Double-blind Randomized Clinical Trial Study Research Articles

The comparison of efficacy of Escitalopram and Bupropion in treatment of depression symptoms in patients with heart failure: randomized clinical trial.

This study aims to compare the effects of two medicines, Escitalopram and Bupropion, on HF patients who have depression symptoms. This double-blind randomized clinical trial study was conducted on HF patients with depression symptoms at the Heart Failure Clinics affiliated with Babol University of Medical Sciences. In this study, 80 participants were examined for depression based on the Beck Depression Inventory (BDI) and Hamilton Depression Rating Scale (HDRS). They were randomly allocated into two groups of 40 participants treated with Bupropion 75mg and Escitalopram 5mg. Following the intervention, the individuals were assessed in terms of their depression score at 4, 8, and 12-week intervals. Finally, the data were analyzed using SPSS version 22.0. In the examination of Beck and Hamilton scores in the two research groups during different follow-ups, a significant decrease was found over time (P<0.001 for both medicines). While the effectiveness of the two medicines was the same at different times (P>0.05 in all cases). Comparing the side effects between the two intervention groups, the orgasm disorder (P=0.018) and sexual dysfunction (P<0.001) were reported significantly more in the Escitalopram group than in the Bupropion group. The findings of this study showed that Escitalopram has the same efficacy as Bupropion in the treatment of depression symptoms in HF patients.

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).

The Effect of Oral Gabapentin and Pregabalin as a Prodrug in Pain Control after Orthopedic Surgery on the Upper Limb: A Double-Blind Parallel Randomized Clinical Trial Study.

To compare the effects of oral gabapentin (GBP) and pregabalin (PGB) in pain control after orthopedic surgery on the upper limb. In this double-blind randomized clinical trial study, 80 patients who were the candidates for elective orthopedic surgery on one of the parts of the upper limb were divided into two groups using balance-block randomization. For the first group, a 150 mg capsule of PGB (one hour before the surgery) and for the second group, a 300 mg capsule of GBP (two hours before the surgery) were prescribed. Patients were subjected to standard monitoring at the beginning and during surgery. The pain scores were evaluated at before surgery, in PACU (postanesthesia care unit), and 6 and 12 hours after the surgery by VAS (visual analog scale). In this study, 37 subjects were allocated to each group. The participation rate was 92.5%. The mean with 95% confidence interval (CI) of pain scores over 4 times in the PGB group was 4.03 (3.25-4.79), 3.76 (3.02-4.49), 3.65 (3.06-4.23), and 3.41 (2.88-3.93) and in the GBP group was 4.08 (3.33-4.83), 2.78 (2.11-4.45), 2.3 (2.05-2.54), and 2 (1.51-2.50), respectively. The within-group comparisons showed a significant decrease in the pain score over time (P < 0.001). Also, the between-group comparison showed significant differences between the two groups in terms of pain score (P < 0.001). In the end, results showed that there is a significant interaction between time and intervention for pain score (P=0.042). Although two medicines led to a reduction in the pain score, but the rate reduction in the PGB group was significantly more than that in the GBP group. This trial is registered with IRCT20211013052759N1.

Effectiveness of Combined Treatment of Transcranial Direct Current Stimulation and Treatment as Usual on Depression, Anxiety and Anger in Adolescents with Bipolar Disorder

