scholarly journals Effects of Perioperative Rosuvastatin for Postoperative Delirium After Elderly General Anesthesia Patients: A Randomized, Double-Blind, and Placebo-Controlled Trial

2021 ◽  
Author(s):  
Xiaoqin Xu ◽  
Jingzhi Luo ◽  
Xiaoyu Li ◽  
Haiqin Tang ◽  
Weihong Lu
Keyword(s):  
Clinical Trials ◽  
General Anesthesia ◽  
Clinical Outcomes ◽  
Postoperative Delirium ◽  
Controlled Trial ◽  
Statistical Significance ◽  
Care Providers ◽  
Double Blind ◽  
Significant Difference ◽  
To Receive

Abstract Background: Experimental evidence has indicated the benefits of statins for the treatment of postoperative delirium. Previously clinical trials had no definite conclusions of statins on delirium. Some clinical trials indicated statins can reduce postoperative delirium and improve outcome, while some studies showed negative results. Therefore, the present study tries to evaluate whether perioperative rosuvastatin treatment could reduce the incidence of delirium and improve clinical outcomes. Methods: This was a randomized, double-blind, and placebo-controlled trial in a single-center in Jiangsu, China. This study enrolled patients aged more than 60 years old who present selective general anesthesia operation, with informed consent. A computer-generated randomization sequence (in a 1:1 ratio) was used to randomly assign patients to receive either rosuvastatin (40 mg/day) or placebos. Participants, care providers, and investigators were all masked to group assignment. The primary endpoint was the incidence of delirium, assessed twice daily with the Confusion Assessment Method during the first 7 postoperative days. Analyses were performed by intention-to-treat and safety populations. Results: Between Jan 1, 2017, and Jan 1, 2020, 3512 patients were assessed. A total of 821 were randomly assigned to receive either a placebo (n=411) or rosuvastatin (n=410). The incidence of postoperative delirium was significantly lower in the rosuvastatin group (23 [5.6%] of 410 patients) than the placebo group (42 [13.5%] of 411 patients (OR=0.522, 95% CI 0.308-0.885; p<0.05). No significant difference on 30-day all-cause mortality (6.1% vs 8.7 %, OR 0.67, P=0.147, 95% CI 0.39–1.2) between two groups. Rosuvastatin can decrease the hospitalization time (13.8±2.5 vs 14.2±2.8, P=0.03) and hospitalization expenses (9.3±2.5 vs 9.8±2.9, P=0.007). No statistical significance between the two groups on abnormal liver enzymes (9.0% vs 7.1%, P=0.30, OR=1.307, 95% CI 0.787-2.169) and rhabdomyolysis (0.73% vs 0.24%, P=0.37, OR=3.020, 95% CI 0.31-29.2. Conclusion: The current study suggests that perioperative rosuvastatin treatment can reduce the incidence of delirium after elective general anesthesia operation. However, no evidence was found that rosuvastatin can improve clinical outcomes. The therapy was safe. Further investigation is necessary to fully understand the potential usefulness of dexmedetomidine in older patients. Trial registration: chictr.org.cn, ChiCTR-IPR-17011984(Registered date: 13/07/2017). The manuscript adheres to CONSORT guidelines.

scholarly journals Effects of Melatonin on Postoperative Delirium After PCI in Elderly Patients: A Randomized, Single-Center, Double-Blind, Placebo-Controlled Trial

2021 ◽  
Vol 24 (5) ◽  
pp. E893-E897
Author(s):  
Yicheng Shi
Keyword(s):  
Placebo Group ◽  
Elderly Patients ◽  
Postoperative Delirium ◽  
Controlled Trial ◽  
Coronary Intervention ◽  
Assessment Method ◽  
Double Blind ◽  
Significant Difference ◽  
Hospitalization Costs ◽  
To Receive

