scholarly journals Comparative study of clinical efficacy and safety of intrathecal isobaric ropivacaine 0.75% with fentanyl versus isobaric ropivacaine 0.75% alone for caesarean

Author(s):  
Pushpal Gandhi ◽  
Mahendra Agrawal ◽  
Bhavika Agrawal ◽  
Simarn Behl

<p><strong>Background: </strong>Compare the clinical efficacy and safety of intrathecal isobaric ropivacaine 0.75% with fentanyl, 10 mcg vs isobaric ropivacaine 0.75% alone for caesarean section.</p><p><strong>Methods: </strong>Two hundred patients were considered eligible for the study of which one hundred and sixty-eight patients undergoing caesarean section under spinal anesthesia and were included in the study. Parturient to ASA physical status I-II scheduled for caesarean section were randomly selected for the study and are divided into group of 84 each.<strong></strong></p><p><strong>Results: </strong>There was significant difference in sensory block duration at T<sub>10</sub> (min) and total duration of analgesia (min) in both groups. This difference between two group’s was not significant. Adverse Effects in group RF 5 (5.9%) patients had hypotension and 2 (2.3%) bradycardias in group R 3 (3.5%) patient had hypotension.<strong></strong></p><p><strong>Conclusions: </strong>Hemodynamic parameters were comparable in both the groups. Total duration of analgesia and sensory block duration at T<sub>10</sub> was significantly shorter with ropivacaine (with saline) compared to ropivacaine with fentanyl.</p>

2021 ◽  
pp. 2021063
Author(s):  
Surabhi Dayal ◽  
Satbir Singh ◽  
Priyadarshini Sahu

Background: Both salicylic acid (SA) and trichloroacetic acid (TCA) have proven efficacy with goodsafety profiles in the treatment of acne vulgaris. Objectives: This study compared the clinical efficacy and safety of 25% TCA and 30% SA peels in thetreatment of mild and moderate acne vulgaris. Methods: Patients with mild or moderate acne vulgaris were randomized into 2 groups of 25 personseach, and treated with either the TCA peel or the SA peel at 2-week intervals for 12 weeks. Evaluationof active acne was done by individual lesion counts (comedones, papules and pustules) and calculationof the Michaelsson acne score (MAS). Results: Both peels led to significant decrease in individual lesion counts and MAS compared to baselinevalues, without significant differences between the treatment groups. Thus, the peels had equivalentefficacy against acne vulgaris. The TCA peel was better in treating non-inflammatory lesions,while the SA peel was better for inflammatory lesions, but the differences were not significant. Noserious adverse effects were recorded, but more patients in the TCA peel group experienced burningand stinging sensations. Conclusion: The efficacy of 25% TCA is comparable to that of 30% SA in mild-to-moderate acnevulgaris, but safety and tolerability were better with the SA peel than TCA peel.


Author(s):  
Shalini A. ◽  
Kokila N. ◽  
Manjunatha H. G. ◽  
Supriya L.

Background and objectives: Various intrathecal adjuvants have been clinically tried for the prolongation of intraoperative and postoperative analgesia. This study aims at evaluating the effects of intrathecal nalbuphine and clonidine as adjuvants to isobaric levobupivacaine in subarachnoid block. Methodology: 60 patients scheduled for elective infra umbilical surgeries were allocated into two groups of thirty each to receive 15 mg of 0.5% isobaric Levobupivacaine with either 1 mg nalbuphine (Group LN) or 30 µg clonidine (Group LC) intrathecally. Characteristics of spinal anesthesia in terms of sensory analgesia and motor blockade were noted. Hemodynamic parameters and adverse effects if any were recorded. Data obtained was compiled and statistically analysed with appropriate tests. Results: Onset of sensory and motor blocks was faster in group LN (2.43 ± 0.93 and 2.2 ± 0.9 min) compared to group LC (3.26 ± 1.04 and 3.13 ± 1.0 min). However, time to two segment regression (186.8 ± 24.5 vs 146.5 ± 21.4), total duration of effective analgesia (384.1 ± 56.6 vs 292.1 ± 40.9) and total duration of motor block (345.3 ± 41.7 vs 235.6 ± 29.5 min) were significantly prolonged in group LC than in group LN. There was no significant difference in hemodynamic changes and adverse effects between the groups. Conclusion: The addition of 30 µg clonidine to intrathecal 0.5% isobaric levobupivacaine as adjuvant, is associated with prolonged sensory and motor blockade with better perioperative analgesia compared to 1 mg nalbuphine. Citation: Shalini A, Kokila N, Manjunatha HG, Supriya L. Comparative study of intrathecal nalbuphine versus clonidine as adjuvants to 0.5% isobaric levobupivacaine for elective infra umbilical surgeries. Anaesth pain & intensive care 2019;23(4)__ Received: 21 August 2019, Reviewed:  13 September, 22 November 2019, Accepted: 26 November 2019


