Opioid-induced Delay in Gastric Emptying 

1997 ◽  
Vol 87 (4) ◽  
pp. 765-770 ◽  
Author(s):  
D. B. Murphy ◽  
J. A. Sutton ◽  
L. F. Prescott ◽  
M. B. Murphy
Keyword(s):  
Gastric Emptying ◽  
Gastric Volume ◽  
Concentration Curve ◽  
Controlled Study ◽  
Opiate Antagonist ◽  
Double Blind ◽  
The Central Nervous System ◽  
The Mean ◽  
Opioid Medications ◽  
Induced Changes

Background Opioids delay gastric emptying, which in turn may increase the risk of vomiting and pulmonary aspiration. Naloxone reverses this opiate action on gastric emptying, but it is not known whether this effect in humans is mediated by central or peripheral opiate antagonism. The importance of peripheral opioid receptor antagonism in modulating opioid-induced delay in gastric emptying was evaluated using methylnaltrexone, a quaternary derivative of the opiate antagonist naltrexone, which does not cross the blood-brain barrier. Methods In a randomized, double-blind, crossover placebo-controlled study, 11 healthy volunteers were given either placebo (saline), 0.09 mg/kg morphine, or 0.09 mg/kg morphine plus 0.3 mg/kg methylnaltrexone on three separate occasions before ingesting 500 ml deionized water. The rate of gastric emptying was measured by two methods: a noninvasive epigastric bioimpedance technique and the acetaminophen absorption test. Results The epigastric bioimpedance technique was sufficiently sensitive to detect opioid-induced changes in the rate of gastric emptying. The mean +/- SD time taken for the gastric volume to decrease to 50% (t0.5) after placebo was 5.5 +/- 2.1 min. Morphine prolonged gastric emptying to (t0.5) of 21 +/- 9.0 min (P < 0.03). Methylnaltrexone given concomitantly with morphine reversed the morphine-induced delay in gastric emptying to a t0.5 of 7.4 +/- 3.0 (P < 0.04). Maximum concentrations and area under the concentration curve from 0 to 90 min of serum acetaminophen concentrations after morphine were significantly different from placebo and morphine administered concomitantly with methylnaltrexone (P < 0.05). No difference in maximum concentration or area under the concentration curve from 0 to 90 min was noted between placebo and methylnaltrexone coadministered with morphine. Conclusions The attenuation of morphine-induced delay in gastric emptying by methylnaltrexone suggests that the opioid effect is mediated outside the central nervous system. Methylnaltrexone may have the potential to decrease the side effects of opioid medications, which are mediated peripherally, while maintaining the central analgesia effect of the opioid.

scholarly journals Percutaneous Mastoid Electrical Stimulator Improves Poststroke Depression and Cognitive F unction in Patients with Ischaemic Stroke: A Prospective, Randomized, Double-blind, and Sham-controlled Study

2020 ◽  
Author(s):  
Taoli Lu ◽  
Lanying He ◽  
Bei Zhang ◽  
Jian Wang ◽  
Lili Zhang ◽  
...  
Keyword(s):  
Ischaemic Stroke ◽  
Sham Group ◽  
Mean Value ◽  
Controlled Study ◽  
Poststroke Depression ◽  
Score Change ◽  
Double Blind ◽  
The Mean ◽  
Electrical Stimulator ◽  
Moca Score

Abstract Background : Poststroke depression can lead to functional dependence, cognitive impairment and reduced quality of life. The aim of this study was to evaluate the effects of a percutaneous mastoid electrical stimulator (PMES) plus antidepressants on poststroke depression and cognitive function. Methods: This study was a prospective, randomized, double-blind, and sham-controlled study . A total of 258 clinically depressed ischaemic stroke patients within 14 days of index stroke were randomly assigned to the PMES plus antidepressant (PMES group, N=125) and sham plus antidepressant (sham group, N=133) groups. All patients underwent the Montreal Cognitive Assessment (MoCA) and Hamilton Rating Scale for Depression (HRSD) test at 2 weeks (baseline), and 6 months(M6) after ischaemic stroke. Primary outcomes were the percentage of patients showing a treatment response (≥50% reduction in HRSD score) and depression remission (HRSD score≤9) at 6 months. The secondary outcome was the percentage of patients with a MoCA score <26 . Results: The percentages of patients showing a treatment response and depression remission were significantly higher in the PMES group than in the sham group (57.60% vs 41.35%, P=0.009; 44.00% vs 29.32%, P=0.014 respectively). The mean value of the HRSD score change [M(month)6-baseline] was significantly higher in the PMES group than in the sham group at 6 months (-11.93 ±5.32 vs -10.48 ± 6.10, P = 0.036, respectively). The percentage of patients with MoCA scores <26 was lower in the PEMS group than in the sham group(12.0% vs 24.06%, P=0.012,respectively), and the mean value of the MoCA score change (M6-baseline) was higher in the PMES group than in the sham group (3.50±2.55 vs 2.72±2.52, P=0.005,respectively). Conclusion: These findings demonstrate that PMES adjunctive to antidepressant therapy is effective in reducing depression, achieving remission in the short term, and improving cognition. Trial registration: This trial was retrospectively registered (registration number: ChiCTR1800016463) on 03 June 2018

