scholarly journals Acute Effects of Ketamine Infusion on Postoperative Mood Scores in Patients Undergoing Dilation and Curettage: A Randomized Double-Blind Controlled Study

2021 ◽  
Vol 2021 ◽  
pp. 1-10
Author(s):  
Raham Hasan Mostafa ◽  
Ahmed Mohamed Khamis ◽  
Ashraf Nabil Saleh ◽  
Yehia Mamdouh Hassan Mekki ◽  
Mohamed Mohamed Kamal ◽  
...  
Keyword(s):  
Low Dose ◽  
Controlled Trial ◽  
Acute Effect ◽  
Controlled Study ◽  
Control Group ◽  
Double Blind ◽  
Ketamine Infusion ◽  
Dilation And Curettage ◽  
Post Infusion ◽  
The Impact

Background. Emotional and psychological effects following abortion are more common than physical side effects and can range from mild regret to more serious complications such as depression. In the last decade, it has been suggested that low dose of ketamine is a fast-acting antidepressant. Purpose. The aim of this study was to investigate the impact of intraoperative ketamine infusion on postoperative mood score in patients undergoing Dilation and Curettage (D&C) under spinal anesthesia. We hypothesized that a single low-dose administration of ketamine infusion during D&C surgery can improve mood scores in the immediate postoperative period. Methods. A prospective, randomized, double-blind, parallel-group, placebo-controlled trial. The study included a total of 60 patients, ≥18 years, physical status ASA II, with up to 12-week gestation undergoing elective D&C surgery. Patients were divided randomly into a ketamine group (group K) and a control group (group C). In group K, 0.4 mg/kg ketamine was given as a continuous infusion over 20 min intraoperatively. Main Outcome Measure. Profile of Mood States (POMS) was recorded preoperatively and 2 hours postoperatively. Results. There were no differences in preoperative POMS between the two groups. Mean postoperative POMS of group K was lower than that of group C indicating mood improvement. Ketamine group patients showed higher sedation score and increased, although self-limiting, psychedelic phenomena than the control group. Conclusion. Observed data here support an acute effect of ketamine on mood but any further claim will be speculative. Further future studies exploring postoperative mood scores after 24 hours post-infusion are needed. This trial is registered with PACTR201907779292947.

Low-Dose Dexamethasone as an Adjuvant for Prolonging the Duration of Brachial Plexus Block with Bupivacaine—a Prospective Randomised Controlled Study

2021 ◽  
Author(s):  
Seetharaman Hariharan
Keyword(s):  
Brachial Plexus ◽  
Low Dose ◽  
Controlled Trial ◽  
Demographic Data ◽  
Local Anaesthetics ◽  
Controlled Study ◽  
Control Group ◽  
Double Blind ◽  
Dexamethasone Group ◽  
Duration Of Surgery

Objectives Dexamethasone, in the dose of 8 mg or higher, has been advocated to be used as an adjuvant to prolong the duration of brachial plexus blocks with local anaesthetics. This study aimed to test the hypothesis that a lower dose of dexamethasone (4 mg) added to bupivacaine would prolong the duration of analgesia in brachial plexus blocks. Methods A randomized double-blind placebo-controlled trial was conducted on patients who underwent supraclavicular brachial plexus blocks using an ultrasound. Patients were randomized to receive 19 mL of 0.5% bupivacaine with dexamethasone (4 mg) (study group) and saline (1 mL) (control group). Primary outcome measure was the duration of analgesia. Onset and duration of sensory, motor blocks, postoperative 24-hour morphine requirements were also recorded. Results A total of 46 patients were studied with 24 patients in the dexamethasone group and 22 patients in the control group. Demographic data, type and duration of surgery were comparable between the groups. Dexamethasone group patients had significantly longer duration of analgesia [Mean (SD): 19.8 (3.8) hours], compared to control group patients [Mean (SD): 14.5 (4.2); p< 0.001]. Morphine requirements over a 24-hour period were not significantly different between the groups. Conclusion Low-dose dexamethasone significantly prolongs the duration of analgesia when used with bupivacaine in supraclavicular brachial plexus blocks, although it does not significantly decrease the overall opioid requirements for 24 hours postoperatively.