Author(s):  
Heena D. Pahuja ◽  
Megha P. Tajne ◽  
Anjali R. Bhure ◽  
Savita M. Chauhan

Background: Levobupivacaine has been purported to be as efficacious as Bupivacaine for epidural anaesthesia in recent literature.Methods: With the intent to study the same in caesarean section cases in our set up, we observed various intra- and post-operative variables in two groups (Levobupivacaine and Bupivacaine) of 60 healthy parturients. Sixty parturients for elective caesarean section were allocated randomly to receive epidural block with 10-20 ml of either 0.5% Levobupivacaine with Fentanyl 25µg or 0.5% Bupivacaine with Fentanyl 25µg to reach T6 level.Results: Mean total volume in Bupivacaine group was 15.23ml and in Levobupivacaine group was 12.76 ml. The difference was statistically significant. There was significant difference between the groups in the sensory block. The onset of analgesia was earlier in Levobupivacaine group. Mean time was 6.20 minutes in Bupivacaine group and 4.36 minutes in Levobupivacaine group. The duration of motor block was significantly short in Levobupivacaine group. Mean Time for recovery from motor block in Bupivacaine group was 2.5 hours and in Levobupivacaine group 1.5 hours. Mean time to achieve T6 height was earlier in Levobupivacaine group i.e. 16.46 minutes in Bupivacaine group and 13.26 minutes in Levobupivacaine group. Duration of postoperative analgesia was similar. There was no significant difference in neonatal outcome.Conclusions: Levobupivacaine was found to fare better than Bupivacaine in the studied intra and post-operative parameters and is hence recommended over racemic Bupivacaine for epidural block in patients undergoing elective cesarean section.


Author(s):  
Ying Zhang ◽  
Xu Hao ◽  
Kelu Hou ◽  
Lei Hu ◽  
Jingyuan Shang ◽  
...  

Aims: To assess the impact of cytochrome P450 (CYP) 2C19 polymorphisms on the clinical efficacy and safety of voriconazole. Methods: We systematically searched PubMed, EMBASE, CENTRAL, ClinicalTrials.gov, and three Chinese databases from their inception to March 18, 2021 using a predefined search algorithm to identify relevant studies. Studies that reported voriconazole-treated patients and information on CYP2C19 polymorphisms were included. The efficacy outcome was success rate. The safety outcomes included overall adverse events, hepatotoxicity and neurotoxicity. Results: A total of 20 studies were included. Intermediate metabolizers (IMs) and Poor metabolizers (PMs) were associated with increased success rates compared with normal metabolizers (NMs) (risk ratio (RR): 1.18, 95% confidence interval (CI): 1.03~1.34, I2=0%, p=0.02; RR: 1.28, 95%CI: 1.06~1.54, I2=0%, p=0.01). PMs were at increased risk of overall adverse events in comparison with NMs and IMs (RR: 2.18, 95%CI: 1.35~3.53, I2=0%, p=0.001; RR: 1.80, 95% CI: 1.23~2.64, I2=0%, p=0.003). PMs demonstrated a trend towards an increased incidence of hepatotoxicity when compared with NMs (RR: 1.60, 95%CI: 0.94~2.74, I2=27%, p=0.08), although there was no statistically significant difference. In addition, there was no significant association between CYP2C19 polymorphisms and neurotoxicity. Conclusions: IMs and PMs were at a significant higher success rate in comparison with NMs. PMs were significantly associated with an increased incidence of all adverse events compared with NMs and IMs. Researches are expected to further confirm these findings. Additionally, the relationship between hepatotoxicity and CYP2C19 polymorphisms deservers clinical attention.


