The effects of target-controlled infusion of lidocaine undergoing vocal cord polypectomy: A randomized controlled trial (CONSORT compliant)

Background:The present study aimed to assess the efficacy and safety of general anesthesia-assisted target-controlled plasma infusion of lidocaine in patients with vocal cord polypectomy using a supporting laryngoscope.Methods:In total, 80 patients undergoing vocal cord polypectomy using a supporting laryngoscope were randomly divided into an intervention group and a control group; each group contained 40 subjects: both groups received general anesthesia; subjects in the intervention also received an additional 3 mg/L of lidocaine by target-controlled plasma infusion during induction and maintenance of anesthesia; heart rate (HR) mean arterial pressure (MAP), propofol and urapidil consumption (Uradil, which is a blood pressure drug that blocks alpha-1, is called Urapidi Hydrochloride Injection. It is produced by Germany, the enterprise name is Nycomed Deutschland GmbH, the import drug registration number is H20090715, and it is widely used in China), recovery time, and cough score (measured by Minogue et al''s 5-grade scoring method) during extubation, and throat pain score (measured by visual analogue scale,[VAS]) after extubation and adverse events were recorded.Results:Significant differences were observed in HR (P < .05) and MAP (P < .05) immediately after intubation (T2), immediately after the operation starting to support laryngoscope exposure (T3), immediately after operation field adrenergic tampon hemostasis (T4), and 5 minutes after hemostasis (T5) between the 2 groups, and significant differences were also observed in HR (P < .05) before intubation (T1). Moreover, significant differences were observed in propofol consumption (P < .05), urapidil consumption (P < .05), cough score during extubation (P < .05), and throat pain score after extubation (P < .05). However, no significant difference was observed in the recovery time (P > .05). Furthermore, no adverse events were detected in either group.Conclusion:The results of this study showed that target-controlled plasma infusion of lidocaine can reduce propofol consumption in patients undergoing vocal cord polypectomy by supporting laryngoscopy, and the hemodynamics are more stable and reduce the coughing reaction in the wake period and throat pain after extubation without adverse events.     

Effect of low-dose lidocaine on MEPs in patients undergoing intracranial tumor resection with propofol anesthesia: A randomized controlled trial

Objective:To investigate the effect of low-dose lidocaine on motor evoked potentials (MEPs) in patients undergoing intracranial tumor resection with propofol anesthesia.Methods:Forty patients who underwent intracranial tumor resection and required MEP monitoring were selected. They were randomly divided into the lidocaine group (group L, n = 20) and the control group (group C, n = 20) by computer-generated randomization. All patients were given propofol anesthesia under the guidance of the bispectral index. In group L, 1 mg/kg of lidocaine was injected intravenously during anesthesia induction. Then, lidocaine was continuously pumped at a speed of 1 mg/kg/h until the operation started. Group C was given an equal volume of normal saline. Heart rate (HR), mean artery pressure (MAP), and bispectral index were recorded before anesthesia induction (T0), 2 minutes after tracheal intubation (T1), and 35 minutes (T2), and 50 minutes (T3) after anesthesia induction. The amplitude and latency of MEP at T2 and T3, the total dosage of propofol after anesthesia induction, and adverse events before T3 were recorded.Results:Compared with those in group C, HR and MAP were significantly decreased at T1 in group L. No significant differences were observed in HR and MAP at T0, T2, and T3 between group L and group C. The total dosage of propofol and the incidence of adverse events were significantly lower in group L than in group C before T3. There were no significant differences in the amplitude and latency of MEP between the 2 groups at each time point.Conclusions:Low-dose lidocaine has no obvious effect on MEP in patients undergoing intracranial tumor resection. However, it increased hemodynamic stability, reduced propofol use, and decreased the incidence of adverse events.     

A randomized controlled trial comparing water exchange and air insufflation during colonoscopy without sedation

Objectives

Previous studies have shown that water exchange is superior to air insufflation in attenuating insertion pain during colonoscopy. We conducted a randomized controlled trial with head-to-head comparison of these methods to assess their effectiveness in colonoscopy without sedation.

Methods

A total of 447 outpatients were randomized to either water exchange (WE) or the standard air (CO₂) insufflation (AI). The primary outcome was the improvement of patient intraprocedural pain (pain score), evaluated using a questionnaire (scores 1 to 5).