Objectives: Bipolar disorder (BD) is a prevalent psychological disorder associated with depressive symptoms. Transcranial direct current stimulation (tDCS) is a portable and non-invasive technique for brain stimulation. The present study was conducted to determine the effectiveness of the combined treatment of tDCS and routine medication on the symptoms of depression, anxiety, and anger in BD adolescents. Methods: In this double-blind randomized clinical trial study, forty adolescents with BD referred to the outpatient clinic of child and psychiatry of Golestan Ahvaz Teaching Hospital were included. Eligible patients aged 12 - 18 years were randomly divided into 2 groups receiving routine medications plus active tDCS (intervention group) or routine medications plus sham tDCS (control group). Transcranial direct current stimulation intervention with an intensity of 2 mA was applied to the dorsolateral prefrontal cortex in two sessions for 20 minutes each day, for 5 consecutive days. Data were collected at baseline, one week, and one month after the start of the intervention using the Hamilton Depression Rating Scale (HDRS-21), Hamilton Anxiety Rating Scale (HDRS), and State-Trait Anger Expression Inventory. Results: Based on our findings, age and gender were not considerably different between the two groups (P = 0.592, P = 0.1, respectively). In both groups, scores of depression (control: 12.25 ± 3.97, intervention: 0.75 ± 1.44, mean [SD]), anxiety (13.55 ± 2.58, 25.0 ± 0.55), and anger (52.65 ± 8.27, 47.25 ± 4.86) improved significantly one month after treatment (P &lt; 0.0001). After one month of treatment, the severity of bipolar symptoms in the intervention group (slightly: 10%, moderately: 50%, and markedly: 40%) improved significantly compared to the control group (slightly: 15%, moderately: 10%, and markedly: 0%) (P &lt; 0.0001). The improvement rate of HDRS in the intervention group was 81.29% and 95.24% at one week and one month after treatment, while these values were 8.41% and 23.04% in the control group, respectively (P &lt; 0.0001). All patients tolerated the treatment well without serious side effects. There was no significant difference between the side effects observed in both groups (P = 0.185). Conclusions: The combination of tDCS with routine medications can reduce depressive symptoms and improve bipolar symptoms. Therefore, tDCS add-on could be an effective, safe, and tolerable intervention for bipolar depression.

Investigation of the probiotic supplement's effect on obese adults demonstrated a reduction in fasting insulin levels: a double-blind randomized clinical trial.

Regarding the importance of obesity concerns and trying to help obese individuals, we planned to develop an effective probiotic formula for weight control. So, this double-blind randomized clinical trial study investigated the impact of probiotics supplementation on anthropometric and biochemical parameters in obese adults. In this study, 66 obese patients with BMI in the range of 30-40kg/m2, were enrolled and randomly assigned to either the probiotic or placebo group. They all received advice to maintain a reduction in daily caloric intake and for 3 months received two unlabeled placebo or probiotic (Lactobacillus plantarum, Lactobacillus rhamnosus, Lactobacillus casei and Bifidobacterium langum) capsules per day. For each participant demographic and medical history questionnaire, semi-quantitative food frequency questionnaire (FFQ), and modifiable activity questionnaire (MAQ) were completed at the beginning of the study and anthropometric and biochemical measurements were done before and after intervention. At the end of the trial 25 subjects in the probiotic group and 26 subjects in the placebo group were analyzed. After the intervention, in the probiotic group, the level of fasting insulin was reduced significantly (P < 0.05). Weight, body mass index, waist circumference, and hip circumference decreased within both groups. This reduction amount's mean was higher in the probiotic group. Also, total cholesterol, triglycerides, and LDL levels were decreased, but not statistically significant. This study may suggest the potential of this combined probiotic supplement for treating obesity and related metabolic disorders. However, further researches are warranted for a definitive determination of its properties.

Effect of Silybum Marianum on Reduction of Chemotherapy-Induced Peripheral Neurotoxicity with Cisplatin.

Chemotherapy-induced peripheral neurotoxicity (CIPN) is one of the major complications of chemotherapy regimens commonly used in the treatment of solid and hematologic cancers. Given the high incidence of CIPN in antitumor therapies in patients and limited studies on antioxidants, this study was aimed to investigate the effect of Silybum marianum (SM) on cisplatin-induced peripheral neuropathy. This double-blind randomized clinical trial study was performed on 60 cancer patients treated with cisplatin chemotherapy at Seyyed-o-Shohada Hospital of Isfahan during 2019-2020. The patients were divided into two parallel groups as intervention (treated by SM) and placebo, and DN4 (Douleur neuropathique 4 questions) and CIPNAT (chemotherapy-induced peripheral neuropathy assessment tool) were completed for patients in the before and after intervention groups and compared between the two groups. The mean of DN4 score in the before and after study in the intervention group was in 1.76 ± 1.24 and 2.07 ± 2.03, respectively (P = 0.38), and in the control group was 1.41 ± 1.28 ± 3.11 ± 2.86, respectively (P = 0.012). The mean CIPNAT score in the intervention groups was 5.93 ± 3.65 and 4.20 ± 3.23 (P = 0.01), and in the control group was 4.20 ± 4.22 and 4.16 ± 4.03 (P = 0.39). Based on our data, SM is an effective agent in reducing peripheral neuropathy. The use of SM was associated with decreased scores of peripheral neuropathy and was helpful in patients undergoing chemotherapy with cisplatin.

