scholarly journals The Comparison of the Effect of Repetitive Doses of Succinylcholine and Thiopental Sodium on the Duration and Severity of Seizure in Electro Convulsive Therapy: Randomized Clinical Trial

2019 ◽  
pp. 1-8
Author(s):  
Farhad Nanaei ◽  
Hadi Bahrami ◽  
Aziz Kasani
Keyword(s):  
Clinical Trial ◽  
Randomized Clinical Trial ◽  
Initial Dose ◽  
Psychiatric Ward ◽  
Convulsive Therapy ◽  
Treatment Groups ◽  
Significant Difference ◽  
Thiopental Sodium ◽  
Hypnotic Drugs

Background and Aim: Regarding the controversial results on the effects of anesthetics, especially thiopental sodium, on the duration and severity of seizure and the lack of adequate information on the use of doses of anesthetic and paralysing drugs during ECT, this study was designed to determine the effect of repetitive doses of succinylcholine and Thiopental sodium was administered on the duration and severity of seizure during ECT. Materials and Methods: The present study was a one-blind randomized clinical trial on patients admitted to the psychiatric ward of Dezful Ganjavian Hospital. The research samples were selected after informed consent and entry criteria. Then, the samples were randomly assigned to two groups. In one group, succinylcholine dose was repeated (one third of the initial dose), and in the other group, the dose of thiopental sodium was repeated (one third of the initial dose). In all patients, seizure duration based on EEG monitoring and severity of seizure was determined by the psychiatrist based on the symptoms of the patient during seizure. Results: There was a significant difference between the quality of seizure in the two treatment groups after the intervention. There was a strong and good seizure in the thiopental sodium group (p <0.0001). There was a significant difference between the variables of seizure status in comparison with the previous shock in the two treatment groups after the intervention (p <0.0001). The duration of seizure was higher in thiopental sodium treatment group, but no significant difference was observed (p = 0.82). Conclusion: The results of this study showed that the duration and quality of seizure was better in patients requiring repetitive doses of hypnotic drugs (Thiopental Sodium), which was used to repeat the dose of muscle relaxant (succinylcholine).

scholarly journals Improving Rehabilitation for Patients with Intermittent Claudication: A Randomized Controlled Trial with a Mixed-Methods Evaluation (The CIPIC Rehab Study)

2021 ◽  
Author(s):  
Maj Siercke ◽  
Sanne Pagh Moller ◽  
Lau Caspar Thygesen ◽  
Henrik Sillesen ◽  
Dorthe Overgaard
Keyword(s):  
Quality Of Life ◽  
Physical Activity ◽  
Clinical Trial ◽  
Mixed Methods ◽  
Usual Care ◽  
Randomized Clinical Trial ◽  
Intermittent Claudication ◽  
Walking Distance ◽  
Significant Difference

Aim: This study aimed to explore how qualitative data about rehabilitation for patients with intermittent claudication do provide an enhanced understanding of the quantitative experimental results. Background: The study was a randomized clinical trial comparing a rehabilitation intervention with usual care. A statistically significant difference between rehabilitation and usual care was found in walking distance, physical activity, quality of life and diet. The findings from the quantitative and qualitative analyses were analysed separately on their own tradition. In this study, mixed methods address whether the qualitative results could help explain the quantitative results and bring forward additional information. Design: Complex mixed-method intervention design with a convergent questionnaire variant. Methods: From April 2017- May 2019, patients diagnosed with intermittent claudication were included in a randomized clinical trial (N=118). In addition, qualitative interview informants from the intervention group were sampled from the quantitative study population for a survey (N=43) and focus group interviews (N=10). Interviews were conducted from April 2018-August 2019. Results: Integrated analyses identified how improvement in walking distance, physical activity, diet and quality of life was affected by team spirit, pedometer, education and fun exercise in a local setting. Quantitative and qualitative findings primarily confirmed and expanded each other; however, two discordant results were also evident. Conclusion: Our study adds empirical evidence regarding how a mixed-methods study can be used to obtain a more nuanced understanding of complex healthcare problems. The study provides new knowledge concerning how to set up a rehabilitation programme for patients with intermittent claudication.

scholarly journals A randomized clinical trial of chlorambucil versus COP in stage B chronic lymphocytic leukemia. The French Cooperative Group on Chronic Lymphocytic Leukemia

Blood ◽  
1990 ◽  
Vol 75 (7) ◽  
pp. 1422-1425 ◽  
Keyword(s):  
Clinical Trial ◽  
Overall Survival ◽  
Chronic Lymphocytic Leukemia ◽  
Randomized Clinical Trial ◽  
Survival Rates ◽  
Lymphocytic Leukemia ◽  
Cooperative Group ◽  
Survival Times ◽  
Treatment Groups ◽  
Significant Difference

