Comparison of the effects of intravenous propofol and propofol with low-dose ketamine on preventing postextubation cough and laryngospasm among patients awakening from general anaesthesia: A prospective randomised clinical trial

2020 ◽  
pp. 175045892091263
Author(s):  
Yanipan Chungsamarnyart ◽  
Jiranun Pairart ◽  
Sithapan Munjupong
Keyword(s):  
Clinical Trial ◽  
General Anaesthesia ◽  
Low Dose ◽  
Randomised Clinical Trial ◽  
Control Group ◽  
Significant Difference ◽  
Comparison Groups

Background Coughing and laryngospasm are undesirable consequences occurring when patients awaken from general anaesthesia. The objective of the study aimed to compare the effects of intravenous propofol and propofol with low-dose ketamine on preventing postextubation cough and laryngospasm. Methods In all, 120 patients scheduled surgery under general anaesthesia were randomly assigned into three groups. Patients in the control group (C-group) obtained intravenous 0.9% NaCl, while patients in the propofol group (P-group) obtained intravenous 0.25mg/kg propofol and patients in the propofol combined with ketamine group (PK-group) obtained intravenous 0.25mg/kg of propofol plus 0.15mg/kg of ketamine. Drugs were administered before extubation. Incidence and severity of coughing and laryngospasm were recorded by a blinded anaesthesiologist. Results Subjects of the PK-group (25%) experienced significantly reduced incidence of postoperative cough than that in the P-group (55%) and C-group (72.5%) (all P < 0.05). The severity of cough in the PK-group was significantly less than that in the P-group and C-group (P = 0.039 and P < 0.001, respectively). No significant difference was found in the incidence and severity of laryngospasm between comparison groups. Conclusion Intravenous combination of propofol and low-dose ketamine significantly reduced the incidence and severity among patients awakening from general anaesthesia.

scholarly journals Efektivitas desloratadin terhadap skor gejala hidung total dan kadar interleukin-4 sekret hidung rinitis alergi

2018 ◽  
Vol 48 (1) ◽  
pp. 56
Author(s):  
Luh Putu Dhena Purwaningsih ◽  
Dwi Reno Pawarti ◽  
Bakti Surarso
Keyword(s):  
Clinical Trial ◽  
Atopic Disease ◽  
Randomised Clinical Trial ◽  
Current Treatment ◽  
Nasal Symptom ◽  
Nasal Secretion ◽  
Interleukin 4 ◽  
Control Group ◽  
Double Blind ◽  
Significant Difference

Latar belakang: Rinitis alergi (RA) adalah penyakit atopi yang umum terjadi, namun terapi yangtersedia mempunyai keterbatasan baik dalam penggunaan maupun angka keberhasilan. Desloratadinberperan sebagai terapi alternatif RA yang dapat menghilangkan keseluruhan gejala RA dan menurunkankadar interleukin-4 (IL-4) sekret hidung. Tujuan: Menganalisis efektivitas desloratadin dibandingkandengan loratadin dalam menurunkan skor gejala hidung total dan IL-4 sekret hidung pada penderita RA.Metode: Merupakan double blind randomised clinical trial with pre-post test design. Analisis data denganindependent sample t-test. Sebanyak 24 penderita RA dibagi menjadi 2 kelompok terapi yaitu kelompokstudi (desloratadin), dan kelompok kontrol (loratadin). Evaluasi berdasarkan skor gejala hidung total danIL-4 sekret hidung, pra dan pasca 15 hari terapi. Hasil: Penelitian yang dilakukan sejak bulan Juli sampaiOktober 2016 menunjukkan hasil berupa perbedaan bermakna rerata persentase penurunan skor gejalahidung total kelompok desloratadin dibandingkan kelompok loratadin (p=0,000). Perbandingan penurunankadar IL-4 sekret hidung antara kelompok desloratadin dengan loratadin adalah berbeda tidak bermakna(p=0,236). Kesimpulan: Penurunan skor gejala hidung total desloratadin lebih besar dibandingkan denganloratadin, dan tidak didapatkan perbedaan penurunan pada kadar IL-4 sekret hidung. ABSTRACTBackground: Allergic rhinitis (AR) is a common atopic disease but its current treatment is limitedboth in usage, as well as in the success rate. Desloratadine is an alternative choice in the treatment ofAR, and it could reduce the Interleukin (IL-4) nasal secretion level. Purpose: To assess the effectivenessof desloratadine compared to loratadine in decreasing total nasal symptom score (TNSS) and levels ofIL-4 nasal secretions in AR patients. Method: A double blind randomized clinical trial (RCT). Twentyfour AR patients were divided into two treatment groups: study group (desloratadin) and control group(loratadine). Evaluation was based on TNSS and IL-4 nasal secretion level pre and post 15 days oftreatment. Result: Conducted from July to October 2016, this study showed the mean of TNSS reductionpercentage between desloratadine group compared to loratadine group was significant (p=0.000).The comparison of reduction of IL-4 nasal secretion level between desloratadine group and loratadinegroup was not significantly different (p=0.236). Conclusion: The TNSS decreased more in desloratadinecompared to loratadine, but there was no significant difference between both groups in the levels of IL-4nasal secretions