Cognitive-Motor Training Improves Reading-Related Executive Functions: A Randomized Clinical Trial Study in Dyslexia.

Children with developmental dyslexia (DD) often struggle with executive function difficulties which can continue into adulthood if not addressed. This double-blinded randomized clinical trial study evaluated the short-term effects of the Verbal Working Memory-Balance (VWM-B) program on reading-related executive functions, reading skills, and reading comprehension in Persian children with DD. The active control group [12 children with DD with a mean age of 9 years (SD = 0.90)] received training using the single-task VWM program, while the experiment group [15 children with DD with a mean age of 8 years (SD = 0.74)] received training with the dual-task VWM-B program. Both groups received fifteen training sessions, and assessments were conducted before and after the intervention. The groups were homogenized for possible confounders of age, gender, IQ level, and attention level. The study employed separate mixed ANOVA analyses to estimate the impact of training programs on various measured functions. Significant improvements were observed in the outcome measures of backward digit span, text comprehension, verbal fluency, Stroop color-word test and interference, and the reading subtests. Additionally, significant correlations were found between reading skills and backward digit span, text comprehension, verbal fluency, and Stroop variables. In conclusion, the dual-task VWM-B program was found to be more effective than the single-task VWM program in improving selective attention, cognitive inhibition, verbal working memory capacity, information processing speed, naming ability, and lexical access speed. These enhanced executive functions were associated with improved reading skills in children with DD.

Effect of Intranasal Remifentanil versus Lidocaine on Facilitation of Laryngeal Mask Airway Insertion and Cardiovascular Response: A Double-blind Clinical Trial Study.

This study aimed to assess and compare the effects of intranasal administration of lidocaine and remifentanil on the condition of LMA insertion and cardiovascular response. From March 2019 to March 2020, this double-blind randomized clinical trial study was conducted on 60 patients, who underwent general anesthesia with LMA insertion at Faiz Hospital, Isfahan, Iran. After induction of anesthesia and before placing the laryngeal mask, the first group received remifentanil 1 μg/Kg, the second group received lidocaine 2% 1 mg/Kg, and the third group received normal saline with the same volume intranasally. The conditions of LMA insertion and hemodynamic changes that occurred during its insertion were investigated. In terms of demographics characteristics (p>0.05), success in placing the LMA on the first try (p=0.73), number of attempts to insert LMA (p=0.61), performance of LMA (p=0.73), need for additional propofol (p=0.53), frequency of gagging (p=0.53), cough (p=0.15) p), and laryngospasm (p=0.99) did not differ significantly. In the remifentanil group, the cardiovascular response to LMA injection was less than that of the lidocaine group. Moreover, both groups were lower than the saline group, but no significant difference was observed. In facilitating LMA insertion, the effect of intranasal remifentanil was comparable to intranasal lidocaine. Intranasal remifentanil was somewhat more effective than intranasal lidocaine in weakening the cardiovascular response to LMA insertion, but it did not outperform lidocaine.

