scholarly journals Residual gastric volume evaluation with ultrasonography after ingestion of carbohydrate- or carbohydrate plus glutamine-enriched beverages: a randomized, crossover clinical trial with healthy volunteers

2017 ◽  
Vol 54 (1) ◽  
pp. 33-36 ◽  
Author(s):  
Paulo Cesar GOMES ◽  
Cervantes CAPOROSSI ◽  
Jose Eduardo AGUILAR-NASCIMENTO ◽  
Ageo Mario Candido da SILVA ◽  
Viviane Maeve Tavares de ARAUJO
Keyword(s):  
Clinical Trial ◽  
Healthy Volunteers ◽  
Postoperative Recovery ◽  
Gastric Volume ◽  
Safe Procedure ◽  
Abdominal Ultrasonography ◽  
Residual Gastric Volume ◽  
Potential Benefits ◽  
The Mean ◽  
To Receive

ABSTRACT BACKGROUND Abbreviation of preoperative fasting to 2 hours with maltodextrin (CHO)-enriched beverage is a safe procedure and may enhance postoperative recovery. Addition of glutamine (GLN) to CHO beverages may include potential benefits to the metabolism. However, by adding a nitrogenous source to CHO beverages, gastric emptying may be delayed and increase the risk of bronchoaspiration during anesthesia. OBJECTIVE In this study of safety, we aimed at investigating the residual gastric volume (RGV) 2 hours after the intake of either CHO beverage alone or CHO beverage combined with GLN. METHODS We performed a randomized, crossover clinical trial. We assessed RGV by means of abdominal ultrasonography (US) in 20 healthy volunteers (10 males and 10 females) after an overnight fast of 8 hours. Then, they were randomized to receive 600 mL (400 mL immediately after US followed by another 200 mL 2 hours afterwards) of either CHO (12.5% maltodextrin) or CHO-GLN (12.5% maltodextrin plus 15 g GLN). Two sequential US evaluations were done at 120 and 180 minutes after ingestion of the second dose. The interval of time between ingestion of the two types of beverages was 2 weeks. RESULTS The mean (SD) RGV observed after 8 hours fasting (13.56±13.25 mL) did not statistically differ (P>0.05) from the RGV observed after ingesting CHO beverage at both 120 (16.32±11.78 mL) and 180 minutes (14.60±10.39 mL). The RGV obtained at 120 (15.63±18.83 mL) and 180 (13.65±10.27 mL) minutes after CHO-GLN beverage also was not significantly different from the fasting condition. CONCLUSION The RGV at 120 and 180 minutes after ingestion of CHO beverage combined with GLN is similar to that observed after an overnight fast.

scholarly journals Effect of Red Wine Intake on Serum and Salivary Melatonin Levels: A Randomized, Placebo-Controlled Clinical Trial

Molecules ◽  
2018 ◽  
Vol 23 (10) ◽  
pp. 2474 ◽  
Author(s):  
Elena Varoni ◽  
Rita Paroni ◽  
Jacopo Antognetti ◽  
Giovanni Lodi ◽  
Andrea Sardella ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Healthy Volunteers ◽  
Red Wine ◽  
Statistical Significance ◽  
Serum Levels ◽  
Controlled Clinical Trial ◽  
Salivary Melatonin ◽  
The One ◽  
To Receive

Melatonin (MLT) is a recently discovered phytochemical in wine, but its influence on physiological MLT levels is still unknown. This study aimed at evaluating variations, in serum and saliva, of MLT concentrations after the intake of MLT-enriched red wine. Twelve healthy volunteers were recruited to receive 125 mL of red wine naturally lacking of MLT (placebo, PLC), or the same wine enriched with MLT (MLT+). A physiological steady decline of serum MLT was observed from baseline up to 90 min, for both wines. After PLC intake, the decrease was significantly faster than the one occurring after MLT+ wine, which thus delayed the drop down of serum MLT with a plateau at 30–60 min. Salivary MLT levels slightly peaked at 45 min after MLT+ wine intake, without statistical significance. Therefore, the intake of a glass of MLT-enriched red wine changed serum levels of the indoleamine, supporting the role of wine MLT in counteracting the physiological decline of the hormone into the bloodstream.

