Single-blind Comparative Trial Research Articles

Safety of removal of ProSeal laryngeal mask airway in children in the supine versus lateral position in a deep plane of anesthesia: A randomized controlled trial.

When a ProSeal laryngeal mask airway (PLMA) is removed with the child in a deep plane of anesthesia, the upper airway muscle tone and protective upper airway reflexes may be obtunded. To determine whether the supine or lateral position is safer for the removal of a PLMA in deeply anesthetized children by comparing the incidence of upper airway complications. This randomized single-blind comparative trial was conducted at a tertiary care hospital between January 2020 and September 2020. Forty children of the American Society of Anesthesiologists class I/II of ages 1-12 years age undergoing surgery under general anesthesia with PLMA used as the definitive airway device were recruited. Patients were randomly allocated to lateral group or supine group for PLMA removal in a deep plane of anesthesia in the lateral or supine position. The primary outcome was the number of patients experiencing one or more upper airway complications and the secondary outcomes were incidence of individual respiratory adverse effects and of severe airway complications. The incidence of airway complications was 30% in the supine group and 20% in the lateral group (P = 0.6641). Incidence of laryngospasm, immediate stridor, and excessive secretions were similar. Early stridor and oxygen desaturation were higher in the supine group (P = 0.0374, P = 0.0183 respectively). The overall incidence of upper airway complications was similar with the removal of a PLMA in the supine or lateral position in deeply anesthetized children. The incidence of oxygen desaturation and stridor were higher with PLMA removal in the supine as compared to the lateral position.

Impact of Yoga as an Add-On Intervention on Neurocognitive Functions Among Adult Athletes: A Pilot Study.

Athletes are vulnerable to musculoskeletal injuries and psychiatric conditions. Previous studies have reported the benefits of yoga on cognitive functions among healthy children, adults, and the elderly. This pilot study aimed to test the neurocognitive functions among athletes with/without yoga intervention. A non-randomized, two-armed parallel-group, single-blind comparative trial was used. The participants were grouped into (i) yoga with sports activity (YSA, n = 15) and (ii) sports activity alone (SA, n = 14). The subjects were assessed at the baseline and after a one-month intervention using digit span forward (DSF), digit span backward (DSB), Trail Making Test(TMT) A & B, and Rey Auditory Verbal Learning Test (RAVLT).A comprehensive one-hour yoga training three days a week for two months constitutes selected asanas (postures), pranayama (breathing techniques), relaxation techniques, and meditation techniques. The control group constitutes the routine sports activity for the same period. A paired sample t-test showed a significant improvement in cognitive performance on TMTA & B duration and RAVLT total score in the YSA group comparedwith the SA group. However, asignificant trend was observed for DSF, DSB, and RAVLT immediate recall. Independent sample t-test (pre-post change scores) showed no significant group difference in cognitive performance, except there was a significant trend observed related to DSF (p = 0.053) and RAVLT distraction (p = 0.09), where the yoga group showed better performance in cognitive functions. The results suggest that yoga may be integrated with sports to enhance neurocognitive functions.

Randomised Trial of Pivampicillin Plus Pivmecillinam vs. Pivampicillin in Children and Young Adults with Chronic Obstructive Pulmonary Disease and Infection with Haemophilus lnf luenzae

SummaryA prospective, randomised, single-blind comparative trial was carried out to determine whether double β-lactam treatment with pivampicillin plus pivmecillinam is more effective than pivampicillin alone in the treatment of recurrent and chronic lung infections with Haemophilus influenzae in patients with chronic obstructive pulmonay disease (COPD) or cystic fibrosis (CF). Fifty-six children and young adults with COPD or CF were randomised to the clinical study. The patients were allocated at random to receive perorally either pivmecillinam, 40mg/kg/day, combined with pivampicillin, 50 mg/kg/day, or pivampicillin 50 mglkglday alone for 14 days. A crossover pharmacokinetic study using the same drugs was carried out in 10 CF patients to determine the antibiotic concentrations in serum and sputum after a single dose of each drug. The clinical study showed no signifcant differences in clinical scoring, lung function tests or adverse events after treatment with pivampicillin plus pivmecillinam or pivarnpicillin alone. Follow-up microbiological evaluation 2 and 6 weeks after the end of treatment showed that the offending pathogen was eradicated in 68% of the patients treated with pivampidin plus pivmecillinam and in 67% of the patients treated with pivampicillin alone. Reinfection with another biotype was more common in the combination group (50% vs. 21%) than in the pivampicillin group. In the pharmacokinetic study the median peak serum concentration occurred two hours after intake of tablets.The eficacy of double β-lactam treatment in lung infections with H. influenzae appears to be equivalent to that ofampicillin on clinical lung symptoms, lung function tests, adverse effects and bacteriology.

