Randomized Study of Phentolamine Mesylate for Reversal of Local Anesthesia

2008 ◽  
Vol 87 (7) ◽  
pp. 635-639 ◽  
Author(s):  
M. Laviola ◽  
S.K. McGavin ◽  
G.A. Freer ◽  
G. Plancich ◽  
S.C. Woodbury ◽  
...  
Keyword(s):  
Soft Tissue ◽  
Local Anesthetic ◽  
Dental Treatment ◽  
Randomized Study ◽  
Study Drug ◽  
Negative Consequences ◽  
Double Blind ◽  
Dental Procedures ◽  
Phase 2 Study ◽  
Pulpal Anesthesia

Local anesthetic solutions frequently contain vasoconstrictors to increase the depth and/or duration of anesthesia. Generally, the duration of soft-tissue anesthesia exceeds that of pulpal anesthesia. Negative consequences of soft-tissue anesthesia include accidental lip and tongue biting as well as difficulty in eating, drinking, speaking, and smiling. A double-blind, randomized, multicenter, Phase 2 study tested the hypothesis that local injection of the vasodilator phentolamine mesylate would shorten the duration of soft-tissue anesthesia following routine dental procedures. Participants (122) received one or two cartridges of local anesthetic/vasoconstrictor prior to dental treatment. Immediately after treatment, 1.8 mL of study drug (containing 0.4 mg phentolamine mesylate or placebo) was injected per cartridge of local anesthetic used. The phentolamine was well-tolerated and reduced the median duration of soft-tissue anesthesia in the lip from 155 to 70 min (p < 0.0001).

scholarly journals 1477. A Randomized Phase 2 Study of Cefepime Combined with the Novel Extended Spectrum β-Lactamase Inhibitor Enmetazobactam in Hospitalized Adults with Complicated Urinary Tract Infections (cUTI) Including Acute Pyelonephritis (AP)

2019 ◽  
Vol 6 (Supplement_2) ◽  
pp. S539-S539
Author(s):  
Yehuda Carmeli ◽  
Philipp Knechtle ◽  
Jeff Hardenberg ◽  
Mathias Knecht
Keyword(s):  
Study Drug ◽  
Generation Cephalosporin ◽  
Double Blind Study ◽  
The Novel ◽  
Phase 2 ◽  
Double Blind ◽  
Extended Spectrum ◽  
Phase 2 Study ◽  
Dosing Regimens ◽  
Tract Infections

Abstract Background Third-generation cephalosporin (3GC)-resistant Enterobacteriaceae has been classified as critical priority pathogens. The novel extended-spectrum β-lactamase (ESBL) inhibitor enmetazobactam (formerly AAI101; EMT) in combination with cefepime (FEP) is currently being developed as a carbapenem-sparing treatment of serious Gram-negative infections in settings with a high prevalence of 3GC-resistant Enterobacteriaceae. We report here the results from a phase 2 study that assessed safety, tolerability, and pharmacokinetics of FEP-EMT in patients with cUTI/AP. Methods Forty-five patients were enrolled in a randomized, multicenter, double-blind study of hospitalized adults with cUTI/AP. Patients received dosing regimens of FEP or FEP-EMT IV therapy q8h by 2 hours infusion (table) for 7 to 10 days with a 28-day follow-up. Efficacy was evaluated in the microbiological-modified ITT (µMITT) population. Safety was monitored in patients who received at least 1 dose of study drug. Clinical cure was designated as the resolution of cUTI symptoms present at study entry. Plasma and urine PK were determined from all patients. Results The study drugs were well tolerated in each cohort, with similar % adverse events and no new or unexpected safety concerns (table). Two discontinuations were due to allergic dermatitis. The microbiological- and clinical responses at test-of-cure for the combined FEP-EMT group were 83.3% (20/24) and 95.8% (23/24) compared with responses in the combined FEP group of 73.3% (11/15) and 93.3% (14/15), respectively (table). The most common baseline pathogens were Escherichia coli (66.7%) and Klebsiella pneumoniae (23.1%): 28.2% of isolates produced ESBLs with eradication rates for the combined FEP-EMT group of 85.7% (6/7) and for the combined FEP group of 75.0% (3/4). FEP and EMT PK were best described by a 2-compartment, linear PK model. Both agents exhibited half-lives of 2.3 hours. Creatinine clearance had a significant covariate effect on FEP and EMT, consistent with predominant renal excretion of both agents. Conclusion Results from this phase 2 study justify advancement to phase 3 studies to evaluate the safety and efficacy of FEP-EMT in patients with cUTI/AP. Disclosures All authors: No reported disclosures.

