly reduced sevoflurane consumption without causing adverse events or prolonging hospital stay.
7.Pharmaceutical amorphous solid dispersion: A review of manufacturing strategies.
Sonal V BHUJBAL ; Biplob MITRA ; Uday JAIN ; Yuchuan GONG ; Anjali AGRAWAL ; Shyam KARKI ; Lynne S TAYLOR ; Sumit KUMAR ; Qi TONY ZHOU
Acta Pharmaceutica Sinica B 2021;11(8):2505-2536
Amorphous solid dispersions (ASDs) are popular for enhancing the solubility and bioavailability of poorly water-soluble drugs. Various approaches have been employed to produce ASDs and novel techniques are emerging. This review provides an updated overview of manufacturing techniques for preparing ASDs. As physical stability is a critical quality attribute for ASD, the impact of formulation, equipment, and process variables, together with the downstream processing on physical stability of ASDs have been discussed. Selection strategies are proposed to identify suitable manufacturing methods, which may aid in the development of ASDs with satisfactory physical stability.
8.Influence of Epidural Ropivacaine with or without Dexmedetomidine on Postoperative Analgesia and Patient Satisfaction after Thoraco-Lumbar Spine Instrumentation: A Randomized, Comparative, and Double-Blind Study
Faisal QURESHI ; Shyam Charan MEENA ; Vishal KUMAR ; Kajal JAIN ; Rajeev CHAUHAN ; Ankur LUTHRA
Asian Spine Journal 2021;15(3):324-332
This was a prospective, randomized, and double-blind study. Thoraco-lumbar spine surgery is associated with severe postoperative pain and can cause chronic pain. We aimed to compare the impact of epidural ropivacaine with and without dexmedetomidine on postoperative analgesia after thoracolumbar spine instrumentation wherein an epidural catheter was placed by the surgeon intraoperatively. Very few studies have reported the use of epidural dexmedetomidine in spine surgeries. When used via the epidural route, dexmedetomidine is safe and efficacious and is associated with reduced rescue analgesia consumption, increased duration of analgesia, reduced pain scores, but not with major hemodynamic adverse effects. Total 60 American Society of Anesthesiologists I–III adult patients aged 18–65 years who were scheduled to undergo thoraco-lumbar spine instrumentation were randomly allocated into group RD (epidural ropivacaine+dexmedetomidine) or group R (epidural ropivacaine plus saline). We aimed to compare the total rescue analgesic consumption on postoperative day 0, 1, and 2. Moreover, we studied the time to first rescue analgesia with visual analogue scale score <4 and the overall patient satisfaction scores. There was no difference between the demographic characteristics of the two groups. The mean value of total rescue analgesia consumption was 162.5±68.4 mg in the RD group and 247.5±48.8 mg in the R group. The mean time to first rescue analgesia was 594.6±83.0 minutes in the RD group and 103.6±53.2 minutes in the R group. The mean patient satisfaction score was 4.2±0.7 in the RD group and 3.2±0.6 in the R group. No patient had any respiratory depression or prolonged motor blockade during the postoperative period. This study demonstrated the superior efficacy, in terms of postoperative analgesia and patient satisfaction scores, of epidural ropivacaine plus dexmedetomidine over that of ropivacaine alone in patients undergoing surgery for thoraco-lumbar spine.
9.Influence of Epidural Ropivacaine with or without Dexmedetomidine on Postoperative Analgesia and Patient Satisfaction after Thoraco-Lumbar Spine Instrumentation: A Randomized, Comparative, and Double-Blind Study
Faisal QURESHI ; Shyam Charan MEENA ; Vishal KUMAR ; Kajal JAIN ; Rajeev CHAUHAN ; Ankur LUTHRA
Asian Spine Journal 2021;15(3):324-332
This was a prospective, randomized, and double-blind study. Thoraco-lumbar spine surgery is associated with severe postoperative pain and can cause chronic pain. We aimed to compare the impact of epidural ropivacaine with and without dexmedetomidine on postoperative analgesia after thoracolumbar spine instrumentation wherein an epidural catheter was placed by the surgeon intraoperatively. Very few studies have reported the use of epidural dexmedetomidine in spine surgeries. When used via the epidural route, dexmedetomidine is safe and efficacious and is associated with reduced rescue analgesia consumption, increased duration of analgesia, reduced pain scores, but not with major hemodynamic adverse effects. Total 60 American Society of Anesthesiologists I–III adult patients aged 18–65 years who were scheduled to undergo thoraco-lumbar spine instrumentation were randomly allocated into group RD (epidural ropivacaine+dexmedetomidine) or group R (epidural ropivacaine plus saline). We aimed to compare the total rescue analgesic consumption on postoperative day 0, 1, and 2. Moreover, we studied the time to first rescue analgesia with visual analogue scale score <4 and the overall patient satisfaction scores. There was no difference between the demographic characteristics of the two groups. The mean value of total rescue analgesia consumption was 162.5±68.4 mg in the RD group and 247.5±48.8 mg in the R group. The mean time to first rescue analgesia was 594.6±83.0 minutes in the RD group and 103.6±53.2 minutes in the R group. The mean patient satisfaction score was 4.2±0.7 in the RD group and 3.2±0.6 in the R group. No patient had any respiratory depression or prolonged motor blockade during the postoperative period. This study demonstrated the superior efficacy, in terms of postoperative analgesia and patient satisfaction scores, of epidural ropivacaine plus dexmedetomidine over that of ropivacaine alone in patients undergoing surgery for thoraco-lumbar spine.
10.Nanotechnology in reproductive medicine: Opportunities for clinical translation
Ruchita SHANDILYA ; Neelam PATHAK ; Nirmal Kumar LOHIYA ; Radhey Shyam SHARMA ; Pradyumna Kumar MISHRA
Clinical and Experimental Reproductive Medicine 2020;47(4):245-262
In recent years, nanotechnology has revolutionized global healthcare and has been predicted to exert a remarkable effect on clinical medicine. In this context, the clinical use of nanomaterials for cancer diagnosis, fertility preservation, and the management of infertility and other pathologies linked to pubertal development, menopause, sexually transmitted infections, and HIV (human immunodeficiency virus) has substantial promise to fill the existing lacunae in reproductive healthcare. Of late, a number of clinical trials involving the use of nanoparticles for the early detection of reproductive tract infections and cancers, targeted drug delivery, and cellular therapeutics have been conducted. However, most of these trials of nanoengineering are still at a nascent stage, and better synergy between pharmaceutics, chemistry, and cutting-edge molecular sciences is needed for effective translation of these interventions from bench to bedside. To bridge the gap between translational outcome and product development, strategic partnerships with the insight and ability to anticipate challenges, as well as an in-depth understanding of the molecular pathways involved, are highly essential. Such amalgamations would overcome the regulatory gauntlet and technical hurdles, thereby facilitating the effective clinical translation of these nano-based tools and technologies. The present review comprehensively focuses on emerging applications of nanotechnology, which holds enormous promise for improved therapeutics and early diagnosis of various human reproductive tract diseases and conditions.

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