“EFFECT ON HEMODYNAMIC RESPONSE TO LARYNGOSCOPY AND TRACHIAL INTUBATION AND THEIR ATTENUATION BY BOLUS ADMINISTRATION OF DEXMEDETOMIDINE”

Background and Aims- Laryngoscopic and endotracheal intubation are noxious stimuli causes tachycardia, arrhythmias and hypertension. The aim of this study was to compare dexmedetomidine with placebo to attenuate stress response during laryngoscopy and endotracheal intubation.Methods-It was a randomised, double-blind placebo-controlled study. After Institutional Ethical Committee clearance, 60 patients of ASA 1& 2 were enrolled and divided into 30 each. Group NS received normal saline and Group D received injection dexmedetomidine 1μg/kgas infusion over 10 min. The general anaesthesia technique was standardised for both groups. The primary outcome measures were haemodynamic response at 1, 2, 5 and 10 min after intubation. The secondary outcome measures were to note down any adverse effects associated with drugs. The statistical package used was SPSS version 15.Results- There was a statistically significant difference (P <0.05) between Group D and Group NS in heart rate, systolic, diastolic and mean arterial pressures after tracheal intubation with dexmedetomidine. Sedation scores were more with dexmedetomidine. None of the patients had any adverse effects. Conclusion-Dexmedetomidine 1 µg/kg as premedication can be used safely and effectively to attenuate hemodynamic response to laryngoscopy and endotracheal intubation.

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Comparison of the hemodynamic response of dexmedetomidine versus additional intravenous lidocaine with propofol during tracheal intubation: a randomized controlled study

BMC Anesthesiology ◽

10.1186/s12871-021-01484-6 ◽

2021 ◽

Vol 21 (1) ◽

Author(s):

Rattaphol Seangrung ◽

Koravee Pasutharnchat ◽

Subundit Injampa ◽

Sirima Kumdang ◽

Rojnarin Komonhirun

Keyword(s):

Blood Pressure ◽

Adverse Effects ◽

Tracheal Intubation ◽

Endotracheal Intubation ◽

Hemodynamic Response ◽

Controlled Study ◽

Time Points ◽

Randomized Controlled ◽

The Mean ◽

Group D

Abstract Background Laryngoscopy and tracheal intubation are strong stimuli that cause a reflex increase in blood pressure (BP), heart rate (HR), and serum catecholamine level. These can lead to myocardial infarction or cerebrovascular accidents. The purpose of this study is to compare the efficacy of dexmedetomidine and lidocaine combined with propofol in attenuating the hemodynamic response following laryngoscopy and endotracheal intubation. Methods This study was a randomized controlled study and adhered to the CONSORT guidelines. One-hundred and six patients undergoing elective general anesthesia with endotracheal intubation were divided randomly into two groups. Group D received dexmedetomidine (1 μg kg− 1) before induction. Group LP received lidocaine (1.5 mg kg− 1) before induction with additional propofol (0.5 mg kg− 1) before laryngoscopy. The primary endpoint was hemodynamic including systolic (S) BP, diastolic (D) BP, mean arterial blood pressure (MAP) and HR measured before and after induction and ≤ 10 min after intubation. Secondary outcome was complications/adverse effects. Results After induction, the mean SBP, DBP, MAP and HR decreased significantly from baseline in both groups except for mean HR in group LP at 1 min. Differences in mean values of SBP, DBP, and MAP were significantly lower in group D after intubation at 4–10 min (P < 0.05). Group LP had a non-inferior effect in blunting BP at all time points except 1 and 2 min after induction, and 2 min after intubation. The mean difference in HR in group D was significantly lower than that in group LP at all time points (P < 0.001). Group D had significantly more episodes of bradycardia (18.87% vs. 0%, P = 0.001) and hypotension (52.83% vs. 15.09%, P < 0.001) than did group LP. Conclusion Lidocaine (1.5 mg kg− 1) with additional propofol (0.5 mg kg− 1) had a non-inferior effect compared with dexmedetomidine (1 μg kg− 1) in attenuating the hemodynamic response following laryngoscopy and endotracheal intubation, and had fewer adverse effects. Trial registration Thai Clinical Trial Registry, (TRTC20190206002). Retrospectively registered 4 February 2019.