Background: Experimental evidence has indicated the benefits of melatonin (Mel) for the treatment of delirium. Clinical trials had no definite conclusions concerning Mel on delirium after percutaneous transluminal coronary intervention (PCI) in elderly patients. The present study explored whether acute Mel treatment could reduce the incidence of delirium. Methods: This trial enrolled patients over the age of 60, who were admitted to intensive care units (ICUs) after PCI. A computer-generated randomization sequence (in a 1:1 ratio) was used to randomly assign patients to receive Mel (3 mg/day) or placebo once daily for up to 7 days. The primary endpoint was the incidence of delirium, assessed twice daily with the Confusion Assessment Method (CAM) during the first 7 postoperative days. Analyses were performed using intention-to-treat and safety populations. Results: A total of 297 patients randomly were assigned to receive either placebo (N = 149) or Mel (N = 148). The incidence of postoperative delirium was significantly lower in the Mel group than in the placebo group (27.0% vs. 39.6%, respectively, P = 0.02). There was no significant difference between 30-day all-cause mortality (12.2% vs. 14.1%, P = 0.62) and drug reactions (0 vs. 2.0%, P = 0.25). The length of stay and hospitalization costs in the Mel group were significantly decreased compared with those in the placebo group (P > 0.05). Conclusion: The current study suggests that Mel is safe and effective in the treatment of delirium after PCI. Further investigation is necessary to fully understand the potential usefulness of Mel in older patients via larger randomized, multicenter, double-blind, and placebo-controlled trials.

A double-blind placebo-controlled trial of perioperative prophylactic antibiotics for elective neurosurgery

1988 ◽  
Vol 69 (5) ◽  
pp. 687-691 ◽  
Author(s):  
Ross Bullock ◽  
James R. van Dellen ◽  
William Ketelbey ◽  
S. Gustav Reinach
Keyword(s):  
Controlled Trial ◽  
Prophylactic Antibiotics ◽  
Risk Of Infection ◽  
Broad Spectrum Antibiotic ◽  
Wound Sepsis ◽  
Double Blind ◽  
Content Type ◽  
Exact Test ◽  
Significant Difference ◽  
To Receive

✓ In this study, 417 patients undergoing “clean” elective neurosurgical operative procedures were randomized to receive a broad-spectrum antibiotic (piperacillin) or placebo given as three perioperative doses, each 6 hours apart. Randomization was carried out by hospital pharmacists, and the investigators remained blinded until the end of the study. Twenty cases were excluded from analysis because either an unforeseen second operation was performed or antibiotic therapy was initiated within 30 days after surgery to treat infection or the risk of infection. Twelve of the 205 patients treated with placebo developed postoperative wound sepsis, and four of the 192 piperacillin-treated patients developed wound sepsis — a statistically significant difference (p < 0.05, Fisher's exact test). Piperacillin thus appeared to reduce the incidence of neurosurgical wound infection in this study.

A Controlled Trial of Dothiepin and Placebo in Treating Benzodiazepine Withdrawal Symptoms

1996 ◽  
Vol 168 (4) ◽  
pp. 457-461 ◽  
Author(s):  
Peter Tyrer ◽  
Brian Ferguson ◽  
Cosmo Hallström ◽  
Marian Michie ◽  
Stephen Tyrer ◽  
...  
Keyword(s):  
Tricyclic Antidepressants ◽  
Drug Withdrawal ◽  
Controlled Trial ◽  
Statistical Significance ◽  
Withdrawal Symptoms ◽  
Antidepressant Effect ◽  
Double Blind ◽  
Benzodiazepine Dependence ◽  
Benzodiazepine Withdrawal ◽  
To Receive

BackgroundThe possibility that treatment with tricyclic antidepressants, in the form of dothiepin, might attenuate benzodiazepine withdrawal symptoms was investigated in a double-blind trial.MethodEighty-seven non-depressed psychiatric out-patients with putative normal dose benzodiazepine dependence had their benzodiazepines reduced in stepwise amounts of 20% of the original dose for eight weeks. The patients were randomised to receive dothiepin (with dosage increasing to 150 mg/day) or placebo as an aid to withdrawal before benzodiazepine reduction and these drugs were taken for four further weeks before being stopped.ResultsFewer patients entered and completed the study than expected and a Type II error was possible in the results. Although there was some evidence of withdrawal symptoms being less marked in those patients allocated to dothiepin this was independent of any antidepressant effect as depression scores were lower in the placebo group in the early phase of withdrawal (P<0.01). Of those completing the study, greater satisfaction (P=0.03) was recorded by those who had received dothiepin; no other differences reached statistical significance.ConclusionsDothiepin (and by implication other tricyclic antidepressants) might have some value in reducing benzodiazepine withdrawal symptoms but does not aid drug withdrawal.