scholarly journals THE EFFECT OF GASTRIC GAS EMPTYING ON THE RESIDUAL GASTRIC VOLUME IN MECHANICALLY-VENTILATED INTENSIVE CARE UNIT PATIENTS FED THROUGH NASOGASTRIC TUBES: A RANDOMIZED, SINGLE-BLIND, CLINICAL TRIAL

2018 ◽  
Vol 11 (9) ◽  
pp. 492
Author(s):  
Ali Mohammadpour ◽  
Mousa Sajadi ◽  
Somayyeh Maghami ◽  
Hossein Soltani
Keyword(s):  
Clinical Trial ◽  
Gastric Volume ◽  
Control Group ◽  
Case Group ◽  
Mechanically Ventilated ◽  
Mechanically Ventilated Patients ◽  
Residual Gastric Volume ◽  
Nasogastric Tubes ◽  
Single Blind ◽  
Ventilated Patients

Objective: Increased gastric residual volume is a complication of enteral nutrition intolerance that leads to gastrointestinal complications such as nausea, vomiting, and aspiration pneumonia. The present study was conducted to determine the effect of gastric gas emptying on the residual gastric volume in mechanically-ventilated patients fed through nasogastric tubes.Methods: This randomized, single-blind, clinical trial was conducted on two groups of patients in the intensive care unit (ICU) of Kamyab Hospital of Mashhad. A total of 64 patients were randomly divided into a case and a control group. In the case group, the gastric gases accumulated through the nasogastric tube were emptied by applying palm pressure on the epigastric region. The control group did not undergo this intervention but received the routine care provided in the ward. Data were collected using a demographic questionnaire and a form containing records of the patients’ residual gastric volume and disease-related information. The residual gastric volume was measured and compared in the two groups before and after the intervention. Data were analyzed in SPSS-19 using the Chi-square test, the independent t-test, and the repeated measures ANOVA at the significance level of 5%.Results: The residual gastric volume did not differ significantly between the two groups before the intervention (p=0.14); after the intervention; however, a significant reduction was observed in the case group compared to the controls (p=0.007).Conclusion: Gastric gas emptying helps reduce the residual gastric volume in mechanically-ventilated patients fed through nasogastric tubes. Further studies are recommended to further ensure the benefits of this method.

scholarly journals Successful Laparoscopic Resection of Gastric Lymphangioma Under the Intraoperative Guidance of Indocyanine Green Fluorescence Imaging: A Case Report

2020 ◽  
Author(s):  
Ryosuke Umino ◽  
Masayuki Urabe ◽  
Yu Ohkura ◽  
Akikazu Yago ◽  
Shusuke Haruta ◽  
...  
Keyword(s):  
Indocyanine Green ◽  
Fluorescence Imaging ◽  
Surgical Resection ◽  
Gastric Volume ◽  
Complete Resection ◽  
Pathological Examination ◽  
Abdominal Ultrasonography ◽  
Residual Gastric Volume ◽  
First Case ◽  
Intraoperative Guidance

Abstract Background: Gastric lymphangioma (GLA) is an extremely rare tumor without an established therapeutic strategy. Surgical resection is considered the mainstay of treatment, although there is a high risk of local recurrence if negative margins are not achieved. Thus, it would be useful to develop tools and strategies to achieve safe and complete resection. We describe our experience with the first case involving GLA resection under the intraoperative guidance of indocyanine green (ICG) fluorescence imaging, which allowed us to achieve limited but complete resection with negative margins.Case Presentation: A 51-year-old Japanese man with a history of alcoholic liver disease underwent routine abdominal ultrasonography, which incidentally detected a 20-mm tumor adjacent to the lesser curvature of the stomach. The mass was suspected to be GLA based on its polycystic appearance. After a 16-month monitoring period, the patient was referred to our hospital for further assessment because of tumor growth and involvement of the left gastric artery. We selected surgical resection to facilitate a pathological diagnosis and treatment of potential invasion to the surrounding organs. Intraoperative use of a ICG navigation system revealed lymphatic drainage from the tumor, which we used to help determine the optimal excision line and minimize the loss of gastric volume. Pathological examination confirmed complete resection with negative margins and supported a diagnosis of lymphangioma.Conclusions: We performed laparoscopic radical resection of GLA under guidance from intraoperative ICG fluorescence imaging, which allowed us to maximize residual gastric volume. Although further cases are needed to validate this strategy, it may be useful for guiding the resection of GLA.