Pilot randomized active-placebo-controlled trial of low-dose ketamine for the treatment of multiple sclerosis–related fatigue

2020 ◽  
pp. 135245852093622
Author(s):  
Kathryn C Fitzgerald ◽  
Bridget Morris ◽  
Aurash Soroosh ◽  
Alexandra Balshi ◽  
Dermot Maher ◽  
...  
Keyword(s):  
Multiple Sclerosis ◽  
Low Dose ◽  
Controlled Trial ◽  
Common Symptom ◽  
Double Blind ◽  
Mixed Effect ◽  
Ketamine Infusion ◽  
Impact Scale ◽  
Post Infusion ◽  
Fatigue Severity

Background: Fatigue is the most common symptom of MS and has no effective pharmacotherapy. Objective: To determine the tolerability, safety, and efficacy of low-dose ketamine infusion for MS-related fatigue. Methods: In this double-blind, randomized, active-placebo-controlled trial, 18 subjects with multiple sclerosis (MS) and reported fatigue received a single intravenous infusion of ketamine (0.5 mg/kg) or midazolam (0.05 mg/kg). The primary outcome was change in Daily Fatigue Severity (DFS) for 7 days following the infusion. Secondary outcomes included Fatigue Severity Scale (FSS) and Modified Fatigue Impact Scale (MFIS) measured up to day 28 post-infusion. We analyzed changes in all outcomes using mixed-effect models. Results: In total, 18 participants were enrolled; 67% participants received ketamine. Side effects of ketamine were transient. No change in the DFS was observed after 7 days (−0.10 point; 95% confidence interval (CI): −0.32, 0.12; p = 0.40). We observed a trend in reduced FSS scores at 1 week (−5.2 points; 95% CI: −10.4, 0.14; p = 0.06) and a clinically and statistically significant reduction in MFIS score at day 28 (−13.5 point; 95% CI: −25.0, −1.98; p = 0.04). Conclusions: Ketamine infusions were safe and well-tolerated. While no change in DFS after 7 days was observed, secondary analyses suggest a benefit of ketamine infusion for reduction of longer term fatigue severity in people with MS.

scholarly journals Biofeedback Intervention for Stress and Anxiety among Nursing Students: A Randomized Controlled Trial

ISRN Nursing ◽  
2012 ◽  
Vol 2012 ◽  
pp. 1-5 ◽  
Author(s):  
Paul Ratanasiripong ◽  
Nop Ratanasiripong ◽  
Duangrat Kathalae
Keyword(s):  
Nursing Students ◽  
Stress Level ◽  
Clinical Training ◽  
Intervention Program ◽  
Controlled Trial ◽  
Controlled Study ◽  
Control Group ◽  
Moderate Increase ◽  
Randomized Controlled ◽  
The Impact

Purpose. It has been well documented that nursing students across the world experience stress and anxiety throughout their education and training. The purpose of this randomized controlled study is to investigate the impact of biofeedback intervention program on nursing students' levels of stress and anxiety during their first clinical training. Methods. Participants consisted of 60 second-year baccalaureate nursing students. The 30 participants in the biofeedback group received training on how to use the biofeedback device to assist in stress and anxiety management for 5 weeks while the 30 in the control group did not receive any training. Findings. Results indicated that the biofeedback group was able to maintain the stress level while the control group had a significant increase in the stress level over the 5-week period of clinical training. Additionally, the biofeedback group had a significant reduction in anxiety, while the control group had a moderate increase in anxiety. Conclusions. The better the nursing students can manage their stress and anxiety, the more successful they can be in their clinical training. Ultimately, the more psychologically healthy the nursing students are, the more likely they will flourish and graduate to become productive and contributing members of the nursing profession.

Controlled Study of the Use of Local Steroid Injection in the Treatment of Trigger Finger and Thumb

1992 ◽  
Vol 17 (1) ◽  
pp. 69-70 ◽  
Author(s):  
M. A. LAMBERT ◽  
R. J. MORTON ◽  
J. P. SLOAN
Keyword(s):  
Local Anaesthetic ◽  
Steroid Injection ◽  
Controlled Trial ◽  
Trigger Finger ◽  
Controlled Study ◽  
Control Group ◽  
Methylprednisolone Acetate ◽  
Double Blind ◽  
Local Steroid Injection ◽  
Control Injection

A controlled double-blind prospective study of injection of methylprednisolone acetate plus local anaesthetic against a control injection of a local anaesthetic in the treatment of trigger finger and thumb has shown a 60% success rate for the steroid injection against 16% for the control group (p < 0.05). This is the first controlled trial of local steroid therapy in this condition.