Results

After exclusion of 44 patients from further analysis, 403 patients were analyzed. There was no difference in clinical background between the WE and AI groups. Patients in the WE group reported less intraprocedural pain than those in the AI group (2.17?±?1.06 vs. 2.42?±?1.03; unpaired t test, p?=?0.021). We divided the cases into two groups, more or less painful colonoscopy, based on age, body mass index, use of anti-peristaltic drugs or not, and physician’s experience. In less painful colonoscopy, the WE method could reduce pain effectively but its effect was limited in the more painful group.

Conclusion

WE is superior to AI for attenuating insertion pain during colonoscopy without sedation, but its efficacy is limited in more painful endoscopy.

     

Dexmedetomidine dosage in critically ill patients undergoing intraoperative wake-up test: A randomized controlled trial

Objective:The aim of this study was to find the optimum dosage of dexmedetomidine in Spinal Orthopedic Scoliosis Correction Surgery when used in combination with propofol and remifentanil in American Society of Anesthesiologists (ASA) III patients with severe scoliosis undergoing intraoperative wake-up test.Materials and methods:We selected a total of 60 ASA III ≤40 years old patients who underwent Spinal Orthopedic Scoliosis Correction Surgery (SOSCS) and randomized them into groups A, B, and C. Group A was administered 0.2 μg/(kg·h) of dexmedetomidine, group B 0.3 μg/(kg·h), and group C 0.4 μg/(kg·h). The main parameters monitored were: wake-up time; wake-up quality; adverse effects that occur while the patient is awake; postoperative awareness of intraoperative wake-up test; heart rate (HR); mean arterial pressure (MAP); and oxygen saturation (SpO₂). Values of these parameters were monitored at 7 timestamps separated by 5 minutes >30 minutes.Results:Group B had a higher MAP at 10 minutes before wake-up (P = .03) and at the moment of wake-up (P = .04) than group A. The Wake-up time of group A was 14.95 ± 7.42 minutes, group B was 14.7 ± 6.52 minutes, which was significantly shorter than that of group C 21.3 ± 10.02 minutes (P = .02). The wake-up quality was excellent. All other parameters had no significant statistical differences.Conclusion:Doses of 0.2 to 0.3 μg/(kg·h) have shorter wake-up time and fewer hemodynamic fluctuations compared to 0.4 μg/(kg·h).     

The effect of binaural beat audio on anxiety in patients undergoing fiberoptic bronchoscopy: A prospective randomized controlled trial

Background:Fiberoptic bronchoscopy is an invasive procedure known to induce anxiety in patients. Binaural beat therapy, in which sounds of different frequencies are delivered to the 2 ears to entrain the brainwaves, has been used to reduce anxiety in some operations. This study aimed to determine the anxiolytic effects of binaural beat audio in patients undergoing fiberoptic bronchoscopy.Methods:Eligible subjects were randomly assigned to receive binaural beat music, plain music, or no music. They were asked to wear earphones starting approximately 15 minutes before the bronchoscopy. The level of anxiety was measured using the State-Trait Anxiety Inventory questionnaire. Blood pressure, heart rate, and sedative drug administration were also recorded.Results:One hundred and twelve subjects were randomized into binaural beat music (n = 38), plain music (n = 38), and no music (n = 36) groups. The mean change in post-bronchoscopy State-Trait Anxiety Inventory state score in the binaural beat music, plain music, and no music group was −7.26 (P < .001), −3.92 (P = .005), and −1.12 (P = .454), respectively. The mean systolic blood pressure and diastolic blood pressure significantly decreased from baseline by −9.89 (P = .002) and −5.76 (P = .005), respectively, in the binaural group. The mean heart rate increased from baseline by 3.32 (P = .035), 5.21 (P = .038), and 3.64 (P = .149) in the binaural beat music, plain music, and no music groups, respectively.Conclusion:Binaural beat music appeared to reduce anxiety among patients undergoing fiberoptic bronchoscopy.Trial registration: TCTR, TCTR20200915002. Registered 14 September 2020 - Retrospectively registered.     