Intra Operative Use of Anti Emetic Drugs for Children Undergoing Full Dental Rehabilitation under General Anesthesia. A Double Blind Randomized Clinical Trial

2016 ◽  
Vol 40 (3) ◽  
pp. 235-240 ◽  
Author(s):  
Hisham Y El Batawi ◽  
Ahmed A Shorrab
Keyword(s):  
Clinical Trial ◽  
General Anesthesia ◽  
Dental Treatment ◽  
Postoperative Nausea And Vomiting ◽  
Control Group ◽  
Double Blind ◽  
Dental Procedures ◽  
Dental Staff ◽  
Significant Difference ◽  
Dental Rehabilitation

Background: Postoperative Nausea and Vomiting (PONV) is a common complication following dental treatment under general anesthesia (DGA) that may lead to unplanned hospitalization, increased costs and dissatisfaction of parents. Aim: To investigate the incidence of Postoperative Vomiting (POV) on children who underwent dental rehabilitation under general anesthesia and to compare possible preventive effect of Dexamethasone and Ondansetron on occurrences of POV. Study design: A double blind randomized parallel clinical trial was carried out on 352 ASA I children who underwent DGA in a private Saudi hospital in Jeddah. Children were allocated randomly to four groups. Group D of 91 children, received Dexamethasone PONV prophylaxis, group O of 87 children received Ondansetron, group DO of 93 children received combination of the two drugs and group C the control group of 81 children. The three groups were investigated by blinded dental staff for POV episodes, number of times analgesia was needed and post anesthesia care unit time (PACUT). Results: There was a no significant difference between the two drugs on POV. There was a significant difference in POV between control group and groups D, O, and DO. There was significant reduction in need for analgesia in the Dexamethasone groups. The three groups, which had PONV prophylaxis, showed significant reduction in PACUT compared to control group. Conclusions: Antiemetic drugs are useful adjuncts in DGA. Some dental procedures may have higher emetic potential than others. The type of dental procedures done is to be considered when deciding the drug profile in children undergoing DGA.

Conatumumab (CON) plus FOLFIRI (F) or ganitumab (GAN) plus F for second-line treatment of mutant (MT) KRAS metastatic colorectal cancer (mCRC).

2012 ◽  
Vol 30 (4_suppl) ◽  
pp. 534-534 ◽  
Author(s):  
Allen Lee Cohn ◽  
Josep Tabernero ◽  
Juan Maurel ◽  
Elzbieta Nowara ◽  
Sarita Dubey ◽  
...  
Keyword(s):  
Death Receptor ◽  
Growth Factor Receptor ◽  
Study Drug ◽  
Death Receptor 5 ◽  
Double Blind ◽  
Anti Vegf ◽  
Medical Need ◽  
Phase 2 Study ◽  
Grade 3

534 Background: EGFR inhibitors are not an option for patients (pts) with MT KRAS mCRC; therefore, there is an unmet medical need for novel agents to treat this pt population. CON (agonist) and GAN (antagonist) are investigational, fully human monoclonal antibodies to death receptor 5 and type 1 insulin-like growth factor receptor, respectively. In colorectal xenografts, CON enhanced the activity of 5FU, and both agents enhanced the activity of irinotecan. A 3-arm, placebo (pbo)-controlled, double-blind, double dummy, randomized phase 2 study evaluated both agents in MT KRAS mCRC. Methods: Planned sample size = 150. Eligibility: MT KRAS mCRC; disease progression on 1 prior oxaliplatin and fluoropyrimidine therapy. Randomization was 1:1:1 to Arm 1: CON 10 mg/kg + GAN pbo + F Q2W; Arm 2: CON pbo + GAN 12 mg/kg + F Q2W; Arm 3: CON pbo + GAN pbo + F Q2W. Randomization was stratified by PS (0 vs 1) and prior anti-VEGF therapy (yes vs no). Pts received CON, GAN, or pbo IV day (D)1 and 15; irinotecan 180 mg/m2 D1; leucovorin 400 mg/m2 over 2 h D1; 5FU bolus 400 mg/m2 over 2-4 min D1 then 5FU 2400 mg/m2 over 46-48 h. Primary endpoint: PFS by investigator assessment. Results: 155 pts (Arms 1/2/3: 51/52/52 pts) were randomized between 3/09 and 2/11; 50/50/52 received ≥ 1 dose of study drug. Median age, 59/58/59 years; women, 47/54/56%; colon cancer, 75/65/83%; PS 1, 37/42/40%; prior anti-VEGF therapy, 43/40/42%. See table for efficacy. % pts with grade 3-5 adverse events (Arms 1/2/3) included: neutropenia 30/25/18%; diarrhea 18/2/10%; intestinal obstruction 4/6/8%. There was 1 treatment-related death of unknown cause on Arm 1. Conclusions: CON + F and GAN + F were tolerable in this pt population. CON + F, but not GAN + F, improved PFS. ORR was increased vs pbo. OS data are immature. Further study of CON may be warranted in mCRC. [Table: see text]

