scholarly journals Phase 2 dose-ranging study of the virologic efficacy and safety of the combination COVID-19 antibodies casirivimab and imdevimab in the outpatient setting

2021 ◽  
Author(s):  
Cynthia Portal Celhay ◽  
Eduardo Forleo-Neto ◽  
Will Eagan ◽  
Bret J. Musser ◽  
John D. Davis ◽  
...  
Keyword(s):  
Viral Load ◽  
Weighted Average ◽  
Study Drug ◽  
Outpatient Setting ◽  
Controlled Study ◽  
Serious Adverse Events ◽  
Double Blind ◽  
Injection Site Reactions ◽  
Grade 3 ◽  
Mean Differences

Background: The monoclonal antibody combination casirivimab and imdevimab (REGEN-COV®) reduced viral load, hospitalisation, or death when administered 1:1 as an intravenous (IV) dose ≥1200 mg in a phase 3 COVID-19 outpatient study. Availability of subcutaneous (SC) and/or lower IV doses should increase accessibility and/or drug supplies for patients. Methods: This is a double-blind, placebo-controlled study of SARS-CoV-2-infected outpatients who were asymptomatic, or symptomatic but without risk factors for severe COVID-19. Patients were randomised to single IV dose (517 patients) of REGEN-COV 300, 600, 1200 or 2400 mg or placebo; or a single SC dose (286 patients) of REGEN-COV 600 or 1200 mg or placebo. The primary endpoint was time-weighted average daily change from baseline (TWACB) in viral load from day 1 (baseline) through day 7 in patients seronegative to SARS-CoV-2 at baseline. Findings: All REGEN-COV treatments showed significant (p<0.001 versus pooled placebo) virologic reduction through day 7. Least-squares mean differences in TWACB viral load for the treatments versus placebo ranged from –0·56 to –0.71 log10 copies/mL. Each REGEN-COV treatment showed significant (p<0.001 versus pooled placebo) and similar virologic reduction through day 7. There were no safety concerns, dose-related safety findings, grade ≥2 infusion related/hypersensitivity reactions, grade ≥3 injection-site reactions, nor fatalities. Two serious adverse events not related to COVID-19 or the study drug were reported. Interpretation: In asymptomatic and low-risk symptomatic SARS-CoV-2-infected outpatients seronegative for antibodies against SARS-CoV-2 at baseline, REGEN-COV significantly and comparably reduced viral load at all IV and SC doses.

The Safety and Efficacy of Oral Magnesium Pidolate in Children with Hemoglobin SC Disease.

Blood ◽  
2005 ◽  
Vol 106 (11) ◽  
pp. 3777-3777
Author(s):  
Brigitta Ursula Mueller ◽  
Marlen Dinu ◽  
Susan Kurth ◽  
Roz Bryant ◽  
Elizabeth Mullen ◽  
...  
Keyword(s):  
Adverse Events ◽  
Sickle Cell ◽  
Serum Magnesium ◽  
Study Drug ◽  
Laboratory Evaluation ◽  
Controlled Study ◽  
Serious Adverse Events ◽  
Double Blind ◽  
Efficacy Analysis ◽  
Cellular Dehydration

