scholarly journals Comparison of ED95 of Butorphanol with Sufentanil for Gastrointestinal Endoscopy Sedation: a randomized controlled trial

2020 ◽  
Author(s):  
Xiaona Zhu ◽  
Limei Chen ◽  
Shuang Zheng ◽  
Linmin Pan
Keyword(s):  
Recovery Time ◽  
Partial Agonist ◽  
Controlled Trial ◽  
Randomized Study ◽  
Sequential Method ◽  
Double Blind ◽  
Gi Endoscopy ◽  
Severity Scores ◽  
Fatigue Severity ◽  
Group B

Abstract Background: Butorphanol, a synthetic opioid partial agonist analgesic, has been widely used for the control of perioperative pain. However, the ideal dose and availability of butorphanol for gastrointestinal (GI) endoscopy are not well known. The aim of this study was to evaluated the 95% effective dose (ED95) of butorphanol and sufentanil in GI endoscopy and compared their clinical efficacy, especially the recovery time. Methods: The study was divided into two parts. For the first part, voluntary patients who needed GI endoscopy anesthesia were recruited to measure the ED95 of butorphanol and sufentanil when they reached successful sedation during GI endoscopy using the sequential method (the Dixon up-and-down method). In the second part, this was a double-blind, randomized study. Two hundred cases of painless GI endoscopy patients were randomly divided into two groups (n=100), including group B (butorphanol at the ED95 dose) and group S (sufentanil at the ED95 dose). Propofol was infused intravenously to both groups as the sedative. The recovery time, VAS (visual analogue scale) score, hand grip strength, fatigue severity scores, incidence of nausea and vomiting, and incidence of dizziness were recorded. Results: The ED95 of butorphanol in painless GI endoscopy was 9.07μg/kg (95% confidence interval: 7.81-19.66μg/kg). The ED95 of sufentanil was 0.1μg/kg (95% CI, 0.079-0.422μg/kg). Both butorphanol and sufentanil provided a good analgesic effect in GI endoscopy. However, the recovery time for butorphanol was significantly shorter than sufentanil (P<0.05, group B versus group S:21.26±7.70 vs. 24.03±7.80, min). Conclusions: Butorphanol at 9.07μg/kg showed a better effect compared with sufentanil in GI endoscopy sedation, notably reduced the recovery time.

Comparison of ED95 of Butorphanol and Sufentanil for Gastrointestinal Endoscopy Sedation: a Randomized Controlled Trial

2020 ◽  
Author(s):  
Xiaona Zhu ◽  
Limei Chen ◽  
Shuang Zheng ◽  
Linmin Pan
Keyword(s):  
Recovery Time ◽  
Partial Agonist ◽  
Controlled Trial ◽  
Randomized Study ◽  
Sequential Method ◽  
Double Blind ◽  
Gi Endoscopy ◽  
Severity Scores ◽  
Clinical Trail ◽  
Group B

Abstract Background: Butorphanol, a synthetic opioid partial agonist analgesic, has been widely used to control perioperative pain. However, the ideal dose and availability of butorphanol for gastrointestinal (GI) endoscopy are not well known. The aim of this study was to evaluated the 95% effective dose (ED95) of butorphanol and sufentanil in GI endoscopy and compared their clinical efficacy, especially regarding the recovery time. Methods: The study was divided into two parts. For the first part, voluntary patients who needed GI endoscopy anesthesia were recruited to measure the ED95 of butorphanol and sufentanil needed to achieve successful sedation before GI endoscopy using the sequential method (the Dixon up-and-down method). The second part was a double-blind, randomized study. Two hundred cases of painless GI endoscopy patients were randomly divided into two groups (n= 100), including group B (butorphanol at the ED95 dose) and group S (sufentanil at the ED95 dose). Propofol was infused intravenously as the sedative in both groups. The recovery time, visual analogue scale (VAS) score, hand grip strength, fatigue severity scores, incidence of nausea and vomiting, and incidence of dizziness were recorded.Results: The ED95 of butorphanol for painless GI endoscopy was 9.07 μg/kg (95% confidence interval: 7.81-19.66 μg/kg). The ED95 of sufentanil was 0.1 μg/kg (95% CI, 0.079-0.422 μg/kg). Both butorphanol and sufentanil provided a good analgesic effect for GI endoscopy. However, the recovery time for butorphanol was significantly shorter than that for sufentanil (P < 0.05, group B vs. group S:21.26 ± 7.70 vs. 24.03 ± 7.80 min).Conclusions: Butorphanol at 9.07μg/kg was more effective than sufentanil for GI endoscopy sedation and notably reduced the recovery time.Trial registration: Chinese Clinical Trail Registry (Registration number # ChiCTR1900022780; Date of Registration on April 25rd, 2019) http://www.chictr.org.cn/showproj.aspx?proj= 37972.