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Comparative study between sprayed and inhaled nebulized lidocaine for suppression of hemodynamic response to laryngoscopy and oral endotracheal intubation

Journal of University of Shanghai for Science and Technology ◽

10.51201/jusst/21/09599 ◽

2021 ◽

Vol 23 (09) ◽

pp. 772-787

Author(s):

Ahmed Abdulmaged Ahmed ◽

◽

Dr. Hasan Sarhan Haider ◽

Keyword(s):

Heart Rate ◽

Tracheal Intubation ◽

General Anesthesia ◽

Endotracheal Intubation ◽

Outcome Measures ◽

Cardiovascular Response ◽

Hemodynamic Response ◽

Secondary Outcome ◽

Patient Acceptance ◽

Significant Difference

Background: Direct laryngoscopic manipulation and endotracheal intubation are noxious stimuli capable of producing hemodynamic changes characterized by tachycardia, hypertension, and arrhythmias. Which are tolerated in normotensive healthy individuals but had greater impact in patients with cardiovascular and cerebrovascular diseases lead to increased morbidity and mortality. Aim of the study: To compare the efficacy of sprayed and inhaled nebulized lidocaine in suppressing the cardiovascular response to laryngoscopy and tracheal intubation in normotensive patients undergoing general anesthesia. Patient and method: 80 adult patients undergoing elective surgery under general anesthesia with endotracheal intubation were randomly allocated into two equal groups. Patients in nebulized lidocaine (NL) group received pre-induction nebulized (1ml of 10%) lidocaine, while those in sprayed lidocaine (SL) group received pre-induction sprayed (10 puffs of 10%) lidocaine. The general anesthesia technique was standardized for the two groups. The primary outcome measures were hemodynamic response at 1, 3, 6, 9, and 12 min after intubation. The secondary outcome measures were to note down any adverse effects associated with drugs. The statistical package used was SPSS version 25.Results: There was a statistically significant difference (P < 0.05) between nebulizes and sprayed lidocaine in heart rate, systolic, diastolic and mean arterial pressures at different time points after tracheal intubation with nebulized lidocaine being most effective and better toleration. Conclusion: The hemodynamic instability was lesser with nebulized lidocaine as compared to sprayed lidocaine. The effect was on heart rate and blood pressure. Use of nebulized lidocaine is simple, safe, effective and better patient acceptance.

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Phase III, Randomized, Double-Blind, Placebo-Controlled Study of Long-Acting Methylphenidate for Cancer-Related Fatigue: North Central Cancer Treatment Group NCCTG-N05C7 Trial

Journal of Clinical Oncology ◽

10.1200/jco.2010.28.1444 ◽

2010 ◽

Vol 28 (23) ◽

pp. 3673-3679 ◽

Cited By ~ 105

Author(s):

Amanda R. Moraska ◽

Amit Sood ◽

Shaker R. Dakhil ◽

Jeff A. Sloan ◽

Debra Barton ◽

...

Keyword(s):

Short Form ◽

Phase Iii ◽

Secondary Outcome ◽

Controlled Study ◽

Symptom Experience ◽

Double Blind ◽

Time Curve ◽

Cancer Related Fatigue ◽

Significant Difference ◽

Long Acting

Purpose Fatigue is one of the most common symptoms experienced by patients with cancer. This trial was developed to evaluate the efficacy of long-acting methylphenidate for improving cancer-related fatigue and to assess its toxicities. Patients and Methods Adults with cancer were randomly assigned in a double-blinded manner to receive methylphenidate (target dose, 54 mg/d) or placebo for 4 weeks. The Brief Fatigue Inventory was the primary outcome measure, while secondary outcome measures included a Symptom Experience Diary (SED), the Short Form-36 (SF-36) Vitality Subscale, a linear analog self-assessment, the Pittsburgh Sleep Quality Index, and the Subject Global Impression of Change. Results In total, 148 patients were enrolled. Using an area under the serum concentration-time curve analysis, there was no evidence that methylphenidate, as compared with placebo, improved the primary end point of cancer-related fatigue in this patient population (P = .35). Comparisons of secondary end points, including clinically significant changes in quality-of-life variables and cancer-related fatigue change from baseline, were similarly negative. However, a subset analysis suggested that patients with more severe fatigue and/or with more advanced disease did have some fatigue improvement with methylphenidate (eg, in patients with stage III or IV disease, the mean improvement in usual fatigue was 19.7 with methylphenidate v 2.1 with placebo; P = .02). There was a significant difference in self-reported toxicities (SED), with increased levels of nervousness and appetite loss in the methylphenidate arm. Conclusion This clinical trial was unable to support the primary prestudy hypothesis that the chosen long-acting methylphenidate product would decrease cancer-related fatigue.

