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  Citation statistics : Table of Contents
   2016| October-December  | Volume 1 | Issue 4  
    Online since November 7, 2016

 
 
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STUDY PROTOCOL
Cognitive function and biomarkers after traumatic brain injury: protocol for a prospective inception cohort study
Wei Lin, Li-kun Yang, Sang Cai, Jie Zhu, Yi Feng, Li-xiang Yang, Zhi-zhong Feng, Pei-pei Li, Jun-hui Chen, Yu-hai Wang
October-December 2016, 1(4):170-176
DOI:10.4103/2468-5577.193144  
Background: Traumatic brain injury is a high-incidence condition that can cause severe cognitive impairment. At present, functional magnetic resonance imaging is used to analyze changes in brain function and network connectivity at different stages of injury. In addition, tau protein expression in nerve cells may reflect cognitive function. However, the combined use of functional magnetic resonance imaging and tau measurement to assess cognitive function following traumatic brain injury has not yet been investigated. Methods/Design: A prospective inception cohort study will be performed at the 101 st Hospital of PLA, Wuxi, China. We will conduct a follow-up visit in 100 patients with traumatic brain injury. Cognitive function will be assessed within 24 hours of injury and 0.5, 1, and 2 years after injury. Primary outcomes will be the Montreal Cognitive Assessment score, functional magnetic resonance imaging results, and tau protein level in the cerebrospinal fluid. Secondary outcomes will include Mini-Mental State Examination Scale and Hamilton Depression Scale scores. We will assess cognitive function in patients with traumatic brain injury and analyze its correlation with functional imaging indexes and tau levels in the cerebrospinal fluid. Discussion: This trial has been designed to determine whether functional imaging indexes and tau level in the cerebrospinal fluid can predict recovery of cognitive function in patients with traumatic brain injury. It will provide objective evidence for the clinical prevention and treatment of cognitive dysfunction following traumatic brain injury. Trial registration: This trial was registered at Chinese Clinical Trial Registry (registration number: ChiCTR-OOC-16008574) on 31 May 2016. Ethics: Approved by the Ethics Committee of the 101 st Hospital of PLA, China (approval number: L2016002), the study protocol will be performed in accordance with the guidelines of the Declaration of Helsinki, formulated by the World Medical Association. Informed consent: Written informed consent will be obtained from participants or their guardians.
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Homeopathic prophylaxis for recurrent urinary tract infections following spinal cord injury: study protocol for a randomized controlled trial
Jürgen Pannek, Susanne Pannek-Rademacher, Mohinder S Jus, Jörg Krebs
October-December 2016, 1(4):191-195
DOI:10.4103/2468-5577.193147  
Background: Virtually many patients with spinal cord injury (SCI) suffer from neurogenic lower urinary tract dysfunction (NLUTD). Although the most severe consequence of NLUTD, damage of renal function, can be treated effectively today, urinary tract infections (UTI) are the most common urologic problems in SCI patients. They severely impair the quality of life, and no evidence-based prophylaxis exists. The goal of this study is to assess the usefulness of adjunctive homeopathic treatment for the reduction of UTI in patients with SCI. Methods/Design: A prospective randomized controlled trial is designed to assess whether adjunctive treatment with classical homeopathy leads to a relevant reduction of the rate of UTI in patients with SCI. In addition, it will be assessed if homeopathic treatment will significantly improve patient satisfaction and quality of life. Fifty patients with SCI and recurrent (3 or more) UTI per year will be recruited from the patients of the neuro-urology of the Swiss paraplegic Centre in Nottwil, Switzerland. All patients will be randomly allocated into two groups: patients in the homeopathy group (n = 25) will receive standard of-care prophylaxis combined with homeopathic treatment; the control group (n = 25) will receive standard of-care prophylaxis alone. Standard of-care prophylaxis consists of cranberry products and urine acidification. Homeopathic treatment consists of a homeopathic medication; the remedy is chosen individually based on the homeopathic case taking. Patients do not routinely present to the homeopaths during the study, but can contact them if a UTI occurs during the course of the study. Primary outcome are the UTI rate, and secondary outcomes are quality of life and satisfaction with the treatment over a follow-up period of 1 year. Discussion: There is a high demand for effective UTI prophylaxis in patients with SCI, because UTI are associated with an increased morbidity and even mortality. The results of the study will significantly add to our knowledge not only about UTI prevention, but the clinical value of homeopathy. Trial registration: ClinicalTrials.gov identifier: NCT01477502, registered on 17 November 2011. Ethics: The "Ethikkommission Nordwest- und Zentralschweiz (EKNZ): PB_2016-00054" approved this study protocol. Informed consent: Patients will sign an informed consent prior to participation in the study.