Effect of amlodipine versus bisoprolol in hypertensive patients on maintenance hemodialysis: A randomized controlled trial

Background:Left ventricular hypertrophy and asymmetric dimethylarginine (ADMA) are surrogate markers of cardiovascular disease (CVD) in the dialysis population. This study aimed to evaluate the effect of a calcium channel blocker-based antihypertensive regimen compared to a beta-blocker-based antihypertensive regimen on left ventricular mass index (LVMI) and ADMA levels in hypertensive patients on hemodialysis (HD).Methods:This was a parallel-design, open-label, single-center randomized controlled trial on 46 hypertensive patients on maintenance HD, with no history of CVD. Patients were randomly assigned to receive amlodipine 10 mg/d (n = 23) or bisoprolol 10 mg/d (n = 23). Office-based blood pressure (BP) was targeted to ≤ 140/ 90 mm Hg. The outcome was the change in LVMI and ADMA from baseline to 6 months.Results:Baseline demographic and clinical characteristics did not vary between groups. After 6 months of treatment, amlodipine-based therapy induced a greater reduction in LVMI from baseline than bisoprolol-based treatment (35 ± 34.2 vs 9.8 ± 35.9 gm/m²; P = .017). A similar reduction in the mean BP occurred with treatment in both groups. ADMA concentration decreased significantly from baseline in the amlodipine group (0.75 ± 0.73 to 0.65 ± 0.67 nmol/mL; P = .001), but increased nonsignificantly in the bisoprolol group (0.64 ± 0.61 to 0.78 ± 0.64 nmol/mL; P = .052).Conclusion:This study showed that compared to a bisoprolol-based regimen, an amlodipine-based antihypertensive regimen resulted in a significantly greater reduction in LVMI and ADMA levels from baseline in hypertensive patients on HD despite similar BP reduction in both groups. These findings support the re-evaluation of amlodipine as a potential first-line antihypertensive treatment in patients on HD without previous CVD.Trial Registration:Clinicaltrials.gov Identifier: NCT04085562, registered September 2019.     

Effects of a preoperative forced-air warming system for patients undergoing video-assisted thoracic surgery: A randomized controlled trial

Background:The incidence of intraoperative hypothermia is still high despite the proposal of different preventive measures during thoracoscopic surgery. This randomized control study evaluated the effects of 30-minute prewarming combined with a forced-air warming system during surgery to prevent intraoperative hypothermia in patients undergoing video-assisted thoracic surgery under general anesthesia combined with erector spinae nerve block.Methods:Ninety-eight patients were randomly and equally allocated to prewarming or warming groups (n = 49 each). The primary outcome was the incidence of intraoperative hypothermia. Secondary outcomes were core temperature, irrigation and infused fluid, estimated blood loss, urine output, type of surgery, intraoperative anesthetic dosage, hemodynamics, recovery time, the incidence of postoperative shivering, thermal comfort, postoperative sufentanil consumption and pain intensity, patient satisfaction, and adverse events.Results:The incidence of intraoperative hypothermia was significantly lower in the prewarming group than the warming group (12.24% vs 32.65%, P = .015). Core temperature showed the highest decrease 30 minutes after surgery start in both groups; however, the rate was lower in the prewarming than in the warming group (0.31 ± 0.04°C vs 0.42 ± 0.06°C, P < .05). Compared with the warming group, higher core temperatures were recorded for patients in the prewarming group from T1 to T6 (P < .05). Significantly fewer patients with mild hypothermia were in the prewarming group (5 vs 13, P = .037) and recovery time was significantly reduced in the prewarming group (P < .05). Although the incidence of postoperative shivering was lower in the prewarming group, it was not statistically significant (6.12% vs 18.37%, P = .064). Likewise, the shivering severity was similar for both groups. Thermal comfort was significantly increased in the prewarming group, although patient satisfaction was comparable between the 2 groups (P > .05). No adverse events occurred associated with the forced-air warming system. Both groups shared similar baseline demographics, type of surgery, total irrigation fluid, total infused fluid, estimated blood loss, urine output, intraoperative anesthetic dosage, hemodynamics, duration of anesthesia and operation time, postoperative sufentanil consumption, and pain intensity.Conclusion:In patients undergoing video-assisted thoracic surgery, prewarming for 30 minutes before the induction of anesthesia combined with a forced-air warming system may improve perioperative core temperature and the thermal comfort, although the incidence of postoperative shivering and severity did not improve.     

