Showing 11 results for Clinical Trial
Nuraei A, Khajenouri R, Soleimani M, Dabbagh A,
Volume 68, Issue 4 (7-2010)
Abstract
Background: Patients with chronic renal disease, if not treated appropriately, will be usually terminated into an irreversible stage known as End Stage Renal Disease (ESRD), the final stage of kidney disease. End stage renal disease patients cannot excrete the appropriately potassium ion through the kidney. Among the crystalloid solutions, normal saline is devoid of potassium so it is used in a widespread manner in renal transplant patients. High doses of this solution may cause hyperchloremic metabolic acidosis that is accompanied by extracellular potassium shift and impaired splanchnic perfusion. The aim of this study was to assess the effects of two types of solutions, normal saline vs. lactated ringer in these patients during the perioperative period. Methods: In a double blind clinical trial, 108 patients were randomly assigned in two groups (54 in each), while were assimilated regarding all aspects except for the type of the crystalloid solution. Age, weight, duration of the surgery, total volume of the infused crystalloid, central venous pressure and sex were all assessed.
Results: The two groups were the same regarding the results gained for pre- and post- operative parameters. Follow up assessments did not show any difference between the two groups regarding above variables.
Conclusions: The results of this study demonstrated that both of the crystalloid
solutions assessed, normal saline and lactated ringer solution, are safe for using in patients undergoing surgical operation and there is not a risk of hyperkalemia in renal transplant patients receiving lactated ringer. This study was performed on live kidney transplants and the results were not applicable to cadaver transplants.
Hamid Reza Hemmati , Mehdi Sadat-Hashemi , Raheb Ghorbani , Toraj Jafari ,
Volume 72, Issue 12 (3-2015)
Abstract
Background: Inguinal hernia is a common surgical problem which increases with aging especially in men. A common method for treatment is surgical repair using prosthesis, Lichtenstein technique. One frequent complication after inguinal herniorrhaphy is soft tissues seroma. There are several methods to prevent or to drain seroma. Some surgeons suggest the insertion of closed suction drainage system but others disagree.
Methods: In this clinical trial study, 42 patients who are candidate for hernia repairing (Lichtenstein technique), referred to Amir Al-Momenin Hospital in Semnan, Iran, from 2011 to 2012, were randomly divided into two groups. So that, the list of eligible patients in the study, were numbered, and then using the patients' code, patients, who assigned an odd number in the registration list, were allocated to group 1, the remainder were placed in group two. The two first numbers in registration list (1 or 2), were randomly assigned to groups. Group 1 underwent hernia surgery without closed suction drainage and the second group underwent hernia surgery with closed suction drainage. The patients were evaluated for seroma, hematoma or wound infection after 24 hours, during days 4 to 7 and days 10 to 15 following surgery.
Results: No adverse event including hematoma, seroma or wound infection occurred in either group with or without closed suction drainage in the first 10 days after surgery. Only one patient carried wound infection during days 10 to 15 following operation who was in the group with closed drainage (P=1.00).
Conclusion: In this study, Seroma and hematoma was not observed in patients with and without closed suction drainage. To avoid drains' complications, indiscriminate use of antibiotics, prolonged hospital stay, we do not recommend the use of drains in this type of surgery.
Nasrin Dodangi , Nastaran Habibi ,
Volume 74, Issue 3 (6-2016)
Abstract
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Background: Attention-deficit/hyperactivity disorder (ADHD) is a common and mostly chronic mental health condition that affects children, adolescents, and adults. Stimulants and atomoxetine are first-line agents for the treatment of ADHD. Despite the impressive track record of stimulants in the treatment of ADHD, they fail in 25% of patients due to lack of efficacy or the emergence of unwanted side effects. Accordingly, this study carried out to compare efficacy and safety of duloxetine (a serotonin and norepinephrine reuptake inhibitor) and methylphenidate (a short acting stimulant) in the treatment of children with attention-deficit/hyperactivity disorder.