scholarly journals 2838. Safety and Immunogenicity of a gp120-CD4 Chimeric Subunit Vaccine: A Phase 1a Randomized Controlled Trial

2019 ◽  
Vol 6 (Supplement_2) ◽  
pp. S65-S66
Author(s):  
Joel V Chua ◽  
Charles Davis ◽  
Amy Nelson ◽  
Ka Wing J Lam ◽  
Lydiah Mutumbi ◽  
...  
Keyword(s):  
Subunit Vaccine ◽  
Vaccine Development ◽  
Controlled Trial ◽  
Chimeric Protein ◽  
Controlled Study ◽  
Control Group ◽  
Single Chain ◽  
Double Blind ◽  
Humoral Responses ◽  
Hiv 1

Abstract Background A primary challenge for HIV vaccine development is to raise antiviral antibodies capable of recognizing highly variable viral antigens. The full-length single chain (FLSC) gp120-CD4 chimeric protein was designed to present a highly conserved CD4-induced HIV-1 envelope structure that evokes cross-reactive humoral responses (Figure 1). IHV01 is an FLSC subunit vaccine formulated in alum adjuvant. The safety and immunogenicity of IHV01 was evaluated in this first-in-human phase 1a trial. Methods This randomized, double-blind placebo-controlled study involved three dose-escalating cohorts (75 µg, 150 µg, and 300 µg doses). Eligible participants were HIV-1 uninfected healthy volunteers aged 18 to 45 years. Participants in each cohort were block randomized in groups of four in a 3:1 ratio to receive either vaccine or placebo. Intramuscular injections were given on weeks 0, 4, 8, and 24. Participants were followed for an additional 24 weeks after the last immunization. Crossreactive antibody binding titers against diverse HIV envelopes and antigens and specific CD4i epitopes on gp120 were assessed. Results Sixty-five volunteers were enrolled—49 vaccine and 16 placebo. Majority (81%) of vaccinations with IHV01 produced no localized or systemic reactions; no different from the control group. The overall incidence of adverse events (AEs) was not significantly different between groups. Majority (89%) of vaccine-related AEs were mild in severity. The most common vaccine-related AEs were injection site pain (31%), pruritus (10%), and headache (10%). There were no vaccine-related serious AE, discontinuation due to AE, or intercurrent HIV infection. By the final vaccination, all subjects in all cohorts had developed antibodies against IHV01; all placebo recipients were negative. The antibodies induced by IHV01 reacted with envelope antigens from diverse HIV-1 strains (Figure 2). Conclusion IHV01 vaccine was safe, well tolerated, and immunogenic in all doses tested. The vaccine raised broadly reactive humoral responses against multiple gp120 domains, transition state structures, and CD4i epitopes. Disclosures All Authors: No reported Disclosures.

scholarly journals Periarticular Injection with Bupivacaine for Postoperative Pain Control in Total Knee Replacement: A Prospective Randomized Double-Blind Controlled Trial

2012 ◽  
Vol 2012 ◽  
pp. 1-6 ◽  
Author(s):  
Varah Yuenyongviwat ◽  
Chaturong Pornrattanamaneewong ◽  
Thitima Chinachoti ◽  
Keerati Chareancholvanich
Keyword(s):  
Pain Control ◽  
Controlled Trial ◽  
Ease Of Use ◽  
Morphine Consumption ◽  
Controlled Study ◽  
Control Group ◽  
Double Blind ◽  
Periarticular Injection ◽  
Post Operative Pain ◽  
Significant Difference

Background. Local periarticular injection with bupivacaine alone in TKA has not been studied. Thus, we aimed to examine the effectiveness of local periarticular injection with bupivacaine for post-operative pain control in TKA.Method. Sixty patients undergoing TKA by a single surgeon were randomly assigned into two groups in a double-blind, placebo-controlled study. In the injection group, patients received periarticular injections with 0.25% bupivacaine before wound closure; in the control group, patients received a 0.9% normal saline injection. Both groups received the same anesthetic procedure, post-operative pain control, and rehabilitation protocol.Results. There was a significant reduction in post-operative morphine consumption in the first six hours after the operation (mean 0.9 mg and 2.43 mg,P=0.01), but there was no significant difference in post-operative morphine consumption between six hours and ninety-six hours after the operation, visual analogue scale (VAS) score, morphine side effects during the first 96 hours, length of hospital stay, or complications from morphine consumption.Conclusion. Local periarticular injection with bupivacaine alone before wound closer was shown to be an effective method to improve pain control after TKA with a few complications and ease of use.