Post-tonsillectomy analgesia: The use of benzocaine lozenges

1988 ◽  
Vol 102 (9) ◽  
pp. 813-814 ◽  
Author(s):  
J. H. Dempster
Keyword(s):  
Clinical Trials ◽  
Analogue Scale ◽  
Controlled Trial ◽  
Adult Population ◽  
Significant Degree ◽  
Conventional Management ◽  
Post Operative Pain ◽  
Significant Difference ◽  
To Receive ◽  
Oral Analgesia

AbstractTonsillectomy frequently results in a significant degree of post-operative pain. Conventional management consists of the administration of intra-muscular opiates prior to the commencement of oral analgesia and is often inadequate, producing variable levels of pain relief.One of the recommended uses of benzocaine lozenges is the relief of throat discomfort following tonsillectomy, but there are no clinical trials to support this claim. Therefore, a prospective placebo controlled trial was undertaken to compare the efficacy of benzocaine lozenges (10 mg.) with standard oral analgesia in the management of post-operative pain following tonsillectomy in an adult population.Consecutive patients undergoing elective tonsillectomy were randomised to receive either benzocaine lozenges (10 mg.) or placebo. Intake of supplementary oral analgesia was recorded, and the level of postoperative pain was assessed by use of a visual linear analogue scale. There was no significant difference in analgesic intake or pain severity as measured by linear analogue between the two groups.These results suggest that there is no benefit in administering benzocaine lozenges for the relief of post-tonsillectomy pain, and its use in this situation cannot be recommended.

Double-blind placebo-controlled trial of etanercept in the prevention of work disability in ankylosing spondylitis: Table 1

2010 ◽  
Vol 69 (11) ◽  
pp. 1926-1928 ◽  
Author(s):  
Nick Barkham ◽  
Laura C Coates ◽  
Helen Keen ◽  
Elizabeth Hensor ◽  
Alexander Fraser ◽  
...  
Keyword(s):  
Placebo Group ◽  
Ankylosing Spondylitis ◽  
Clinical Outcomes ◽  
Job Loss ◽  
Controlled Trial ◽  
Controlled Study ◽  
Double Blind ◽  
Treatment Groups ◽  
Gait Parameters ◽  
Significant Difference

ObjectivesEtanercept has been shown to be rapidly effective in suppressing disease activity in ankylosing spondylitis (AS). The aim of this study was to determine whether etanercept improves work instability as measured by the Ankylosing Spondylitis Work Instability Scale (AS-WIS).MethodForty patients with active AS who were in work but were work unstable were recruited. Patients were randomised to receive 25 mg etanercept or placebo twice weekly for 12 weeks. The primary outcome was change in AS-WIS at week 12. The AS-WIS is a patient-derived outcome measure which allows stratification of the risk of job loss. Secondary outcomes included clinical outcomes and gait parameters.ResultsThe mean improvement in AS-WIS score at week 12 was 2.75 in the etanercept group and 0.68 in the placebo group (p=0.125). The risk of job loss decreased for 11 (55%) of the etanercept group compared with 7 (35%) in the placebo group. Conversely, the risk of job loss increased in 3 (15%) of the placebo group compared with 1 (5%) in the etanercept group. There was no statistically significant difference between treatment groups in change in WIS categories (Mann–Whitney U test=0.153, p=0.160). Significant improvement with etanercept was seen at week 12 in clinical outcomes and gait parameters. Etanercept was well tolerated, with no dropouts due to adverse events.ConclusionThis small study confirms the efficacy of etanercept on clinical outcome measures in patients with AS and suggests an effect on work instability which needs to be replicated in a larger controlled study.

scholarly journals Oxycodone 5 Miligram is More Effective Than Ketorolac 30 Miligram in Suppressing Cortisol Levels During General Anesthesia

2021 ◽  
Vol 2 (1) ◽  
pp. 148-158
Author(s):  
Kelvin ◽  
Rizal Zainal ◽  
Irwanto FH ◽  
Erial Bahar
Keyword(s):  
General Anesthesia ◽  
Sample Size ◽  
Intravenous Administration ◽  
Elective Surgery ◽  
Controlled Trial ◽  
Post Intervention ◽  
Chi Square ◽  
Double Blind ◽  
Significant Difference ◽  
Cortisol Levels