Methods: Twenty-four children diagnosed with ADHD participated in this 6 weeks open clinical trial. Patients were between 6 to 11 years old that had been referred to psychiatry clinic at Akhavan and Rofide Medical and Rehabilitation Center in Tehran from September 2012 to July 2014. Diagnosis was made by two child psychiatrist according to DSM-IV TR criteria. Thirteen patients received duloxetine and others received methylphenidate. Conner’ parent rating scale-revised-short form (CPRS-RS) and ADHD-rating scale (ADHD-RS) were used at the beginning and then each two weeks to assess efficacy of treatment. Routine laboratory tests and electrocardiogram (ECG) was carried out in the beginning and end of the trial.
Results: Twenty children with ADHD completed the study (Ten in methylphenidate and ten in duloxetine group). In both groups, scales of CPRS-RS and ADHD-RS were reduced from baseline to endpoint, but this reduction in methylphenidate group was significantly greater than duloxetine group (P= 0.000). The most common side effect was gastrointestinal problems in duloxetine group and anorexia in methylphenidate group. No serious side effects and no changes in laboratory and ECG indexes were seen in both groups.
Conclusion: Duloxetine is not efficacious as well as methylphenidate in treatment of children with ADHD. Although more research are needed to achieve more accurate results.
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Parvin Bastani , Sakineh Hajebrahimi , Fariba Ghaderi , Zahra Vakilazad , Morteza Ghojazadeh ,
Volume 74, Issue 7 (10-2016)
Abstract
Background: Dyspareunia is a pain that is occurs in the genital area before, during or after intercourse and is an important factor for sexual dysfunction. The aim of this study was to evaluate the effect of pelvic floor physical therapy on sexual function and muscle strength and endurance of pelvic floor (as a non-invasive therapy) in women with dyspareunia.
Methods: In this clinical trial study, 32 women in the age range of 20-50-year-old and sexually active with complaints of dyspareunia, before the investigation were examined in terms of genital health and strength and endurance of the pelvic floor muscles. After the confidence of mental health, patients underwent pelvic floor rehabilitation for 10 sessions during 3 months. After assessment, myofascial release techniques and progressive pelvic floor muscles exercise was performed for patients based on their primary strength. Finally, patients were compared in terms of the severity of dyspareunia, sexual performance status (by using female sexual function index questionnaire), improvement of symptoms, pelvic floor muscle strength and endurance before (first session of physiotherapy) and after (after 3 months) investigation.
Results: In the remaining 32 patients with dyspareunia with a mean age of 38±1.24 years, desire index score 0.95 unit, arousal index score 1.01 unit, lubrication index score 0.67 unit, orgasm index score 0.71 unit, satisfaction index score 1.03 unit, pain index score was increased 1.05 unit, strength index score 2.44 unit, endurance index score 7.06 unit were increased in comparison to before the investigation that showed a significant different with P< 0.0001.
Conclusion: According to obtained results, pelvic floor physical therapy had a significant effect in women with dyspareunia. So that the severity of dyspareunia, pelvic floor muscle strength and endurance had clinically significant improvement after pelvic floor physiotherapy.
Fariba Jaffary , Mohammad Ali Nilforoushzadeh , Hanieh Sharifian Koupaiee , Gita Faghihi , Seyed Mohsen Hosseini , Fateme Sokhanvari , Nazli Ansari , Giti Sadeghian ,
Volume 75, Issue 1 (4-2017)
Abstract
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Background: Acne vulgaris is self-limiting, multifactorial disease involving sebaceous glands. Omeprazole is a proton pump inhibitor with in vitro antibacterial effects against staphylococcus aureus and anti-androgen that can be potential treatment of acne vulgaris. This study was designed to evaluate the efficacy of oral omeprazole and erythromycin 4% compared to doxycycline combination therapy in the treatment of acne vulgaris.
Methods: In this clinical trial study, patients with moderate acne were referred to Skin Diseases and Leishmaniasis Research Center, Isfahan University of Medical Science, Iran, during August 2014 until November 2015 and were randomized into two groups receiving topical erythromycin 4% plus omeprazole (34 patients) or doxycycline (35 patients) for 3 months. Moderate acne, lack of sensitivity to proton pump inhibitors, lack of warfarin, phenytoin, diazepam consumption, lack of active liver or kidney disease, being older than 12 years, were considered as inclusion criteria. Pregnant or lactating patients, patients with drug allergy history, patients taking oral contraceptives, acne topical medications (including retinoids) or systemic treatment within 30 days of study, patients with oligomenorrhea, hirsutism, acne conglobata, acne fulminant or body acne alone were excluded from the study. All patients were tested for Helicobacter pylori test at the beginning of the study.
