A randomized controlled trial to evaluate the effectiveness and safety of electro acupuncture and transcranial direct current stimulation with computerized cognitive rehabilitation in patients with vascular cognitive impairment.
- 作者列表："Park HK","Song MK","Kim JH","Han JY
BACKGROUND:Vascular cognitive impairment (VCI) refers to all cognitive disorders caused by cerebrovascular disorders. For the treatment, many types of pharmacologic and nonpharmacologic treatments are used but their underlying mechanisms and effects are unclear. Regarding nonpharmacologic treatment, electroacupuncture (EA), transcranial direct current stimulation (tDCS), and computerized cognitive rehabilitation treatment (CCRT) are effective. Here, we report the protocol for a randomized controlled trial of the effect and safety of combination therapy of EA or tDCS and CCRT in patients with VCI. METHODS:This study will be a prospective, outcome assessor-blinded, parallel-arm, randomized controlled clinical trial. Participants with cognitive impairment caused by stroke after 3 months of onset (n = 45) will be randomly assigned to a CCRT, combination therapy with EA and computerized cognitive rehabilitation treatment, or combination therapy with tDCS and computerized cognitive rehabilitation treatment group. All groups will receive treatment 3 times per week for 8 weeks, giving a total of 24 treatments. The CCRT group will perform a training task like shopping, calculating, and others and involving computerized cognitive assessment and brain training system (RehaCom) for 30 minutes. The combination therapy with EA and computerized cognitive rehabilitation treatment group will receive EA using 8 acupuncture points - baekhoe, sinjeong, both sides of pungji, 4 sites of sishencong - and will be applied using an EA stimulator and receive CCRT for 30 minutes at the same time. The combination therapy with tDCS and computerized cognitive rehabilitation treatment group will receive tDCS treatment and receive CCRT for 30 minutes at the same time. The primary outcome will be evaluated using the Lowenstein occupational therapy cognitive assessment, while other scales assessing walking ability, activities of daily living, and quality of life are considered secondary outcome measures. Outcomes will be evaluated before intervention, at the end of intervention 8 weeks after the first intervention, and 4 weeks after completion of the intervention program. DISCUSSION:This study aims to examine the effect and safety of combination therapy with EA or tDCS and CCRT in patients with VCI. This study can be useful in developing new treatment technologies using collaborative research with combined traditional Korean and conventional medicines. TRIAL REGISTRATION:This trial has been registered with cris.nih.go.kr (registration number, KCT 0003644 Registered 01 April 2019, http://cris.nih.go.kr).
背景: 血管性认知障碍 (VCI) 是指由脑血管疾病引起的所有认知障碍。对于治疗，使用了许多类型的药物和非药物治疗，但其潜在的机制和效果尚不清楚。关于非药物治疗，电针 (EA) 、经颅直流电刺激 (tDCS) 和计算机认知康复治疗 (CCRT) 是有效的。在此，我们报告了一项随机对照试验的方案，该试验旨在研究EA或tDCS和CCRT联合治疗VCI患者的效果和安全性。 方法: 本研究将是一项前瞻性、结果评估盲法、平行对照、随机对照临床试验。发病3个月后因卒中导致认知障碍的参与者 (n = 45) 将被随机分配到CCRT、EA联合治疗和计算机化认知康复治疗组，或tDCS联合治疗和计算机化认知康复治疗组。所有组每周治疗3次，共8周，共24次。CCRT小组将进行30分钟的训练任务，如购物、计算等，包括计算机认知评估和大脑训练系统 (RehaCom)。与EA和计算机认知康复治疗组的联合疗法将使用8个穴位-baekhoe，sinjeong，pungji的两侧，四神聪的4个部位-进行EA治疗，并使用EA刺激器进行应用，同时接受CCRT 30分钟。tDCS与计算机认知康复治疗组的联合治疗将接受tDCS治疗，同时接受CCRT 30 min。主要结局将使用Lowenstein职业疗法认知评估进行评估，而评估步行能力、日常生活活动和生活质量的其他量表被视为次要结局指标。结果将在干预前、干预结束时、第一次干预后8周和干预计划完成后4周进行评估。 讨论: 本研究旨在研究EA或tDCS和CCRT联合治疗VCI患者的效果和安全性。这项研究可以用于开发新的治疗技术，使用与韩国传统和传统药物相结合的合作研究。 试验注册: 本试验已在cris.nih.go.kr注册 (注册号，KCT 0003644注册，2019年4月1日，http://cris.nih.go.kr)。
METHODS:BACKGROUND:Anxiety and distress behaviors during anesthesia induction are associated with negative postoperative outcomes for pediatric patients. Documenting behavioral responses to induction is useful to evaluate induction quality at hospitals and to optimize future anesthetics for returning patients, but we lack a simple tool for clinical documentation. The Induction Compliance Checklist is a tool for grading induction behaviors that is well validated for research purposes, but it is not practical for routine documentation in busy clinical practice settings. The Child Induction Behavioral Assessment tool was developed to provide a simple and easy to use electronic tool for clinical documentation of induction behaviors. The aim of this study was to test the Child Induction Behavioral Assessment tool's concurrent validity with the Induction Compliance Checklist and the interrater reliability. METHODS:This prospective, observational study included 384 pediatric patients undergoing anesthesia inhalation induction. Concurrent validity with the Induction Compliance Checklist and interrater reliability of the Child Induction Behavioral Assessment were evaluated. Two researchers alternated scoring the Induction Compliance Checklist. The 2 researchers independently scored the Child Induction Behavioral Assessment. The anesthesia clinician caring for the patient also independently scored the Child Induction Behavioral Assessment by completing their routine documentation in the patient's medical record. Two age groups were evaluated (ages 1-3 and 4-12 years old). RESULTS:Clinicians' and researchers' Child Induction Behavioral Assessment scores demonstrated a strong correlation with the Induction Compliance Checklist (P < .0001). There was an excellent agreement between the 2 researchers' Child Induction Behavioral Assessment scores for the younger and older age groups, respectively (Kappa [95% CI] = 0.97 (0.94-0.99); K = 0.94 (0.89-0.99)]. The agreement between the researchers and the 117 clinicians who documented Child Induction Behavioral Assessment assessments in the medical record was good overall (intraclass correlation coefficient = 0.70), with fair agreement with the 1- to 3-year-old patients (intraclass correlation coefficient = 0.56) and good agreement for the 4- to 12-year-old patients (intraclass correlation coefficient = 0.74). CONCLUSIONS:The Child Induction Behavioral Assessment scale is a simple and practical electronic tool used to document pediatric behavioral responses to anesthesia inductions. This study provides evidence of the tool's validity and reliability for inhalation inductions. Future research is needed at other hospitals to confirm validity.