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Postoperative Effects of Continuous Dexmedetomidine Infusion During Gynecological Laparoscopy: A Randomized, Placebo-Controlled, Double-Blind, Single Center Clinical Trial

10.21203/rs.3.rs-19402/v1 ◽

2020 ◽

Author(s):

SiYuan Liu ◽

Binbin Wang ◽

Yongtao Gao ◽

Xingguo Xu

Keyword(s):

Adverse Events ◽

General Anesthesia ◽

Outcome Measures ◽

Normal Saline ◽

Saline Group ◽

Secondary Outcome ◽

Double Blind ◽

Gynecological Laparoscopy ◽

Blood Pressures ◽

Group D

Abstract Background: Dexmedetomidine(DEX) has proven to be an effective adjuvant to anesthetics owing to its sympatholytic, analgesic, and sedative properties. This study was designed to investigate the postoperative effects of continuous DEX infusion during gynecological laparoscopy and to evaluate the safety of this treatment. Methods: Sixty patients undergoing selective gynecological laparoscopy with general anesthesia were randomly assigned into DEX group (group D )and normal saline group (group N). DEX was infused at 0.5ug/kg/h during anesthesia maintenance in group D while normal saline was infused at the same rate in group N. The primary outcome measures were heart rate and blood pressure at extubation, 1, 2, 3, 4, 5, 6, 7, 8, 12, 24 and 48 hours after operation, NRS scores at 1, 2, 3 ,4, ,8,12,24 hours after surgery and OAA/S scores after extubation. The secondary outcome measures were time to extubation, propofol and remifentanil dosage during anesthesia, postoperative adverse events, and postoperative hospital stay.Results: Systolic and diastolic blood pressures were lower in group D at extubation when compared with group N (P<0.05), but not different at the first postoperative hour or after. HR was lower both at extubation and the first postoperative hour in group D (P<0.05). NRS scores were lower in patients given DEX both at rest and movement at the first postoperative hour (P<0.05). Time to extubation and OAA/S scores after extubation were not different between groups. Postoperative respiratory depression, shivering and pruritus didn’t occur in this research. There were no significant differences in the incidence rate of postoperative adverse events or postoperative hospital stay between the groups.Conclusions: Continuous infusion of DEX during gynecological laparoscopy provided better hemodynamic stability at extubation and the effects on HR continued until 1 hour after operation. DEX administration was associated with lower NRS scores at the first postoperative hour without excessive sedation. DEX is a useful and safe adjuvant for general anesthesia during gynecological laparoscopy.

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Use of Fast Gamma Magnetic Stimulation Over the Left Prefrontal Dorsolateral Cortex for the Treatment of MCI and Mild Alzheimer's Disease: A Double-Blind, Randomized, Sham-Controlled, Pilot Study

Frontiers in Neurology ◽

10.3389/fneur.2021.729872 ◽

2021 ◽

Vol 12 ◽

Author(s):

Alberto José Mimenza-Alvarado ◽

Sara Gloria Aguilar-Navarro ◽

Francisco M. Martinez-Carrillo ◽

Alma E. Ríos-Ponce ◽

Gabriel Villafuerte

Keyword(s):