Beneficial effects of pelvic floor muscle exercises on sexual function among postmenopausal women: a randomised clinical trial

Sexual Health ◽  
2018 ◽  
Vol 15 (5) ◽  
pp. 396 ◽  
Author(s):  
Soheila Nazarpour ◽  
Masoumeh Simbar ◽  
Hamid Alavi Majd ◽  
Fahimeh Ramezani Tehrani
Keyword(s):  
Clinical Trial ◽  
Sexual Function ◽  
Pelvic Floor ◽  
Postmenopausal Women ◽  
Pelvic Floor Muscle ◽  
Intervention Group ◽  
Randomised Clinical Trial ◽  
General Information ◽  
Control Group ◽  
Significant Difference

Background The adverse effects of menopause on sexual function could be mitigated by pelvic floor muscle (PFM) training. This study aimed to investigate the effects of PFM exercises on sexual function in postmenopausal women. Methods: A randomised clinical trial was conducted among 97 Iranian postmenopausal women, aged 40 to 60 years. The participants’ baseline sexual functions were assessed using the Female Sexual Function Index (FSFI) questionnaire. They were then randomly designated to two groups: (1) the intervention group, which received specific instructions on PFM exercises and was followed up on a weekly basis; and (2) the control group, which received general information on menopause. After 12 weeks, the sexual functions of the participants were reassessed. Results: No significant difference was initially observed between the two groups in terms of demographic and socioeconomic characteristics and total scores of FSFI. After the intervention, however, the scores of arousal, orgasm and satisfaction were significantly higher in the intervention group (3.10, 4.36, and 4.84 vs 2.75, 3.89, and 4.36 respectively; P < 0.05). Conclusion: PFM exercises have the potential to improve the sexual function of postmenopausal women and are thus suggested to be included in healthcare packages designed for postmenopausal women.

Comparison of the Effects of Fenugreek Vaginal Cream and Ultra Low- Dose Estrogen on Atrophic Vaginitis

2020 ◽  
Vol 17 (9) ◽  
pp. 815-822
Author(s):  
Maryam Safary ◽  
Sevil Hakimi ◽  
Noushin Mobaraki-Asl ◽  
Paria Amiri ◽  
Habib Tvassoli ◽  
...  
Keyword(s):  
Postmenopausal Women ◽  
Low Dose ◽  
Intervention Group ◽  
Clinical Signs ◽  
Control Group ◽  
Conjugated Estrogens ◽  
Atrophic Vaginitis ◽  
Vaginal Cream ◽  
Intergroup Comparison ◽  
Significant Difference