Author(s):  
Anjali R. Kanada ◽  
Mahima Jain

Background: In cervical ripening, before induction of labour, is needed to increase the success of labour induction, to reduce complications and to diminish the rate of caesarean section and duration of labour. Pharmacological preparations are in widespread use for cervical ripening but are not free from side-effects and complications. Mechanical methods, i.e. the use of Foley’s catheter balloon, though effective have not gained much popularity because of the fear of infection. Therefore, the study has been conducted to prove the efficacy and safety of extra amniotic Foley catheter balloon and to compare it with intra-cervical prostaglandin E2 (PGE2) gel. The objective of the study was to the success of induction of labor depends on the cervical status at the time of induction. For effective cervical ripening both Foley's catheter and PGE2 gel are used. The aim of this study was to compare the efficacy of intra cervical Foley's catheter and intra cervical PGE2 gel in cervical ripening for the successful induction of labor.Methods: A randomized, comparative study was conducted in the department of obstetrics and gynaecology, Civil hospital, B.J. Medical College Ahmedabad, during a period of 8 month from September 2018 to April 2019. 100 patients at term with a Bishop's score ≤5 with various indications for induction were randomly allocated to group F (intra-cervical Foley’s catheter) and group P (PGE2 gel) with 50 women included in each group.Results: The groups were comparable with respect to maternal age, gestation age, indication of induction and initial Bishop's score. Both the groups showed significant change in the Bishop's score, 5.10±1.55 and 5.14±1.60 for Foley's catheter and PGE2 gel, respectively, p <0.001. However there was no significant difference between the two groups. There was no significant difference in the side effects and caesarean section rate in both groups. The induction to delivery interval was 16.01±5.50 hours in group F and 16.85 ± 3.81 hours in group P (p=0.073). Apgar scores, birth weights and NICU admissions showed no significant difference between the two groups.Conclusions: The study shows that both Foley's catheter and PGE2 gel are equally effective in pre induction cervical ripening.


Blood ◽  
2008 ◽  
Vol 112 (11) ◽  
pp. 2269-2269
Author(s):  
Catherine J Rea ◽  
Alex Dunkerley ◽  
Benny Sorensen ◽  
Savita Rangarajan

Abstract Introduction: Treatment with B-domain deleted recombinant factor VIII (BDD-rFVIII) has proven to be effective and safe both in clinical trials and post marketing surveillance studies. However, intermittent concerns have been raised regarding the pharmacokinetic performance, efficacy and incidence of inhibitor formation with the BDD-rFVIII product. Aims: The objective of the present study was to perform a retrospective survey of half-life measurements, clinical efficacy and safety in patients with severe Haemophilia A, when switching treatment from full-length FVIII (FL-FVIII) to BDD- rFVIII and then back to full-length FVIII. We hypothesized that the biological half-life of FVIII would be equal regardless of the product used. Furthermore, we hypothesized that the total factor consumption and bleeding frequency would be indistinguishable irrespective of product used. Finally, we report on safety as evaluated by development of inhibitors and clinical outcome following surgery. Methods: Patients treated with BDD-rFVIII (between 1998 and 2008) were identified from an in-house database. Data collected included annual half-life (T/2) and recovery times (K values), total coagulation factor consumption, and number of bleeds per year as measures of clinical efficacy. Safety data consisted of surgical outcome data and incidence of inhibitor formation. The information was extracted from electronic databases and verified by a review of patients’ clinical notes. The outcome data was non-parametric, hence, paired analysis was performed using Wilcoxon signed rank test and Friedman ANOVA. Data is given as a median value and range. P-value &lt; 0.05 was set as level of statistical significance. Results: In total, 70 patients received BDD-rFVIII on at least one occasion. Following a specified list of criteria, evaluable data was obtainable for 15 males, all with verified severe Haemophilia A (FVIII:C &lt;1%). The average age was 10.2 years (median 10, range 4–17). The median duration on BDD-rFVIII was 30 months (range 20–54). Using the one-way non-parametric ANOVA, no statistically significant difference was detected between the half-life and recovery times recorded during the switch from FL-FVIII (T/2 median 9.15 hours, range 6.4–22; K median 2.7, range 2.0–3.4) to BDD-rFVIII (T/2 median 9.7, range 4.7–16.8; K median 1.8, range 1.0–3.5) and back to FL-FVIII (T/2 median 9.0, range 5.0–19.5; K median 2.0, range 1.6–2.8). Furthermore, there was no significant difference in coagulation factor usage (BDD-rFVIII median 4803 iu/kg/year, range 659–11304; FL-FVIII median 5349, range 1691–10146), nor number of reported bleeds (BDDrFVIII median 6, range 0–24; FL-FVIII median 5.0, range 0–17). None of the 15 patients developed an inhibitor on BDD-rFVIII. Of the total 70 patients, 11 received BDD-rFVIII to cover surgical procedures (8 minor, 3 major interventions). There were no reports of excess bleeding. Conclusions: In this retrospective survey, BDD-rFVIII was found to be equivalent to other FVIII products in terms of half-life measurements, clinical efficacy and safety.