Abstract An important characteristic of the Hb SC erythrocyte is its high intracellular Hb concentration, which is due to cell K+ loss and dehydration mediated by an abnormally active K-Cl co-transport. This pathologic state of cellular dehydration raises the intracellular concentration of Hb S, thereby increasing its tendency to polymerize. Previous studies in patients with sickle cell disease have shown that oral Mg supplements can increase erythrocyte Mg content, reduce the activity of K-Cl co-transport and diminish erythrocyte dehydration. We performed a randomized, double blind, placebo-controlled study with crossover design on oral Mg supplementation in children with HbSC disease. Methods: Two major pediatric sickle cell centers participated in this IRB-approved study: Texas Children’s Sickle Cell Center and The Children’s Hospital in Boston. Over 100 eligible patients were contacted and invited to participate. The enrolled patients or their parents/guardians gave informed consent. Patients were randomized to either receive oral Mg pidolate or placebo for 6 months followed by a wash-out period of 2 months, then followed by a 6 month period of the other agent (placebo/Mg pidolate) and 2 months wash-out. Patients were initially followed every 2 weeks, then every 4 weeks. Safety was assessed both by clinical assessment as well as laboratory evaluation, including serum magnesium levels. Results: Between January 2002 and December 2004 we enrolled 12 patients (7 males, 5 female, age range 3.9 to 16.8 years) with HbSC disease and at least one pain crisis within the last year. Only 5 patients are fully evaluable for efficacy assessment. Seven patients came off study for the following reasons: 3 for non-compliance, 2 for study violation (pharmacy dispensed wrong formulation), and 2 withdrew for personal reasons (no longer interested), but all of them were included in the safety assessment. There were 3 events that were considered probably related to study drug (or placebo): diarrhea, grade 2 once and headaches, grade 3, in 2 instances. There were 6 events possibly related to drug (or placebo): diarrhea in three patients (all grade 1) and headaches of grade 2 or 3 in three patients. All adverse events resolved without stopping the drug/placebo. The results of the intracellular Mg concentrations and thus efficacy analysis will be available after unblinding the study in September 2005. Conclusion: Mg pidolate appears to be safe and well-tolerated when used in children with HbSC disease. No serious adverse events occurred that were considered definitively related to the study drug(s). Efficacy results will be available at the time of the meeting. However, despite the fact that study was open at 2 major sickle cell centers and had relatively non-restrictive enrollment criteria, accrual was extremely slow, presumably due to the sporadic and rather low disease intensity of Hb SC disease, and several patients did not complete the study. This should be taken into consideration when designing larger studies for patients with HbSC disease exclusively.

A randomized double-blind phase II study to evaluate same-day vs next-day administration of pegfilgrastim with carboplatin and docetaxel in patients with NSCLC

2006 ◽  
Vol 24 (18_suppl) ◽  
pp. 7110-7110 ◽  
Author(s):  
C. P. Belani ◽  
S. Ramalingam ◽  
A. Al-Janadi ◽  
E. Eskander ◽  
H. Ghazal ◽  
...  
Keyword(s):  
Lung Cancer ◽  
Study Drug ◽  
Serious Adverse Events ◽  
Double Blind ◽  
Lung Cancer Patients ◽  
Treatment Groups ◽  
The Difference ◽  
Cycle 24 ◽  
Grade 3 ◽  
Experienced Grade

7110 Background: Combination therapy with carboplatin and docetaxel has demonstrated activity against non-small cell lung cancer (NSCLC), but is associated with at least a moderate risk of febrile neutropenia (FN). Though pegfilgrastim is given only once-per-cycle 24 hours after chemotherapy (CT), administering pegfilgrastim on the same day as CT would be convenient for patients (pts). Methods: Pts ≥18 years with previously untreated stage IIIB or IV NSCLC and ECOG ≤2 who were candidates for carboplatin AUC 6 and docetaxel 75 mg/m2 were randomized 1:1 to receive pegfilgrastim 6 mg within 4 hours or approximately 24 hours after CT. The primary endpoint was the duration of grade 4 neutropenia (DSN) in cycle 1. Same-day administration was considered noninferior to next-day if the upper 95% confidence interval (CI) limit for the difference in DSN between groups in cycle 1 was <2 days. Results: As planned, 90 pts were enrolled. 88 pts received blinded study drug. Pts in the same-day and next-day groups had comparable mean baseline ANC and similar proportions of pts completed the study (43% vs 45%). In cycle 1, only 5% of pts in both groups experienced grade 4 neutropenia; resulting in a mean DSN of 0 days. Similarly in cycle 4, 10% (lasting for 1 day only) and 0% of pts in the same-day and next-day groups experienced grade 4 neutropenia. No pts experienced FN during the study. 44% of pts in the same-day and 33% of pts in the next-day group experienced serious adverse events. Conclusions: In this study of lung cancer patients receiving carboplatin and docetaxel, use of pegfilgrastim from the first cycle was well-tolerated in both treatment groups. Although the incidence of grade 3/4 neutropenia was lower than previously reported for this regimen, DSN appeared to be similar for patients in the same-day and next-day groups. Additionally, few patients experienced reductions or delays in CT delivery. [Table: see text] [Table: see text]