Introduction: Atrophic vaginitis is a common problem in postmenopausal women and results from decreased levels of blood estrogen. It is associated with symptoms of itching, burning, dyspareunia, and postmenopausal bleeding. The present study evaluated the effects of fenugreek extract on atrophic vaginitis. Materials and Methods: This randomized controlled clinical trial was performed on 60 postmenopausal women in Ardabil, Iran, in 2018. The participants were selected using block randomization with the allocation ratio 1:1. Those in the intervention group received 0.5g (the applicator filled to the half-full mark) fenugreek vaginal cream 5% twice a week for 12 weeks. The control group received conjugated estrogens vaginal cream at the dose of 0.625 mg (the applicator filled to the half-full mark) containing 0.3 mg of conjugated estrogens. Atrophic vaginitis was evaluated before and after the treatment through clinical examination, clinical signs, and measurement of Vaginal Maturation Index (VMI). Findings: After the 12-week intervention and modification of the baseline score, the mean (standard error) score for atrophic vaginitis signs was 3.100 (1.43-4.75). This difference was statistically significant in intragroup comparison and in favor of the control group in intergroup comparison (p=0.001). VMI was less than 49% in 86.7% and 46.7% of the participants in the intervention and control groups, respectively. This was a significant difference in favor of the control group (p=0.001). Conclusion: The results of this study showed that total fenugreek extract could be effective in treating signs of atrophic vaginitis, but it was not as effective as ultra-low-dose estrogen.

Efficacy of Aloe vera/ Plantago Major Gel in Diabetic Foot Ulcer: A Randomized Double-Blind Clinical Trial

2019 ◽  
Vol 16 (2) ◽  
pp. 223-231 ◽  
Author(s):  
Younes Najafian ◽  
Zahra M. Khorasani ◽  
Mona N. Najafi ◽  
Shokouh S. Hamedi ◽  
Marjan Mahjour ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Diabetic Foot ◽  
Intervention Group ◽  
Aloe Vera ◽  
Foot Ulcer ◽  
Diabetic Foot Ulcer ◽  
Control Group ◽  
Plantago Major ◽  
Double Blind ◽  
Significant Difference

Background:Diabetic foot ulcer (DFU) is one of the most common complications of diabetic patients. Mostly, non-healing DFU leads to infection, gangrene, amputation and even death. High costs and poor healing of the wounds need a new treatment such as alternative medicine. So, the aim of this study was to evaluate the efficacy of Aloe vera/ Plantago major gel (Plantavera gel) in healing of DFUMethods:Forty patients with DFU enrolled in a double-blind randomized clinical trial. The patients who were randomly assigned into the intervention group (n = 20), received topical Plantavera gel in addition to the routine cares, whereas the patients in the control group (n = 20), received topical Placebo gel in addition to the routine cares. Intervention was done twice a day for 4 weeks in the both groups. Photography and an evaluation of DFU healing were conducted by a checklist and then were scored at baseline and at the end of each week. The collected data was analyzed by SPSS software.Results:At the end of the study, there was a significant difference between the two groups in terms of total ulcer score (P<0.001) and Plantavera gel significantly reduced the ulcer surface comparing with the control group (P=0.039). However, there was not a significant difference between the two groups (P=0.263) in terms of the ulcer depth. During this study, no side effect was observed for Plantavera gel in the intervention group.Conclusion:Topical Plantavera gel seems to be an effective, cheap and safe treatment. Of course, further studies are required to confirm the properties of the wound healing of this gel.

scholarly journals The effect of oat bran consumption on gestational diabetes: a randomized controlled clinical trial

2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Zahra Barati ◽  
Mina Iravani ◽  
Majid Karandish ◽  
Mohammad Hosein Haghighizadeh ◽  
Sara Masihi
Keyword(s):  
Clinical Trial ◽  
Blood Glucose ◽  
Gestational Diabetes ◽  
Fasting Blood Glucose ◽  
Intervention Group ◽  
Control Group ◽  
Controlled Clinical Trial ◽  
Standard Diet ◽  
Oat Bran ◽  
Significant Difference