Alzheimer’S Disease ◽

Alzheimer's Disease ◽

Adverse Effects ◽

Magnetic Stimulation ◽

Controlled Study ◽

Magnetic Pulse ◽

Double Blind ◽

Clinical Trial Registration ◽

Significant Difference ◽

Dorsolateral Cortex

Background: Alzheimer's disease (AD) animal models have shown a reduced gamma power in several brain areas, and induction of these oscillations by non-invasive methods has been shown to modify several pathogenic mechanisms of AD. In humans, the application of low-intensity magnetic fields has shown to be able to produce neural entrainment at the magnetic pulse frequency, making it useful to induce gamma frequencies.Objective: The aim of this study was to assess if the application of fast gamma magnetic stimulation (FGMS) over the left prefrontal dorsolateral cortex would be a safe and well-tolerated intervention that could potentially improve cognitive scores in subjects with mild cognitive impairment and mild AD.Methods: In these randomized, double-blind, sham-controlled study, participants were assigned to either receive daily sessions two times a day of active or sham FGMS for 6 months. Afterward, measurements of adverse effects, cognition, functionality, and depression were taken.Results: Thirty-four patients, 17 in each group, were analyzed for the primary outcome. FGMS was adequately tolerated by most of the subjects. Only four patients from the active FGMS group (23.52%) and one patient from the sham FGMS group (5.88%) presented any kind of adverse effects, showing no significant difference between groups. Nevertheless, FGMS did not significantly change cognitive, functionality, or depressive evaluations.Conclusion: FGMS over the left prefrontal dorsolateral cortex applied twice a day for 6 months resulted to be a viable intervention that can be applied safely directly from home without supervision of a healthcare provider. However, no statistically significant changes in cognitive, functionality, or depression scores compared to sham stimulation were observed.Clinical Trial Registration:www.ClinicalTrials.gov, Identifier: NCT03983655, URL: https://clinicaltrials.gov/ct2/show/NCT03983655.

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Single, intra-articular treatment with 6 ml hylan G-F 20 in patients with symptomatic primary osteoarthritis of the knee: a randomised, multicentre, double-blind, placebo controlled trial

Annals of the Rheumatic Diseases ◽

10.1136/ard.2008.094623 ◽

2009 ◽

Vol 69 (01) ◽

pp. 113-119 ◽

Cited By ~ 143

Author(s):

X Chevalier ◽

J Jerosch ◽

P Goupille ◽

N van Dijk ◽

F P Luyten ◽

...

Keyword(s):

Knee Osteoarthritis ◽

Outcome Measures ◽

Global Assessment ◽

Treatment Phase ◽

Secondary Outcome ◽

Controlled Study ◽

Double Blind ◽

Repeat Treatment ◽

Primary Osteoarthritis ◽

Study Results

Objectives:The primary objective was to compare a single, 6 ml, intra-articular injection of hylan G-F 20 with placebo in patients with symptomatic knee osteoarthritis. The safety of a repeat injection of hylan G-F 20 was also assessed.Methods:Patients with primary osteoarthritis knee pain were randomly assigned to arthrocentesis plus a 6 ml intra-articular injection of either hylan G-F 20 or placebo in a prospective, double-blind (one injector/one blinded observer) study. Results were evaluated at 4, 8, 12, 18 and 26 weeks post-injection. The primary outcome criterion was change from baseline over 26 weeks in Western Ontario and McMaster Universities (WOMAC) Osteoarthritis Index A pain. Secondary outcome measures included WOMAC A1 and C, patient global assessment (PGA) and clinical observer global assessment (COGA) and Outcome Measures in Rheumatology, Osteoarthritis Research Society International responder rates. A 4-week, open, repeat treatment phase evaluated safety only.Results:A total of 253 patients (Kellgren–Lawrence grade II or III) was randomly assigned. Patients receiving hylan G-F 20 experienced statistically significantly greater improvements in WOMAC A pain scores (−0.15, SE 0.076, p = 0.047), and several of the secondary outcome measures (WOMAC A1, PGA and COGA), than patients receiving placebo. There was no difference between the safety results of the two groups. No increased risk of local adverse events was observed in the open, repeat treatment phase.Conclusions:This placebo-controlled study demonstrated that, in patients with knee osteoarthritis, a single 6 ml intra-articular injection of hylan G-F 20 is safe and effective in providing statistically significant, clinically relevant pain relief over 26 weeks, with a modest difference versus placebo.Trial registration number:NCT00131352.