The Effect of Rivaroxaban in the Complementary Therapy of Sudden Sensorineural Hearing Loss

Abstract Background: Due to the importance of sudden sensorineural hearing loss (SSNHL) and the possible role of blood coagulation in its mechanism and the likely therapeutic effect of anticoagulants and also the lack of studies in this field, this study aimed to evaluate the effect of rivaroxaban (RXA) in the treatment of this disease. Materials and Methods: The present double-blind randomized clinical trial study was performed on 34 patients with SSNHL. Patients were randomly divided into two groups. In the first group, in addition to corticosteroid therapy (CST), RXA 10 mg tablets were used daily for 10 days (RXA group), and in the second group, only CST (CST group) treatment was prescribed. Hearing recovery was then assessed and recorded according to the American Academy of Otolaryngology–Head and Neck Surgery (AAO-HNS) criteria. Results: This study showed that the grade of hearing recovery in the RXA group (58.8%) was higher than the CST group (47.1%), but this difference was not significant (P value &gt;0.05). Also, RXA treatment increased the odds of hearing recovery, and this difference was not statistically significant (odd ratio (95% confidence interval)(OR (95% CI): 2.327 (0.180–18.082); P value = 0.518). In contrast, delay to treatment, more increased PTA (pure tone average (PTA)), and having vertigo reduced the odds of hearing recovery by 0.138-, 0.019-, and 0.069-fold, respectively (P value &lt;0.05). Conclusion: According to the results of this study, although the percentage of hearing recovery was higher in the RXA group, in general, the results of the two treatments were not significantly different.

The effects of atomoxetine and trazodone combination on obstructive sleep apnea and sleep microstructure: A double-blind randomized clinical trial study

Study objectiveswe aimed to compare the effects of atomoxetine and trazodone (A-T) in combination with placebo in patients with obstructive sleep apnea (OSA). MethodsThis randomized, placebo-controlled, double-blind, crossover trial study was conducted in adults with OSA referred to a Sleep Clinic. Participants with eligibility criteria were recruited. Patients were studied on two separate nights with one-week intervals, once treated with trazodone (50 mg) and atomoxetine (80 mg) combination and then with a placebo and the following polysomnography tests. ResultsA total of 18 patients with OSA completed the study protocol, 9(50%) were male, the mean age was 47.5 years (SD = 9.8) and the mean Body mass index of participants was 28.4 kg/m2 (SD = 3.4). Compared with the placebo, the A-T combination resulted in significant differences in AHI (28.3(A-T) vs. 42.7 (placebo), p = 0.025), duration of the REM stage (1.3%TST (A-T) vs. 13.1%TST (placebo), p = 0.001), and the number of REM cycles (0.8 (A-T) vs. 4.7 (placebo), p = 0.001), number of apneas (38.3 (A-T) vs. 79.3 (placebo), p = 0.011), number of obstructive apneas (37.2 (A-T) vs. 75.2 (placebo), p = 0.011), oxygen desaturation index (29.5 (A-T) vs. 42.3 (placebo), p = 0.022) and number of respiratory arousals (43.2 (A-T) vs. 68.5 (placebo), p = 0.048). This decrement effect did not change among those with a low-arousal phenotype of OSA. ConclusionsThe A-T combination significantly improved respiratory events’ indices compared with placebo in patients with OSA. This combination is recommended to be assessed in a large trial. It could be an alternative for those who do not adhere to the standard available treatments for OSA.

Evaluation of the effect of oral Ketamine compared to placebo on pain reduction in patients with renal colic: a double-blind randomized clinical trial study

Introduction: Renal colic caused by urolithiasis is one of the common causes of severe pain and referral to the emergency room. Using a multimodal method in controlling this type of pain by available anesthetics such as ketamine can help relieve pain, increase satisfaction and reduce hospitalization. Method: This study was conducted as a double-blind clinical trial. 44 patients with renal colic with ASA class 1 were divided into two intervention and control groups. Pethidine (1mg/kg) was administered to both groups. In the intervention group, oral ketamine (0.5 mg/kg) dissolved in 5% dextrose was prescribed, and in the control group, 5% dextrose serum (0.1 ml/kg) was used. Pain intensity was measured by numerical method (NRS) before the treatment and half, one, two and three hours after the intervention. Findings: The median age of the intervention group was 35.2 and the control group was 38.9 (p=0.092). The average amount of pethidine consumed in the intervention group was 94 mg and in the control group was 89 mg, and there was no significant difference between the two groups (p=0.095). In the intervention group, 27.3% and in the control group, 72.7% needed additional pethidine (p=0.000). In hours one, two and three after treatment, the intensity of pain in the intervention group was lower than in the control group, and only in the third hour this difference was statistically significant (p = 0.03). Conclusion: The use of oral ketamine can reduce restlessness without causing side effects and along with pethidine can help relieve the pain of renal colic in the emergency department