scholarly journals A Randomised Controlled Trial on the Efficacy and Safety of Oral Ketamine in Neonatal Circumcision

2021 ◽  
Author(s):  
Victor Ifeanyichukwu Modekwe ◽  
Jideofor Okechukwu Ugwu ◽  
Okechukwu Hyginus Ekwunife ◽  
Andrew Nwankwo Osuigwe ◽  
Jideofor Chukwuma Orakwe ◽  
...  
Keyword(s):  
Placebo Group ◽  
Controlled Trial ◽  
Controlled Study ◽  
Categorical Variables ◽  
Paediatric Surgery ◽  
Peripheral Oxygen Saturation ◽  
Double Blind ◽  
Oral Ketamine ◽  
The Mean ◽  
Neonatal Circumcision

Introduction: Procedural analgesia use in neonatal circumcision is not widespread in the developing world. An easy-to-administer, adequate and safe analgesia will encourage usage in neonatal circumcision. Orally administered ketamine may prove effective and safe, and may encourage procedural analgesia use in neonatal circumcision. Aim: To determine the analgesic efficacy of oral ketamine in Plastibell® neonatal circumcision. Materials and Methods: A hospital based randomised double blind controlled study was conducted at the paediatric surgery unit of the hospital, from March 2015 to December 2015. Total 121 neonates were sequentially recruited, and randomised into two groups. Group A received oral ketamine, and Group B received plain syrup (placebo) as procedural analgesia. Continuous pulse oximeter monitoring was done before, during and immediately after the procedure. The pre-procedural and intra-procedural peripheral oxygen saturation (SpO2) and Pulse Rate (PR) were determined at the various stages. Also, the Neonatal Infant Pain Scale (NIPS) scores were assessed during the stages of the procedure. Differences in mean scores were analysed. Mann-Whitney U test and Independent t-test were used to compare means of continuous variable, while Fisher’s exact test was used to compare categorical variables. Significance was set at p<0.05. Results: Sixty-one neonates received oral ketamine, while 60 received placebo. The intraoperative mean SpO2 were lower in the placebo group and significant at the tying stage with p=0.022. The mean intraoperative PR was higher in the placebo group and significant at dorsal-slit, tying and excision stages (p<0.05). The mean intraoperative NIPS scores were significantly higher in the placebo group. Conclusion: Oral ketamine provides effective and safe analgesia for neonatal Plastibell® circumcision in comparison to placebo.

Effect of Chlorophyllin on Urinary Odor in Incontinent Geriatric Patients

1983 ◽  
Vol 17 (10) ◽  
pp. 732-734 ◽  
Author(s):  
Milap C. Nahata ◽  
Carole A. Slencsak ◽  
Judith Kamp
Keyword(s):  
Visual Analog Scale ◽  
Washout Period ◽  
Geriatric Patients ◽  
Odor Intensity ◽  
Controlled Study ◽  
Analog Scale ◽  
Double Blind ◽  
Mean Intensity ◽  
The Mean ◽  
Percent Decrease

This randomized, double-blind, crossover, placebo-controlled study involved 20 incontinent geriatric patients; all had indwelling Foley catheters. Each patient received chlorophyllin 100 mg/d for two weeks and placebo daily for two weeks, separated by a washout period of one week. For each subject, the intensity of urinary odor was measured ten times during both the treatment and placebo regimen and three times during the washout period, using a visual analog scale. A decrease in urinary odor was associated with chlorophyllin in 12 patients and with placebo in 6 patients at the end of two weeks on each regimen. Chlorophyllin treatment was associated with about a 21-percent decrease in mean urinary odor intensity, whereas placebo increased the odor by about 9 percent. The mean intensity of urinary odor was lowest during the second week of chlorophyllin treatment. Despite the decrease in urinary odor in many patients receiving chlorophyllin, its effect was not significantly greater than that of placebo. Our data suggest that chlorophyllin 100 mg/d for two weeks may not be effective in incontinent geriatric patients with mild to moderate urinary odor.