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Bispectral index-guided fast track anesthesia by sevoflurane infusion combined with dexmedetomidine for intracranial aneurysm embolization: study protocol for a multi-center parallel randomized controlled trial
Chao-liang Tang, Juan Li, Bo Zhao, Zhong-yuan Xia
October-December 2016, 1(4):177-185
DOI:10.4103/2468-5577.193145  
Background: After intracranial aneurysm embolization, rapid recovery from general anesthesia is necessary for timely monitoring of adverse events. Fast-track anesthesia using a balanced technique or combination of drugs at their minimum required dosages is preferred for these neurosurgical patients. However, fast-track anesthesia is still limited by a lack of standardization and quality control standards. Methods/Design: A multi-center, parallel, randomized controlled clinical trial will be conducted at Anhui Provincial Hospital and Renmin Hospital of Wuhan University, China. One hundred and twenty patients with intracranial aneurysm will be randomly assigned to a normal saline group and a dexmedetomidine group. General anesthesia will be induced intravenously with propofol. Additionally, either 1.0 μg/kg dexmedetomidine or normal saline will be delivered completely within 10 minutes before anesthesia induction. Once anesthesia has begun, dexmedetomidine (0.3 μg/kg per hour) or normal saline will be continuously infused. Intraoperatively, anesthesia will be maintained with 2-3% sevoflurane. Primary outcomes will be anesthesia time, operative time, time from the end of anesthesia until recovering spontaneous breathing, time until eye opening on command, and time until orientation to time and place. Secondary outcomes will be dose of sevoflurane, Visual Analogue Scale score, and bispectral index. Discussion: In this trial, we will assess the clinical efficacy of sevoflurane anesthesia with dexmedetomidine as a fast track anesthesia for intracranial aneurysm embolization. Trial registration: This protocol was registered at Chinese Clinical Trial Registry (identifier: ChiCTR-IPR-16008113) on 17 March 2016. Ethics: Written approval for this trial has been obtained from the Ethics Committee of the Anhui Provincial Hospital of China (approval No. 2015-31). This study will be performed in accordance with the guidelines of the Declaration of Helsinki, formulated by the World Medical Association. Informed consent: Prior to the trial, participants and their family members will be informed of the risks and benefits of this trial. Written informed consent will be obtained from each participant.