Efficacy of Omaha system-based nursing management on nutritional status in patients undergoing peritoneal dialysis: A randomized controlled trial protocol

The chronic kidney disease (CKD) patients may have a variety of complications during receiving peritoneal dialysis (PD). The malnutrition in CKD patients is related to their lower life quality, higher hospitalization rates, and higher risk of cardiovascular disease, as well as the increased morbidity and mortality. Hence, it is very important to monitor and then manage the nutritional status of CKD patients. Thus, we perform this randomized controlled study protocol to introduce a continuing nursing program based on Omaha system (OS) for the patients with CKD receiving PD treatment.The randomized trial will be implemented from November 2020 to May 2021 and was granted through the Research Ethics Committee of Wuhan No.1 Hospital (2020003281). Two hundred patients meet inclusion criteria and exclusion criteria are included.Patients who meet the following criteria will be selected: voluntary participation, aged 20 to 60; undergoing the regular PD treatment for at least 3 months. Patients will be excluded if the patients are in unstable status, or experience the intermittent PD or some other kinds of dialysis mode, have severe cachexia, infection, or malnutrition, or if they have mental disorders. In control group, patients are given routine treatment, containing general guidance associated with PD and the outpatient telephone calls from the clinical nurses during follow-up. In study group, the patients are given the continuous nursing treatment scheme based on OS. The clinical results are the biochemical parameters after intervention, anthropometry, as well as the subjective global assessment.Table 1 reveals the clinical endpoints between the 2 groups.This protocol can guide nurses to develop a nursing program based on evidence for patients with CKD receiving PD.Trial registration:This study protocol was registered in Research Registry (researchregistry6202).     

Hospital- versus community-based syringe exchange: a randomized controlled trial.

This study examined the effect of syringe exchange program setting on the injection practices, health status, and health service utilization patterns of injection drug users (IDUs) recruited from a public urban hospital. One hundred sixty-six participants were randomized to either community- or hospital-based syringe exchange services. Poisson regression models were used to compare service utilization between groups. In both conditions, risky drug use practices decreased, and physical health functioning improved over time. Hospital-based syringe exchange program (SEP) attendees had 83% more inpatient admissions (p < .0001) and 22% more ambulatory care visits (p < .0001) than those assigned to the community-based SEP condition. Syringe exchange services that are integrated into public hospital settings may serve as a valuable strategy to engage hard to reach IDU populations in behavioral interventions designed to reduce HIV risk transmission behaviors and increase access to, or engagement in, the use of secondary and tertiary preventive medical care.     

Effect of acupuncture treatment on post-stroke cognitive impairment: A randomized controlled trial

Introduction:Post-stroke cognitive impairment (PSCI), which has a high morbidity, is closely associated with the recurrence and rehabilitation of ischemic stroke. There are 2 different stages of PSCI, including post-stroke cognitive impairment with no dementia (PSCIND) and post-stroke dementia (PSD). The latter has a significantly higher mortality rate than the previous one. Therefore, preventing the onset of PSD is of vital importance. However, there is no unequivocally effective prevention or treatment for PSCI, except intensive secondary prevention of stroke. The primary aim of this protocol is to explore whether acupuncture can improve cognitive function of patients with PSCIND and reduce the chances of developing PSD. On this bias, we also want to explore its possible mechanisms.Methods and analysis:A prospective, multicenter, large sample, randomized controlled trial will be conducted. A total of 360 eligible patients will be recruited from 5 different hospitals and randomly allocated into the acupuncture group (AG), sham acupuncture group (NAG), and waiting-list group (WLG) in a 1:1:1 ratio. The intervention period of NAG and AG will last 3 months (30 minutes per day, 3 times per week). Primary and secondary outcomes will be measured at baseline, 12 weeks (at the end of the intervention), 24 weeks (after the 12-week follow-up period), and 36 weeks (after the 24-week follow-up period). Resting-state and task-state functional MRI will be conducted at baseline and 12 weeks.Ethics and dissemination:The ethic committee of First Teaching Hospital of University of Traditional Chinese Medicine approved the study. Study results will be first informed to each participant and later disseminated to researchers, and the general public through courses, presentations and the internet, regardless of the magnitude or direction of effect. The results will also be documented in a published peer-reviewed academic journal.Registration:We have registered at ClinicalTrials.gov(ChiCTR2000033801).     