Paroxetine in the Treatment of Panic Disorder a Randomised, Double-Blind, Placebo-Controlled Study

1995 ◽  
Vol 167 (3) ◽  
pp. 374-379 ◽  
Author(s):  
S. Oehrberg ◽  
P. E. Christiansen ◽  
K. Behnke ◽  
A. L. Borup ◽  
B. Severin ◽  
...  
Keyword(s):  
Panic Disorder ◽  
Cognitive Therapy ◽  
Panic Attacks ◽  
Controlled Study ◽  
Positive Trend ◽  
Double Blind ◽  
Treatment Groups ◽  
Efficacy Measures ◽  
The Mean ◽  
Primary Measure

BackgroundThis study compared the efficacy and tolerability of paroxetine with placebo in the treatment of panic disorder.MethodAfter three weeks of placebo, patients received 12 weeks of treatment with paroxetine (20, 40, or 60 mg) or placebo, and finally two weeks of placebo. Dosages were adjusted according to efficacy and tolerability. Standardised cognitive therapy was given to all patients. The primary measure of outcome was reduction in the number of panic attacks.ResultsAnalysis of the results showed statistically significant differences in favour of paroxetine between the two treatment groups in two out of the three primary measures of outcome, i.e. 50% reduction in total number of panic attacks and number of panic attacks reduced to one or zero over the study period. For the third measure of outcome, the mean change in the total number of attacks from baseline, there was a positive trend in favour of paroxetine. The results of the primary measures of outcome were strongly supported by the results of the secondary efficacy measures of outcome. In addition, paroxetine, at all doses, was very well tolerated.ConclusionParoxetine plus cognitive therapy was significantly more effective than placebo plus cognitive therapy in the treatment of panic disorder.

scholarly journals Comparative Study of 0.2% Glyceryl Trinitrate Ointment for Pain Reduction after Hemorrhoidectomy Surgery

2019 ◽  
Vol 05 (04) ◽  
pp. e192-e196 ◽  
Author(s):  
Sepideh Vahabi ◽  
Siavash Beiranvand ◽  
Arash Karimi ◽  
Mahmoudreza Moradkhani
Keyword(s):  
Glyceryl Trinitrate ◽  
Controlled Study ◽  
Analog Scale ◽  
Double Blind ◽  
Mean Values ◽  
Analgesic Effects ◽  
Total Pain ◽  
Significant Difference ◽  
The Mean ◽  
Glyceryl Trinitrate Ointment

Abstract Context Hemorrhoid is one of the most common diseases in both, men and women, affecting half of the world's population over the age of 50. Aims The aim of this study was to evaluate the analgesic effects of local ointment of glyceryl trinitrate ointment (GTN) after hemorrhoidectomy. Methods and Materials In this randomized double-blind, placebo-controlled study, the patients were grouped as the treatment, that is GTN, and placebo (P) group. After surgery, 0.2% gelatin GTN ointment (250 mg), and P ointment (n = 20 for each group) were applied topically on 1 cm on the anus using a standard ruler, three times a week in respective groups. visual analog scale was used to assess the intensity of the pain and complications of the drugs were observed at 6, 12, 18, and 24 hours. Statistical Analysis Used Data and questionnaires were analyzed statistically using SPSS17 software and results were recorded in the tabular form. Results Six hours after the application of the ointment, no significant difference was found among the groups, however, after 12, 18, and 24 hours significant reduction in pain was seen in GTN group, which was least after 18 hours. The mean values of the total pain score in the first 24 hours after surgery in the GTN group were 3.15 and 5.45 in the P group which were statistically significant. Nonetheless, headache was significantly increased in the GTN group. Conclusion Simple and safe topical GTN ointment can reduce the pain after hemorrhoidectomy, leading to the reduced need of other analgesics.