Background: Preemptive analgesia is a developing clinical concept, which involves administering analgesics before pain stimulation occurs, to prevent the sensitization of the nervous system to further stimuli that can cause pain. Ketorolac has strong analgesic properties oxycodone is a semisynthetic opioid that is synthesized from the alkaloid thebaine opiate. Pain could induce stress hormone such as cortisol. Study to compare ketorolac and oxycodone with cortisol has not been investigated. This study aimed to assess intravenous administration of ketorolac 30 mg compared with intravenous 5 mg oxycodone for pain as measured by cortisol levels post-intervention in surgery performed under general anesthesia. Method: A study randomized controlled trial in double-blind form for patients at dr. Mohammad Hoesin Palembang, who will undergo elective surgery with general anesthesia at the Central Surgical Installation building, with the period September-October 2020. There are 24 study samples, to anticipate dropouts, an added sample size is 10%, so the sample size is 26 for each treatment group. The selection of subjects according to the purpose of the study was carried out by simple random. Data analysis using SPSS ver 22.0 software. Data were analyzed using Independent T-Test, Mann Whitney, and Chi-Square Test. Result: The results showed, there was a significant difference in the effectiveness of intravenous administration of ketorolac 30 mg and intravenous oxycodone 5 mg on pain as measured by cortisol levels in patients undergoing general anesthesia at dr. Mohammad Hoesin Palembang (p = 0.013). The value of cortisol levels in pre- operative patients who will be given general anesthesia at dr. There was no statistically significant difference between Mohammad Hoesin in the two groups (p = 0.107). The value of cortisol levels in preoperative patients who were given ketorolac 30 mg intravenously at dr. Mohammad Hoesin was 9.90 ± 4.2. The value of cortisol levels in postoperative patients who were given ketorolac 30 mg intravenously at dr. Mohammad Hoesin was 17.75 ± 6.08. The value of preoperative cortisol levels for patients who were given oxycodone 5 mg intravenously at dr. Mohammad Hoesin was 12.03 ± 5.10. The value of postoperative cortisol levels for patients who were given oxycodone 5 mg intravenously at dr. Mohammad Hoesin is 14.50 ± 4.75. Conclusion: There was a significant difference in the effectiveness of intravenous administration of ketorolac 30 mg and oxycodone 5 mg intravenously on BSS levels (p = 0.005) and VAS scores (p = 0.001) who underwent general anesthesia at dr. Mohammad Hoesin Palembang.

scholarly journals Comparison of azithromycin vs doxycycline prophylaxis in leptospirosis, A randomized double blind placebo-controlled trial

2018 ◽  
Vol 12 (11) ◽  
pp. 991-995
Author(s):  
Ahmad Alikhani ◽  
Ebrahim Salehifar ◽  
Fatemeh Zameni ◽  
Alireza Rafiei ◽  
Jamshid Yazdani-charati ◽  
...  
Keyword(s):  
Paddy Field ◽  
Controlled Trial ◽  
Fisher Exact Test ◽  
Mazandaran Province ◽  
Double Blind ◽  
Double Blind Placebo ◽  
Informed Consent Form ◽  
Significant Difference ◽  
Field Workers ◽  
To Receive

Introduction: Leptospirosis is an important zoonotic disease in paddy field with 29.5% prevalence rate in Mazandaran province and 4% to 52% mortality rate among hospitalized patients. Prevention is an important strategy for the control of this disease. This study aimed to compare the prophylactic effect of azithromycin versus doxycycline against leptospirosis in an endemic area in north of Iran. Methodology: In this randomized double-blind placebo-controlled trial, paddy field workers (n = 187) were randomized to receive azithromycin (500mg weekly), doxycycline (200 mg weekly) or placebo starting one week before exposure to paddy field, during and to four weeks after. Paddy field workers aged 18- 65 years who signed the informed consent form were assessed for signs and symptoms of leptospirosis in addition to serologic evidence of the disease 6th and 12th week. Data were analyzed with SPSS version 13 using Chi-square and Fisher exact test and ANOVA. Results: From June to September 2016, 187 participants were entered the study to receive azithromycin (n = 66), doxycycline (n = 71) or placebo (n = 50). In terms of preventing against clinical leptospirosis, there was not any significant difference between three arms, though there was statistically significant difference of seropositivity after 6 and 12 weeks in comparison to baseline among all three groups (P = 0.029) and between active treatment (eg. azithromycin and doxycycline) groups and placebo group (P = 0.01). Conclusion: Azithromycin like doxycycline decreased seropositivity without significant effect on clinical leptospirosis.

scholarly journals The Effects of Quetiapine on Craving and Withdrawal Symptoms in Methamphetamine Abuse: A Randomized, Double-Blind, Placebo-Controlled Trial

2020 ◽  
Vol 10 (4) ◽  
pp. 29374.1-29374.7
Author(s):  
Najme Sadat Javdan ◽  
◽  
Amir Ghaderi ◽  
Hamid Reza Banafshe ◽  
◽  
...  
Keyword(s):  
Controlled Trial ◽  
Withdrawal Symptoms ◽  
Chi Square ◽  
Double Blind ◽  
Methamphetamine Abuse ◽  
Beneficial Effects ◽  
Amphetamine Withdrawal ◽  
Significant Difference ◽  
Chi Square Test ◽  
To Receive