Results: Both inflammatory and non-inflammatory lesions decreased in both groups with negative correlation with age (P< 0.05). There was no significant correlation between positive Helicobacter pylori test and inflammatory or non-inflammatory lesion reduction (P= 0.794, P= 0.514). Also, patient satisfaction and rate of total drug side effects was not different between two treatment groups. Rate of skin reactions was 20.58% in omeprazole treated group and 11.42% in doxycycline group. For side effects, other than skin it was 2.94% versus 14.28% respectively.
Conclusion: Omeprazole could be suggested as an alternative for doxycycline in the treatment of patients with moderate acne vulgaris especially in non-inflammatory lesions.
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Alireza Mahoori , Ebrahim Hassani , Nazli Karami , Mehrdad Azizpoure ,
Volume 75, Issue 5 (8-2017)
Abstract
Background: Tracheal intubation and direct laryngoscopy are powerful noxious stimuli that can elicit sever hemodynamic responses. These hemodynamic responses should be attenuated by appropriate use of premedication, smooth induction of anesthesia and rapid tracheal intubation. Gabapentin and pregabalin have been suggested in several studies to be efficient. Gabapentin is an antiepileptic drug and a structural analogue of gamma-Aminobutyric acid (GABA) but it does not act through GABA receptors and pregabalin, is also an antiepileptic agent. The aim of this study was to compare the effect of gabapentin and pregabalin as premedication for attenuation of hemodynamic response to laryngoscopy and endotracheal intubation.
Methods: In a prospective double blinded randomized clinical trial, during April 2015 to March 2016 in Urmia Imam Khomeini Hospital, a total of ninety normotensive adult consented patients, candidate to elective abdominal surgery aged 20-50 years, American Society of Anesthesiologist (ASA) class I, of both gender were randomized into three groups. Patients in group I received oral placebo, group II received oral gabapentin 900 mg and group III patients received oral pregabalin 150 mg two hours prior to induction of anesthesia. Anesthetic technique was same in three groups and all groups were assessed for hemodynamic changes such as heart rate, systolic blood pressure and diastolic blood pressure, after the premedication, before and after induction of anesthesia, and 1, 3 and 5 minutes. after laryngoscopy and tracheal intubation.
Results: Significant increase in heart rate and systolic blood pressure and diastolic arterial pressure was observed in placebo group after tracheal intubation, while statistically significant attenuation of hemodynamic changes was seen in gabapentin and pregabalin groups. (P=0.001) No adverse outcome was reported in the study groups.
Conclusion: Oral gabapentin premedication is effective for control of hemodynamic pressor response of laryngoscopy and tracheal intubation. The study data showed that the pregabalin have the same effect. Pregabalin and gabapentin are both useful and safe for control of hemodynamic pressor response as premedication.
Bahman Hasannasab , Nadia Banihashem , Shahram Seyfi , Manizheh Yazdanmehr ,
Volume 76, Issue 6 (9-2018)
Abstract
Background: The post-dural puncture headache (PDPH) is a common complication in spinal anesthesia. Headache may occure seven days after dural puncture. The headache may be worsened in sitting position and be better in supine position. PDPH is common in younger and tall people. The incidence rate of PDPH related to the size of spinal needle and the number of try and decrease with small, cutting needle and less puncture try. PDPH is a well-known iatrogenic complication of spinal anesthesia, which continues to be a major problem. In this study, we assessed the effect of intravenous aminophylline on prevention of post-spinal anesthesia headache in who were elective for cesarean sections.