Effect of a selective chloride channel activator, lubiprostone, on gastrointestinal transit, gastric sensory, and motor functions in healthy volunteers

2006 ◽  
Vol 290 (5) ◽  
pp. G942-G947 ◽  
Author(s):  
Michael Camilleri ◽  
Adil E. Bharucha ◽  
Ryuji Ueno ◽  
Duane Burton ◽  
George M. Thomforde ◽  
...  
Keyword(s):  
Healthy Volunteers ◽  
Chloride Channel ◽  
Chloride Channels ◽  
Gastrointestinal Transit ◽  
Intestinal Secretion ◽  
Gastric Volume ◽  
Colonic Transit ◽  
Controlled Study ◽  
Double Blind

Chloride channels modulate gastrointestinal neuromuscular functions in vitro. Lubiprostone, a selective type 2 chloride channel (ClC-2) activator, induces intestinal secretion and has been shown to relieve constipation in clinical trials; however, the effects of lubiprostone on gastric function and whole gut transit in humans are unclear. Our aim was to compare the effects of the selective ClC-2 activator lubiprostone on maximum tolerated volume (MTV) of a meal, postprandial symptoms, gastric volumes, and gastrointestinal and colonic transit in humans. We performed a randomized, parallel-group, double-blind, placebo-controlled study evaluating the effects of lubiprostone (24 μg bid) in 30 healthy volunteers. Validated methods were used: scintigraphic gastrointestinal and colonic transit, SPECT to measure gastric volumes, and the nutrient drink (“satiation”) test to measure MTV and postprandial symptoms. Lubiprostone accelerated small bowel and colonic transit, increased fasting gastric volume, and retarded gastric emptying. MTV values were reduced compared with placebo; however, the MTV was within the normal range for healthy adults in 13 of 14 participants, and there was no significant change compared with baseline measurements. Lubiprostone had no significant effect on postprandial gastric volume or aggregate symptoms but did decrease fullness 30 min after the fully satiating meal. Thus the ClC-2 activator lubiprostone accelerates small intestinal and colonic transit, which confers potential in the treatment of constipation.

Temelastine, a New H1-Receptor Antagonist

1986 ◽  
Vol 14 (4) ◽  
pp. 200-204 ◽  
Author(s):  
Fred Alexander ◽  
Robert M Stote ◽  
Nancy Allison ◽  
Robert G Familiar ◽  
Dianne Tatoian ◽  
...  
Keyword(s):  
Receptor Antagonist ◽  
Plasma Concentrations ◽  
Controlled Study ◽  
Blood Levels ◽  
Double Blind Study ◽  
Double Blind ◽  
The Central Nervous System ◽  
H1 Receptor Antagonist ◽  
Oral Doses ◽  
Wheal Size

Temelastine is a selective, competitive histamine H1-receptor antagonist which does not penetrate the central nervous system. The effect of varying doses of temelastine was compared in a randomized, double-blind, controlled study by measuring the inhibition of cutaneous histamine wheals. In twelve subjects single oral doses of 50, 100 and 200 mg of temelastine produced dose-dependent reductions in wheal areas. The inhibition of wheal size was maximal by 2 hr after dosing and was present at 8 hr. At 2 hr the 50, 100, and 200 mg doses reduced the wheal size by 53, 64, and 78%, respectively. Chlorpheniramine, 4 mg, reduced wheal size by 32% at the same period. The ability of temelastine to antagonize the histamine-induced skin reaction over 20 hr was evaluated in a second randomized, double-blind study. Eight subjects participated. Temelastine, 100 mg, produced reductions of 64, 49, 56 and 51% in histamine wheal area at 8, 12, 16 and 20 hr, respectively. Plasma concentrations at these times were 4.04, 2.77, 1.88, and 1.44 μmol/l, respectively. These data suggest that blood levels as low as 1.44 μmol/l may be sufficient to produce an antihistaminic effect, and that daily or twice daily dosing with 100 mg may be adequate to control allergic symptoms.

Pyridoxine is not effective for the prevention of hand foot syndrome (HFS) associated with capecitabine therapy: Results of a randomized double-blind placebo-controlled study

2007 ◽  
Vol 25 (18_suppl) ◽  
pp. 9007-9007 ◽  
Author(s):  
S. Lee ◽  
S. Lee ◽  
Y. Chun ◽  
M. Kim ◽  
H. Chang ◽  
...  
Keyword(s):  
Placebo Group ◽  
Chemotherapy Regimen ◽  
Controlled Study ◽  
Double Blind Study ◽  
Double Blind ◽  
Significant Difference ◽  
Hand Foot Syndrome ◽  
Version 2.0 ◽  
The Mean ◽  
To Receive

