Droperidol (Xomolix, Kyowa Kirin) 1.25 mg i.v. bolus

Arrhythmia, Droperidol

An electrocardiogram analysis in: 5,10,15,20 minutes after injection of 1.25 mg of droperidol used as PONV prophylaxis.

Droperidol Injectable Solution

Medical University of Gdansk

Gender Influence on Torsadogenic Actions of Droperidol.

Gender Influence on Torsadogenic Actions of Droperidol Used as Postoperative Nausea and Vomiting Prophylaxis.

Radoslaw Owczuk

Clinical Professor, Head of Department of Anaesthesiology and Intensive Care

flecainide x 6 months, then crossover to sotalol x 6 months

sotalol x 6 months, then crossover to flecainide x 6 months

Atrial Fibrillation

flecainide up to 150mg twice daily for the control of atrial fibrillation

Flecainide

sotalol up to 120mg twice daily for the control of atrial fibrillation

Sotalol

Jesse Brown VA Medical Center

Rush University Medical Center

University of Illinois at Chicago

Advocate Christ Medical Center

Pharmacogenetic Study of Antiarrhythmic Drugs for Atrial Fibrillation

A Prospective, Multi-Center, Randomized, Open Label Trial to Determine if a Common Atrial Fibrillation Risk Locus Modulates Differential Response to Antiarrhythmic Drugs

Subjects will be monitored with the Medtronic Reveal LINQ Insertable Cardiac Monitor (ICM) system to assess AF burden. The device will be programmed to optimize the memory for storing AF episode..

Quality of life assessment: Patients will be asked to fill out the AFEQT quality of life questionnaire baseline (study randomization), two, four, six, eight, ten, and 12 months (completion of the study). The questionnaire at the end of the 6rd month will be administered just prior to stopping the first study drug. The validated questionnaire is comprised of 20 questions about AF symptoms with answers given on a Likert scale. The questionnaire will be provided to the patients in paper format either in person or by mail, as applicable. A follow-up phone call will be made to each patient to ensure that the questionnaire is completed and returned.

Dawood Darbar, MD

Professor of Medicine

Medtronic

Adult emergency department patients receiving 4mg of IV ondansetron as part of their treatment plan.

Adult emergency department patients receiving 4mg of IV ondansetron as part of their treatment plan.
Ondansetron: 4mg of intravenous ondansetron

IV Ondansetron

Sex: Female, Male

The primary objective is to determine the mean maximal prolongation in QTc interval from baseline as measured by the Bazett formula. A baseline EKG will be obtained and then after drug administration an EKG will be performed every 2 minutes until 20 minutes has passed. The mean maximal QTc change will be calculated.

Change in QTc Interval With Ondansetron Administration

The secondary objective is to determine the number of severe adverse cardiac electrical events (non-sinus rhythm, severe bradycardia, sudden cardiac death) associated with routine use of intravenous ondansetron in the adult emergency department patient. All of these outcomes will be recorded for each patient during the emergency department stay which could range from 20 minutes to several hours.

Number of Adverse Events

Overall Study

Peter Moffett MD

Ondansetron

Carl R Darnall Army Medical Center

Madigan Army Medical Center

Ondansetron and the QT Interval In Adult Emergency Department Patients

Director of Research, Department of Emergency Medicine

C.R.Darnall Army Medical Center

200mg/5ml elixir administered orally three times a day half an hour prior to meals.

The dose of Azithromycin was determined based on our dose response curve obtained on 10 healthy subjects who were given three different doses of Azithromycin, 50 mg, 100 mg and 133 mg and underwent breath testing to determine the gastric emptying half-time. These doses were determined based on a maximum safe dosage per day of Azithromycin of 400 mg given the medication would then be administered three times daily before meals. The appearance of the medication (azithromycin) and administration period was then identical to that of Erythromycin, i.e. 5ml elixir administered orally three times a day half an hour prior to meals. The total daily dosage of Azithromycin was determined after obtaining the dose- response analysis.

Erythromycin is given for 4 weeks (1-4), there is a 3 week washout (5-7), then Azithromycin is given for 4 weeks (Weeks 8-11).

Erythromycin First Then Azithromycin

Azithromycin is given for 4 weeks (1-4), there is a 3 week washout (5-7), then Erythromycin is given for 4 weeks (Weeks 8-11).

Azithromycin Then Erythromycin

Total

Region of Enrollment

Patients will be given a standardized meal enriched with a labeled material and the breath samples are then collected and analyzed. The estimated time to empty 50% (t 1/2) of the accumulated contents is recorded. Because the difference is RX-B -RX A in one group and RX A -RX B in the other, the difference between these two estimates twice the effect size. Hence the Half is applied, as is standard in the two sample method for crossover studies.

Time in Minutes for 50% of the Ingested Meal to Empty the Stomach With a Standardized Breath Test: Half the of the Week 11 Value (Period 2) Less Half the of the Week 4 Value (Period 1). This Estimates the Effect Size.

