Propofol 2.5 mg/kg intravenous in induction

Hernia, Inguinal

Cryptorchidism

Comparison of different induction drugs and techniques

Sevofluorane

Propofol

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Mustafa Kemal University Medicine Faculty Anesthesiology Department

The Effect of Induction Technique on Postoperative Pain and Agitation

THE EFFECT OF DIFFERENT INDUCTION TECHNIQUES ON POSTOPERATIVE PAIN AND AGITATION IN CHILDREN

Onur Koyuncu

Asist.Prof

Mustafa Kemal University

A single dose of sugammadex 2 mg/kg iv. Dose calculation will be based on the patient's actual body weight. No dose adjustments are allowed

A single dose of neostigmine 0.04 mg/kg iv plus glycopyrrolate 0.01 mg/kg iv. Dose calculation will be based on the patient's actual body weight. No dose adjustments are allowed.

Anesthesia Recovery Period

Sugammadex

A single dose of neostigmine 0.04 mg/kg iv plus glycopyrrolate 0.01 mg/kg iv

Neostigmine/Glycopyrrolate

Placebo

UMC Sint Radboud

Street Fitness in Surgical Patients Undergoing General Anesthesia After Reversal of Neuromuscular Blockade

Street Fitness in Surgical Patients Undergoing General Anesthesia After Reversal of Neuromuscular Rest Blockade With Sugammadex

Radboud University

Each subject will receive each intervention BID during a 7 days period. The treatment periods are separated by 14 days washout. The sequence in which the interventions are administered are at random and double blind.

All participants received one of the following three treatments in one of three treatment periods, one inhalation in the morning and evening from Day 1 to 6 and one inhalation on the morning on Day 7, from the Dry Powder Inhaler (DPI): Placebo; Fluticasone propionate (FP) 100 micrograms (µg); and FP 500 µg. Participants were randomized to receive treatment in one of the six following sequences: (1) Placebo, FP 100 µg, FP 500 µg; (2) Placebo, FP 500 µg, FP 100 µg; (3) FP 100 µg, Placebo, FP 500 µg; (4) FP 100 µg, FP 500 µg, Placebo; (5) FP 500 µg, Placebo, FP 100 µg; (6) FP 500 µg, FP 100 µg, Placebo. The three treatment periods were separated by a washout period of 14 days.

Placebo, FP 100 µg, and FP 500 µg in 1 of 6 Sequences

Sex: Female, Male

Race/Ethnicity, Customized

FEV1 is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second. Participants were exposed to an allergen 1 hr after dosing on Day 6. Minimum FEV1 over 4-10 hours post-allergen challenge is the minimum value of all of the post-saline time points between 4 and 10 hrs post-allergen challenge, inclusive of the 4 hr and 10 hr timepoints (i.e., minimum over 4 hrs, 4.5 hrs, 5 hrs, 5.5 hrs, 6 hrs, 6.5 hrs, 7 hrs, 7.5 hrs, 8 hrs, 8.5 hrs, 9 hrs, 9.5 hrs, and 10 hrs). Absolute change from saline at each time point was calculated as the highest allergen challenge FEV1 value minus the highest saline FEV1 value. Data were adjusted for the following covariates: period, smoking status, treatment, participant-level Baseline, period-level Baseline, and treatment by smoking status interaction.

Participants received placebo, one inhalation in the morning and one in the evening from Day 1 to 6, and one inhalation in the morning on Day 7 from the DPI during one of the three treatment periods. Each treatment period was followed by a washout period of 14 days.

Participants received FP 100 µg, one inhalation in the morning and one in the evening from Day 1 to 6, and one inhalation in the morning on Day 7 from the DPI during one of the three treatment periods. Each treatment period was followed by a washout period of 14 days.

FP 100 µg

Participants received FP 500 µg, one inhalation in the morning and one in the evening from Day 1 to 6, and one inhalation in the morning on Day 7 from the DPI during one of the three treatment periods. Each treatment period was followed by a washout period of 14 days.

FP 500 µg

Late Asthmatic Response (LAR) - Smokers: Absolute Change From Saline in Minimum Forced Expiratory Volume in One Second (FEV1) Between 4-10 Hours (Hrs) After Allergen Challenge on Day 6 of Each Treatment Period

FEV1 is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second. Participants were exposed to an allergen 1 hr after dosing on Day 6. Minimum FEV1 over 0-2 hrs post-allergen challenge (Minimum EAR) is the minimum value of all of the post-allergen challenge timepoints up to and including 2 hours post-allergen challenge (i.e., minimum over 5 minutes [min], 10 min, 15 min, 20 min, 30 min, 45 min and 1 hr, 1.5 hrs, and 2 hrs). The WM FEV1 was derived by calculating the area under the curve, and then dividing the value by the relevant time interval. Absolute change from saline at each time point was calculated as the highest allergen challenge FEV1 value minus the highest saline FEV1 value. Data were adjusted for the following covariates: period, smoking status, treatment, participant-level Baseline, period-level Baseline, and treatment by smoking status interaction.

