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.

Timing of operation for ruptured supratentorial aneurysms: a prospective randomized study

1989 ◽  
Vol 70 (1) ◽  
pp. 55-60 ◽  
Author(s):  
Juha Öhman ◽  
Olli Heiskanen
Keyword(s):  
Aneurysmal Subarachnoid Hemorrhage ◽  
Anterior Part ◽  
Controlled Trial ◽  
Randomized Study ◽  
Prospective Randomized Study ◽  
Double Blind ◽  
Content Type ◽  
Acute Surgery ◽  
Significant Difference ◽  
Fine Print

✓ A total of 216 patients with a ruptured aneurysm of the anterior part of the circle of Willis were enrolled into this prospective randomized study of timing of the operation after aneurysmal subarachnoid hemorrhage (SAH). Only patients in clinical Grades I to III (according to the classification of Hunt and Hess) who were admitted and randomly assigned to a treatment group within 72 hours after the SAH were included in the trial. The patients were randomly assigned to one of three operation groups: acute surgery (AS: 0 to 3 days after the SAH; day of SAH = Day 0), intermediate surgery (IS: 4 to 7 days after the SAH), or late surgery (LS: 8 days to an indefinite time after the SAH). Three patients (4.3%) in the IS group and six patients (8.6%) in the LS group died before surgery was undertaken. At 3 months post-SAH, 65 patients (91.5%) from the AS group were classified as independent compared to 55 (78.6%) from the IS group and 56 (80.0%) from the LS group. The management mortality rate in the AS group was 5.6% compared to 12.9% in the LS group. Of the 216 patients enrolled in the timing study, 159 were randomly assigned to an independent double-blind placebo-controlled trial of nimodipine in Grade I to III patients. A total of 79 patients received nimodipine and 80 placebo. When the nimodipine group and the no-nimodipine group (the 80 placebo-treated patients plus the 52 patients who were not entered into the nimodipine trial) were analyzed separately, a significant difference was seen in the outcome of the no-nimodipine group (dependent AS vs. dependent IS, p = 0.01). Nimodipine treatment was associated with a significant reduction of delayed ischemic deterioration (all operation groups combined, nimodipine vs. no nimodipine p = 0.01; LS with nimodipine vs. LS with no nimodipine, p = 0.03).

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.

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 Uji Perbandingan Antibiotik Profilaksis Ceftriaxone versus Cefazolin pada Bedah Obstetri dan Ginekologi

2021 ◽  
Vol 10 (4) ◽  
Author(s):  
Asri Rahayu ◽  
Fita Rahmawati ◽  
Tri Murti Andayani ◽  
Ammar Siradjuddin
Keyword(s):  
Side Effects ◽  
Clinical Outcome ◽  
Controlled Trial ◽  
Prophylactic Antibiotic ◽  
Prophylactic Antibiotics ◽  
Surgical Patients ◽  
High Morbidity ◽  
Chi Square ◽  
Double Blind ◽  
Exact Test

Surgical site infection (SSI) is the most common complication in postoperative surgical patients which is associated with high morbidity, mortality, and cost burden. These complications can be prevented by giving proper prophylactic antibiotics. Cefazolin is a recommended prophylactic antibiotic, but in the practice in Indonesia hospital, there are still many uses of ceftriaxone. This study aimed to compare the clinical outcome and safety of cefazolin and ceftriaxone as prophylactic antibiotics in preventing SSI in obstetric and gynecological surgical patients. The study design was double-blind randomized controlled trial. The data collection was conducted from January to June 2020 at dr. Dradjat Prawiranegara Regional Hospital Serang. A total of 82 subjects who met the inclusion criteria were divided into two groups by block randomization, 41 subjects were given cefazolin and 41 subjects were given ceftriaxone. The clinical outcome was measured by preventing SSI for the effectiveness and side effects for safety outcomes in both groups. The comparison of effectiveness and side effects were analyzed using the bivariate test (chi-square or fisher’s exact test) and relative risk (RR). The study showed that the effectiveness of cefazolin was the same as ceftriaxone in preventing SSI for 30 days (RR= 0.89; p= 0.724; 95%CI: 0,193-3,133) with the number of SSI 12.2% vs 9.8%. Side effects included nausea, vomiting, and phlebitis was observed in the administration of antibiotic by intravenous push (IVP) pre-operating.  Cefazolin have safetier than ceftriaxone with the incidence of side effects were 9.8% vs 29.3% ((RR = 0,33; p= 0.003; 95% CI: 0.076-0.895).  Cefazolin is an antibiotic recommended by Indonesian Ministry of Health and the Association of Obstetrics and Gynecology.  This study encourages the use of cefazolin to prevent resistance due to ceftriaxone to overuse.

scholarly journals Adjunctive simvastatin treatment in schizophrenia patients; a double blind randomized and placebo controlled trial

2021 ◽  
Vol 7 (1) ◽  
pp. e02-e02
Author(s):  
Somaieh Ashrafi ◽  
Seyyed Mohammad Ghaffari ◽  
Hatam Boostani ◽  
Somaieh Raz ◽  
Negar Ebadi ◽  
...  
Keyword(s):  
Negative Symptoms ◽  
Mixed Model ◽  
Controlled Trial ◽  
Repeated Measure ◽  
Antipsychotic Treatment ◽  
Double Blind ◽  
Exact Test ◽  
Beneficial Effects ◽  
Significant Difference ◽  
Double Blinded