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Polyethylene Glycol Electrolyte Lavage Solution versus Colonic Hydrotherapy for Bowel Preparation before Colonoscopy: A Single Center, Randomized, and Controlled Study

Gastroenterology Research and Practice ◽

10.1155/2014/541586 ◽

2014 ◽

Vol 2014 ◽

pp. 1-8 ◽

Cited By ~ 1

Author(s):

Yan Cao ◽

Kai-Yuan Zhang ◽

Jiao Li ◽

Hao Lu ◽

Wan-Ling Xie ◽

...

Keyword(s):

Patient Satisfaction ◽

Polyethylene Glycol ◽

Adverse Effects ◽

Outcome Measures ◽

Bowel Preparation ◽

Arrival Rate ◽

Secondary Outcome ◽

Controlled Study ◽

Single Center ◽

Detection Rates

This single center, randomized, and controlled study aimed to compare the effectiveness and safety of polyethylene glycol electrolyte lavage (PEG-EL) solution and colonic hydrotherapy (CHT) for bowel preparation before colonoscopy. A total of 196 eligible outpatients scheduled for diagnostic colonoscopy were randomly assigned to the PEG-EL (n=102) or CHT (n=94) groups. Primary outcome measures included colonic cleanliness and adverse effects. Secondary outcome measures were patient satisfaction and preference, colonoscopic findings, ileocecal arrival rate, examiner satisfaction, and cecal intubation time. The results show that PEG-EL group was associated with significantly better colonic cleanliness than CHT group, fewer adverse effects, and increased examiner satisfaction. However, the CHT group had higher patient satisfaction and higher diverticulosis detection rates. Moreover, the results showed the same ileocecal arrival rate and patient preference between the two groups (P>0.05). These findings indicate that PEG-EL is the preferred option in patients who followed the preparation instructions completely.

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Is Infusion of Subhypnotic Propofol as Effective as Dexamethasone in Prevention of Postoperative Nausea and Vomiting Related to Laparoscopic Cholecystectomy? A Randomized Controlled Trial

BioMed Research International ◽

10.1155/2015/349806 ◽

2015 ◽

Vol 2015 ◽

pp. 1-5 ◽

Cited By ~ 10

Author(s):

Mine Celik ◽

Aysenur Dostbil ◽

Mehmet Aksoy ◽

Ilker Ince ◽

Ali Ahiskalioglu ◽

...

Keyword(s):

Laparoscopic Cholecystectomy ◽

Postoperative Nausea ◽

Controlled Trial ◽

Postoperative Nausea And Vomiting ◽

Nausea And Vomiting ◽

Controlled Study ◽

Control Group ◽

Double Blind ◽

Significant Difference ◽

Group D

Background. Postoperative nausea and vomiting (PONV) is one of common complications in patients undergoing laparoscopic cholecystectomy (LC). Aim of this study was to compare the efficacy of subhypnotic (1 mg/kg/h) infusion of propofol with dexamethasone on PONV in patients undergoing LC.Methods. A total of 120 patients were included in this randomized, double-blind, placebo-controlled study. Patients were randomly assigned to 3 groups; patients of group dexamethasone (group D) were administrated 8 mg dexamethasone before induction of anesthesia, patients of group propofol (group P) were infused to subhypnotic (1 mg/kg/h) propofol during operation and patients of group control (group C) were applied infusion of 10% intralipid. The incidence of PONV and needs for rescue analgesic and antiemetic were recorded in the first 24 h postoperatively.Results. In the 0–24 h, the incidence of PONV was significantly lower in the group D and group P compared with the group C (37.5%, 40%, and 72.5%, resp.). There was no significant difference in the incidence of PONV and use of antiemetics and analgesic between group D and group P.Conclusion. We concluded that infusion of propofol 1 mg/kg/h is as effective as dexamethasone for the prevention of PONV during the first 24 hours after anesthesia in patients undergoing LC.