A controlled clinical trial of the addition of transdermal scopolamine to a standard metoclopramide and dexamethasone antiemetic regimen.

1987 ◽  
Vol 5 (12) ◽  
pp. 1994-1997 ◽  
Author(s):  
B R Meyer ◽  
V O'Mara ◽  
M M Reidenberg
Keyword(s):  
Clinical Trial ◽  
Statistical Significance ◽  
Prospective Clinical Trial ◽  
Controlled Clinical Trial ◽  
Combination Regimen ◽  
Potential Utility ◽  
Standard Regimen ◽  
Antiemetic Regimen ◽  
The Mean ◽  
To Receive

A randomized prospective clinical trial was conducted to evaluate the potential utility of adding transdermal scopolamine to a standard regimen of metoclopramide and dexamethasone for the prevention of cisplatin-induced emesis. Thirty-one patients who were about to receive their first cycle of chemotherapy, using a combination regimen including cisplatin at a dose greater than or equal to 60 mg/m2 were randomized to receive an antiemetic regimen of either metoclopramide and dexamethasone alone, or these two drugs plus transdermal scopolamine patches. The mean number of episodes of emesis was .63 +/- 1.31 in the 16 scopolamine-treated patients, and 2.27 +/- 2.66 in the 15 patients who did not receive scopolamine (P less than .01). The scopolamine appeared to inhibit extrapyramidal reactions to the metoclopramide, but the number of cases was too small for statistical significance. We conclude that the addition of transdermal scopolamine to a standard metoclopramide and dexamethasone antiemetic regimen provides additive benefit in the control of cisplatin-induced emesis.

scholarly journals The efficacy of suppository versus oral ibuprofen for reducing fever in children

2016 ◽  
Vol 45 (5) ◽  
pp. 211
Author(s):  
Suhesti Handayani ◽  
Sri Rezeki Hadinegoro ◽  
Sudigdo Sastroasmoro
Keyword(s):  
Clinical Trial ◽  
Body Weight ◽  
Maximum Temperature ◽  
Duration Of Effect ◽  
Significant Difference ◽  
Oral Group ◽  
Oral Ibuprofen ◽  
The Mean ◽  
To Receive ◽  
Mean Time

Background Ibuprofen suppository is used to reduce fever inchildren who are unable to receive it orally. The effectiveness ofibuprofen suppository compared to that of oral ibuprofen has notbeen documented in Indonesian children.Objective The aim of this study was to compare the efficacy ofibuprofen suppository with that of oral ibuprofen for reducingfever in children.Methods This study was a randomized clinical trial without blind-ing on children aged 2-5 years with body weight of 12.5 to 16 kgwho had fever. Subjects received ibuprofen in either oral (7.5mg/kg) or suppository (125 mg) form. The temperature was mea-sured prior to ibuprofen administration, 30 minutes afterwards,and every subsequent half hour until the end of the sixth hour.Any observed adverse effects were recorded.Results Mean time needed for fever reduction was 2.72 (SD 1.1)hours in the suppository group, compared to 3.43 (SD 0.9) hoursin the oral group (P=0.004). The mean rate of fever reduction inthe suppository group was 0.90 (SD 0.4) °C/hour, while in theoral group it was 0.61 (SD 0.3) °C/hour. However, mean maxi-mum temperature lowering ability did not differ significantly [2.11(SD 0.7) °C for the suppository group and 1.99 (SD 0.7) °C, forthe oral group (P=0.489)]. There was no significant difference inmean duration of effect [220.8 (SD 83.0) hours for the supposi-tory group and 196.6 (SD 92.7) hours for the oral group (p=0.231)].Conclusions There was no significant difference between bothpreparations in maximum temperature lowering ability and dura-tion of effect. Temperature reduction was significantly fasterwith the administration of ibuprofen suppository

Absorption of Colesevelam Hydrochloride in Healthy Volunteers

2002 ◽  
Vol 36 (3) ◽  
pp. 398-403 ◽  
Author(s):  
Dennis P Heller ◽  
Steven K Burke ◽  
David M Davidson ◽  
Joanne M Donovan
Keyword(s):  
Healthy Volunteers ◽  
Whole Blood ◽  
Open Label ◽  
Total Recovery ◽  
Equivalent Concentration ◽  
Fecal Recovery ◽  
The Mean ◽  
Using Data ◽  
To Receive ◽  
Cumulative Recovery