Pegfilgrastim in colorectal cancer (CRC) patients (pts) receiving every-two-week (Q2W) chemotherapy (CT): Long-term results from a phase II, randomized, controlled study

2009 ◽  
Vol 27 (15_suppl) ◽  
pp. 4072-4072
Author(s):  
J. R. Hecht ◽  
M. Pillai ◽  
R. Gollard ◽  
L. Dreiling ◽  
M. Mo ◽  
...  
Keyword(s):  
Study Drug ◽  
Treatment Phase ◽  
Progression Free Survival ◽  
Long Term Results ◽  
Controlled Study ◽  
Serious Adverse Events ◽  
Long Term Follow Up ◽  
Grade 3

4072 Background: Survival in advanced CRC is prolonged by adding oxaliplatin (Ox) and/or irinotecan (Iri) to Q2W 5-fluorouracil/leucovorin (5FU/LV). Combination therapy, however, has a higher incidence of febrile neutropenia (FN) and related toxicities. This study evaluated pegfilgrastim dosing on day 4 of Q2W regimens in CRC. Here we present long-term follow-up of these pts. Methods: Advanced CRC pts were randomized (1:1) to pegfilgrastim 6mg or placebo, which was stratified by CT regimen received: FOIL, FOLFOX, or FOLFIRI. We previously reported grade 3/4 neutropenia (primary endpoint) in 43% placebo and 13% pegfilgrastim pts in the 4-cycle treatment phase (odds ratio = 0.19, 95% CI: 0.10–0.37; p < 0.0001). After end of treatment, pts were followed long term for ≤ 2 years (inclusive of ≤ 8 additional cycles) for serious adverse events (SAEs), overall survival (OS), and progression-free survival (PFS). Median follow-up time was 519 days. Kaplan-Meier methods estimated OS and PFS from study day 1. The study was not powered to detect PFS or OS differences between treatment groups. Results: Of 241 pts analyzed (123 pegfilgrastim, 118 placebo), 49% received FOLFOX, 26% FOLFIRI, and 25% FOIL. In the treatment period, 8% placebo and 2% pegfilgrastim pts had grade 3/4 FN ( Table ). Pegfilgrastim was well tolerated with no dose delays attributed to leukocytosis. Pegfilgrastim and placebo had similar PFS and OS ( Table ). No SAEs related to study drug were reported in the follow-up period. Conclusions: In this randomized, placebo-controlled study, pegfilgrastim significantly lowered neutropenic risk. Bone pain incidence in this CRC population was lower than in breast cancer pts treated with a taxane (Vogel J Clin Oncol 2005); the incidence in pegfilgrastim pts was modestly increased over placebo. Leukocytosis was not a concern despite the 11-day dosing interval. Long-term results suggest similar PFS and OS in the pegfilgrastim and placebo pts in this CRC study. [Table: see text] [Table: see text]

Plerixafor and G-CSF versus placebo and G-CSF to mobilize hematopoietic stem cells for autologous stem cell transplantation in patients with multiple myeloma

Blood ◽  
2009 ◽  
Vol 113 (23) ◽  
pp. 5720-5726 ◽  
Author(s):  
John F. DiPersio ◽  
Edward A. Stadtmauer ◽  
Auayporn Nademanee ◽  
Ivana N. M. Micallef ◽  
Patrick J. Stiff ◽  
...  
Keyword(s):  
Stem Cells ◽  
Multiple Myeloma ◽  
Hematopoietic Stem Cells ◽  
Primary Endpoint ◽  
Controlled Study ◽  
Double Blind ◽  
Hematopoietic Stem ◽  
Injection Site Reactions ◽  
Cd34 Cells ◽  
Stimulating Factor

