Intravenous Esmolol Infusion Improves Surgical Fields during Sevoflurane-Anesthetized Endoscopic Sinus Surgery: A Double-Blind, Randomized, Placebo-Controlled Trial

2011 ◽  
Vol 25 (6) ◽  
pp. e208-e211 ◽  
Author(s):  
Ping-Hung Shen ◽  
Erik Kent Weitzel ◽  
Jen-Tsung Lai ◽  
Peter-John Wormald ◽  
Chee-Sang Ho
Keyword(s):  
Blood Pressure ◽  
Blood Loss ◽  
Endoscopic Sinus Surgery ◽  
Controlled Trial ◽  
Sinus Surgery ◽  
Constant Infusion ◽  
Saline Control ◽  
Control Group ◽  
Double Blind ◽  
The Impact

Background There is increasing evidence to support the use of anesthetics to affect operative fields during endoscopic sinus surgery and thus the speed, thoroughness, and safety of the surgery itself. Previous research has suggested preoperative beta-blockers improve surgical fields (SFs); our study is novel in showing the impact of a beta-blocker infusion on SFs during sinus surgery. Methods A prospective, randomized, double-blind, placebo-controlled trial was conducted in 40 patients. Patients undergoing endoscopic sinus surgery for chronic rhinosinusitis received a constant infusion of i.v. esmolol or saline in addition to a standard inhaled anesthetic protocol. At regular 15-minutes intervals, the quality of SF, heart rate (HR), systolic blood pressure (SBP), and diastolic blood pressure (DBP) were assessed. Total blood loss was also recorded. Results Average vital sign parameters (HR/SBP/DBP) were significantly lower in the esmolol group (69.1/90.2/55.1 versus 77.2/99.5/63.5; p < 0.01). The esmolol infusion improved SFs relative to control (2.3 versus 2.6; p = 0.045). Esmolol infusion resulted in good SFs (grades 1 and 2) more often than poor fields (grades 3 and 4); on the contrary, the control group showed more poor than good SFs (chi-square; p = 0.04). A correlation between increasing HR and worsening SFs was identified (r = 0.259; p = 0.002). The control group had significantly higher average blood loss (1.3 versus 0.8 mL/min; p = 0.037). Conclusion Esmolol-induced relative hypotension and bradycardia during endoscopic sinus surgery achieves significantly improved SFs relative to saline control.

Effect of Fentanyl Nasal Packing Treatment on Patients With Acute Postoperative Pain After Nasal Operation: A Randomized Double-Blind Controlled Trial

2018 ◽  
Vol 127 (5) ◽  
pp. 297-305 ◽  
Author(s):  
Kwan-Sub Kim ◽  
Nam-Kyung Yeo ◽  
Seong-Su Kim ◽  
Woong-Sub Park ◽  
Su-Hyun Kwak ◽  
...  
Keyword(s):  
Endoscopic Sinus Surgery ◽  
Rating Scale ◽  
Controlled Trial ◽  
Numeric Rating Scale ◽  
Sinus Surgery ◽  
Control Group ◽  
Double Blind ◽  
Ramsay Sedation Scale ◽  
Numeric Rating ◽  
Fentanyl Group

Purpose: Nasal packing is an option for bleeding control after endoscopic sinus surgery and septoplasty. Although new packing materials have been developed, patients still suffer from pain and require additional analgesics treatments. In this study, a prospective, randomized, and double-blind controlled trial was designed to evaluate the effect of fentanyl-soaked packing on pain after endoscopic sinus surgery and septoplasty. Methods: One hundred fifty-two patients who underwent nasal surgeries due to chronic rhinosinusitis or nasal septal deviation were enrolled in this study. At the end of operation, 50 mcg fentanyl-soaked biodegradable synthetic polyurethane foams packing Nasopore or Merocel were applied to a group of 79 patients, and saline-soaked ones were applied to another group of 73 patients. To evaluate the influence of fentanyl on postoperative nasal pain, patients’ conditions were assessed via means of Numeric Rating Scale, patient satisfaction, and Ramsay Sedation Scale. In addition, symptoms of headache or sore throat and any signs of cardiopulmonary-relevant indicators were monitored. Results: The fentanyl group had significantly decreased Numeric Rating Scale and increased patient satisfaction in every operation type for the majority of postoperative time periods ( P < .05) with reduced postoperative headache and sore throat compared to the control group. The fentanyl group showed a higher score on Ramsay Sedation Scale than the control group ( P < .05 in group including endoscopic sinus surgery). There were no significant differences in cardiopulmonary-relevant indicators between the 2 groups ( P > .05). Conclusion: Fentanyl group showed significantly reduced postoperative pain without serious adverse effects. We suggest that topical fentanyl application to nasal packs can be a useful method to reduce pain during the early postoperative period after endoscopic sinus surgery and septoplasty.