Abstract In 1980, the French Cooperative Group on Chronic Lymphocytic Leukemia started a randomized clinical trial in which intermediate prognosis patients (stage B) received either an indefinite course of chlorambucil (0.1 mg/kg/d) or 12 cycles of the COP regimen (vincristine, cyclophosphamide, and prednisone). We present the results of the third interim analysis based on 291 patients (151 in the chlorambucil group and 140 in the COP group) with a mean follow-up of 53 months at the reference date of June 1, 1987. At this date, 129 deaths were observed, 65 in the chlorambucil group and 64 in the COP group; there was no improvement in overall survival with the COP regimen (P = .44) even after adjusting for both prognostic and imbalanced factors (P = .24). The 3-year and 5-year overall survival rates were, respectively, 69% and 44% in the chlorambucil group as compared with 73% and 43% in the COP group. The median survival times were 58 months in the chlorambucil group and 57 months in the COP group. Moreover, no significant difference was observed between the two treatment groups in terms of either treatment response, 9-month status, time to disease progression to stage C, or causes of death.

scholarly journals A randomized clinical trial of chlorambucil versus COP in stage B chronic lymphocytic leukemia. The French Cooperative Group on Chronic Lymphocytic Leukemia

Blood ◽  
1990 ◽  
Vol 75 (7) ◽  
pp. 1422-1425 ◽  
Keyword(s):  
Clinical Trial ◽  
Overall Survival ◽  
Chronic Lymphocytic Leukemia ◽  
Randomized Clinical Trial ◽  
Survival Rates ◽  
Lymphocytic Leukemia ◽  
Cooperative Group ◽  
Survival Times ◽  
Treatment Groups ◽  
Significant Difference

In 1980, the French Cooperative Group on Chronic Lymphocytic Leukemia started a randomized clinical trial in which intermediate prognosis patients (stage B) received either an indefinite course of chlorambucil (0.1 mg/kg/d) or 12 cycles of the COP regimen (vincristine, cyclophosphamide, and prednisone). We present the results of the third interim analysis based on 291 patients (151 in the chlorambucil group and 140 in the COP group) with a mean follow-up of 53 months at the reference date of June 1, 1987. At this date, 129 deaths were observed, 65 in the chlorambucil group and 64 in the COP group; there was no improvement in overall survival with the COP regimen (P = .44) even after adjusting for both prognostic and imbalanced factors (P = .24). The 3-year and 5-year overall survival rates were, respectively, 69% and 44% in the chlorambucil group as compared with 73% and 43% in the COP group. The median survival times were 58 months in the chlorambucil group and 57 months in the COP group. Moreover, no significant difference was observed between the two treatment groups in terms of either treatment response, 9-month status, time to disease progression to stage C, or causes of death.

scholarly journals Topical estrogen, testosterone, and vaginal dilator in the prevention of vaginal stenosis after radiotherapy in women with cervical cancer: a randomized clinical trial

BMC Cancer ◽  
2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Jumara Martins ◽  
Ana Francisca Vaz ◽  
Regina Celia Grion ◽  
Lúcia Costa-Paiva ◽  
Luiz Francisco Baccaro
Keyword(s):  
Clinical Trial ◽  
Cervical Cancer ◽  
Randomized Clinical Trial ◽  
Open Label ◽  
Treatment Groups ◽  
Vaginal Stenosis ◽  
Significant Difference ◽  
Vaginal Dilators ◽  
The Mean ◽  
Topical Estrogen

Abstract Background We aimed to evaluate the effects of different therapeutic options to prevent the evolution of vaginal stenosis after pelvic radiotherapy in women with cervical cancer. Methods open-label randomized clinical trial of 195 women, stage I-IIIB, aged 18–75 years, using topical estrogen (66), topical testosterone (34), water-based intimate lubricant gel (66), and vaginal dilators (29) to assess the incidence and severity of vaginal stenosis after radiotherapy at UNICAMP-Brazil, from January/2013 to May/2018. The main outcome measure was vaginal stenosis assessed using the Common Terminology Criteria for Adverse Events (CTCAE) scale and percental changes in vaginal volume. The women were evaluated at four different times: shortly after the end of radiotherapy, and four, eight, and 12 months after the beginning of the intervention. Statistical analysis was carried out using Symmetry test, Kruskal-Wallis test and multiple regression. Results the mean age of women was 46.78 (±13.01) years, 61,03% were premenopausal and 73,84% had stage IIB-IIIB tumors. The mean reduction in vaginal volume in the total group was 25.47%, with similar worsening in the four treatment groups with no statistical difference throughout the intervention period. There was worsening of vaginal stenosis evaluated by CTCAE scale after 1 year in all groups (p < 0.01), except for the users of vaginal dilator (p = 0.37). Conclusions there was a reduction in vaginal volume in all treatment groups analyzed, with no significant difference between them. However, women who used vaginal dilators had a lower frequency and severity of vaginal stenosis assessed by the CTCAE scale after one year of treatment. Trial registration Brazilian Registry of Clinical Trials, RBR-23w5fv. Registered 10 January 2017 - Retrospectively registered.