The effect of lumbopelvic manipulation on electromyography parameters of gluteus medius and vastus medialis in patients with patellofemoral pain syndrome: A double-blind, placebo-controlled trial

BackgroundPatellofemoral Pain Syndrome is the most common cause of anterior knee pain, especially in active young people. This study aimed to evaluate the effect of lumbopelvic manipulation on electromyography parameters of gluteus medius and vastus medialis in patients with patellofemoral pain syndrome. MethodsIn this double-blind placebo-controlled randomized clinical trial study, 26 patients with a diagnosis of patellofemoral pain syndrome were randomly divided into two groups. The first group received Lumbopelvic manipulation and the second group was a control group that received placebo manipulation. Electromyography activity of vastus medialis and gluteus medius muscles were evaluated as primary outcomes during the single-leg squat; pain intensity during rest and functional tasks (step up, step down, single leg squat) were assessed by numerical pain rating scale. Functional status was evaluated by step-down test and the score of the Kujala patellofemoral questionnaire, as secondary outcomes. All evaluations were performed before and after the intervention, except pain intensity at rest and the Kujala patellofemoral questionnaire that were assessed before the intervention and one week after. ResultIn both groups, no significant difference was observed before and after the intervention in terms of average amplitude and the onset of gluteus medius and vastus medialis. However, in the lumbopelvic manipulation group, pain intensity during rest and functional tests significantly decreased compared to the control group. Functional status significantly improved in the lumbopelvic manipulation group, with no significant difference between group comparisons. ConclusionLumbopelvic manipulation caused a reduction in pain intensity and improvement of functional status in the rehabilitation of patients with patellofemoral Pain Syndrome. However, it seems that this method could not change the EMG activity of muscles in these patients. Implications for practice•The results of present study can help physiotherapists to understand the possible underlying pathomechanics of patellofemoral pain syndrome and more effective treatment of these group of patients.

Effect of pentoxifylline on the dose of erythropoietin among hemodialysis patients: A double-blind randomized clinical trial

Introduction: It was suggested that pentoxifylline (PTX) might improve the response to recombinant human erythropoietin (rhEPO) in anemic hemodialysis (HD) patients. However, there is no considerable evidence for it. We aimed to evaluate the effect of PTX on anemia and prescription of rhEPO dose in HD patients. Methods: This double-blind randomized clinical trial study was conducted on 57 HD patients (54.1 ± 13.8 years old and 52.6% of them were women). Patients were randomly categorized into 2 groups (27 PTX cases and control group with 30 cases). Hemoglobin (Hb), erythrocyte sedimentation rate (ESR), C-reactive protein (CRP), and albumin (Alb) were measured before and after the study. Data were analyzed using SPSS, and p-value &lt;0.05 was considered significant. Results: Hb levels increased significantly after treatment in both groups (p&lt;0.002). Although the mean Hb change in the PTX group was more but not significant (p=0.195). rhEPO dose decreased significantly after treatment in the PTX groups (11000.0 ± 3140.0 IU vs. 9100.0 ± 3400.0 IU, p=0.018) compared to the control (11130.0 ± 3180.0 IU vs. 10870.0 ± 3900.0 IU, p= 0.690). CRP levels significantly reduced only in the PTX group (22.8 ± 15.3 vs. 16.5 ± 9.5, p=0.005). Also, a significant increase in Alb was observed only in the PTX (3.9 ± 0.4 vs. 4.1 ± 0.3, p=0.031). Conclusion: Using the PTX may reduce the required rhEPO dose, so it could be used in the anemia treatment in HD patients. Although, as a therapeutic strategy in HD patients with anemia it is controversial. Due to the limitations of the studies in this field, further studies with more sample size are recommended.