scholarly journals The impact of virtual reality training on laparoscopic surgical skills; A prospective blinded controlled trial

2021 ◽  
Vol 6 (1) ◽  
pp. 37-42
Author(s):  
Prashanth A T ◽  
Nishanth Lakshmikantha ◽  
Krish Lakshman
Keyword(s):  
Virtual Reality ◽  
Controlled Trial ◽  
Skills Training ◽  
Surgical Skills ◽  
Simulator Training ◽  
Research Centre ◽  
Controlled Study ◽  
Control Group ◽  
The Impact ◽  
Vr Simulator

Background. Laparoscopic surgery has gained popularity in the last few decades replacing open standard techniques in several procedures. While its use and scope expand, a standardized method of training and assessment in laparoscopic skills is lacking. Aim. To assess the effect of virtual reality (VR) training on laparoscopic surgical skills. Materials and Methods. It is a prospective, controlled study conducted at Sagar Hospital’s skill lab and Shanthi Hospital and Research Centre (SHRC). We included 27 post graduates in general surgery. They were divided into two groups. One group underwent training in VR Simulator for one week, 30 minutes each day. The second group received no training. Their proficiency while mobilizing the Gallbladder from its liver bed was assessed using a validated scale by a single blinded observer. Results. The statistical analysis was done using a non-parametric test (Mann-Whitney U test). Residents who underwent training in VR simulator got better scores in Overall rating and also in individual parameters when compared with the control group (P = <0.05). Conclusions. Laparoscopic surgical skills can be increased by using proficiency-based VR simulator training and it can be transferred to actual operations. VR simulators are a valid tool for laparoscopic surgical skills training.

scholarly journals Probiotics with vitamin C for the prevention of upper respiratory tract symptoms in children aged 3-10 years: randomised controlled trial

2021 ◽  
pp. 1-10
Author(s):  
I. Garaiova ◽  
Z. Paduchová ◽  
Z. Nagyová ◽  
D. Wang ◽  
D.R. Michael ◽  
...  
Keyword(s):  
Vitamin C ◽  
Respiratory Tract ◽  
Controlled Trial ◽  
Bifidobacterium Bifidum ◽  
Active Group ◽  
Controlled Study ◽  
Upper Respiratory Tract ◽  
Double Blind ◽  
Upper Respiratory ◽  
The Impact

In a double-blind, randomised, parallel-group, placebo-controlled study, healthy school children aged 3-10 years received a probiotic based supplement daily for 6 months to assess the impact on the incidence and duration of upper respiratory tract infection (URTI) symptoms. The intervention comprised Lab4 probiotic (Lactobacillus acidophilus CUL21 and CUL60, Bifidobacterium bifidum CUL20 and Bifidobacterium animalis subsp. lactis CUL34) at 12.5 billion cfu/day plus 50 mg vitamin C or a matching placebo. 171 children were included in the analysis (85 in placebo and 86 in active group). Incidence of coughing was 16% (P=0.0300) significantly lower in the children receiving the active intervention compared to the placebo. No significant differences in the incidence rate of other URTI symptoms were observed. There was significantly lower risk of experiencing five different URTI related symptoms in one day favouring the active group (Risk ratio: 0.31, 95% confidence interval: 0.12, 0.81, P=0.0163). Absenteeism from school and the use of antibiotics was also significantly reduced for those in the active group (-16%, P=0.0060 and -27%, P=0.0203, respectively). Our findings indicate that six months daily supplementation with the Lab4 probiotic and vitamin C combination reduces the incidence of coughing, absenteeism and antibiotic usage in 3 to 10 year old children.

scholarly journals Impact of Epley manoeuvre on self-perceived disability: A randomised controlled trial in primary care

2020 ◽  
Author(s):  
Ricard Carrillo Muñoz ◽  
Jose Luis Ballve Moreno ◽  
Ivan Villar Balboa ◽  
Yolanda Rando Matos ◽  
Oriol Cunillera Puertolas ◽  
...  
Keyword(s):  
Primary Care ◽  
Controlled Trial ◽  
Intervention Group ◽  
Control Group ◽  
Controlled Clinical Trial ◽  
Double Blind ◽  
Perceived Disability ◽  
Randomised Controlled ◽  
The Impact