Abstract Background Gestational diabetes is the most common medical complication in pregnancy, and it has many side effects for the mother and the fetus. The aim of this study was to evaluate the effect of oat bran consumption on gestational diabetes. Methods This study is a randomized clinical trial that was performed on 112 women with gestational diabetes treated with diet. Participants were randomly divided into two groups of 56. Participants in both groups were given a diet for gestational diabetes. In addition to the diet, the intervention group received 30 g of oat bran daily for 4 weeks at lunch and dinner. Tests of fasting blood glucose and two-hour postprandial (2hpp) glucose were taken from both groups: before the intervention, and 2 and 4 weeks after the start of the intervention. Data analysis was performed using SPSS statistical software (version 22) using independent t-test, as well as Chi-square and Mann-Whitney tests. P values less than 0.05 were considered statistically significant. Results There was no statistically significant difference between the two groups in terms of mean blood glucose before the intervention, while 2 and 4 weeks after the intervention, mean fasting blood glucose and two-hour postprandial (2hpp) glucose decreased significantly in the intervention group compared with the control group (P < 0.001). Conclusion Based on the results of this study, the addition of oat bran to the standard diet for pregnant women with gestational diabetes reduced fasting blood glucose and two-hour postprandial (2hpp) glucose. More detailed studies with higher sample sizes are recommended to prove the effectiveness of this valuable dietary supplement. Trial registration IRCT registration number:IRCT20191220045828N1. Registration date: 2020-04-18. Registered while recruiting.

scholarly journals Combined low-dose everolimus and low-dose tacrolimus after Alemtuzumab induction therapy: a randomized prospective trial in lung transplantation

Trials ◽  
2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Alberto Benazzo ◽  
Ara Cho ◽  
Anna Nechay ◽  
Stefan Schwarz ◽  
Florian Frommlet ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Lung Transplantation ◽  
Kidney Function ◽  
Induction Therapy ◽  
Low Dose ◽  
Prospective Trial ◽  
Control Group ◽  
Long Term Outcomes ◽  
Maintenance Immunosuppression

Abstract Background Long-term outcomes of lung transplantation are severely affected by comorbidities and development of chronic rejection. Among the comorbidities, kidney insufficiency is one of the most frequent and it is mainly caused by the cumulative effect of calcineurin inhibitors (CNIs). Currently, the most used immunosuppression protocols worldwide include induction therapy and a triple-drug maintenance immunosuppression, with one calcineurin inhibitor, one anti-proliferative drug, and steroids. Our center has pioneered the use of alemtuzumab as induction therapy, showing promising results in terms of short- and long-term outcomes. The use of alemtuzumab followed by a low-dose double drug maintenance immunosuppression, in fact, led to better kidney function along with excellent results in terms of acute rejection, chronic lung allograft dysfunction, and survival (Benazzo et al., PLoS One 14(1):e0210443, 2019). The hypothesis driving the proposed clinical trial is that de novo introduction of low-dose everolimus early after transplantation could further improve kidney function via a further reduction of tacrolimus. Based on evidences from kidney transplantation, moreover, alemtuzumab induction therapy followed by a low-dose everolimus and low-dose tacrolimus may have a permissive action on regulatory immune cells thus stimulating allograft acceptance. Methods A randomized prospective clinical trial has been set up to answer the research hypothesis. One hundred ten patients will be randomized in two groups. Treatment group will receive the new maintenance immunosuppression protocol based on low-dose tacrolimus and low-dose everolimus and the control group will receive our standard immunosuppression protocol. Both groups will receive alemtuzumab induction therapy. The primary endpoint of the study is to analyze the effect of the new low-dose immunosuppression protocol on kidney function in terms of eGFR change. The study will have a duration of 24 months from the time of randomization. Immunomodulatory status of the patients will be assessed with flow cytometry and gene expression analysis. Discussion For the first time in the field of lung transplantation, this trial proposes the combined use of significantly reduced tacrolimus and everolimus after alemtuzumab induction. The new protocol may have a twofold advantage: (1) further reduction of nephrotoxic tacrolimus and (2) permissive influence on regulatory cells development with further reduction of rejection episodes. Trial registration EUDRACT Nr 2018-001680-24. Registered on 15 May 2018