METHODS:BACKGROUND:Fentanyl and morphine are the 2 most commonly added opioids to bupivacaine for spinal anesthesia during cesarean delivery. Numerous clinical trials have assessed efficacy and safety of different doses of fentanyl added to intrathecal bupivacaine for spinal anesthesia, yet its benefit, harm, and optimal dose remain unclear. This study aimed to systematically review the evidence of the efficacy of fentanyl when added to intrathecal bupivacaine alone and when added to bupivacaine with morphine for spinal anesthesia during cesarean delivery. METHODS:Key electronic databases (PubMed, Embase, and Cochrane Library) were searched for randomized controlled trials in the cesarean delivery population. The primary outcome was the failure rate of spinal anesthesia, as assessed by the need for either conversion to general anesthesia or intraoperative analgesic supplementation. Two reviewers independently extracted the data using a standardized electronic form. Results are expressed as relative risks or mean differences with 95% CIs. RESULTS:Seventeen randomized controlled clinical trials (most judged as low or unclear risk of bias) with 1064 participants provided data for the meta-analysis. Fentanyl added to intrathecal bupivacaine alone reduced the need for intraoperative supplemental analgesia (relative risk, 0.18; 95% CI, 0.11-0.27; number needed to treat, 4) and the incidence of nausea/vomiting (relative risk, 0.41; 95% CI, 0.24-0.70; number needed to treat, 6.5), with longer time to first postoperative analgesia request (mean difference, 91 minutes; 95% CI, 69-113). No difference was observed regarding the need for conversion to general anesthesia (relative risk, 0.67; 95% CI, 0.12-3.57), the incidence of hypotension, the onset of sensory block, or the duration of motor block. However, the addition of intrathecal fentanyl was associated with higher incidence of intraoperative pruritus (relative risk, 5.89; 95% CI, 2.07-16.79; number needed to harm, 13.5). The inclusion of fentanyl to intrathecal bupivacaine-morphine compared to intrathecal bupivacaine-morphine alone conferred a similar benefit, with a significantly reduced need for intraoperative supplemental analgesia (relative risk, 0.16; 95% CI, 0.03-0.95; number needed to treat, 9). Analysis using a funnel plot indicated a possibility of publication bias in included studies. CONCLUSIONS:Current evidence suggests a benefit of using fentanyl as both an additive to intrathecal bupivacaine alone and to intrathecal bupivacaine combined with morphine for cesarean delivery under spinal anesthesia. The possibility of publication bias, small sample size, and high risk of bias in some of the included studies warrant treating the results with caution.
METHODS::Ophthalmic pediatric regional anesthesia has been widely described, but infrequently used. This review summarizes the available evidence supporting the use of conduction anesthesia in pediatric ophthalmic surgery. Key anatomic differences in axial length, intraocular pressure, and available orbital space between young children and adults impact conduct of ophthalmic regional anesthesia. The eye is near adult size at birth and completes its growth rapidly while the orbit does not. This results in significantly diminished extraocular orbital volumes for local anesthetic deposition. Needle-based blocks are categorized by relation of the needle to the extraocular muscle cone (ie, intraconal or extraconal) and in the cannula-based block, by description of the potential space deep to the Tenon capsule. In children, blocks are placed after induction of anesthesia by a pediatric anesthesiologist or ophthalmologist, via anatomic landmarks or under ultrasonography. Ocular conduction anesthesia confers several advantages for eye surgery including analgesia, akinesia, ablation of the oculocardiac reflex, and reduction of postoperative nausea and vomiting. Short (16 mm), blunt-tip needles are preferred because of altered globe-to-orbit ratios in children. Soft-tip cannulae of varying length have been demonstrated as safe in sub-Tenon blockade. Ultrasound technology facilitates direct, real-time visualization of needle position and local anesthetic spread and reduces inadvertent intraconal needle placement. The developing eye is vulnerable to thermal and mechanical insults, so ocular-rated transducers are mandated. The adjuvant hyaluronidase improves ocular akinesia, decreases local anesthetic dosage requirements, and improves initial block success; meanwhile, dexmedetomidine increases local anesthetic potency and prolongs duration of analgesia without an increase in adverse events. Intraconal blockade is a relative contraindication in neonates and infants, retinoblastoma surgery, and in the presence of posterior staphylomas and buphthalmos. Specific considerations include pertinent pediatric ophthalmologic topics, block placement in the syndromic child, and potential adverse effects associated with each technique. Recommendations based on our experience at a busy academic ophthalmologic tertiary referral center are provided.