OBJECTIVE: To assess whether colesevelam hydrochloride is absorbed in healthy volunteers. METHODS: A single-center, open-label, radiolabeled study was performed with 16 healthy volunteers. Subjects were administered non-radiolabeled colesevelam hydrochloride 1.9 g twice daily for 4 weeks, followed by a single dose of [14C]-colesevelam 2.4 g (480 μCi). These subjects continued to receive non-radioactive colesevelam 1.9 g twice daily for 4 days after administration of the radiolabeled dose. Blood, urine, and feces were collected immediately prior to administration of [14C]-colesevelam and at specified intervals after administration. The whole-blood equivalent concentration of colesevelam was calculated using data collected throughout the 96 hours following radiolabeled drug administration. The proportion of [14C]-colesevelam excreted through urine or feces was calculated based on the amount of radioactivity recovered up to 216 hours after the radiolabeled dose. RESULTS: The mean cumulative total recovery of [14C]-colesevelam in urine and feces was 0.05% and 74%, respectively. Excluding 2 subjects for whom cumulative recovery was <25%, the mean cumulative fecal recovery was 82%. The mean maximum whole-blood equivalent concentration of colesevelam was 0.165 ± 0.10 μg equiv/g 72 hours after administration of [14C]-colesevelam, which was estimated to be 0.04% of the administered dose. All blood samples contained <4 × the number of background counts (dpm). CONCLUSIONS: The cumulative recovery data in urine and feces are consistent with the conclusion that colesevelam is not absorbed and is excreted entirely through the gastrointestinal system.

Single and Multiple Oral Doses of AKR-501 (YM477) Increase the Platelet Count in Healthy Volunteers.

Blood ◽  
2006 ◽  
Vol 108 (11) ◽  
pp. 477-477 ◽  
Author(s):  
Robert E. Desjardins ◽  
Donna L. Tempel ◽  
Rudolph Lucek ◽  
David J. Kuter
Keyword(s):  
Platelet Count ◽  
Single Dose ◽  
Healthy Volunteers ◽  
Multiple Dose ◽  
In Vivo Models ◽  
Dose Cohort ◽  
Dose Study ◽  
The Mean ◽  
Oral Doses ◽  
To Receive

Abstract AKR-501 is an orally active thrombopoietin (TPO) receptor agonist that increases platelet production through stimulation of megakaryocyte proliferation and differentiation. The effect of AKR-501 in in vitro and in vivo models is additive with that of rhTPO. AKR-501 is a potential new therapy for use in the prevention or treatment of thrombocytopenia of various etiologies. We evaluated the safety, pharmacokinetics and pharmacodynamic activity of AKR-501 when administered as single and multiple oral doses to healthy volunteers. In the single dose study, 7 dose cohorts of 9 subjects each were randomized in a ratio of 2:1 to receive increasing doses (1, 3, 10, 20, 50, 75 and 100 mg) of AKR-501 or placebo. In the multiple dose study, 5 dose cohorts of 9 subjects each were to be randomized in a ratio of 2:1 to receive increasing doses (3, 10, 20, 50 and 100 mg) of AKR-501 or placebo administered daily for 14 days. All subjects were evaluated for safety and pharmacodynamic activity as assessed by peripheral blood platelet counts (PBPC). Dose escalation was stopped on Day 10 of dosing in the 3rd dose cohort (20 mg/day) when 6 of the volunteers exhibited a platelet count above 500,000/mL. The protocol defined endpoint of &gt;50% increase over baseline platelet count was achieved in 5 of 6 volunteers given a single dose of 100 mg, and in all 6 volunteers given daily doses of 10 mg for 14 days and 20 mg for 10 days. The drug was well tolerated in both the single and multiple dose studies with no serious drug-related adverse experiences reported at any dose. AKR-501 was consistently well absorbed exhibiting dose linear pharmacokinetics following single and multiple dose administration, and a serum half-life of approximately 16 hours. The mean observed Cmax following administration of single doses increased from 5.67 ng/mL at 1 mg to 388 ng/mL at 100 mg. The mean observed AUC increased from 174 ng·hr/mL at 1 mg to 11052 ng·hr/mL at 100 mg. Accumulation to steady state with multiple dosing was consistent with predictions based on a linear model and the single dose PK parameter estimates. There was a linear correlation of individual observed peak activity with corresponding Cmax (single-dose r2=0.70 p&lt;.0001, multiple-dose r2=0.67 p&lt;0.0001). The mean change from baseline PBPC for each dose cohort in the single-dose (Figure 1) and multiple-dose (Figure 2) studies are shown in the following graphs. Figure 1 Figure 1. Figure 2 Figure 2.