scholarly journals The Effect of Pelvic Floor Muscle Strengthening Exercise on Urinary Incontinence and Quality of Life in Patients after Prostatectomy: a Randomized Clinical Trial

2020 ◽  
Vol 9 (1) ◽  
pp. 33-38
Author(s):  
Seyedeh Fatemeh Jalalinia ◽  
Majid Raei ◽  
Vahid Naseri-Salahshour ◽  
Shokoh Varaei
Keyword(s):  
Quality Of Life ◽  
Clinical Trial ◽  
Urinary Incontinence ◽  
Pelvic Floor ◽  
Randomized Clinical Trial ◽  
Pelvic Floor Muscle ◽  
Statistical Tests ◽  
Pelvic Floor Muscle Exercises ◽  
Significant Difference

Introduction: Urinary incontinence is a common problem after Prostatectomy that affects patients’ life. Nurses can assist patients in improving urinary problems. This study aimed to assess the effects of pelvic floor muscle exercises on urinary incontinence and the quality of life in patients after Prostatectomy. Methods: This randomized clinical trial was performed on 60 patients with suprapubic prostatectomy and urinary incontinence who had referred to urology department of Vali-e-Asr Hospital in Tehran. The subjects were selected and randomly divided into control and intervention groups. The control and intervention groups received standard care and pelvic floor muscles exercises after surgery, respectively. The data were gathered in the course of seven days; one, two and three months after surgery, using three questionnaires and a check list for the evaluation of urinary incontinence and assessing Quality of Life. The data were then analyzed, using SPSS ver.13, and statistical tests such as t-test, ANOVA and Chi- square. Results: The quality of life and urinary incontinence score before intervention were not significant between two groups. The findings showed that there was a statistically significant difference between two groups in the average scores of urinary incontinence and the quality of life after intervention. Conclusion: Pelvic muscles exercises reduced urinary incontinence and enhanced quality of life. It’s recommended as a non-pharmacologic, non-invasive way to control urinary incontinence. Patients with adequate cognitive and mental abilities can easily be trained on pelvic floor muscle exercises.

Post-Tympanostomy Otorrhea: A Randomized Clinical Trial of Topical Prophylaxis

1992 ◽  
Vol 106 (1) ◽  
pp. 34-41 ◽  
Author(s):  
Bruce A. Scott ◽  
Chester L. Strunk
Keyword(s):  
Clinical Trial ◽  
Randomized Clinical Trial ◽  
Middle Ear ◽  
Tube Placement ◽  
Tympanostomy Tube ◽  
Treatment Groups ◽  
Time Of Surgery ◽  
Significant Difference ◽  
Tympanostomy Tubes ◽  
Prophylactic Use

Myringotomy with the insertion of tympanostomy tubes has become the most frequently performed otolaryngologic procedure, and otorrhea is the most common post-tympanostomy complication. Many otolaryngologists routinely use prophylactic topical antibiotic solutions when performing tympanostomy tube placement. Relatively little has been written regarding early post-tympanostomy otorrhea and scarcely any examining the efficacy of such prophylaxis. The current study is a randomized clinical trial to critically evaluate the efficacy of prophylactic otic drops after tympanostomy tube placement. The ototoxic potential of these solutions, combined with constant pressures to decrease medication expenses and eliminate unnecessary use of antibiotics, makes determination of the shortest effective course of application paramount. Subjects were randomized at the time of surgery into one of three groups; one group received no prophylaxis, a second group received gentamicin otic drops Immediately after tympanostomy tube placement in the operating room only, and the third group received an additional 48 hours of drops (4 drops in each ear, three times a day). All patients were seen within 2 weeks postoperatively. An overall early post-tympanostomy otorrhea incidence of 8.7% is documented with 12%, 8.8%, and 5.6% for each study group, respectively. While these findings may suggest possible efficacy of topical prophylaxis, a statistically significant difference between the treatment groups was not proved ( p = 0.62). Further analysis by subdivision of the patients, on the basis of middle ear cavity finding at the time of surgery, reveals a highly significant statistical association of the occurrence of post-tympanostomy otorrhea in ears having mucoid effusions ( p < 0.001) as compared to ears without effusion or with serous effusions. On the basis of the results of this randomized trial, the routine prophylactic use of potentially ototoxic topical solutions does not appear to be Justified in patients found to have a middle ear cleft that is dry or has a serous effusion. Patients found to have mucoid effusions are at statistically significantly higher risk of development of otorrhea postoperatively. Use of prophylactic otic drops may be indicated in this group.