Abstract This phase 3, multicenter, randomized (1:1), double-blind, placebo-controlled study evaluated the safety and efficacy of plerixafor with granulocyte colony-stimulating factor (G-CSF) in mobilizing hematopoietic stem cells in patients with multiple myeloma. Patients received G-CSF (10 μg/kg) subcutaneously daily for up to 8 days. Beginning on day 4 and continuing daily for up to 4 days, patients received either plerixafor (240 μg/kg) or placebo subcutaneously. Starting on day 5, patients began daily apheresis for up to 4 days or until more than or equal to 6 × 106 CD34+ cells/kg were collected. The primary endpoint was the percentage of patients who collected more than or equal to 6 × 106 CD34+ cells/kg in less than or equal to 2 aphereses. A total of 106 of 148 (71.6%) patients in the plerixafor group and 53 of 154 (34.4%) patients in the placebo group met the primary endpoint (P < .001). A total of 54% of plerixafor-treated patients reached target after one apheresis, whereas 56% of the placebo-treated patients required 4 aphereses to reach target. The most common adverse events related to plerixafor were gastrointestinal disorders and injection site reactions. Plerixafor and G-CSF were well tolerated, and significantly more patients collected the optimal CD34+ cell/kg target for transplantation earlier compared with G-CSF alone. This study is registered at www.clinicaltrials.gov as #NCT00103662.

scholarly journals Safety, pharmacokinetics and antiviral activity of PGT121, a broadly neutralizing monoclonal antibody against HIV-1: a randomized, placebo-controlled, phase 1 clinical trial

2021 ◽  
Author(s):  
Kathryn E. Stephenson ◽  
Boris Julg ◽  
C. Sabrina Tan ◽  
Rebecca Zash ◽  
Stephen R. Walsh ◽  
...  
Keyword(s):  
Viral Load ◽  
T Cell ◽  
Adverse Events ◽  
Antiviral Activity ◽  
Controlled Trial ◽  
Phase 1 ◽  
Serious Adverse Events ◽  
Double Blind ◽  
Cell Counts ◽  
Hiv 1

AbstractHuman immunodeficiency virus (HIV)-1-specific broadly neutralizing monoclonal antibodies are currently under development to treat and prevent HIV-1 infection. We performed a single-center, randomized, double-blind, dose-escalation, placebo-controlled trial of a single administration of the HIV-1 V3-glycan-specific antibody PGT121 at 3, 10 and 30 mg kg–1 in HIV-uninfected adults and HIV-infected adults on antiretroviral therapy (ART), as well as a multicenter, open-label trial of one infusion of PGT121 at 30 mg kg–1 in viremic HIV-infected adults not on ART (no. NCT02960581). The primary endpoints were safety and tolerability, pharmacokinetics (PK) and antiviral activity in viremic HIV-infected adults not on ART. The secondary endpoints were changes in anti-PGT121 antibody titers and CD4+ T-cell count, and development of HIV-1 sequence variations associated with PGT121 resistance. Among 48 participants enrolled, no treatment-related serious adverse events, potential immune-mediated diseases or Grade 3 or higher adverse events were reported. The most common reactions among PGT121 recipients were intravenous/injection site tenderness, pain and headache. Absolute and relative CD4+ T-cell counts did not change following PGT121 infusion in HIV-infected participants. Neutralizing anti-drug antibodies were not elicited. PGT121 reduced plasma HIV RNA levels by a median of 1.77 log in viremic participants, with a viral load nadir at a median of 8.5 days. Two individuals with low baseline viral loads experienced ART-free viral suppression for ≥168 days following antibody infusion, and rebound viruses in these individuals demonstrated full or partial PGT121 sensitivity. The trial met the prespecified endpoints. These data suggest that further investigation of the potential of antibody-based therapeutic strategies for long-term suppression of HIV is warranted, including in individuals off ART and with low viral load.

scholarly journals A Phase 1 Randomized Placebo-Controlled Study to Assess the Safety, Immunogenicity and Genetic Stability of a New Potential Pandemic H7N9 Live Attenuated Influenza Vaccine in Healthy Adults