Comparison of the Effects of Nano Micelles Curcumin and Ibuprofen on Pain Reduction After Initial Arch Wire Placement: A Double-Blind Randomized Clinical Trial Study

Aim: To compare the effect of nano micelles curcumin and ibuprofen on pain reduction after primary arch wire placement in orthodontic patients. Materials and Methods: In this double-blind randomized clinical trial study, 60 female patients between the ages of 14 and 30 years who had moderate tooth crowding and were candidates for fixed orthodontic treatment were examined. The subjects were divided into four groups ( n = 15) of nano micelles curcumin (SinaCurcumin), ibuprofen, placebo of SinaCurcumin, and placebo of ibuprofen. Each patient received a questionnaire and a rectangular, flexible cube of silicone to record the severity of their pain under each of the three situations (biting posterior teeth together, fitting anterior teeth together, and without fitting the teeth together) at the designated time points (2 h, 6 h, bedtime, the second, third, and seventh days after archwire placement). The obtained outcomes were statistically verified and analyzed by the employment of SPSS Statistics Version 22. Results: despite the lack of any significant differences among the four groups in terms of pain severity upon biting by the anterior teeth 2 h after the intervention, there was a considerable difference in the cases of 6 h, bedtime, and the second, third, and seventh days subsequent of the placement of archwire. Our data indicated a lower rate of pain severity for SinaCurcumin group than the placebo of SinaCurcumin and ibuprofen groups at 6 h after the archwire placement. However, the pain severity of SinaCurcumin group at bedtime was significantly lower than ibuprofen group, which also resulted in a notably lower rate than the other groups at the second, third, and seventh days after the placement of archwire. Conclusion: These findings support the effectiveness of curcumin in reducing the pain severity of orthodontic patients. Nevertheless, it is a necessity to conduct further confirmation trials on this latter.

Evaluating the Effects of Camellia Sinensis (Green Tea) and Teucrium Polium Extracts on Salivary Streptococcus Mutans Levels in Children.

Camelia Sinenis or green tea (GT) and Teucrium polium (TP) are known to have a great antimicrobial potential on salivary Streptococcus mutans (S. mutans). Their efficacy should be examined compared to the gold standard antimicrobial agents. To evaluate the effects of Camelia Sinenis or green tea (GT) and Teucrium polium (TP) extracts in comparison with chlorhexidine gluconate (CHG) on salivary S. mutans levels. This double-blinded randomized clinical trial study was conducted on 90 preschool children aged 4 to 6 years and assigned randomly (simple randomization) to three groups as GT, TP, and CHG. Unstimulated saliva samples were then collected in three times as before application of agents, after half an hour, and after one week. To determine S. mutans levels, quantitative polymerase chain reaction (qPCR) technique was additionally utilized. Statistical analysis was also fulfilled using Shapiro-Wilk test, Friedman test, Chi-square test, paired sample t-test, repeated measures analysis of variance (ANOVA), and Mann-Whitney U test at a significance level of 0.05. The results of this study established a significant difference between mean salivary S. mutans levels after administration of the three compounds. Although the mean of S. mutans levels reduced significantly following the application of CHG and TP after half an hour, the mean salivary S. mutans levels in the group receiving GT declined in a significant manner only one week later (p< 0.05). The results of this study indicated that GT and TP extracts had considerable effects on salivary S. mutans levels compared with CHG.