Early Asthmatic Response (EAR): Absolute Change From Saline in Minimum FEV1 and WM FEV1 Between 0-2 Hours (Hrs) After Allergen Challenge on Day 6 of Each Treatment Period

FEV1 is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second. Baseline FEV1 was measured on Day 1 pre-dose administration. FEV1 was measured on Day 1 post-dose, on Day 6 (prior to allergen challenge), and on Day 7 pre dose administration. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Data were adjusted for the following covariates: period, smoking status, treatment, participant-level Baseline, period-level Baseline, and treatment by smoking status interaction.

Absolute Change From Baseline in FEV1 Post-dose on Day 1, Day 6 (Prior to Allergen Challenge), and Day 7

FEV1 is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second. Participants inhaled doubling increments of methacholine until a >=20% decrease in FEV1 from the post-saline value was achieved.

Provocative Concentration of Methacholine Resulting in a 20% Reduction in FEV1 (PC20) on Day 7 of Each Treatment Period

The concentration of eNO was measured on Day 6 pre-dose and on Day 7 post-study medication administration. eNO was measured 3 times at each time point, and all 3 measurements were recorded. The mean of the 3 measurements was calculated and was used in the derivation of summary statistics.

Concentration of Exhaled Nitric Oxide (eNO) on Day 6 and Day 7 of Each Treatment Period

LAR - Non-smokers: Absolute Change From Saline in Minimum FEV1 Between 4-10 Hours (Hrs) After Allergen Challenge on Day 6 of Each Treatment Period

FEV1 is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second. Participants were exposed to an allergen 1 hour after dosing on Day 6. The WM FEV1 was derived by calculating the area under the curve, and then dividing the value by the relevant time interval. LAR WM FEV1 was measured at 4 hrs, 4.5 hrs, 5 hrs, 5.5 hrs, 6 hrs, 6.5 hrs, 7 hrs, 7.5 hrs, 8 hrs, 8.5 hrs, 9 hrs, 9.5 hrs, and 10 hrs post-allergen challenge on Day 6. Absolute change from saline at each time point was calculated as the highest allergen challenge FEV1 value minus the highest saline FEV1 value. Data were adjusted for the following covariates: period, smoking status, treatment, participant-level Baseline, period-level Baseline, and treatment by smoking status interaction.

LAR - Smokers: Absolute Change From Saline in Weighted Mean (WM) FEV1 Between 4-10 Hrs Following Post-treatment Allergen Challenge on Day 6 of Each Treatment Period

LAR - Non-smokers: Absolute Change From Saline in WM FEV1 Between 4-10 Hrs Following Post-treatment Allergen Challenge on Day 6 of Each Treatment Period

Sputum induction was performed using hypertonic saline solution to collect an adequate sample of secretions from lungs. The collected sputum was analyzed for neutrophil and eosinophil counts. Sputum induction was performed after methacholine challenge and post-dose administration on Day 7. Zero values are imputed to 0.001 for this analysis. Data were adjusted for the following covariates: period, smoking status, treatment, participant-level Baseline, period-level Baseline, and treatment by smoking status interaction.

Neutrophil and Eosinophil Cell Counts in Induced Sputum on Day 7 of Each Treatment Period

Participants received placebo, Fluticasone Propionate (FP) 100 micrograms (µg), and FP 500 µg in Treatment Periods 1, 2, and 3, respectively. Participants received all treatments, one inhalation in the morning and evening from Day 1 to 6 and one inhalation in the morning on Day 7, from the Dry Powder Inhaler (DPI). The three treatment periods were separated by a washout period of 14 days.

Sequence 1: Placebo, FP 100 µg, FP 500 µg

Participants received Placebo, FP 500 µg, and FP 100 µg in Treatment Periods 1, 2, and 3, respectively. Participants received all treatments, one inhalation in the morning and evening from Day 1 to 6 and one inhalation in the morning on Day 7, from the DPI. The three treatment periods were separated by a washout period of 14 days.

Sequence 2: Placebo, FP 500 µg, FP 100 µg

Participants received FP 100 µg, Placebo, and FP 500 µg in Treatment Periods 1, 2, and 3, respectively. Participants received all treatments, one inhalation in the morning and evening from Day 1 to 6 and one inhalation in the morning on Day 7, from the DPI. The three treatment periods were separated by a washout period of 14 days.

Sequence 3: FP 100 µg, Placebo, FP 500 µg

Participants received FP 100 µg, FP 500 µg, and Placebo in Treatment Periods 1, 2, and 3, respectively. Participants received all treatments, one inhalation in the morning and evening from Day 1 to 6 and one inhalation in the morning on Day 7, from the DPI. The three treatment periods were separated by a washout period of 14 days.