Vaccines ◽  
2020 ◽  
Vol 8 (2) ◽  
pp. 296
Author(s):  
Irina Kiseleva ◽  
Irina Isakova-Sivak ◽  
Marina Stukova ◽  
Marianna Erofeeva ◽  
Svetlana Donina ◽  
...  
Keyword(s):  
Adverse Events ◽  
Influenza Vaccine ◽  
Phase 1 ◽  
Healthy Adults ◽  
Controlled Study ◽  
Temperature Sensitive ◽  
Serious Adverse Events ◽  
Double Blind ◽  
Human Influenza Virus ◽  
Live Attenuated Influenza Vaccine

This study describes a double-blind randomized placebo-controlled phase I clinical trial in healthy adults of a new potential pandemic H7N9 live attenuated influenza vaccine (LAIV) based on the human influenza virus of Yangtze River Delta hemagglutinin lineage (ClinicalTrials.gov Identifier: NCT03739229). Two doses of H7N9 LAIV or placebo were administered intranasally to 30 and 10 subjects, respectively. The vaccine was well-tolerated and not associated with increased rates of adverse events or with any serious adverse events. Vaccine virus was detected in nasal swabs during the 6 days after vaccination or revaccination. A lower frequency of shedding was observed after the second vaccination. Twenty-five clinical viral isolates obtained after the first and second doses of vaccine retained the temperature-sensitive and cold-adapted phenotypic characteristics of LAIV. There was no confirmed transmission of the vaccine strain from vaccinees to placebo recipients. After the two H7N9 LAIV doses, an immune response was observed in 96.6% of subjects in at least one of the assays conducted.

scholarly journals Effects of BI 655064, an antagonistic anti-CD40 antibody, on clinical and biomarker variables in patients with active rheumatoid arthritis: a randomised, double-blind, placebo-controlled, phase IIa study

2019 ◽  
Vol 78 (6) ◽  
pp. 754-760 ◽  
Author(s):  
Sudha Visvanathan ◽  
Stefan Daniluk ◽  
Rafał Ptaszyński ◽  
Ulf Müller-Ladner ◽  
Meera Ramanujam ◽  
...  
Keyword(s):  
Rheumatoid Arthritis ◽  
Bone Resorption ◽  
Primary Endpoint ◽  
Study Drug ◽  
Nuclear Factor Κb ◽  
Inadequate Response ◽  
Serious Adverse Events ◽  
Double Blind ◽  
Autoantibody Production ◽  
Bone Resorption Markers

ObjectiveTo evaluate the safety, efficacy and therapeutic mechanism of BI 655064, an antagonistic anti-CD40 monoclonal antibody, in patients with rheumatoid arthritis (RA) and an inadequate response to methotrexate (MTX-IR).MethodsIn total, 67 patients were randomised to receive weekly subcutaneous doses of 120 mg BI 655064 (n=44) or placebo (n=23) for 12 weeks. The primary endpoint was the proportion of patients who achieved 20% improvement in American College of Rheumatology criteria (ACR20) at week 12. Safety was assessed in patients who received at least one dose of study drug.ResultsAt week 12, the primary endpoint was not met, with 68.2% of patients treated with BI 655064 achieving an ACR20 vs 45.5% with placebo (p=0.064); using Bayesian analysis, the posterior probability of seeing a difference greater than 35% was 42.9%. BI 655064 was associated with greater changes in CD40–CD40L pathway-related markers, including reductions in inflammatory and bone resorption markers (interleukin-6, matrix metalloproteinase-3, receptor activator of nuclear factor-κB ligand), concentration of autoantibodies (immunoglobulin [Ig]G rheumatoid factor [RF], IgM RF, IgA RF) and CD95+ activated B-cell subsets. No serious adverse events (AEs) related to BI 655064 treatment or thromboembolic events occurred; reported AEs were mainly of mild intensity.ConclusionAlthough blockade of the CD40–CD40L pathway with BI 655064 in MTX-IR patients with RA resulted in marked changes in clinical and biological parameters, including reductions in activated B-cells, autoantibody production and inflammatory and bone resorption markers, with a favourable safety profile, clinical efficacy was not demonstrated in this small phase IIa study.Trial registration numberNCT01751776

scholarly journals Safety and Immunogenicity of the GamTBvac, the Recombinant Subunit Tuberculosis Vaccine Candidate: A Phase II, Multi-Center, Double-Blind, Randomized, Placebo-Controlled Study