scholarly journals SUBCHRONIC TOXICITY TEST OF COMBINATION ETHANOL EXTRACT OF DETAM 1 SOYBEAN (GLYCINE MAX L. MERR) AND JATI BELANDA (GUAZUMA ULMIFOLIA LAMK) TOWARD FUNCTION, WEIGHT, AND HISTOPATHOLOGICAL OF WISTAR RAT LIVER

2016 ◽  
Vol 9 (5) ◽  
pp. 197
Author(s):  
Meilinah Hidayat ◽  
Sijani Prahastuti ◽  
Estherolita Dewi ◽  
Dewi Safitri ◽  
Siti Farah Rahmawati ◽  
...  
Keyword(s):  
Liver Function ◽  
Toxicity Test ◽  
Low Dose ◽  
Ethanol Extract ◽  
Good Effect ◽  
Control Group ◽  
High Dose ◽  
Subchronic Toxicity ◽  
Treatment Groups ◽  
Significant Difference

ABSTRACTObjective: As an antiobesity therapy, combination extracts of Detam 1 soybean and Jati Belanda will be consumed for a long time; therefore, theirtoxicities to the liver need to be investigated. To determine the effect of subchronic toxicity test of combination of ethanol extract of Detam 1 soybean(EEDS) and ethanol extract of Jati Belanda (EEJB) on liver function with parameters: Alanine transaminase (ALT), macroscopic, and histopathologicalof liver.Methods: This study was conducted on 120 Wistar rats (60 males and 60 females), 90 days (treatment group) and 120 days (satellite group). Ratswere divided into six treatment groups (3 test materials, 1 control, and 2 satellites); each group included 10 males and 10 females.Results: ALT levels of treatment groups (low dose, medium, and high), both males and females were lower than the control group (p<0.05). Thetreatment groups demonstrated a good effects effect on liver function. Liver weight of all groups showed no significant difference compared with thecontrol group (p>0.05). Results of histopathological score interpretation of male and female liver rats of low dose groups were not disturbed; middledose groups were slightly disturbed and high dose groups were damaged. Satellite high doses of male groups were disrupted, while female groupswere not.Conclusion: The combination of EEDS and EEJB has a good effect on liver function, did not lead to change organ weight and at low doses did not causerenal histopathology damage in rats after 90 days administration.Keywords: Combination of soybean Jati Belanda, Toxicity subchronic test, Function, Weight, Histopathology, Liver.

scholarly journals A randomized controlled clinical trial of the effect of supportive counseling on mental health in Iranian mothers of premature infants

2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Leila Seiiedi-Biarag ◽  
Mojgan Mirghafourvand ◽  
Khalil Esmaeilpour ◽  
Shirin Hasanpour
Keyword(s):  
Mental Health ◽  
Clinical Trial ◽  
Premature Infants ◽  
Control Group ◽  
Controlled Clinical Trial ◽  
Randomized Controlled Clinical Trial ◽  
Randomized Controlled ◽  
Significant Difference ◽  
Postpartum Bonding ◽  
Supportive Counseling