Endocrinology: A prospective randomized single-blind comparative trial of nafarelin acetate with buserelin in long-protocol gonadotrophin-releasing hormone analogue controlled in-vitro fertilization cycles

The use of gonadotrophin-releasing hormone (GnRH) agonists to control ovulation induction cycles for in-vitro fertilization (IVF) has been shown to increase the pregnancy rate and live birth rate compared with non-analogue cycles. Different formulations of GnRH agonist are available with different routes and frequencies of administration. In this prospective study, the efficacy and safety of intranasal nafarelin and buserelin as adjunctive therapy during IVF were assessed. A total of 240 female patients were recruited to the study and in the first phase patients were randomized to receive either intranasal nafarelin 200 micrograms twice daily or buserelin 200 micrograms five times daily. In the second phase, patients received either nafarelin 400 micrograms twice daily or buserelin 200 micrograms five times daily. Nafarelin 400 micrograms and buserelin 200 micrograms both produced clinical pregnancy rates of 31% per recruit and 39% per embryo transfer. The rates for nafarelin 200 micrograms were 23 and 37% respectively. There was no statistically significant difference in pregnancy rates, by either drug or dosage. The time taken for pituitary down-regulation to be achieved was significantly longer on nafarelin 200 micrograms than on either nafarelin 400 micrograms or buserelin. The total number of days stimulation with human menopausal gonadotrophin required to reach criteria for human chorionic gonadotrophin (HCG) administration was significantly longer on buserelin than on either dose of nafarelin. Median serum oestradiol concentrations on the day of HCG administration were significantly higher on either dose of nafarelin than on buserelin.

The effects of amineptine on the mood and nocturnal sleep of depressed patients

Di Perri, Raoul, Federico Mailland and Placido Bramanti: The effects of amineptine on the mood and nocturnal sleep of depressed patients. Prog. Neuro-Psychopharmacol. & Biol. Psychiat. 1987, 11 : 65–70. 1. 1. The effect of amineptine, a new tricyclic antidepressant, was studied on the sleep of 12 depressed patients. 2. 2. A single blind comparative trial vs placebo was carried out and changes in depression symptoms were recorded using Hamilton Rating Scale for Depression (HRSD). 3. 3. The sleep was evaluated according to the Rechtschaffen and Kales criteria to determine various parameters. 4. 4. Amineptine treatment induced statistically significant reduction of HRSD total score after 14 days of treatment. 5. 5. Polysomnographic analysis revealed significant differences between depressed patients and healthy volunteers.

A COMPARATIVE TRIAL OF CO‐TRIMOXAZOLE AND AMOXYCILLIN IN THE TREATMENT OF ACUTE EXACERBATIONS OF CHRONIC BRONCHITIS

A single-blind comparative trial of the effectiveness of co-trimoxazole and amoxycillin in the treatment of acute exacerbations of chronic bronchitis was carried out on 60 hospital patients. Both forms of treatment were equally effective in producing clinical improvement and reduction of sputum purulence and volume. There was no significant difference, either in the speed of recovery, or in the relapse rate, after treatment with co-trimoxazole and amoxycillin.

Controlled Trial of Nomifensin (HOE 984) and Viloxazine in the Treatment of Depression in the Elderly

The new antidepressant nomifensin (Hoechst 36984), a drug which showed less cardiotoxicity than tricyclics, was compared in a single-blind comparative trial with viloxazine. Forty elderly depressed patients were treated during four weeks. Nomifensin, N=21, 75 mg/day; viloxazine, N=19, 150 mg/day). Antidepressant effects were assessed by the Hamilton Rating Scale (HRS) for depression, and physical disability, by the Northwestern University Disability Scales. The HRS disclosed statistically significant improvement with both treatments. However, the scores in the nomifensin group fell distinctly form the second week on (P less than 0.01). There were no side effects reported spontaneously by the patients. Sinus tachycardia was recorded in two instances (one viloxazine and one nomifensin patient).

Use of combinations of trimethoprim and sulfamethoxazole in the treatment of chest infections.

Combinations of trimethoprim (TMP) and sulfamethoxazole (SMZ) have been used to treat patients with chest infections caused predominantly by Haemophilus influenzae and Diplococcus pneumoniae. In a single blind comparative trial with ampicillin TMP-SMZ was superior in reducing volume of sputum and purulence and in eradicating pathogens from the sputum. Two groups of patients with severe bronchitis received the combination for periods of between three and 30 months, with excellent clinical effect and minimal effects on the blood count. No resistant strains of H. influenzae or D. pneumoniae emerged. Pneumonia, lung abscess, and bronchiectasis were also treated, with excellent clinical response. The pathogenic organisms eradicated from the sputum in these cases included penicillin-resistant staphylococci and Klebsiella. It has been demonstrated that TMP is concentrated in the sputum. This may account for the efficacy of TMP-SMZ in treating chest infections.