Methods: This double-blind randomized clinical trial was conducted on 140 women with 18 to 35 years old and American Society of Anesthesiologists Classification (ASA Class) I and II undergoing spinal anesthesia in elective cesarean section. Patients were randomly divided into two groups called case and control. After umbilical cord clamping 1 mg/kg aminophylline dissolved in 100 cc normal saline was infused to the case group but only 100 cc normal saline was infused for the control group. Patient's blood pressure and heart rate were recorded before spinal anesthesia, immediately after spinal anesthesia, after uterine incision and umbilical cord clamping, after drug injection and then every five minutes. The incidence of headache was assessed at 4, 8, 24, 48 and 72 hours after the surgery.
Results: Although severity and duration of headache in case group was more than in control group, no meaningful difference was found between two groups. The mean changes in systolic blood pressure were greater in control group (P<0.001). The mean changes in heart rate was greater in case group than control group (P<0.001).
Conclusion: This study showed that intravenous aminophylline although, caused hemodynamic changes in some case, but it doesn't have any effect on prevention of incidence and severity of post-spinal anesthesia headache in elective cesarean section.
Fatemeh Nasimi , Hossein Zeraati , Javad Shahinfar , Mohammadreza Safdari , Ali Esmaeili , Maryam Ghorbanzadeh ,
Volume 78, Issue 2 (5-2020)
Abstract
Background: Premature infants undergo a lot of stressors during treatment procedures in the neonatal intensive care units which causes significant physiological changes in these neonates. Multi-sensory stimulation is a broad category of interventions designed to improve the evolutionary and physiological outcomes of premature infants hospitalized in the neonatal intensive care unit to minimize stress in this environment. So, the study aimed to evaluate the effect of multi-sensory stimulation on physiological parameters in preterm infants.
Methods: This double-blind clinical trial conducted in the neonatal intensive care unit of Shahid Motahari Hospital in Jahrom from April to December 2016. In this study, 80 preterm infants with a gestational age of 34 to 36 weeks were selected by non-probability sampling method and were randomly divided into two groups of multi-sensory stimulation and control. Neonates in the intervention group received a multi-sensory stimulation program for 60 minute. The multi-sensory stimulation program was included a combination of auditory, tactile, motor and visual stimulation. The preterm infants in the control group received only usual care. The data collecting tool was a questionnaire and checklist for physiological parameters of preterm infants.
Results: The results showed that the two groups were homogeneous in terms of fetal age, birth weight, the height of birth, first and fifth minute Apgar score of birth. The results showed that there was no significant difference between the mean of physiological indexes in the two groups before the intervention. Statistical tests showed that there was a decreasing trend in the average of all physiological indices during the intervention (first and second half during the intervention) (P<0.001), However, these changes were not significant in the control group (P<0.05). Also, analysis of variance (ANOVA) with repeated measures showed that there was a significant difference between changes in physiological variables between the two groups at different stages of evaluation (P<0.001).
Conclusion: Multi-sensory stimulation leads to a decrease in heart rate and respiratory rate and the stability of blood pressure in preterm infants.
Hossein Shakeri , Aliasghar Arabi Mianroodi , Mohammadali Haghbin , Narges Khanjani ,
Volume 78, Issue 3 (6-2020)
Abstract
Background: A major problem in surgical procedures is postoperative pain. The effectiveness of prescribing preoperative tizanidine in reducing postoperative pain is not clear. The aim of this study was to determine the efficacy of tizanidine as a premedication in reducing pain after septoplasty.
Methods: This double blind clinical trial study was performed in 71 patients aged from 18 to 50 years, undergoing septoplastic surgery for the first time, who were classified in ASA (American Society of Anesthesiologists) classes 1 and 2 in the Ear, Nose, and Throat (ENT) Department of Shafa Hospital, in Kerman, Iran from April 2014 to March 2015. Patients were randomly assigned into two groups using numbers from a randomization table. A dosage of 4 mg of tizanidine was administered orally to the patients two hours before the surgery (septoplasty) in the intervention group. In the control group, placebo pills which were 100 mg vitamin B1 were prescribed. The severity of pain was measured and recorded after 4 and 8 hours, and the morning after the surgery.