Abstract Background Premature birth can affect maternal mental health. Considering that the mental health disorder in mothers may play a vital role in the growth and development of their children, therefore, this study was conducted to determine the effect of supportive counseling on mental health (primary outcome), mother-child bonding and infant anthropometric indices (secondary outcomes) in mothers of premature infants. Methods This randomized controlled clinical trial was carried out on 66 mothers with hospitalized neonates in the NICU of Alzahra hospital in Tabriz- Iran. Participants were randomly allocated into two groups of intervention (n = 34) and control (n = 32) through a block randomization method. The intervention group received 6 sessions of supportive counseling (45–60 minutes each session) by the researcher, and the control group received routine care. Questionnaires of Goldberg General Health and the postpartum bonding were completed before the intervention (first 72 hours postpartum) and 8 weeks postpartum. Also, the anthropometric index of newborns were measured at the same time. Results There was no statistically significant difference between the two groups in terms of socio-demographic characteristics. After the intervention, based on ANCOVA with adjusting the baseline score, mean score of mental health (AMD: -9.8; 95% Confident Interval (95% CI): -12.5 to -7.1; P < 0.001) and postpartum bonding (AMD: -10.0; 95% CI: -0.6 to 13.9; P < 0.001) in the counseling group was significantly lower than those of the control group; however, in terms of weight (P = 0.536), height (P = 0.429) and head circumference (P = 0.129), there was no significant difference between the two groups. Conclusions Supportive counseling may improve mental health and postpartum bonding in mothers of premature infants. Thus, it may be recommendable for health care providers to offer it to mothers. Trial registration Iranian Registry of Clinical Trials (IRCT): IRCT20120718010324N45. Date of registration: October 29, 2018.

scholarly journals Effect of vitamin D supplementation on disease activity (SLEDAI) and fatigue in Systemic Lupus Erythematosus patients with hipovitamin D: An Open Clinical Trial

2018 ◽  
Vol 8 (2) ◽  
Author(s):  
Achmad Rifa’i ◽  
Handono Kalim ◽  
Kusworini Kusworini ◽  
Cesarius Singgih Wahono
Keyword(s):  
Systemic Lupus Erythematosus ◽  
Clinical Trial ◽  
Vitamin D ◽  
Placebo Group ◽  
Disease Activity ◽  
Lupus Erythematosus ◽  
Vitamin D Supplementation ◽  
Control Group ◽  
Systemic Lupus ◽  
Significant Difference

Background : Low level of vitamin D impact the disease activity and the degree of fatigue in SLE patients. This study aims to determine the effect of vitamin D supplementation on disease activity and fatigue condition in Systemic Lupus Erythematosus (SLE) patients with hipovitamin D.Methods: We performed an open clinical trial. Subjects were randomized into two different groups (supplementation or placebo) using simple random sampling. The treatment group got vitamin D3 softgel/ cholecalciferol 1200 IU/day or 30 mg/day, while the control group gotplacebo for 3 months. SLEDAI scores and FSS scores were calculated at pre and posttreatment.Results: There were 20 subjectsfor supplementation group and 19 subjects in the placebo group. From this study, before and after treatment, we found a significant difference of mean level of vitamin D in supplementation group (p=0.000), and no significant difference inpatients with placebo (p=0.427). Moreover, from the SLEDAI score analysis, observed a significant difference bothin the supplemented group (p=0.000) and the placebo group (p=0.006). FSS scores significantly different in the supplemented group (p=0.000). Incorrelation test,there was a negative correlation (r=-0763) between vitamin D level and disease activity (SLEDAI), and both showing stastistical significance between thepre supplementation (p=0.000) and post supplementation (r=-0846; p=0.000). Similarly to theFSS scores, there was a meaningfulnegative correlation (r=-0.931, p=0.000) between the level of vitamin D with FSS scores pre and post supplementation (r=-0.911; p= 0.000). Furthermore, there was a significant correlation between disease activity (SLEDAI) pre supplementation with fatigue condition pre supplementation (r=0.846; p = 0.000) and postsupplementation (r=0.913; p= 0.000).Conclusion: The supplementation of vitamin D 1200 IU per day in patients with SLE improve disease activity and degree of fatigue. Keywords: vitamin D, disease activity, fatigue, SLE

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