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CORRECTION
Correction: Effects of cognitive behavioral therapy on white matter fibers of patients with obsessive-compulsive disorder as assessed by diffusion tensor imaging: study protocol for a parallel group, controlled trial

October-December 2016, 1(4):176-176
DOI:10.4103/2468-5577.193150  
  - 1,319 134
ORIGINAL ARTICLE
Utilization patterns of benzodiazepines in psychiatric patients in a tertiary care teaching hospital
Uday Venkat Mateti, Pramitha Prabhakaran, TS Sanal
October-December 2016, 1(4):196-201
DOI:10.4103/2468-5577.193148  
To assess the utilization patterns of benzodiazepines in psychiatric patients in a tertiary care teaching hospital, a prospective observational study was conducted for a period of 8 months. Drug therapy details in medication chart review and clinical review in patients treated with benzodiazepines was analyzed to measure the utilization pattern of benzodiazepines in terms of defined daily dose (DDD) per 100 bed-days. A total of 160 patients, including 88.8% of males and 11.2% of females, were included in the study. Most of the patients were between the age groups of 30-39 years (33.1%). The most common clinical conditions treated with benzodiazepines were mental and behavioural disorders due to alcohol (65.6%). The majority of patients were prescribed with lorazepam (83.1%). The DDD per 100 bed-days of benzodiazepines were found to be 0.98. The prescribed daily dose and DDD of benzodiazepines were 57.16 ± 30.3 and 89.69 ± 39.16, respectively. The total cost per DDD of benzodiazepines was 28.9 Indian Rupees (INR). Our study results indicate that the most common clinical conditions treated with benzodiazepines were mental and behavioural disorders due to alcohol and the majority of patients were prescribed lorazepam.
  - 2,220 259
REVIEW
Regional anesthesia to scalp for craniotomy surgery
Pathomporn Pin-on
October-December 2016, 1(4):202-204
DOI:10.4103/2468-5577.193149  
The main purposes of the review in the scalp blockade topic are to explore the background and the importance of post-craniotomy pain, briefly review scalp innervation, and give some examples of the controversial results of many previous studies. I also included my previous study of pre-incisional scalp blockade which added some inconclusive results to this arena.
  - 1,533 158
STUDY PROTOCOL
Effectiveness of cerebellar repetitive transcranial magnetic stimulation in essential tremor: study protocol for a randomized, sham-controlled trial
Ali Shoeibi, Nahid Olfati
October-December 2016, 1(4):186-190
DOI:10.4103/2468-5577.193146  
Background: Recent studies have shown that the cerebellum has a significant role in development of essential tremor and repetitive transcranial magnetic stimulation (rTMS) has therapeutic effects on its motor symptoms. Methods/Design: This is a prospective, randomized, triple-blind, sham-controlled, add-on, crossover trial involving patients with essential tremor. Thirty patients will be included and randomized to either real rTMS (900 daily pulses of rTMS over each cerebellar hemisphere) or sham stimulation (low current electrical stimulation). After 2 months of follow-up, patients will undergo crossover and receive the other treatment. For the primary outcome measure, patients will be assessed using Fahn-Tolosa-Marin scale. Adverse events will be assessed as the secondary outcome measure. Discussion: This study evaluates the effect of cerebellar rTMS on tremor severity of patients afflicted with essential tremor, and aims to address the shortcomings of previous studies using a relatively larger sample size and randomized, sham-controlled, crossover design. Trial registration: This trial has been registered at ClinicalTrials.gov (identifier: NCT02704793) on 5 March 2016 and also at Iranian Registry of Clinical Trials (IRCT) (registration ID: IRCT2015100824428N1) on 1 April 2016. Ethics: This study has been approved by the Research Ethics Committee of Mashhad University of Medical Sciences, Iran (approval number: ir.mums.sm.rec.1394.353). Informed consent: Written informed consent will be obtained from all participants.