Intravenous Ondansetron for Attenuation of Post Spinal Anesthesia Hypotension

QJM ◽  
2021 ◽  
Vol 114 (Supplement_1) ◽  
Author(s):  
Ahmed Saeed Mohamed Ibrahim ◽  
Rania Mahrous Aly Hussien ◽  
Hazem Mohamed Sabry Abdel Aziz Ahmed
Keyword(s):  
Spinal Anesthesia ◽  
Local Anesthetic ◽  
Normal Saline ◽  
Demographic Data ◽  
Randomized Study ◽  
P Value ◽  
Anthropometric Measures ◽  
Double Blind ◽  
Induced Hypotension ◽  
Significant Difference

Abstract Background Spinal Anesthesia is a common type of anesthesia used during many surgical procedures. This regional technique can be accomplished by administering an intrathecal dose of hyperbaric local anesthetic solution. The local anesthetic within the subarachnoid space can block sensory, motor and sympathetic pathways. Objectives The Purpose of this study was to find out the effectiveness of prophylactic administration of intravenous ondansetron for attenuation of spinal anesthesia induced hypotension in non-obstetric spinal anesthesia surgeries. Patients and Methods Therefore, A prospective double-blind, placebo-controlled, randomized study was found to be the most suitable design in order to achieve the study objectives. A total of 90 patients males & females included in the study, aged 20-40 years, and were divided equally into two groups: Group A received 8 mg ondansetron diluted in volume of 10 cm normal saline 5 minutes prior to spinal anesthesia. Group B received a placebo of 10 cm normal saline 5 minutes prior to spinal anesthesia. Results There was no statistically significant difference found between the two studied groups regarding demographic data, anthropometric measures, ASA score and total time of surgery. There was statistically significant increase in the incidence of hypotension immediately after spinal and at 5 min in placebo group than ondansetron group with p-value = 0.026 and 0.014 respectively. Conclusion The present study demonstrated that, among patients who received spinal anesthesia with bupivacaine for elective for surgeries below umbilicus, prophylactic intravenous ondansetron 8mg iv 5 mins prior to spinal anesthesia reduced spinal anesthesia induced hypotension decreases in SBP, MAP, and heart rate. Ondansetron did not have a significant effect on DBP. Ondansetron did not have a significant effect on DBP. The incidence of nausea and vomiting was lower following the administration of ondansetron, and vasopressor use and dosages were reduced.

scholarly journals Once-Daily Oral Gatifloxacin versus Oral Levofloxacin in Treatment of Uncomplicated Skin and Soft Tissue Infections: Double-Blind, Multicenter, Randomized Study

2001 ◽  
Vol 45 (8) ◽  
pp. 2358-2362 ◽  
Author(s):  
Gary A. Tarshis ◽  
Barry M. Miskin ◽  
Terry M. Jones ◽  
John Champlin ◽  
Kevin J. Wingert ◽  
...  
Keyword(s):  
Soft Tissue ◽  
Randomized Study ◽  
Common Adverse Event ◽  
Soft Tissue Infections ◽  
Bacterial Eradication ◽  
Double Blind ◽  
Once Daily ◽  
End Of Treatment ◽  
The Difference ◽  
Cure Rates

ABSTRACT This was a double-blind, multicenter study in which 410 adults (≥18 years of age) with uncomplicated skin and soft tissue infections (SSTIs) were randomized to receive either 400 mg of gatifloxacin orally once daily or 500 mg of levofloxacin orally once daily for 7 to 10 days. The study protocol called for four assessments—before and during treatment, at the end of treatment, and posttreatment. Efficacy evaluations included clinical response and bacterial eradication rates. Of 407 treated patients, 202 (108 women, 94 men) received gatifloxacin and 205 (111 women, 94 men) received levofloxacin. For clinically evaluable patients, the cure rates were 91% for gatifloxacin and 84% for levofloxacin (95% confidence interval [CI] for the difference, −2.0 to 15.2%). Clinical cure rates for microbiologically evaluable patients were 93% for gatifloxacin and 88% for levofloxacin (95% CI for the difference, −6.5 to 16.8%). The bacterial eradication rate was 92% for each group, with gatifloxacin eradicating 93% of the methicillin-susceptible Staphylococcus aureus isolates and levofloxacin eradicating 91% of them. Both drugs were well tolerated. Most of the adverse events were mild to moderate, and nausea was the most common adverse event in each treatment arm. Once-daily oral gatifloxacin (400 mg) is clinically efficacious and well tolerated compared with once-daily levofloxacin (500 mg) for the treatment of patients with uncomplicated SSTIs.