Outcomes of near confluent laser versus combined less dense laser and bevacizumab treatment of prethreshold ROP Type 1 Zone 2: a randomized controlled trial

BackgroundTo evaluate the results of near confluent laser therapy versus combined less dense laser and intra vitreal bevacizumab in treatment of infants with type 1 retinopathy of prematurity (ROP) in zone II.MethodsThis is a prospective double-blinded randomized clinical trial study. Infants with Type 1 ROP in Zone 2 were randomized into case and control groups. Conventional laser therapy was executed for control group and combination of IVB and laser treatment was employed for the case group.ResultsEighty-six eyes from 43 infants were analyzed in this trial. The first group included 42 eyes from 21 infants receiving a combination of laser ablation and IVB. The second group contained 44 eyes from 22 infants who received only conventional laser therapy. The combined IVB and laser ablation group demonstrated the neovascularization regression (20 out of 21 infants) one week after the procedure. In the conventional laser therapy group, this regression was found in (12 out of 22 infants) within one week after laser therapy (P = 0.001). Plus disease regression was observed in 20 (20/21) of combined treatment group and 7 infants (7/22) of conventional laser treatment group after one week.ConclusionCombined less dense laser and bevacizumab treatment resulted in more rapid regression in comparison with the conventional laser treatment.Trial registrationIRCT20201120049450N1, 27/12/2021.

Intra-articular remifentanil on postoperative pain in knee arthroscopic surgery; a double blind randomized clinical trial

BackgroundWe aimed to assess the efficacy of intra-articular remifentanil in relieving postoperative pain after knee arthroscopy. MethodsWe conducted a double-blind randomized clinical trial study on 60 patients. Patients were divided into two equal groups. The control group received 25 ml of intra-articular normal saline, and the intervention group received 200 μg of remifentanil dissolved in 25 ml of saline. We evaluated at rest postoperative pain at 1, 3, 6, 12, 18, and 24 h after the surgery using the Visual Analog Scale (VAS). Patients with VAS scores of 4 or more received meperidine (pethidine). The first time meperidine was requested and the total amount of meperidine consumed was recorded. ResultsOut of 60 patients, 49 were male (81.6%), and the mean age of participants was 32.71 (7.02) years. An hour after the surgery, the control group showed a mean VAS score of 8.66 (1.26), and decreased to 2.53 (1.67) at the end of 24 h. The intervention group started with a mean VAS score of 2.23 (1.81) and ended at 0.10 (0.305). All patients in the control group and 11 (36.7%) patients in the intervention group asked for analgesics during follow-up. The mean total meperidine dose in the control and intervention groups was 108.33 (23.97) mg and 13.33 (19.40) mg, respectively (P < 0.001; 95% confidence interval of the difference 83.72 to 106.27). ConclusionsIntra-articular remifentanil may decrease postoperative pain and analgesic requirements in patients undergoing knee arthroscopy.

The effect of remifentanil on hemodynamic response to laryngeal mask airway insertion in induction of anesthesia with propofol fentanyl or propofol ketamine in cataract surgery

Background. Induction of general anesthesia may cause hemodynamic instability. Remifentanil is often prescribed to suppress the hemodynamic response to anesthesia. The aim of this study was to investigate the effect of remifentanil on hemodynamic response to induction of anesthesia with propofol fentanyl or propofol ketamine and laryngeal mask airway (LMA) insertion. Methods. This double-blind randomized clinical trial study was performed on 44 candidates for cataract surgery in Feyz Hospital, Isfahan, Iran from March to June 2020. Patients were randomly assigned into two groups using random allocation software. The first group received 1 mcg/kg fentanyl and the second group received 0.5 mg/kg ketamine. Also, both groups received 1 mg/kg propofol and 0.5 mcg/kg remifentanil intravenously. Hemodynamic parameters were measured and recorded at study times, and the results were analyzed statistically. Results. The mean age (P=0.199), weight (P=0.050), height (P=0.9), and frequency distribution of gender (0.763) and American Society of Anesthesiologists (ASA) score (0.069) were not significantly different between the two groups. Systolic blood pressure (SBP), diastolic blood pressure (DBP), and mean arterial pressure (MAP) in fentanyl group were significantly lower than the ketamine group immediately before LMA insertion, as well as 1, 3, and 5 minutes after LMA insertion (P &lt;0.050). In addition, the mean heart rate (HR) in the fentanyl group decreased significantly at different time (P&lt;0.001), but no significant difference was observed in ketamine group (P=0.056). In addition, the mean HR did not differ significantly between the two groups in any of the follow-up times (P&gt;0.050). Conclusion. Intravenous administration of remifentanil in induction of anesthesia with propofol-ketamine and propofol-fentanyl reduced changes in hemodynamic responses to LMA insertion. This hemodynamic stability was increased by adding remifentanil to the propofol-ketamine combination. Practical Implications. Remifentanil is associated with weakening of hemodynamic responses to LMA insertion in induction of anesthesia with propofol and ketamine or propofol and fentanyl; this effect can be associated with safety in cardiac patients.