Sequence 4: FP 100 µg, FP 500 µg, Placebo

Participants received FP 500 µg, Placebo, and FP 100 µg in Treatment Periods 1, 2, and 3, respectively. Participants received all treatments, one inhalation in the morning and evening from Day 1 to 6 and one inhalation in the morning on Day 7, from the DPI. The three treatment periods were separated by a washout period of 14 days.

Sequence 5: FP 500 µg, Placebo, FP 100 µg

Participants received FP 500 µg, FP 100 µg, and Placebo in Treatment Periods 1, 2, and 3, respectively. Participants received all treatments, one inhalation in the morning and evening from Day 1 to 6 and one inhalation in the morning on Day 7, from the DPI. The three treatment periods were separated by a washout period of 14 days.

Sequence 6: FP 500 µg, FP 100 µg, Placebo

Treatment Period 1

Washout Period 1

Treatment Period 2

Washout Period 2

Treatment Period 3

GSK Response Center

Asthma

100 micrograms micronized drug blended with lactose in dry powder inhalator

100 micrograms Fluticasone propionate

500 micrograms micronized drug blended with lactose in dry powder inhalator

500 micrograms Fluticasone propionate

lactose powder in dry powder device : placebo comparator

lactose powder

Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.

GSK Investigational Site

Inhalation of Corticosteroids in Smoking and Non-smoking Asthmatics.

A Randomized, Double Blind, Placebo-controlled Three-way Crossover Study in Mild Asthmatics to Evaluate the Effect of Smoking Status on the Attenuation by Inhaled Corticosteroids of the Allergen-induced Asthmatic Response.

Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

GlaxoSmithKline

Group in which the I-Gel will be used in the first and second attempts to secure the airway. If a third attempt is needed, the LMA Supreme will be used. If the third attempt fails, a standard endotracheal tube will be used.

Group in which the LMA Supreme will be used in the first and second attempts to secure the airway. If a third attempt is needed, the I-Gel will be used. If the third attempt fails, a standard endotracheal tube will be used.

A Standard endotracheal tube will be inserted in case both other airway devices (LMA Supreme and iGel) devices fail to provide adequate ventilation.

Group in which the I-Gel will be used in the first and second attempts to secure the airway. If a third attempt is needed, the LMA Supreme will be used. If the third attempt fails, a standard endotracheal tube will be used.
Peak and mean airway pressure will be measured once the device is fixed with tape to the patient. Leak pressure will be measured as well. It will be done while closing the Adjustable Pressure Limiting valve and putting the fresh gas flow at 3 L/min. We will be looking at the manometer to see either a plateau (that would be a leak equal to the fresh gas flow) or the maximum allowed pressure 40 cm H2O.

I-Gel

Group in which the LMA Supreme will be used in the first and second attempts to secure the airway. If a third attempt is needed, the I-Gel will be used. If the third attempt fails, a standard endotracheal tube will be used.
The cuff of the LMA Supreme will be inflated with 25 mL of air and then by intervals of 5 mL until no leak is heard (max 45 mL). Peak and mean airway pressure will be measured once the device is fixed with tape to the patient. Leak pressure will be measured at a cuff volume without audible leak and also at 45 mL. It will be done while closing the Adjustable Pressure Limiting valve and putting the fresh gas flow at 3 L/min. We will be looking at the manometer to see either a plateau (that would be a leak equal to the fresh gas flow) or the maximum allowed pressure 40 cm H2O. Once the leak tests are done, the cuff will be deflated to initial volume necessary to avoid audible leaks.

LMA Supreme

Total

Weight

Height

Measure of the Airway Leak Pressure

Measure of the Peak Airway Pressure

Time Needed to Secure the Airway

Number of Participants With Successful Attempts to Introduce the Devices

Intent to treat assessment of adverse events, per intervention, was intended. The adverse effects were assessed by phone; or in person if patient in the hospital; on the following day.

Adverse Effects After Anesthesia (Sore Throat, Cough, Dysphagia, Dysphonia)

Airway Manipulation and Blood on Device at Removal

Overall Study

Nikola Joly, M.D.

Anesthesia Airway Management

2 attempts to secure the airway will be tried. If they both fail, there will be a crossover with a Supreme LMA.

I-Gel supraglottic airway device

In the LMA Supreme group, the same interventions will be done as in the I-Gel group. The cuff of the LMA Supreme will be inflated with 25 mL of air and then by intervals of 5 mL until no leak is heard (max 45 mL). Leak pressure will also be measure at 45 mL. Once the leak test is done, the cuff will be deflated to initial volume necessary to avoid audible leaks.

LMA Supreme supraglottic airway device

In case both supraglottic airway devices fail, a standard endotracheal tube will be inserted

bronchial spasm/− nicotine

The Effect of Induction Technique on Postoperative Pain and Agitation

Street Fitness in Surgical Patients Undergoing General Anesthesia After Reversal of Neuromuscular Blockade

Inhalation of Corticosteroids in Smoking and Non-smoking Asthmatics.

Comparison Study of Two Supraglottic Airway Devices Used for Patients Under General Anesthesia

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