2017 ◽  
Vol 35 (15_suppl) ◽  
pp. e15632-e15632
Author(s):  
Lakshmi Manogna Chintalacheruvu ◽  
Avanija Buddam ◽  
Arun Kanmanthareddy ◽  
Apar Kishor Ganti

e15632 Background:Conventional chemotherapy has limited role in metastatic unresectable hepatocellular carcinoma (HCC). Sorafenib is currently approved for metastatic unresectable HCC. We wanted to assess the efficacy and safety of other tyrosine kinase inhibitors (TKI) targeting vascular endothelial growth factor (VEGF) receptor such as brivanib, linifanib and regorafenib in metastatic HCC. Methods: We have searched electronic databases Pubmed, Google scholar to identify published trials using brivanib, linifanib and regorafenib in HCC. The outcomes evaluated were overall survival, time to disease progression (TTDP) and adverse effects. Hazard ratios (HR) with their respective 95% confidence intervals (CI) were then computed using the appropriate model for categorical variables. We used STATA 13.0 and Comprehensive Meta Analysis 2.0 software for all analyses. Results: We included seven randomized control studies. A combined analysis of these seven randomised control trials showed improved overall survival (OS) in VEGF-TKI group when compared to placebo HR - 0.79; (95% CI 0.62-1.00). However, there was no significant survival benefit of the newer VEGF receptor inhibitors when compared to sorafenib (HR - 1.05; 95% CI 0.95-1.17). The time to disease progression (TTDP) was significantly better in VEGF-TKI group as compared to placebo (HR - 0.61; 95% CI 0.39-0.97). However, there was no significant difference in TTDP between VEGF-TKI group and Sorafenib (HR - 0.88; 95% CI 0.66-1.16). Adverse effects were noted to be higher in VEGF-TKI group when compared to placebo (HR- 1.07; 95% CI 1.01-1.13). Conclusions: Treatment with TKI targeting VEGF receptor is associated with a significant improvement in OS and TTDP with tolerable side effect profile. Inhibiting the VEGF receptor pathway could lead to improved outcomes in HCC.


1996 ◽  
Vol 11 (S3) ◽  
pp. 141s-143s ◽  
Author(s):  
E Smeraldi ◽  
E Haefele ◽  
G Crespi ◽  
GL Casadei ◽  
F Biondi ◽  
...  

SummaryThe efficacy and safety of low doses of amisulpride (50 mg/day) and of fluoxetine (20 mg/day) were compared respectively in 139 and 129 outpatients with dysthymia during three months in a multi-centre double-blind trial. No statistically significant difference between the two groups was found in the number of responders at study-end with the Montgomery and Asberg Depressive Rating Scale, which was the main criterion for efficacy. In addition, amisulpride was well tolerated. These preliminary results suggest that low doses of amisulpride may be effective in the treatment of dysthymic patients.


Author(s):  
Anuradha Dubey ◽  
Hanmant Amane

Background: Acne vulgaris is characterised by comedones, papules, pustules and nodules occurring in a sebaceous distribution. Topical treatments, such as adapalene and benzoyl peroxide, are popular in mild to moderate acne vulgaris. This study was aimed to compare the efficacy and safety of adapalene with benzoyl peroxide in the patients of mild to moderate acne vulgaris.Methods: We planned a randomized, open-labelled, prospective study to compare the efficacy and side effects of adapalene and benzoyl peroxide in acne patients. A total of 100 patients with mild to moderate acne vulgaris were included in the study. They were randomly divided into 2 groups with 50 patients in each group. One group was given 0.1% adapalene gel and the other group received 2.5% benzoyl peroxide gel. Efficacy was assessed as reduction in the lesion counts, whereas for safety, the side effects like dryness, burning, irritation, erythema were recorded during the treatment. Total duration of the study was 3 months.Results: The study revealed that adapalene was more effective than benzoyl peroxide in treating non-inflammatory and inflammatory lesions of acne vulgaris, and there was a statistically significant difference found between the groups (p≤0.05) in efficacy. Adapalene was also found to be comparatively safer than benzoyl peroxide because the patients treated with adapalene had lesser side effects than those treated with benzoyl peroxide.Conclusions: Our study concludes a better efficacy and safety of adapalene than benzoyl peroxide in the treatment of mild to moderate acne vulgaris.


Sign in / Sign up

Export Citation Format

Share Document