Enoxaparin for the Prevention of Venous Thromboembolism Associated With Central Vein Catheter: A Double-Blind, Placebo-Controlled, Randomized Study in Cancer Patients

2005 ◽  
Vol 23 (18) ◽  
pp. 4057-4062 ◽  
Author(s):  
Melina Verso ◽  
Giancarlo Agnelli ◽  
Sergio Bertoglio ◽  
Franco C. Di Somma ◽  
Francesco Paoletti ◽  
...  
Keyword(s):  
Venous Thromboembolism ◽  
Cancer Patients ◽  
Randomized Study ◽  
Study Drug ◽  
Placebo Treatment ◽  
Bleeding Complications ◽  
Central Vein ◽  
Double Blind Study ◽  
Double Blind ◽  
Study Drug Administration

Purpose The extent of venous thromboembolism (VTE) associated with central vein catheters (CVC) in cancer patients remains unclear. The aim of this study was to evaluate the efficacy and safety of the low molecular weight heparin, enoxaparin, in the prevention of VTE. Patients and Methods In a multicenter, double-blind study, consecutive cancer patients scheduled for CVC insertion were randomly assigned to receive either subcutaneous enoxaparin 40 mg once a day or placebo. Treatment was started 2 hours before CVC insertion and continued for 6 weeks. The primary end points of the study were deep vein thrombosis (DVT), confirmed by venography of the CVC limb performed 6 weeks after randomization, or clinically overt pulmonary embolism, confirmed by objective testing during the study drug administration. Patients were assessed for bleeding complications. Results Three hundred eighty-five patients were randomized, of which 321 (83.4%) underwent venography. A venography was adequate for adjudication in 155 patients in each treatment group. A DVT was observed in 22 patients (14.1%) treated with enoxaparin and in 28 patients (18.0%) treated with placebo, corresponding to a relative risk of 0.78 (95% CI, 0.47 to 1.31). No major bleeding occurred. Five patients (2.6%) in the enoxaparin group and two patients (1.0%) in the placebo group died during the treatment period. Conclusion In this study, no difference in the rate of CVC-related VTE was detected between patients receiving enoxaparin and patients receiving placebo. The dose of enoxaparin used in this study proved to be safe. Clinical trials evaluating higher enoxaparin doses could optimize the efficacy of this agent for this indication.

scholarly journals Efficacy and safety of 4% articaine with epinephrine for the anterior middle superior alveolar nerve block comparing to the computer-controlled and conventional anesthetic delivery: Prospective, randomized, cross-over clinical study

2019 ◽  
Vol 76 (10) ◽  
pp. 1045-1053
Author(s):  
Dejan Cetkovic ◽  
Marija Milic ◽  
Vladimir Biocanin ◽  
Ivana Brajic ◽  
Dejan Calasan ◽  
...  
Keyword(s):  
Heart Rate ◽  
Clinical Study ◽  
Nerve Block ◽  
Dental Treatment ◽  
Onset Time ◽  
Cardiovascular Function ◽  
Double Blind ◽  
Randomized Clinical Study ◽  
Computer Controlled ◽  
Pulpal Anesthesia

Bacground/Aim. The efficient dental anesthesia, which is related to the clinically adequate depth, duration and the width of anesthetic field, is an important prerequisite for successful dental treatment. The aim of this study was to investigate and compare the pulpal anesthesia and cardiovascular parameters after the anterior middle superior alveolar (AMSA) nerve block with 4% articaine with epinephrine administered by conventional cartridge-syringe and computer- controlled local anesthetic delivery system (CCLADS). Methods. This controlled double-blind cross-over randomized clinical study included 38 healthy volunteers. Efficacy of pulpal anesthesia after the AMSA nerve block was evaluated by measuring a success rate, onset and duration of pulpal anesthesia, using an electrical pulp tester. The parameters of cardiovascular function (systolic and diastolic blood pressure, heart rate) were monitored noninvasively. Results. Successful pulpal anesthesia of all tested teeth was obtained in 57.9% participants with CCLADS and in 44.7% participants with conventional syringe. The onset time was not significantly different between two investigated groups. The pulpal anesthesia duration was not significantly different neither within nor between investigated groups. The systolic and diastolic blood pressures were significantly decreased in both investigated groups, in comparison with the baseline values. Heart rate significantly decreased within CCLADS from 10th to 30th minute when compared to baseline. Conclusion. The efficacy of pulpal anesthesia and safety of cardiovascular profile of 0.6 mL of articaine with epinephrine (1:100.000) delivered with CCLADS were improved in comparison to the conventional syringe delivery. Significant changes of cardiovascular function were not observed.

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