Dexmedetomidine versus Midazolam-Fentanyl in Procedural Analgesia Sedation for Reduction of Anterior Shoulder Dislocation: A Randomized Clinical Trial

2019 ◽  
Vol 14 (4) ◽  
pp. 269-274
Author(s):  
Kambiz Masoumi ◽  
Seyyed Javad Maleki ◽  
Arash Forouzan ◽  
Ali Delirrooyfard ◽  
Saeed Hesam
Keyword(s):  
Clinical Trial ◽  
Randomized Clinical Trial ◽  
Significant Relationship ◽  
Initial Dose ◽  
Shoulder Dislocation ◽  
The Body ◽  
Anterior Shoulder Dislocation ◽  
Joint Dislocation ◽  
Group I ◽  
Significant Difference

Background: Shoulder joint dislocation is the most common dislocation of joints in the body. To reduce the anterior shoulder dislocation, it is necessary to have analgesia and sedation. Methods: In this randomized clinical trial, patients were divided into two equal groups. Group I received midazolam-fentanyl (0.05 mg/kg fentanyl at a dose of 1 µg/kg) for 10 minutes and group II received dexmedetomidine (1 µg/kg in the initial dose and then 0.2 µg/kg/h) for 10 minutes. The levels of analgesia according to VAS criteria and the time to reach desired sedation were compared between the two groups. Results: A total of 60 patients participated in this study. The time to reach the desired sedation was 8.60 ± 2.3 minutes in the dexmedetomidine group and 11.27 ± 3.57 minutes in the midazolamfentanyl group (p= 0.001). Also, the VAS score in both midazolam-fentanyl and dexmedetomidine groups was 3.3 ± 1.24 and 2.57 ± 0.9, respectively. The differences were statistically significant (p=0.015). There was significant relationship between the time to reach desired sedation and the level of analgesia. Moreover, there was no significant difference between patient age and the time to reach the desired level of analgesia. During this study, no side effect was observed. Conclusion: The findings of this study show that dexmedetomidine provides a higher level of analgesia than midazolam-fentanyl. Moreover, it was also shown that dexmedetomidine causes quicker procedural sedation than midazolam-fentanyl.

scholarly journals Melatonin as a Potential Prophylactic Therapy for Menstrual-Related Migraine Headache: A Randomized Clinical Trial

2020 ◽  
Vol 7 (4) ◽  
Author(s):  
Elham Mohammadyahya ◽  
Payam Sarraf ◽  
Nina Javadian ◽  
Mamak Shariat ◽  
Sama Bitarafan ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Drug Use ◽  
Sleep Quality ◽  
Randomized Clinical Trial ◽  
Blood Level ◽  
Melatonin Level ◽  
Berlin Questionnaire ◽  
Treatment Groups ◽  
Significant Difference

Background: Migraine is a common disabling and chronic neurological disorder affecting women aged 25 - 55 with a considerably higher frequency. It has been shown that migraine attack rates change according to the hormonal changes during the menstrual cycle. A study showed that reduced progesterone levels, especially during the end days of the luteal phase and menstruation, are associated with increased episodes of attacks in more than half of the migraine patients. Moreover, another study suggested that the melatonin level changes are positively correlated with the progesterone blood level. Previous studies indicated that the level of nocturnal urinary melatonin is lower in patients with menstrual-related migraine than in healthy subjects. Objectives: Considering the potential role of melatonin in the circadian system and its relationship with gonadal steroid blood level changes in patients, we aimed to investigate the therapeutic efficacy of melatonin in patients with menstrual-related migraines. Methods: An open-label randomized clinical trial was conducted (IR code: IRCT20121110011424N4). Patients with menstrual-related migraine referring to the Neurology Clinic of Imam Khomeini Hospital were evaluated and randomly assigned to either naproxen (250 mg every 12 hours) or melatonin (3 mg, half an hour before sleep) treatment groups. At the end of the first and third menstrual bleeding phases, the patients were assessed by a migraine diary, Visual Analog scale (VAS) for pain, and the Berlin questionnaire. Results: The study evaluated 56 patients (26 in the melatonin arm and 30 in the naproxen arm). Attack days (P < 0.001) and the headache severity (P < 0.001) improved in both groups compared to baseline. A significant difference was found between the melatonin and naproxen treatment groups in sedative and analgesic drug use (P < 0.05). Also, melatonin significantly changed the snoring rate and post-sleep tiredness compared to baseline (P < 0.05 and P < 0.05, respectively) whereas no improvement was observed in the naproxen treatment group concerning the sleep quality. Conclusions: We showed the beneficial role of melatonin in reducing the attack frequency and severity in migraine patients with menstrual-related headaches. Preventive therapy with melatonin also showed a significant reduction in the number of sedative drug use during attacks and improved the patients’ sleep quality when compared to naproxen.