Low-Dose Gabapentin in Treatment of High-Altitude Headache

Cephalalgia ◽  
2007 ◽  
Vol 27 (11) ◽  
pp. 1274-1277 ◽  
Author(s):  
S Jafarian ◽  
F Gorouhi ◽  
S Salimi ◽  
J Lotfi
Keyword(s):  
Clinical Trial ◽  
Placebo Group ◽  
High Altitude ◽  
Low Dose ◽  
Acute Mountain Sickness ◽  
Preliminary Observation ◽  
The Mean ◽  
Mountain Sickness ◽  
To Receive ◽  
Prevalent Symptom

Headache is the most prevalent symptom of acute mountain sickness. We conducted a pilot clinical trial at an altitude of 3500 m to evaluate the efficacy of gabapentin in treatment of high-altitude headache (HAH). Twenty-four adult HAH patients (10 female, 14 male; age 18–50 years) were randomly assigned to receive either 300 mg of gabapentin capsule or identical placebo. After 1 h the presence of HAH and need to receive supplementary analgesic were assessed. The duration of the HAH-free phase after taking additional analgesic was also registered. Four patients in the gabapentin group asked for additional analgesics, whereas nine placebo recipients did not find primary medication satisfactory after the first hour of treatment ( P = 0.04). The mean HAH-free period was 17.10 h in the gabapentin group, which was significantly higher than in the placebo group with a mean of 10.08 h ( P = 0.02). This preliminary observation indicates that gabapentin is effective in treatment and alleviation of HAH.

The Antiaggressive Action of Combined Haloperidol-Propranolol Treatment in Schizophrenia

2000 ◽  
Vol 5 (4) ◽  
pp. 312-325 ◽  
Author(s):  
Gadi Maoz ◽  
Daniel Stein ◽  
Sorin Meged ◽  
Larisa Kurzman ◽  
Joseph Levine ◽  
...  
Keyword(s):  
Rating Scales ◽  
Double Blind ◽  
Propranolol Group ◽  
Schizophrenic Patients ◽  
Propranolol Treatment ◽  
Simultaneous Decrease ◽  
The Mean ◽  
Haloperidol Treatment ◽  
To Receive ◽  
Drug Free

Psychopharmacological interventions for managing aggression in schizophrenia have thus far yielded inconsistent results. This study evaluates the antiaggressive efficacy of combined haloperidol-propranolol treatment. Thirty-four newly admitted schizophrenic patients were studied in a controlled double-blind trial. Following a 3-day drug-free period and 7 days of haloperidol treatment, patients were randomly assigned to receive either haloperidol-propranolol or haloperidol-placebo for eight consecutive weeks. Doses of medications were adjusted as necessary; biperiden was administered if required. Rating scales were applied to assess aggression, anger, psychosis, depression, anxiety and extrapyramidal symptoms. The mean daily dose of haloperidol was 21 mg (SD = 6.4) in the research group and 29 mg (SD = 6.9) in the controls. Mean and maximal daily doses of propranolol were 159 mg (SD = 61) and 192 mg (SD = 83), and of placebo, 145 mg (SD = 50) and 180 mg (SD = 70), respectively. Compared with the controls, the scores for the research patients decreased significantly from baseline, particularly after 4 weeks of treatment, for some dimensions of anger, psychosis, anxiety, and neuroleptic-induced parkinsonism. A tendency for reduced aggression was shown in the combined haloperidol-propranolol group for some dimensions but not others. These patients also required significantly less biperiden. The tendency toward elevated antiaggressive effect of combined haloperidol-propranolol treatment compared to haloperidol alone may be explained by a simultaneous decrease in aggression, psychotic symptomatology, and anxiety.

Sign in / Sign up

Export Citation Format

Share Document