scholarly journals Comparison of Lignocaine and Esmolol in attenuating cardiovascular response to laryngoscopy and endotracheal intubation

2015 ◽  
Vol 1 (1) ◽  
pp. 29-35
Author(s):  
Anil Shrestha ◽  
Subhash Prasad Acharya ◽  
Roshna Amatya
Keyword(s):  
Blood Pressure ◽  
Tracheal Intubation ◽  
Elective Surgery ◽  
Cardiovascular Response ◽  
Cerebrovascular Disorders ◽  
Study Drug ◽  
Controlled Study ◽  
Saline Control ◽  
Control Group ◽  
Double Blind

Background: Laryngoscopy and tracheal intubation induces cardiovascular stress response characterized by tachycardia and hypertension, which are well tolerated in normotensive individuals but are of greater significance in patients with cardiovascular and cerebrovascular disorders. The quest for an effective suppression of these responses continues.Materials and Methods: A randomized, prospective, double blind, placebo controlled study was conducted in which the efficacy of Lignocaine 1.5 mg/kg and Esmolol 1.5 mg/kg were compared in attenuating the cardiovascular response to laryngoscopy and tracheal intubation in sixty patients undergoing elective surgery under general endotracheal anaesthesia. Patients were divided into three groups receiving Lignocaine, Esmolol or Normal saline (control). Anaesthesia was induced with intravenous Thiopental Sodium 5 mg/kg and intubation was facilitated with Vecuronium 0.12 mg/kg after administering the study drug. Blood pressure and heart rate were compared among the three groups.Results: The increase in Systolic blood pressure was not significant, but Diastolic and Mean Arterial Pressures increased significantly in control group whereas it was attenuated more effectively in Esmolol group (p<0.05) compared to lignocaine group. The increase in HR was significantly lower (p<0.05) in Esmolol group compared with lignocaine and control group.Conclusion: Esmolol is more effective than lignocaine in attenuating cardiovascular response to laryngoscopy and tracheal intubationJournal of Society of Anesthesiologists 2014 1(1): 29-35

scholarly journals A food-based dietary strategy lowers blood pressure in a low socio-economic setting: a randomised study in South Africa

2008 ◽  
Vol 11 (12) ◽  
pp. 1397-1406 ◽  
Author(s):  
Karen E Charlton ◽  
Krisela Steyn ◽  
Naomi S Levitt ◽  
Nasheeta Peer ◽  
Deborah Jonathan ◽  
...  
Keyword(s):  
Blood Pressure ◽  
South African ◽  
Controlled Trial ◽  
Control Diet ◽  
Diet Group ◽  
Post Intervention ◽  
Intervention Effect ◽  
Double Blind ◽  
Cation Content ◽  
The Impact

AbstractObjectiveTo assess the impact of a food-based intervention on blood pressure (BP) in free-living South African men and women aged 50–75 years, with drug-treated mild-to-moderate hypertension.MethodsA double-blind controlled trial was undertaken in eighty drug-treated mild-to-moderate hypertensive subjects randomised to an intervention (n40) or control (n40) arm. The intervention was 8-week provision of six food items with a modified cation content (salt replacement (SOLO™), bread, margarine, stock cubes, soup mix and a flavour enhancer) and 500 ml of maas (fermented milk)/d. The control diet provided the same quantities of the targeted foods but of standard commercial composition and 500 ml/d of artificially sweetened cooldrink.FindingsThe intervention effect estimated as the contrast of the within-diet group changes in BP from baseline to post-intervention was a significant reduction of 6·2 mmHg (95 % CI 0·9, 11·4) for systolic BP. The largest intervention effect in 24 h BP was for wake systolic BP with a reduction of 5·1 mmHg (95 % CI 0·4, 9·9). For wake diastolic BP the reduction was 2·7 mmHg (95 % CI −0·2, 5·6).ConclusionsModification of the cation content of a limited number of commonly consumed foods lowers BP by a clinically significant magnitude in treated South African hypertensive patients of low socio-economic status. The magnitude of BP reduction provides motivation for a public health strategy that could be adopted through lobbying of the food industry by consumer and health agencies.