scholarly journals Improving Rehabilitation for Patients with Intermittent Claudication: A Randomized Controlled Trial with a Mixed-Methods Evaluation (The CIPIC Rehab Study)

2021 ◽  
pp. 1-13
Author(s):  
Maj Siercke ◽  
Maj Siercke ◽  
Sanne Pagh Moller ◽  
Lau Caspar Thygesen ◽  
Henrik Sillesen ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Physical Activity ◽  
Clinical Trial ◽  
Mixed Methods ◽  
Usual Care ◽  
Randomized Clinical Trial ◽  
Intermittent Claudication ◽  
Walking Distance ◽  
Significant Difference

Aim: This study aimed to explore how qualitative data about rehabilitation for patients with intermittent claudication do provide an enhanced understanding of the quantitative experimental results. Background: The study was a randomized clinical trial comparing a rehabilitation intervention with usual care. A statistically significant difference between rehabilitation and usual care was found in walking distance, physical activity, quality of life and diet. The findings from the quantitative and qualitative analyses were analysed separately on their own tradition. In this study, mixed methods address whether the qualitative results could help explain the quantitative results and bring forward additional information. Design: Complex mixed-method intervention design with a convergent questionnaire variant. Methods: From April 2017- May 2019, patients diagnosed with intermittent claudication were included in a randomized clinical trial (N=118). In addition, qualitative interview informants from the intervention group were sampled from the quantitative study population for a survey (N=43) and focus group interviews (N=10). Interviews were conducted from April 2018-August 2019. Results: Integrated analyses identified how improvement in walking distance, physical activity, diet and quality of life was affected by team spirit, pedometer, education and fun exercise in a local setting. Quantitative and qualitative findings primarily confirmed and expanded each other; however, two discordant results were also evident. Conclusion: Our study adds empirical evidence regarding how a mixed-methods study can be used to obtain a more nuanced understanding of complex healthcare problems. The study provides new knowledge concerning how to set up a rehabilitation programme for patients with intermittent claudication.

scholarly journals ART Acceptability in children: A Randomized Clinical Trial

2012 ◽  
Vol 53 (1) ◽  
pp. 27-31 ◽  
Author(s):  
Patricia Blaya Luz ◽  
Cecilia Romero Meller ◽  
Sonia Blauth Slawutsky ◽  
Juliana Sarmento Barata ◽  
Fernando Borba de Araújo
Keyword(s):  
Clinical Trial ◽  
Randomized Clinical Trial ◽  
Group Treatment ◽  
Test Group ◽  
Control Group ◽  
Primary Molar ◽  
Treatment Groups ◽  
Significant Difference ◽  
Before And After ◽  
Short Time

Purpose: The aim of the present study was to compare the acceptability of the ART and the conventional restoration approaches in children. Methods: The sample of the current randomized clinical trial was 30 children 4 to 7 years old who had at least one class II active cavity in a primary molar that was accessible to hand instruments. The treatment groups were: Control Group- treatment with local anesthesia, rubber dam, rotary instruments and composite resin. Test Group- treatment according to ART approach using only hand instruments, no anesthesia and glass ionomer. In both groups, only the demineralized carious tissue and unsupported enamel were removed. The acceptability of the two groups was assessed by measuring the emotional feelings represented by Face Image Scale (FIS) before and after the procedure. Results: There was no significant difference between the two groups regarding changes in FIS scores. Fifty percent of the children from the Test Group got more satisfied after the procedure, while 64% of the participants from Control Group did not change their feelings. Conclusion: The ART approach had not demonstrated to have a best acceptability then the conventional approach. However the short time taken to complete the procedure seems to be worthy aspects when dealing with very young children or patients with behaviors problems.

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