Introduction: Statins such as simvastatin are recently introduced as agents that may have beneficial effects in schizophrenia regarding their prominent anti-inflammatory properties. Objectives: This study was designed to evaluate the effects of simvastatin on schizophrenia symptoms. Patients and Methods: In a double-blinded randomized clinical trial, 40 hospitalized schizophrenia patients (according to the DSM-IV-TR criteria) were studied for 6 weeks. One group of the patients (n=20) received simvastatin (with the dose of 40 mg/d) and the other group received (n=20) placebo. The patients were evaluated by the Positive and Negative Syndrome Scale (PANSS) for schizophrenia symptoms. Data were analyzed with mixed model repeated measure ANOVA, t test, and χ2 test or Fischer’s exact test by SPSS software. The significant cutoff was considered at P<0.05. Results: The mean age of the patients was 34.05±9.74 years and 50% of them were men. There was not a significant difference between the two groups regarding negative symptoms reduction. Conclusion: Our study demonstrated that adding simvastatin on atypical antipsychotic treatment had no significant beneficial effects on the negative and positive symptoms in patients with schizophrenia disorder. Trial Registration: The trial protocol was approved by the Iranian Registry of Clinical Trials (identifier: IRCT2017052034046N1; https://en.irct.ir/trial/26134, ethical code; ETH-457).

Prospective study on Incidence and Functional Impact of Transient Neurologic Symptoms Associated with 1%Versus  5% Hyperbaric Lidocaine in Short Urologic Procedures

2003 ◽  
Vol 98 (2) ◽  
pp. 485-494 ◽  
Author(s):  
Doris Tong ◽  
Jean Wong ◽  
Frances Chung ◽  
Mark Friedlander ◽  
Joseph Bremang ◽  
...  
Keyword(s):  
Prospective Study ◽  
Controlled Trial ◽  
Double Blind ◽  
Neurologic Symptoms ◽  
Intention To Treat ◽  
Pain Scores ◽  
Significant Difference ◽  
Functional Scores ◽  
Urological Procedures ◽  
To Receive

Background The objectives of this study were to compare the incidence, onset, duration and pain scores of transient neurologic symptoms (TNS) with 1% versus 5% hyperbaric lidocaine in spinal anesthesia for short urological procedures in a large prospective study. This study would also evaluate patient satisfaction, and impact of TNS on functional recovery to assess the clinical significance of TNS. Methods This was a multicenter, double-blind, randomized controlled trial. Four hundred fifty-three patients undergoing short transurethral procedures were randomized to receive 1% or 5% hyperbaric lidocaine. Eighty milligrams of 1% or 5% hyperbaric lidocaine was administered. During the first 3 days after surgery, the presence of TNS, its intensity and duration, and patient functional level were recorded. An intention-to-treat analysis was used. Results There was no difference in the incidence of TNS (21% vs. 18%) between 1% versus 5% lidocaine. Patients with TNS had significantly higher pain scores (5.3 +/- 3 vs. 2.3 +/- 3) than patients without TNS during the first 24 h. This difference in pain scores persisted until 72 h postoperatively. There was a significant difference in the daily activities functional scores (2.2 +/- 1 vs. 1.4 +/- 0.8) of TNS non-TNS patients during the first 24 h postoperatively. Conclusions There was no difference in the incidence of TNS between the 1% versus 5% spinal lidocaine groups. Pain scores were higher in patients with TNS than those who did not have TNS. During the first 48 h postop, a small proportion of patients who had TNS experienced functional impairment of walking, sitting, and sleeping.

scholarly journals Efficacy of Chuanxiong Ding Tong Herbal Formula Granule in the Treatment and Prophylactic of Migraine Patients: A Randomized, Double-Blind, Multicenter, Placebo-Controlled Trial

2012 ◽  
Vol 2012 ◽  
pp. 1-9 ◽  
Author(s):  
Caihong Fu ◽  
Lihua Yu ◽  
Yihuai Zou ◽  
Kegang Cao ◽  
Jianjun Zhao ◽  
...  
Keyword(s):  
Controlled Trial ◽  
Blood Stasis ◽  
Controlled Study ◽  
Herbal Formula ◽  
Double Blind ◽  
Chinese Herbal ◽  
Significant Difference ◽  
Vas Scores ◽  
To Receive

Objective.To evaluate the efficacy of traditional Chinese herbal ChuanXiong Ding Tong herbal formula granule (CXDT-HFG) for migraine patients with “the Syndrome of Liver Wind and Blood Stasis.”Methods.150 migraine patients were recruited and assigned randomly in a double-blind, placebo-controlled study to receive CXDT-HFG (n=99) plus necessary analgesics, or placebo (n=51) plus necessary analgesics for 16 weeks (12 weeks’ intervention and 4 weeks’ follow up). Outcome measures included migraine days, frequency of migraine attacks, analgesics consumption for acute treatment, and the proportion of responders as well as the visual analogue scale (VAS) scores and intensity for pain.Results.Compared with the placebo group, the CXDT-HFG group showed significant reduction in migraine days and attacks frequency at week 12 and follow-up period (P<0.05) as well as in the reduction of VAS scores at follow-up period.There was significant difference in the proportion of responders between the two groups at follow-up period (P=0.014). However there were no significant differences between the two groups in analgesics consumption (P>0.05). Conclusion.CXDT-HFG was more effective than placebo in decreasing days of migraine attacks, frequency, VAS scores, and relieving pain intensity for migraine patients.

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