Pharmacoequivalence of Enoxaparin and Contaminated Enoxaparin

Blood ◽  
2008 ◽  
Vol 112 (11) ◽  
pp. 3018-3018
Author(s):  
Jacqueline Kuziej ◽  
Walter Jeske ◽  
Debra Hoppensteadt ◽  
Evangelos Litinas ◽  
Elizabeth McGeehan ◽  
...  
Keyword(s):  
Blood Pressure ◽  
Heart Rate ◽  
Drug Administration ◽  
Jugular Vein ◽  
Ex Vivo ◽  
Subcutaneous Administration ◽  
Saline Control ◽  
Control Group ◽  
Serious Adverse Events ◽  
The Impact

Abstract Introduction: Earlier this year, heparin was found to be contaminated with a non-heparin sulfated polymer identified as oversulfated chondroitin sulfate (OSCS). The presence of this contaminant was associated with severe adverse reactions such as hypotension and anaphylaxis, leading to death in some patients. Some batches of a widely used low-molecular heparin, enoxaparin, also contained OSCS. However, the amount of this contaminant was much lower (less than 5%) in the low-molecular weight heparin batches compared to unfractionated heparin where the amount of the contaminant was up to 30%. Owing to the sizeable number of syringes in Europe that contained the low level of OSCS and the absence of any serious adverse events, the European Medicines Equivalence Agency (EMEA) allowed the qualified use of the subcutaneous administration of the contaminated enoxaparin to ensure access to this essential medication. Despite this, no studies on the anti-thrombotic and bleeding effects or basic physiologic parameters have been reported. To address the bioequivalence of enoxaparin and its contaminated version, studies were undertaken in established animal models of bleeding and thrombosis. Materials & Methods: Contaminant-free enoxaparin (CFE) and one of the commercially available contaminated enoxaparin (CCE) batches were compared at an equivalent subcutaneous dosage of 2.5 mg/kg in a jugular vein clamping model of thrombosis (n=6/group). A separate group comprised of saline control animals served as control. Blood pressure and heart rate measurements were made at 90 minutes after drug administration, followed by jugular vein clamping model at 120 minutes after drug administration. After the completion of the jugular vein clamping model, blood samples were collected via cardiac puncture for ex-vivo monitoring of anti-coagulant and anti-protease effects. Results: No differences in the blood pressure and heart rate were observed between the two groups. The anti-thrombotic effects of both the CCE and CFE were measured by jugular vein clamping model. In comparison to the saline treated group (3.5 ± 0.5 clampings), both the CCE and CFE treated animals required a significantly higher number of clampings to induce thrombosis (4.8 ± 0.7 and 5.0 ± 0.6, respectively; p = 0.001 vs. saline; p=0.658 CFE vs. CCE). The ex-vivo analysis of whole blood aPTT revealed a slight elevation in both of the enoxaparin-treated groups in comparison to saline control. (CFE: 36.8 ± 18.6 sec; CCE: 30.5 ± 10.9 sec vs. saline: 26.7 ± 3.9 sec). The anti-Xa effects in plasma were significantly higher with the CFE (84.4 ± 1.5% inhibition) compared to that observed with the CCE (80.5 ± 2.9 % inhibition; p=0.026) while the anti-IIa levels were comparable in the two groups (37.1 ± 22.0 and 30.6 ± 17.9 % inhibition). Ex-vivo analysis of plasma samples from the control group did not reveal any anti-protease or anti-coagulant activity. Discussion: These results demonstrate that small amounts of OSCS (less than 5%) in enoxaparin do not impact its anti-thrombotic effects when administered subcutaneously. Since OSCS exhibits only anti-IIa activity and does not have any anti-Xa effects, the observed anti-Xa activity of the CCE was less than that of CFE. Other plasmatic anti-coagulant and anti-protease activities were not altered by the presence of OSCS. Since OSCS is highly charged it is likely that upon subcutaneous administration it is not absorbed. This observation is supported by the fact that the anti-Xa and IIa ratios of the samples collected after jugular vein clamping are approximately equal. Thus, the anti-thrombotic and pharmacodynamic effects of the two versions of enoxaparin are identical. The impact of repeated administration of contaminated enoxaparins and long-term pharmacodynamic and immunogenic effects need to be further explored.

scholarly journals Impact of Epley manoeuvre on self-perceived disability: A randomised controlled trial in primary care

2020 ◽  
Author(s):  
Ricard Carrillo Muñoz ◽  
Jose Luis Ballve Moreno ◽  
Ivan Villar Balboa ◽  
Yolanda Rando Matos ◽  
Oriol Cunillera Puertolas ◽  
...  
Keyword(s):  
Primary Care ◽  
Controlled Trial ◽  
Intervention Group ◽  
Control Group ◽  
Controlled Clinical Trial ◽  
Double Blind ◽  
Perceived Disability ◽  
Randomised Controlled ◽  
The Impact