This is a Validated instrument for measuring symptom severity in patients with gastroparesis. This scoring is based on a Likert Scale from (0-5) with zero being no symptoms and five being very severe symptoms on 9 subscales, making the overall score range from 0-45. The higher the score, the more severe patient's symptoms.
Reference for GCSI: Revicki DA, REntz AM, Dubois D, et al. Development and validation of a patient-assessed gastroparesis symptoms severity measure: the Gastroparesis Cardinal Symptom Index. Ailment Pharm Ther 2003; 18: 141:50.
Because the difference is RX-B -RX A in one group and RX A -RX B in the other, the difference between these two estimates twice the effect size. Hence the Half is applied, as is standard in the two sample method for crossover studies.

Gastroparesis Cardinal Symptom Index (GCSI) Score

Nepean Dyspepsia Index (NDI) is a measure of symptom status and quality of life in functional dyspepsia. This scale is scored using each subscale (Tension, interference with daily activities), Eating/drinking, Knowledge/control, work/study) and adding up the items for each of the five subscale score (2-10). Total score range would be 10-50).
For the NDI, a lower number is better meaning the symptom is not effecting quality of life and a higher score closer to 50 is worse meaning it is effecting patients quality of life.
Reference: Talley NJ, Verlinden M, Jones M. Quality of life in functional dyspepsia: responsiveness of the Nepean Dyspepsia Index and developement of a new 10-iten short form. Aliment Pharmacol Ther 2001: 15: 207-216.
Because the difference is RX-B -RX A in one group and RX A -RX B in the other, the difference between these two estimates twice the effect size. Hence the Half is applied, as is standard in the two sample method for crossover studies.

NDI Score

This is defined as the time from ingestion of the meal to the beginning of the emptying process in minutes. Because the difference is RX-B -RX A in one group and RX A -RX B in the other, the difference between these two estimates twice the effect size. Hence the Half is applied, as is standard in the two sample method for crossover studies.

TLAG (Time From Ingestion of Meal to Start of Gastric Emptying)

Patients will be given a standardized meal enriched with a labeled material and the breath samples are then collected and analyzed. The estimated time to reaching 50% of the accumulated contents is recorded.

200mg/5ml elixir administered orally three times a day half an hour prior to meals.
Erythromycin: 200mg/5ml elixir administered orally three times a day half an hour prior to meals.

Erythromycin

Change in Time to 50% Gastric Emptying: Post Test Less Baseline Pooled Over Orderings

The dose of Azithromycin given was previously determined based on our dose-response analysis in 10 healthy subjects to be 50 mg. The total daily dosage of Azithromycin given therefore was 150 mg which was divided three times daily and administered as 50mg/5ml given three times a day as elixir orally, similar to the erythromycin volume.

Azithromycin

Change in Time to 50% Emptying: Post Test Less Baseline Pooled Over Orderings

This is a Validated instrument for measuring symptom severity in patients with gastroparesis. This scoring is based on a Likert Scale from (0-5) with zero being no symptom and five being very severe symptoms on 9 subscales, making the overall score range from 0-45. The higher the score, the more severe patient's symptoms are. The scale is reported in the references. The change was calculated by measuring the end of treatment minus baseline GCSI score.
Negative value reflects this change.

Gastroparesis Cardinal Symptom Index (GCSI) Score Change From Baseline to Post Treatment

This is a Validated instrument for measuring symptom severity in patients with gastroparesis. This scoring is based on a Likert Scale from (0-5) with zero being no symptom and five being very severe symptoms on 9 subscales, making the overall score range from 0-45. The higher the score, the more severe patient's symptoms are. The scale is reported in the references.
This is a calculation taken with GCSI score at end of treatment minus baseline. Negative value reflects this change.

Does GCSI Score Improve (Lower) on Treatment, Pooling the AZ Patients Over Their Treatment Periods? Endpoint is Difference in Post-test Less Baseline

Weeks 1-4 (First Period)

Weeks 5-7 (Washout)

Weeks 8-11 (Period 2)

Baharak Moshiree MD

Gastroparesis

The dose of Azithromycin given was determined based on the following study on 10 healthy subjects. In random order, each of ten healthy subjects underwent OBT studies following administration of AZI, at doses of 50mg, 100mg, and 133mg. The T½ and Tlag was then compared for the three doses by a randomized block analysis using Analysis of Variance followed by Tukey's multiple comparison. Results: The T½ for each of the respective doses of AZI (50mg, 100mg, and 133mg) was 129 ± 27, 128 ± 31, and 128 ± 16 minutes (p = 0.98). This data suggested that AZI at doses of 50mg, 100mg and 133 mg have fairly similar activity in its effects on gastric emptying in healthy subjects. Based on this analysis , we decided to use a dose of 50 mg/5 ml for administered TID prior to meals.

torsades de pointes/vomiting

Gender Influence on Torsadogenic Actions of Droperidol.

Pharmacogenetic Study of Antiarrhythmic Drugs for Atrial Fibrillation

Ondansetron and the QT Interval In Adult Emergency Department Patients

Comparison of Two Macrolides, Azithromycin and Erythromycin, for Symptomatic Treatment of Gastroparesis

Plasma and Abscess Fluid Pharmacokinetics of Cefpirome and Moxifloxacin After Single and Multiple Dose Administration

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