Background: Patients with Methamphetamine Abuse (MA) are susceptible to many complications like craving, and withdrawal symptoms. These trials were designed to evaluate the effect of quetiapine administration on craving and withdrawal symptoms in MA abuse. Methods: This trial was conducted on 60 people with MA abuse to receive either 100 mg quetiapine (n=30), or placebo (n=30) every day for 2 months. The Desire for Drug Questionnaire (DDQ) and Amphetamine Withdrawal Questionnaire (AWQ) scores were evaluated at baseline and after 2 months’ intervention. For data analysis, t test, and the Chi-square test were applied in SPSS v. 18. Results: Quetiapine significantly decreased DDQ (P=0.002) and AWQ symptoms (P=0.001) compared to the placebo. Furthermore, there was a significant difference among groups in terms of the frequency of negative urine tests (P<0.001). Conclusion: This trial showed that administration of quetiapine supplements for 2 months in individuals with MA abuse had beneficial effects on craving and withdrawal syndrome.

scholarly journals Safety and Efficacy of Misoprostol versus Oxytocin for the Prevention of Postpartum Hemorrhage

2014 ◽  
Vol 2014 ◽  
pp. 1-4 ◽  
Author(s):  
Minoo Rajaei ◽  
Samieh Karimi ◽  
Zohreh Shahboodaghi ◽  
Hamidreza Mahboobi ◽  
Tahereh Khorgoei ◽  
...  
Keyword(s):  
Postpartum Hemorrhage ◽  
Controlled Trial ◽  
Clinical Settings ◽  
Double Blind ◽  
Safety And Efficacy ◽  
Ringer’S Solution ◽  
Oral Misoprostol ◽  
Significant Difference ◽  
Misoprostol Group ◽  
To Receive

Postpartum hemorrhage (PPH) is the commonest cause of maternal death worldwide. Studies suggest that the use of misoprostol may be beneficial in clinical settings where oxytocin is unavailable. The aim of this study was to compare the safety and efficacy of oxytocin and misoprostol when used in the prevention of PPH. In a double-blind randomized controlled trial, 400 pregnant women who had a vaginal delivery were assigned into two groups: to receive either 20 IU of oxytocin in 1000 mL Ringer’s solution and two placebo tablets or 400 mcg oral misoprostol (as two tablets) and 2 mL normal saline in 1000 mL Ringer’s solution. The quantity of blood loss was higher in the oxytocin group in comparison to the misoprostol group. There was no significant difference in the decrease in hematocrit and hemoglobin between the two groups. Although there was no significant difference in the need for transfusions between the two groups, the patients in the oxytocin group had greater need for additional oxytocin. Results from this study indicate that it may be considered as an alternative for oxytocin in low resource clinical settings. This study is registered with ClinicalTrials.govNCT01863706.

scholarly journals The Effect of Viola odorata Flower Syrup on the Cough of Children With Asthma

2015 ◽  
Vol 20 (4) ◽  
pp. 287-291 ◽  
Author(s):  
Mohammad Javad Qasemzadeh ◽  
Hosein Sharifi ◽  
Mohammad Hamedanian ◽  
Mohammad Gharehbeglou ◽  
Mojtaba Heydari ◽  
...  
Keyword(s):  
Controlled Trial ◽  
Inverse Correlation ◽  
Therapeutic Effects ◽  
Double Blind ◽  
Short Acting ◽  
Significant Difference ◽  
Children With Asthma ◽  
Basic Characteristics ◽  
To Receive ◽  
Intermittent Asthma

This study aimed to investigate the effect of violet syrup on cough alleviation in children with intermittent asthma. In a parallel, double-blind, randomized controlled trial, 182 children aged 2 to 12 years with intermittent asthma were randomly assigned 1:1 to receive violet syrup or placebo along with the common standard treatments in both groups (short-acting β-agonist). Both groups were evaluated in terms of the duration until cough suppression was achieved. No significant difference was observed in basic characteristics. The duration lasting to yield more than 50% cough reduction and 100% cough suppression was significantly less in the violet syrup group compared to placebo ( P = .001, P < .001, respectively). There was no significant difference in therapeutic effects between boys and girls. There was a significant inverse correlation between the age of children and rate of cough alleviation and suppression by violet syrup. This study showed that the adjuvant use of violet syrup with short-acting β-agonist can enhance the cough suppression in children with intermittent asthma.

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