Effect of dietary sodium chloride on gastro-oesophageal reflux: A randomized controlled trial

Objective.It has been suggested that a high consumption of sodium chloride (NaCl) is associated with reflux symptoms. The objective of this study was to investigate the effect of increased dietary NaCl intake on gastro-oesophageal reflux and reflux mechanisms. Material and methods. In this double-blind, placebo-controlled, crossover study 10 healthy male subjects received 5?g NaCl or placebo in capsules per day for one week, after which concurrent manometric, pH and impedance monitoring was carried out for 4.5?h. Results. Oesophageal acid exposure time (pH?p<0.01). Conclusions. High dietary sodium intake does not increase gastro-oesophageal reflux in healthy volunteers, despite a decrease in LOS pressure.     

Acupuncture for patients with mild hypertension: A randomized controlled trial

Acupuncture may be beneficial for patients with mild hypertension, but the evidence is not convincing. We aimed to examine the effect of acupuncture on blood pressure (BP) reduction in patients with mild hypertension. We conducted a multicenter, single‐blind, sham‐controlled, randomized trial in eleven hospitals in China. The trial included 428 patients with systolic blood pressure (SBP) from 140 to 159 mm Hg and/or with diastolic blood pressure (DBP) from 90 to 99 mm Hg. The patients were randomly assigned to receive 18 sessions of affected meridian acupuncture (n = 107) or non‐affected meridian acupuncture (n = 107) or sham acupuncture (n = 107) during 6 weeks, or to stay in a waiting‐list control (n = 107). All patients received 24‐hour ambulatory blood pressure monitoring at weeks 6, 9, and 12. We included 415 participants in the intention‐to‐treat analysis. The two acupuncture groups were pooled in the analysis, since they had no difference in all outcomes. SBP decreased at week 6 in acupuncture group vs sham acupuncture vs waiting‐list group (7.2 ± 11.0 mm Hg vs 4.1 ± 11.5 mm Hg vs 4.1 ± 13.2 mm Hg); acupuncture was not superior to sham acupuncture (mean difference 2.7 mm Hg, 95% CI 0.4 to 5.9, adjusted P = 0.103) or waiting‐list control (2.9 mm Hg, 95% CI −0.2 to 6.0, adjusted P = 0.078). However, acupuncture was superior to sham acupuncture (3.3 mm Hg, 95% CI 0.2 to 6.3, adjusted P = 0.035) and waiting‐list control (4.8 mm Hg, 95% CI 1.8 to 7.8, P < 0.001) at week 9. Acupuncture had a small effect size on the reduction of BP in patients with mild hypertension.     

Effects of music on patients undergoing a C-clamp procedure after percutaneous coronary interventions: a randomized controlled trial

OBJECTIVE: The study objective was to assess the effect of music on the physiologic and psychologic parameters in patients undergoing application of a C-clamp after percutaneous coronary interventions (PCI). DESIGN: A repeated-measures randomized controlled trial was used. SETTING: The study took place in three intensive care units in Hong Kong. PATIENTS: Sixty-six patients undergoing application of a C-clamp after PCI were recruited. OUTCOME MEASURES: Physiologic parameters were blood pressure, heart rate, respiratory rate, and oxygen saturation. Psychologic parameters were measured using the University of California at Los Angeles universal pain score. INTERVENTION: Patients were randomized to receive 45 minutes of music therapy or 45 minutes of an uninterrupted rest period. Three types of music were used, including Chinese classical music, religious music, and Western classical music that had slow beats and was relaxing. The data were collected from September 2004 to December 2005. RESULTS: In the experimental group there were statistically significant reductions in heart rate (P < .001), respiratory rate (P < .001), and oxygen saturation (P < .001), and a lower pain score (P < .001) than in the control group. CONCLUSION: Music is a simple, safe, and effective method of reducing potentially harmful physiologic and psychologic responses arising from pain in patients post-PCI undergoing a C-clamp procedure.