Vaccines ◽  
2020 ◽  
Vol 8 (4) ◽  
pp. 652 ◽  
Author(s):  
Artem P. Tkachuk ◽  
Evgeniia N. Bykonia ◽  
Liubov I. Popova ◽  
Denis A. Kleymenov ◽  
Maria A. Semashko ◽  
...  
Keyword(s):  
Interferon Gamma ◽  
Phase Ii ◽  
Intracellular Cytokine Staining ◽  
Study Drug ◽  
Controlled Study ◽  
Interferon Gamma Release Assay ◽  
Double Blind ◽  
Igra Test ◽  
Th1 Cytokine ◽  
Release Assay

GamTBvac is a candidate tuberculosis vaccine with two fusion proteins, containing Ag85a, ESAT6, CFP10, and a dextran-binding domain (DBD). Phase II of a double-blind, randomized, multicenter, placebo-controlled study in parallel groups in healthy adults to evaluate the safety and immunogenicity of GamTBvac in 180 previously-vaccinated with Bacillus Calmette–Guérin vaccine (BCG) healthy volunteers without Mycobacterium tuberculosis (MTB) infection was conducted. The dose (0.5 mL) of either the study drug or a placebo was administered subcutaneously twice with an 8-week interval. At eight timepoints from 14 to 150 days, whole blood and sera were assayed. Antigen-specific T-cell responses were measured by an in-house interferon-gamma release assay (IGRA-test), the QuantiFERON (QTF) test, and intracellular cytokine staining (ICS). For antibody response detection, the bead-based multiplex immunoassay (MIA) was applied. The vaccine confirmed an acceptable safety profile previously shown in a first-in-human clinical study. After stimulation with both fusions, the highest median level of INF-γ was detected on day 21. The GamTBvac vaccine induced antigen-specific interferon-gamma release, Th1 cytokine-expressing CD4+ T-cells, and IgG responses and results support further clinical testing of GamTBvac.

Efficacy of Phenazone in the Treatment of Acute Migraine Attacks: A Double-Blind, Placebo-Controlled, Randomized Study

Cephalalgia ◽  
2004 ◽  
Vol 24 (10) ◽  
pp. 888-893 ◽  
Author(s):  
H Göbel ◽  
A Heinze ◽  
U Niederberger ◽  
T Witt ◽  
V Zumbroich
Keyword(s):  
Adverse Events ◽  
Randomized Study ◽  
Controlled Study ◽  
Acute Migraine ◽  
Serious Adverse Events ◽  
Double Blind ◽  
Double Blind Placebo ◽  
Number Of Patients ◽  
Significant Difference ◽  
Main Target

In this study we compared the efficacy of 1000 mg phenazone with that of placebo in the treatment of acute migraine attacks in a randomized double-blind, placebo-controlled study of 208 patients. The main target criterion was the number of patients with a pain reduction from severe or moderate to slight or no pain 2 h after taking the pain medication. The percentage of patients satisfying the main target criterion was 48.6% for phenazone and 27.2% ( P < 0.05) for placebo. Freedom from pain after 2 h was reported by 27.6% with phenazone treatment and 13.6% ( P < 0.05) with placebo. Compared with placebo, the phenazone treatment also resulted in a significant improvement in the associated migraine symptoms of nausea, phonophobia and photophobia. Of patients treated with phenazone 11.4%, and 5.8% of those treated with placebo reported adverse events. There was no significant difference between the groups with regard to numbers of patients with adverse events. No serious adverse events occurred. The results show that phenazone at a dosage of 1000 mg is effective and well tolerated in the treatment of acute migraine attacks.

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

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