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Efficacy of a standardised saffron extract (affron®) as an add-on to antidepressant medication for the treatment of persistent depressive symptoms in adults: A randomised, double-blind, placebo-controlled study

Journal of Psychopharmacology ◽

10.1177/0269881119867703 ◽

2019 ◽

Vol 33 (11) ◽

pp. 1415-1427 ◽

Cited By ~ 5

Author(s):

Adrian L Lopresti ◽

Stephen J Smith ◽

Sean D Hood ◽

Peter D Drummond

Keyword(s):

Depressive Symptoms ◽

Outcome Measures ◽

Short Form ◽

Self Report ◽

Secondary Outcome ◽

Controlled Study ◽

Double Blind ◽

Double Blind Placebo ◽

Persistent Depression ◽

Saffron Extract

Background: As a stand-alone intervention, saffron has efficacy for the treatment of mild-to-moderate depression. However, research as an adjunct agent is limited. Aims: The effects of saffron as an adjunct to pharmaceutical antidepressants in adults with persistent depression was investigated. Methods: In this eight-week, randomised, double-blind, placebo-controlled study, adults with persistent depression, currently taking a pharmaceutical antidepressant were given a placebo or a saffron extract (affron®, 14 mg b.i.d.). Primary outcome measures included the clinician-rated Montgomery–Åsberg Depression Rating Scale (MADRS) and self-rated MADRS (MADRS-S). Secondary outcome measures included the Antidepressant Side-Effect Checklist (ASEC) and Short Form-36 Health Survey (SF-36). Results: Of the 160 participants enrolled, 139 provided usable data. Based on the MADRS, depressive symptoms decreased more in participants taking saffron compared with a placebo, with reductions of 41 and 21%, respectively ( p = 0.001). However, scores on the MADRS-S decreased 27 and 26% in the saffron and placebo conditions, respectively ( p = 0.831). Saffron was associated with a greater reduction in adverse effects of antidepressants ( p = 0.019), although this was non-significant after covarying for baseline values ( p = 0.449). Quality of life improved in both groups with no significant between-group differences ( p = 0.638). Conclusion: Adjunctive administration of a standardised saffron extract (affron®) for eight weeks was associated with a greater improvement in depressive symptoms as measured by the clinician-rated MADRS but not the self-report MADRS-S. Given the conflicting results, further research is needed to clarify the clinical benefits of saffron as an adjunctive treatment for adults with persistent depressive symptoms despite antidepressant drug treatment.

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Attenuation of hemodynamic response to laryngoscopy and endotracheal intubation with dexmedetomidine: a randomized controlled trial

Journal of Society of Anesthesiologists of Nepal ◽

10.3126/jsan.v3i1.14648 ◽

2016 ◽

Vol 3 (1) ◽

pp. 28-31

Author(s):

Nabin Pokhrel ◽

Uday Bajra Bajracharya

Keyword(s):

Heart Rate ◽

Mean Arterial Pressure ◽

Arterial Pressure ◽

Endotracheal Intubation ◽

Controlled Trial ◽

Hemodynamic Response ◽

Saline Group ◽

Controlled Study ◽

Randomized Controlled ◽

Group D

Background: Laryngoscopy and endotracheal intubation causes marked increase in heart rate and blood pressure. Even though various agent tried to blunt the hemodynamic response but none of them proved to be an ideal. The aim of the study was to compare dexmedetomidine and placebo in blunting the hemodynamic response to laryngoscopy and endotracheal intubation.Methods: A randomized placebo controlled study with total of 90 patients were included in the study of which 30 patients received dexmedetomidine (Group D) 10 minutes prior to endotracheal intubation and 30 patients received 3 ml Normal Saline (Group C) 10 minutes prior to endotracheal intubation. They were evaluated with change in heart rate and mean arterial pressure at 1, 3 and 5 minutes post laryngoscopy and endotracheal intubation. Any adverse effect of the drug was noted. Results: Age, gender, physical status and weight were comparable between the groups. Heart rate and mean arterial pressure attenuated significantly in dexmedetomidine group (p<0.001 in 1, 3 and 5 minute intervals respectively), whereas placebo failed to attenuate hemodynamic response after laryngoscopy and intubation in any measured interval. No complications were noted. Conclusions: Dexmedetomidine 1 mcg/kg given 10 min prior to endotracheal intubation significantly attenuates heart rate and mean arterial pressure at 1, 3 and 5 minutes compared to placebo.

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