Remifentanil and perioperative glycaemic response in cardiac surgery: an open-label randomised trial.

BACKGROUND: This study investigated whether remifentanil infusion decreased intraoperative hyperglycaemia and insulin resistance compared with intermittent fentanyl administration in patients undergoing elective cardiac surgery. METHODS: This was a randomised, prospective, open-label trial. Patients undergoing elective cardiac surgery (n=116) were randomised to receive either continuous intravenous remifentanil infusion or intermittent fentanyl boluses. Hourly blood glucose values were obtained for 24 h starting from induction of anaesthesia. The difference in percentage of patients with ≥2 intraoperative blood glucose concentrations >10 mM (180 mg dl-1) between the groups was the primary outcome measure. Secondary outcome measures included insulin requirements, select stress hormone and inflammatory cytokine concentrations, and safety events and adverse outcomes. RESULTS: The trial included 106 subjects in the final intention-to-treat analysis. There were fewer patients with ≥2 intraoperative blood glucose values >10 mM (180 mg dl-1) in the remifentanil group (17 [31.5%]) compared with the fentanyl group (33 [63.5%]) (relative risk: 0.50; 95% confidence interval [CI]: 0.32-0.77; P=0.001). The administered intraoperative insulin was a median of 8.1 units (range: 0-46.7) in the fentanyl group and 2.9 units (range: 0-35.1) in the remifentanil group (median difference=5 units; 95% CI: 1-7; P=0.004). Cortisol and adrenocorticotropic hormone were increased less in the remifentanil group (P<0.001), but there was no relative decrease in this group in select inflammatory cytokines. Postoperative measures of glycaemic control and adverse clinical outcomes were not significantly different between groups. CONCLUSIONS: Compared with patients treated with intermittent fentanyl, patients receiving continuous remifentanil infusion had fewer episodes of hyperglycaemia and less need for insulin administration during the intraoperative period of cardiac surgery. CLINICAL TRIAL REGISTRATION: NCT02349152.

Implementation of a quality improvement project for universal genetic testing in women with ovarian cancer.

OBJECTIVE: The National Comprehensive Cancer Network recommends all women with ovarian cancer be offered genetic testing. Despite a decade of endorsement, many oncology practitioners have yet to make this a part of routine practice. Referral to genetic counseling and completion of genetic testing among patients at substantial risk of germline mutations are significantly lacking, adversely affecting patient care and squandering an opportunity to maximize cancer prevention efforts. This project determined the impact and feasibility of implementing a basic model for universal referral to genetic counseling and completion of genetic testing in women with a diagnosis of ovarian cancer in an academic gynecology oncology practice with access to electronic health records (EHRs). METHODS: Patients diagnosed with ovarian cancer from January 2008 to November 2013 were retrospectively reviewed to determine the baseline referral rate for genetic counseling and testing completion in our practice. Implementation of a process change model combining provider training, patient education, enhanced electronic health record documentation and improved patient appointment scheduling strategies were implemented. We then prospectively collected data on all newly diagnosed ovarian cancer patients that had not already undergone genetic testing presenting from December 1, 2013 to November 30, 2016. RESULTS: Genetic referral rates, genetic counseling and testing completion rates were markedly improved. Pre-implementation our genetic testing rate was 27% and post implementation our testing rate was 82% (p-value≤0.001). CONCLUSIONS: Low cost interventions that target education of both providers and patients regarding the importance of genetic testing along with utilization of the EHR and streamlined patient appointment services can significantly increase rates of genetic testing completion.

First report of the point-of-care TEG: A technical validation study of the TEG-6S system.

Thrombelastography (TEG) measured by the TEG5000 Hemostasis Analyzer is an established but the labor-intensive method for assessing global hemostasis. The first true point-of-care TEG, the TEG6s system, uses resonance-frequency viscoelasticity measurements and a disposable multi-channel microfluidic cartridge to assess hemostasis and response to antiplatelet therapy. TEG assays (n = 5,100) were performed on the blood of healthy volunteers (n = 157) and patients undergoing coronary revascularization at three hospitals (n = 300). The results from the TEG6s were compared with the conventional TEG5000 in accordance with Clinical and Laboratory Standards Institute (CLSI) and FDA recommendations. Precision testing was conducted using blood from healthy donors, all assays were run for 5 consecutive days in duplicate using multiple operators, lots, and instruments. Reference ranges were comparable between the TEG systems. Deming regression analysis demonstrated a strong correlation between the two systems for the standard hemostasis tests (R r = 0.932, MA r = 0.972, LY30 r = 0.938). Method comparison analysis showed an acceptable agreement between PlateletMapping (PM) assays for measuring arachidonic acid (indicator of aspirin response)- and adenosine diphosphate (indicator of P2Y12 inhibitor response)-induced platelet aggregation (total agreement = 90%, and 72%, respectively). TEG6s precision testing yielded low variability (CV 0-13%) in all measures. The new point-of-care TEG6s is associated with greater ease of use than the TEG5000 and provides precise results. The results correlated between methods for all variables. TEG6s is a promising device for near-patient hemostasis monitoring and future trials of personalized therapy designed to reduce bleeding and thrombosis.