9007 Introduction: Although pyridoxine has been used empirically for the prevention of HFS associated with capecitabine, its efficacy has not been proven yet. We performed a prospective randomized double-blind study to determine whether pyridoxine can prevent the development of HFS when given concurrently with capecitabine. Method: Chemotherapy-naive patients (pts) with gastrointestinal tract cancers who were going to have capecitabine-containing chemotherapy were randomized to receive either oral pyridoxine (200 mg/day) or placebo daily during chemotherapy after stratified by chemotherapy regimen: 1) capecitabine alone, 2) capecitabine and cisplatin, or 3) docetaxel, capecitabine, and cisplatin. The patients were observed until grade 2 or 3 HFS (by NCI CTC version 2.0) developed or capecitabine containing chemotherapy ended. When grade 2 or 3 HFS developed in pts in placebo group, the pts were randomized again to receive either pyridoxine or placebo for next cycle of chemotherapy in order to determine whether pyridoxine could improve the HFS. Result: From Jun 2004 to Oct 2005, total 389 pts were entered onto the study. But, 29 pts (15 in placebo group and 14 in pyridoxine group) were excluded from the study because of ineligibility or pts’ refusal. Pts’ characteristics were well balanced between the 2 groups. Grade 2 or 3 HFS developed in 55 of 180 (30.6%) pts in placebo group and in 57 of 180 (31.7%) pts in pyridoxine group. (p=0.788) The median cycles of chemotherapy to grade 2 or 3 HFS was 3 in both groups. The mean cumulative dose of capecitabine until occurrence of grade 2 or 3 HFS was not different statistically between the two groups. (221,157.5 mg/m2 vs. 259,808.5 mg/m2, p=0.788). Total 44 of 55 pts in placebo group who had grade 2 or 3 HFS were randomized to receive either placebo or pyridoxine at next cycle. There was no significant difference between the two groups in the proportion of pts with improvement of HFS (43% vs 48%, p=0.94). Conclusion: These results indicated that pyridoxine is not effective for the prevention of HFS associated with capecitabine therapy. No significant financial relationships to disclose.

Effect of oral CCK-1 agonist GI181771X on fasting and postprandial gastric functions in healthy volunteers

2004 ◽  
Vol 287 (2) ◽  
pp. G363-G369 ◽  
Author(s):  
Emma Janet Castillo ◽  
Silvia Delgado-Aros ◽  
Michael Camilleri ◽  
Duane Burton ◽  
Debra Stephens ◽  
...  
Keyword(s):  
Gastric Emptying ◽  
Adverse Effects ◽  
Single Photon ◽  
Photon Emission ◽  
Area Under The Curve ◽  
Gastric Volume ◽  
Oral Solution ◽  
Gallbladder Emptying ◽  
Double Blind ◽  
Computed Tomographic

CCK influences satiation and gastric and gallbladder emptying. GI181771X is a novel oral CCK-1 agonist; its effects on gastric emptying of solids, accommodation, and postprandial symptoms are unclear. Effects of four dose levels of the oral CCK-1 agonist GI181771X and placebo on gastric functions and postprandial symptoms were compared in 61 healthy men and women in a randomized, gender-stratified, double-blind, double-dummy placebo-controlled, parallel group study. Effects of 0.1, 0.5, and 1.5 mg of oral solution and a 5.0-mg tablet of GI181771X on gastric emptying of solids by scintigraphy, gastric volume by 99mTc-single photon emission computed tomographic imaging, maximum tolerated volume of Ensure, and postprandial nausea, bloating, fullness, and pain were studied. On each of 3 study days, participants received their randomly assigned treatment. Adverse effects and safety were monitored. There were overall group effects of GI181771X on gastric emptying ( P < 0.01) and fasting and postprandial volumes ( P = 0.036 and 0.015, respectively). The 1.5-mg oral solution of GI181771X significantly delayed gastric emptying of solids ( P < 0.01) and increased fasting ( P = 0.035) gastric volumes without altering postprandial ( P = 0.056) gastric volumes or postprandial symptoms relative to placebo. The effect of the 5.0-mg tablet on gastric emptying of solids did not reach significance ( P = 0.052). Pharmacokinetic profiles showed the highest area under the curve over 4 h for the 1.5-mg solution and a similar area under the curve for the 0.5-mg solution and 5-mg tablet. Adverse effects were predominantly gastrointestinal and occurred in a minority of participants. GI181771X delays gastric emptying of solids and exhibits an acceptable safety profile in healthy participants. CCK-1 receptors can be modulated to increase fasting gastric volume.

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