Abstract Background: Posterior canal benign paroxysmal positional vertigo (pc-BPPV) causes physical, functional, and emotional impairment. The treatment of choice is the Epley manoeuvre (EM). The purpose of the study was to compare the impact of the EM and a sham manoeuvre in primary care on self-perceived disability.Method: Randomised, double-blind, sham-controlled clinical trial conducted in primary care with a follow-up of 1 year. Patients aged ≥18 years old diagnosed with pc-BPPV according to the Dix-Hallpike test (DHT) were randomised to an intervention (EM) group or a control (sham manoeuvre) group. The main study covariables were age, sex, history of depression and anxiety, presence of nystagmus in the DHT, patient-perceived disability assessed with the Dizziness Handicap Inventory-screening version (DHI-S). Data were analyzed using bivariate and multivariate mixed Tobit analyses. Results: Overall, 134 patients were studied: 66 in the intervention group and 68 in the control group. Median age was 52 years (interquartile range [IQR], 38.25–68.00 years) and 76.12% of the patients were women. The DHT triggered nystagmus in 40.30% of patients. The median total DHI-S score for the overall sample at baseline was 16 (IQR, 8.00–22.00); 16 [IQR, 10.5–24.0] vs 10 [6.0–14.0] for women vs men (P<0.001) and 16 [IQR, 10.0-24.0] vs 12 [IQR, 8.0–18.0] for patients without nystagmus vs those with nystagmus (P=0.033).Patients treated with the EM experienced a mean reduction of 2.03 points in DHI-S score over the follow-up period compared with patients in the sham group. Conclusion: Pc-BPPV affects the quality of life of primary care patients. A single EM can improve self-perceptions of disability by around 2 points on the DHI-S scale, Trial registration: ClinicalTrials.gov Identifier: NCT01969513. Retrospectively registered. First Posted: October 25, 2013. https://clinicaltrials.gov/ct2/show/NCT01969513

scholarly journals Effects of Bushen-Jiangya granules on blood pressure and pharmacogenomic evaluation in low-to-medium risk hypertension: study protocol for a randomized double-blind controlled trial

2021 ◽  
Author(s):  
xiaochen Yang ◽  
Xingjiang Xiong ◽  
Yun Zhang ◽  
Yongmei Liu ◽  
Hongzheng Li ◽  
...  
Keyword(s):  
Blood Pressure ◽  
Inflammatory Responses ◽  
Controlled Trial ◽  
Controlled Study ◽  
Control Group ◽  
Double Blind ◽  
Double Blind Placebo ◽  
Medium Risk ◽  
Tcm Syndrome ◽  
And Control

Abstract IntroductionHypertension is one of the most important risk factors for cardiovascular disease, and its treatment and control rates are still low worldwide. The most effective strategy is that patients with hypertension should be diagnosed and treated early. Preliminary studies showed that the Bushen Jiangya granule (BSJY) may suppress ventricular hypertrophy and inflammatory responses, lower blood pressure and protect the target organs of hypertension. We designed a randomized, double-blind, placebo-controlled trial to evaluate the efficacy of BSJY in patients with low-to-medium risk hypertension.Methods and analysisThis trial is a one-center, randomized, double-blind, placebo-controlled study. A total of 260 participants will be randomized in a 1:1 ratio to an experiment group (BSJY plus amlodipine) and a control group (placebo plus amlodipine). The trial cycle will last 8 weeks. The primary outcome is blood pressure, which is reduced to a threshold set out in Guiding Principles for Clinical Research of New Chinese Medicines. The secondary outcomes include the change in 24-h average systolic and diastolic blood pressure, heart rate variability, pharmacogenomic Evaluation, improvement in TCM Syndrome, serum pro-inflammatory/anti-inflammatory cytokines, etc. between the two groups. Safety in medication will also be evaluated. All the data will be recorded in electronic case report forms and analyzed by SPSS V.22.0.Ethics and dissemination This study has been approved by Research Ethics Committee of Guang’anmen Hospital,China Academy of Chinese Medical Sciences in Beijing, China (No. 2019-186-KY-01). The participants are volunteers, understand the process of this trial and sign an informed consent. The results of this study will be disseminated to the public through peer-reviewed journals and academic conferences. DiscussionWe hypothesize that patients with low-to-medium risk hypertension will benefit from BSJY. If successful, this study will provide evidence-based recommendations for clinicians.

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