SuRxgWell: study protocol for a randomized controlled trial of telemedicine-based digital cognitive behavioral intervention for high anxiety and depression among patients undergoing elective hip and knee arthroplasty surgery.

BACKGROUND: Mood disorders (anxiety, depression), sleep disorders, and catastrophizing lead to increased post-operative pain perception, increase in postoperative opioid consumption, decreased engagement with physical activity, and increased resource utilization in surgical patients. Psychosocial disorders significantly affect postoperative outcome. Unfortunately, studies focused on perioperative psychological assessment and treatment are scarce. We propose to test whether digital cognitive behavioral intervention (dCBI) can help surgical patients. dCBI such as RxWell™ is a proven treatment for mood disorders in medical patients such as reducing depression in patients with inflammatory bowel disease. We hypothesize that RxWell™ will also be effective in surgical patients. This study aims to test whether RxWell™ can improve preoperative mood disorders and subsequently reduce postoperative pain and opioid requirement in patients scheduled for primary total hip and knee arthroplasty (THA, TKA). We named the trial as the SuRxgWell trial. METHODS: This is a randomized, controlled trial that will enroll primary and unilateral THA or TKA patients with anxiety and/or depression symptoms before surgery to receive the SuRxgWell dCBI program and investigate its impact on postoperative outcomes including postoperative pain, anxiety, depression, sleep disorder, and catastrophizing. After signing an informed consent, subjects will be screened using the PROMIS questionnaires, and subjects with a T-score of ≥ 60 on the short Patient-Reported Outcomes Measurement Information System (PROMIS) 4a Anxiety and/or short PROMIS 4a Depression questionnaires will be randomized to either usual care (control group) or the cognitive behavioral intervention, RxWell™, plus usual care (intervention group). The control group will receive information on how to locate tools to address anxiety and depression, whereas the intervention group will have access to SuRxgWell 1 month prior to surgery and up to 3 months after surgery. The allocation will be 3:1 (intervention to control). Investigators will be blinded, but research coordinators approaching patients and research subjects will not. The primary outcome will be day of surgery anxiety or depression symptoms measured with the PROMIS Short Form v1.0 -Anxiety 4a/Depression and Generalized Anxiety Disorder Measure (GAD-7) and Patient Health Questionnaire (PHQ-8). Secondary end points include measuring other health-related quality of life outcomes including sleep disturbance, fatigue, ability to participate in social roles, pain interference, cognitive function, pain catastrophizing, and physical function. Other secondary outcomes include collecting data about preoperative and postoperative pain scores, and pain medication usage, and orthopedic functional recovery at baseline, day of surgery, and 1, 2, and 3 months after the surgery with the Pain Catastrophizing Scale, the Knee injury and Osteoarthritis Outcome Score (KOOS), and Hip injury and Osteoarthritis Outcome Score (HOOS). In addition, subjects will be asked to complete a GAD-7 and PHQ-8 questionnaires bi-weekly (via the RxWell™ app for the interventional group or REDCAP for the control group). Data about postsurgical complications, and resource utilization will also be recorded. We will also receive monthly reports measuring the usage and engagement of RxWell use for each participant randomized to that arm. The primary hypotheses will be assessed with intention-to-treat estimates, and differences in primary outcome will be tested using independent two sample t-tests. This trial is registered to the ClinicalTrials.gov database (NCT05658796) and supported by the DAPM, UPMC Health Plan, and the NIH. DISCUSSION: Our trial will evaluate the feasibility of digital cognitive behavioral intervention as a perioperative tool to improve anxiety and depression before and after major orthopedic surgery in comparison to education. If digital cognitive behavioral intervention proves to be effective, this might have important clinical implications, reducing the incidence of chronic postsurgical pain and improving outcomes.

Auricular field nerve stimulation using the NSS-2 BRIDGE® device as an alternative to opioids following kidney donor surgery.