Analgesic Characteristics of Bupivacaine Alone and in Combination with Dexmedetomidine or Meperidine in Spinal Anesthesia during Cesarean Section: A Double-Blind Randomized Clinical Trial Study.

Background Comparing bupivacaine's adjuvants in spinal anesthesia, we assessed the specific blocking characteristics and adverse effects of bupivacaine alone and in combination with dexmedetomidine or meperidine in spinal anesthesia during cesarean section. Methods In this double-blind randomized clinical trial study, ninety pregnant women were divided into groups to receive 10 mg bupivacaine (group B), 10 mg bupivacaine with 5 μg dexmedetomidine (group BD), or 10 mg bupivacaine with 10 mg meperidine (group BM) intrathecal. Patients were assessed for the quality of analgesia during operations. Durations of sensory and motor blocks and anesthesia-related complications were analyzed using SPSS 21, and p values <0.05 were considered statistically significant. Results The onset of sensory and motor blocks was essentially the same in all treated groups. Block regression time was significantly prolonged in the BD group compared to the B and BM groups (p < 0.001). The duration of analgesia was significantly longer in the BD and BM groups than in the B group (p < 0.001). The level of sedation in the BD group was higher than in the B group. Shivering occurred in 40% of patients in the B group, which was significantly more than that of the BD (16.6%) and BM (33.3%) groups. Itching happened in 33.3% of women in the BM group which was statistically more than that of the B (3.33%) and BD (0) groups. The incidence of adverse effects was the same in all groups. Conclusion The combination of bupivacaine with dexmedetomidine significantly prolonged sensory and motor regression time and duration of analgesia.

Effect of Polycitra-K and Bicitra in the Treatment of Pediatric Nephrolithiasis: A Double-Blind Randomized Trial.

Background: Urolithiasis is a common, sever, painful, and costly disease with a high probability of relapse. This study was performed to compare the effect of Polycitra-K containing potassium citrate and Bicitra containing sodium citrate in the treatment of kidney stones in children who referred to Hazrat Masoumeh hospital in Qom. Methods: This double-blind randomized clinical trial study was carried out on 176 patients aged between 5 and 18 years old with kidney stones, hypocitraturia, and negative urine who referred to Hazrat Masoumeh hospital in Qom (Iran). Patients were divided into 2 groups of treatment (a dose of 1 mL/kg or 1-1.5 mg/ kg Polycitra-K) and control (Bicitra in the same dose). The results of kidney ureter bladder X ray (KUB ) was followed and the 2 groups were compared. The chi-square test or the Fisher exact test was used to analyze qualitative values in the treated groups. Results: Regarding bladder stones, there was a significant difference between the 2 treatment groups (p = 0.025), in which16 patients (18.2%) in the Polycitrat-K group and 29 patients (33%) in the Bicitra group had bladder stones. With respect to stone passage, 58 patients (65.9%) in the Polycitra-K group and 36 patients (40.9%) in the Bicitra group were recorded. Conclusion: Oral Polycitrat-K is an effective preferential supplement against kidney stones in children due to urine alkalization, but the results of our study showed that both Polycitrat-K and Bicitra drugs have similar effects as therapeutic agents. Registration code in the Iranian Registry of Clinical Trials: IRCT20190619043945N1