  - 2,074 133
Effect of intravenous acetaminophen on post-operative opioid-related complications: study protocol for a randomized, placebo-controlled trial
Wael Saasouh, Nelroy Jones, Taylor Stang, Karen Hovsepyan, Christine Chang, Alparslan Turan
October-December 2016, 1(4):154-163
DOI:10.4103/2468-5577.193142  
Background: Unrelieved post-operative pain leads to physiological and psychological consequences which worsen outcomes. Patients still report a 31% incidence of severe pain and 47% incidence of moderate pain after surgery. Multimodal analgesia aims to improve satisfaction while reducing side effects. Opioids are the most common treatment for post-operative pain; however, acute tolerance and opioid-induced hyperalgesia increase opioid requirements and the risk of side effects. Previous studies with acetaminophen have shown consistent and clinically important opioid-sparing effects but were unable to demonstrate significant reductions in opioid-related adverse events (inadequate sample sizes, poorly monitored complications). Specifically, we propose to test the primary hypothesis that total duration of hypoxia (defined as saturation of peripheral oxygen (SpO 2 ) < 90%) is less in patients receiving intravenous acetaminophen than placebo. Methods/Design: A total of 528 patients undergoing elective open or laparoscopic abdominal surgery will be included in this prospective, randomized, double-blinded, placebo-controlled trial. Patients who have renal disease, liver disease, acetaminophen allergy, are on warfarin therapy, or are receiving regional blocks will be excluded. The incidence and duration of hypoxic events will be the primary outcome of the study. Secondary outcomes include opioid consumption, pain scores, post-operative nausea and vomiting, sedation, fatigue, respiratory rate, movement, and cost-benefit analysis. We will use a ViSi mobile device (Sotera Wireless, San Diego, CA, USA) that will provide continuous non-invasive pulseoximetry, blood pressure, skin temperature, and patient position. Respiratory function will be measured using an ExSpiron (Respiratory Motion Inc., Waltham, MA, USA) monitor which provides continuous non-invasive monitoring of tidal volume, respiratory rate, and minute ventilation. Discussion: The outcomes will reveal the effect of peri-operative IV acetaminophen use on post-operative opioid-related complications. Continuous non-invasive monitoring of vital signs is expected to accurately assess opioid-related complications after major abdominal surgery and provide reliable results correlated with opioid use. The use of novel technology in the post-operative setting permits the collection of a dense amount of data and eliminates gaps in post-operative vital sign measurements. Trial registration: ClinicalTrials.gov identifier: NCT02156154, registered on 3 June 2014. Ethics: The study protocol was approved by the Cleveland Clinic Institutional Review Board (IRB) on 28 April 2014, approval number 14-241. Informed consent: Written informed consent will be obtained from participants or their guardians.
  - 2,773 1,225
Electroencephalographic changes following trigeminal nerve stimulation for major depressive disorder: study protocol for a randomized sham-controlled trial
Alisson Paulino Trevizol, Pedro Shiozawa, Quirino Cordeiro
October-December 2016, 1(4):164-169
DOI:10.4103/2468-5577.193143  
Background: Major depressive disorder (MDD) is one of the most common psychiatric disorders. Trigeminal nerve stimulation (TNS) is a novel neuromodulation technology with impressive initial results in the treatment of MDD that lacks a better evaluation of neurobiological mechanisms of action. Methods/Design: This is a two-arm, randomized, double-blind, sham-controlled trial to evaluate the effect of TNS on severe MDD through quantitative electroencephalography (QEEG) pre and post intervention. Forty-four patients diagnosed with severe MDD will be randomly assigned to either a 10-session treatment protocol of real TNS or a 10-session treatment protocol of sham TNS. Outcome measures will be evaluated at baseline, at the end of the stimulation protocol and 30 days after the end of the 10-day treatment period. The primary outcome is changes in the previously established frequency band ranges in QEEG during resting state. The secondary outcome is heart rate variability for better evaluation of the sympathetic and parasympathetic changes after TNS. Discussion: Due to the high prevalence of MDD, the limited effect of antidepressant medications, the high rate of intolerable adverse events, and the high rate of refractoriness, we believe non-invasive neuromodulation strategies, e.g., TNS can be a useful tool for the treatment of MD. The evaluation of the effect of TNS with QEEG before and after stimulation may help us clarify the mechanisms involved in the clinical responses. Trial registration: ClinicalTrials.gov identifier: NCT02562703, registered on 25 September 2015. Ethics: This study protocol has been approved by the institutional review board (IRB) (approval number: 30960814.7.0000.5479) and will be performed in accordance with the Declaration of Helsinki. Informed consent: Patients will sign an informed consent prior to participation in the study.
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