Abstract Background: Posterior canal benign paroxysmal positional vertigo (pc-BPPV) causes physical, functional, and emotional impairment. The treatment of choice is the Epley manoeuvre (EM). The purpose of the study was to compare the impact of the EM and a sham manoeuvre in primary care on self-perceived disability.Method: Randomised, double-blind, sham-controlled clinical trial conducted in primary care with a follow-up of 1 year. Patients aged ≥18 years old diagnosed with pc-BPPV according to the Dix-Hallpike test (DHT) were randomised to an intervention (EM) group or a control (sham manoeuvre) group. The main study covariables were age, sex, history of depression and anxiety, presence of nystagmus in the DHT, patient-perceived disability assessed with the Dizziness Handicap Inventory-screening version (DHI-S). Data were analyzed using bivariate and multivariate mixed Tobit analyses. Results: Overall, 134 patients were studied: 66 in the intervention group and 68 in the control group. Median age was 52 years (interquartile range [IQR], 38.25–68.00 years) and 76.12% of the patients were women. The DHT triggered nystagmus in 40.30% of patients. The median total DHI-S score for the overall sample at baseline was 16 (IQR, 8.00–22.00); 16 [IQR, 10.5–24.0] vs 10 [6.0–14.0] for women vs men (P<0.001) and 16 [IQR, 10.0-24.0] vs 12 [IQR, 8.0–18.0] for patients without nystagmus vs those with nystagmus (P=0.033).Patients treated with the EM experienced a mean reduction of 2.03 points in DHI-S score over the follow-up period compared with patients in the sham group. Conclusion: Pc-BPPV affects the quality of life of primary care patients. A single EM can improve self-perceptions of disability by around 2 points on the DHI-S scale, Trial registration: ClinicalTrials.gov Identifier: NCT01969513. Retrospectively registered. First Posted: October 25, 2013. https://clinicaltrials.gov/ct2/show/NCT01969513

scholarly journals Effects of Bushen-Jiangya granules on blood pressure and pharmacogenomic evaluation in low-to-medium risk hypertension: study protocol for a randomized double-blind controlled trial

2021 ◽  
Author(s):  
xiaochen Yang ◽  
Xingjiang Xiong ◽  
Yun Zhang ◽  
Yongmei Liu ◽  
Hongzheng Li ◽  
...  
Keyword(s):  
Blood Pressure ◽  
Inflammatory Responses ◽  
Controlled Trial ◽  
Controlled Study ◽  
Control Group ◽  
Double Blind ◽  
Double Blind Placebo ◽  
Medium Risk ◽  
Tcm Syndrome ◽  
And Control

Abstract IntroductionHypertension is one of the most important risk factors for cardiovascular disease, and its treatment and control rates are still low worldwide. The most effective strategy is that patients with hypertension should be diagnosed and treated early. Preliminary studies showed that the Bushen Jiangya granule (BSJY) may suppress ventricular hypertrophy and inflammatory responses, lower blood pressure and protect the target organs of hypertension. We designed a randomized, double-blind, placebo-controlled trial to evaluate the efficacy of BSJY in patients with low-to-medium risk hypertension.Methods and analysisThis trial is a one-center, randomized, double-blind, placebo-controlled study. A total of 260 participants will be randomized in a 1:1 ratio to an experiment group (BSJY plus amlodipine) and a control group (placebo plus amlodipine). The trial cycle will last 8 weeks. The primary outcome is blood pressure, which is reduced to a threshold set out in Guiding Principles for Clinical Research of New Chinese Medicines. The secondary outcomes include the change in 24-h average systolic and diastolic blood pressure, heart rate variability, pharmacogenomic Evaluation, improvement in TCM Syndrome, serum pro-inflammatory/anti-inflammatory cytokines, etc. between the two groups. Safety in medication will also be evaluated. All the data will be recorded in electronic case report forms and analyzed by SPSS V.22.0.Ethics and dissemination This study has been approved by Research Ethics Committee of Guang’anmen Hospital,China Academy of Chinese Medical Sciences in Beijing, China (No. 2019-186-KY-01). The participants are volunteers, understand the process of this trial and sign an informed consent. The results of this study will be disseminated to the public through peer-reviewed journals and academic conferences. DiscussionWe hypothesize that patients with low-to-medium risk hypertension will benefit from BSJY. If successful, this study will provide evidence-based recommendations for clinicians.

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