OBJECTIVES: The purpose of this study was to investigate the role that the NSS-2 BRIDGE® device, an auricular field nerve stimulator, may play in reducing opioid requirement and pain in kidney donor surgery. It was not a randomized study. Electrophysiologic studies have demonstrated that the stimulation of the cranial nerves produced by the NSS-2 BRIDGE® device modulates the ascending/descending spinal pain pathways, especially at the level of the limbic system. METHODS: The design compared the effects of the NSS-2 BRIDGE® device (NSS 2-BRIDGE® device group; n=10) to a control group (n=10). In both groups, the surgery was performed using the same standard enhanced recovery after surgery protocol based on the use of a multimodal analgesic approach. For the active treatment group, the NSS-2 BRIDGE® device was placed in the post anesthesia care unit. The primary endpoint was opioid requirement (oral morphine equivalent, OME in mg) at 24 h post-surgery. Secondary endpoints included pain (0-10), at 24 and 48 h, time to discharge from the recovery room, incidence of post-operative nausea and vomiting at 24 h, time to oral intake, time to ambulation, and time to discharge from the hospital. Data was analyzed using unpaired t-test and presented as mean ± standard deviation. RESULTS: Compared to control, the use of the NSS-2 BRIDGE® was associated with a 75.4% reduction in OME (33.6 vs. 8.3 mg; p=0.03) and 41.5% reduction in pain (5 vs. 3.28; p=0.06) at 24 h and a 73.3% difference in pain at 48 h (1.6 ± 1.6 vs. 6.0 ± 2.8; p=0.0004). There was no difference in non-opioid analgesics administration between groups. CONCLUSIONS: The tolerability of NSS-2 BRIDGE® device was reported by most to be excellent. This study suggests that the NSS-2 BRIDGE® device may represent a complementary approach for controlling postoperative opioid consumption and pain in patients undergoing kidney donation.

Auricular nerve stimulation using the NSS-2 BRIDGE device to reduce opioid requirement following laparoscopic Roux-en-Y gastric bypass.

BACKGROUND: Evidence supports the use of complementary techniques to reduce pain and opioid use after surgery. The NSS-2 BRIDGE device (NBD; Innovative Health Solutions, Inc., Versailles, Indiana) modulates pain via stimulation of the nucleus of the auricular branch of the cranial nerves at the level of the brainstem and the limbic system. OBJECTIVE: To investigate the role of auricular nerve field stimulation for pain control following gastric bypass surgery. SETTINGS: U.S. academic medical center. METHODS: A total of 18 subjects were included. Subjects were divided in 2 groups: NBD group (n = 8) and a control group (n = 10). The NBD was placed following laparoscopic Roux-en-Y gastric bypass (LRYGB) surgery in the recovery room. The effectiveness of NBD was assessed comparing the relative use of opioid consumption (oral morphine equivalents) and pain (0 = no pain to 10= worst possible pain) at 24 and 48 hours after surgery. In addition, the device tolerability (1-10) was assessed, with 8-10 considered excellent. Data were analyzed using unpaired t tests and presented as mean ± standard deviation. Alpha was set up at .1. RESULTS: Compared with the control group, the use of NBD was associated with a 60.2% reduction in oral morphine equivalents (38.15 vs 15.2 mg; P < .1) and a 28% reduction in pain (5.0 vs 3.6; P = .1) at 24 hours after surgery. The tolerability of NBD was reported to be excellent. CONCLUSIONS: This report suggests that NBD may represent an interesting alternative to control perioperative pain and limit opioid use following bariatric surgery. This needs to be confirmed by a placebo-controlled, randomized study.

The Effects of Audiovisual Stimulation on the Acceptance of Background Noise.

BACKGROUND: Previous examinations of noise acceptance have been conducted using an auditory stimulus only; however, the effect of visual speech supplementation of the auditory stimulus on acceptance of noise remains limited. PURPOSE: The purpose of the present study was to determine the effect of audiovisual stimulation on the acceptance of noise in listeners with normal and impaired hearing. RESEARCH DESIGN: A repeated measures design was utilized. STUDY SAMPLE: A total of 92 adult participants were recruited for this experiment. Of these participants, 54 were listeners with normal hearing and 38 were listeners with sensorineural hearing impairment. DATA COLLECTION AND ANALYSIS: Most comfortable levels and acceptable noise levels (ANL) were obtained using auditory and auditory-visual stimulation modes for the unaided listening condition for each participant and for the aided listening condition for 35 of the participants with impaired hearing that owned hearing aids. Speech reading ability was assessed using the Utley test for each participant. RESULTS: The addition of visual input did not impact the most comfortable level values for listeners in either group; however, visual input improved unaided ANL values for listeners with normal hearing and aided ANL values in listeners with impaired hearing. ANL benefit received from visual speech input was related to the auditory ANL in listeners in each group; however, it was not related to speech reading ability for either listener group in any experimental condition. CONCLUSIONS: Visual speech input can significantly impact measures of noise acceptance. The current ANL measure may not accurately reflect acceptance of noise values when in more realistic environments, where the signal of interest is both audible and visible to the listener.