Results: 62 patients (87.32%) were male and 9 (12.68%) were female. The mean age of the subjects was 24.6±7.5 years. The two groups were similar in regard to age (P=0.54), but the duration of surgery was different in the two groups (P=0.038) and was longer in the group that received tizanidine. The mean of pain was different between the two groups, after 4 hours and was significantly higher in the group that received tizanidine (P=0.043). The mean of pain was not significantly different between the two groups after 8 hours (P=0.95) or one day after surgery (P=0.79).
Conclusion: Although some researchers have reported that taking tizanidine before some surgeries may reduce postoperative pain, in this study the administration of tizanidine before surgery was not effective in reducing pain after septoplasty.
Alireza Rai, Siros Amiri, Mohammadreza Sobhiyeh,
Volume 78, Issue 4 (7-2020)
Abstract
Background: The ineffectiveness of hemodialysis fistulas causes high costs and increases mortality and morbidity rates. The efficacy of drug-coated balloon and nondrug-coated balloon in dysfunctional arteriovenous Fistula was evaluated over six month period.
Methods: In this randomized clinical trial, a total of a total of 50 hemodialysis patients who referred to Imam Reza Hospital in Kermanshah for failing of arteriovenous fistula in 2018 year, were randomly divided into two separate groups of drug-coated balloon angioplasty and non-drug coated balloon angioplasty. All of these procedures were done with the same surgeon. Patients were followed-up for 6 months. Variables and data of patients like age, gender, diabetes mellitus, hypertension, and location of arteriovenous fistula were documented and analyzed by SPSS software, version 21 (SPSS Inc., Chicago, IL, USA) using statistical tests. T-test and chi-square test were used for data analysis and the significance level was considered less than 0.05.
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Results: The success rate of drug-coated balloon angioplasty versus plain balloon angioplasty in the efficacy of arteriovenous fistulas increased significantly (19 vs. 6 and 13 vs. 12, respectively, P<0.05). There is also a significant relationship between age and diabetes over the lifetime of the arteriovenous fistula. According to results, the efficacy of arteriovenous fistula in the elderly patients (>65 years) and the diabetes mellitus patients were lower than other risk factors causing end-stage renal disease.
Conclusion: According to the results of this study, the use of drug-coated balloons rather than non drug-coated balloon is more effective in the efficiency of arteriovenous artery fistula.
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Arash Bostani, Hadi Gharabaghian Azar, Mehdi Jafari, Mastane Babaei Gramkhani,
Volume 80, Issue 1 (4-2022)
Abstract
Background: Multiple sclerosis (MS), as an inflammatory autoimmune disease and chronic degenerative central nervous system degeneration, often occurs in early adulthood. One of the common and debilitating symptoms of this disease is fatigue, which can affect up to 80% of patients with MS. This study aimed to evaluate the effectiveness of magnetic field therapy on fatigue in patients with MS.
Methods: Present study is a single-blind randomized clinical trial (RCT) that Was conducted on patients with multiple sclerosis from March 2019 to September 2021. In this study, 46 patients who met our inclusion criteria were divided into two groups randomly: magnetotherapy intervention and control group. The intervention was performed in the form of a pulsed magnetic field with a frequency of 15 Hz and an intensity of 4.5 Millie Tesla. In order to blind patients, they were unaware of the intervention or control group, and the technician in charge of the treatment and the statistician knew about it. Data were then collected and recorded using the Fatigue Severity Scale, the Patient Health Questionnaire, and the Epworth Sleepiness Scale Questionnaire.
Results: Of the 46 patients studied, 22 (48%) were male and the rest of them were female [24 cases (52%)]. The mean age of men and women was 34.4±7.3 and 33.5±1.7 years, respectively. Among the intervention and control groups, 8 people took amantadine equally in each group. In the magneto-therapy intervention group, the mean severity of fatigue reduced from 4.91±0.86 to 4.27±1.10, which was significant (p=0.024). In our control group, the mean intensity of fatigue reduced from 4.83±0.83 to 4.37±0.81, which was significant statistically (p=0.028). Although, the difference between the response of the two groups to treatment was not significant (p=0.382).
Conclusion: Due to the lack of significant differences in the reduction of fatigue severity, this treatment is not recommended for the treatment and management of fatigue in patients with MS.