scholarly journals Early combination therapy with etanercept and methotrexate in JIA patients shortens the time to reach an inactive disease state and remission: results of a double-blind placebo-controlled trial

2021 ◽  
Vol 19 (1) ◽  
Author(s):  
Ekaterina Alexeeva ◽  
Gerd Horneff ◽  
Tatyana Dvoryakovskaya ◽  
Rina Denisova ◽  
Irina Nikishina ◽  
...  
Keyword(s):  
Combination Therapy ◽  
Controlled Trial ◽  
Randomized Study ◽  
Primary Objective ◽  
Disease State ◽  
Inactive Disease ◽  
Open Label ◽  
Standard Regimen ◽  
Double Blind ◽  
Early Combination Therapy

Abstract Background Remission is the primary objective of treating juvenile idiopathic arthritis (JIA). It is still debatable whether early intensive treatment is superior in terms of earlier achievement of remission. The aim of this study was to evaluate the effectiveness of early etanercept+methotrexate (ETA+MTX) combination therapy versus step-up MTX monotherapy with ETA added in refractory disease. Methods A multi-centre, double-blind, randomized study in active polyarticular JIA patients treated with either ETA+MTX (n = 35) or placebo+MTX (n = 33) for up to 24 weeks, followed by a 24-week open-label phase. The efficacy endpoints included pedACR30 criteria improvement at week 12, inactive disease at week 24, and remission at week 48. Patients who failed to achieve the endpoints at week 12 or at week 24 escaped to open-label ETA+MTX. Safety was assessed at each visit. Results By intention-to-treat analysis, more patients in the ETA+MTX group reached the pedACR30 response at week 12 (33 (94.3%)) than in the placebo+MTX group (20 (60.6%); p = 0.001). At week 24, comparable percentages of patients reached inactive disease (11 (31.4%) vs 11 (33.3%)). At week 48, 11 (31.4%) and eight (24.2%) patients achieved remission. The median (+/−IQR) times to achieve an inactive disease state in the ETA+MTX and placebo+MTX groups were 24 (14–32) and 32 (24–40) weeks, respectively. Forty-four (74/100 patient-years) adverse events (AEs) were reported, leading to treatment discontinuation in 6 patients. Conclusions Early combination therapy with ETA+MTX proved to be highly effective compared to the standard step-up regimen. Compared to those treated with the standard regimen, more patients treated with a combination of ETA+MTX reached the pedACR30 response and achieved inactive disease and remission more rapidly.

The effect of external ventricular drain tunneling length on CSF infection rate in pediatric patients: a randomized, double-blind, 3-arm controlled trial

2021 ◽  
pp. 1-8
Author(s):  
Esmaeil Mohammadi ◽  
Sara Hanaei ◽  
Sina Azadnajafabad ◽  
Keyvan Tayebi Meybodi ◽  
Zohreh Habibi ◽  
...  
Keyword(s):  
Infection Rate ◽  
Pediatric Patients ◽  
Controlled Trial ◽  
External Ventricular Drain ◽  
Hazard Ratio ◽  
Spontaneous Discharge ◽  
Standard Group ◽  
Double Blind ◽  
Group A ◽  
Group B

OBJECTIVE The role of tunneling an external ventricular drain (EVD) more than the standard 5 cm for controlling device-related infections remains controversial. METHODS This is a randomized, double-blind, 3-arm controlled trial done in the Children’s Medical Center in Tehran, Iran. Pediatric patients (< 18 years old) with temporary hydrocephalus requiring an EVD and no evidence of CSF infection or prior EVD insertion were enrolled. Patients were randomly assigned (1:1:1) into the following arms: 5-cm (standard; group A); 10-cm (group B); or 15-cm (group C) EVD tunnel lengths. The investigators, parents, and person performing the analysis were masked. The surgeon was informed of the length of the EVD by the monitoring board just before operation. Patients were followed until the EVD’s fate was established. Infection rate and other complications related to EVDs were assessed. RESULTS A total of 105 patients were enrolled in three random groups (group A = 36, group B = 35, and group C = 34). The EVD was removed because there was no further need in most cases (67.6%), followed by conversion to a new EVD or ventriculoperitoneal shunt (15.2%), infection (11.4%), and spontaneous discharge without further CSF diversion requirement (5.7%). No statistical difference was found in infection rate (p = 0.47) or EVD duration (p = 0.81) between the three groups. No group reached the efficacy point sooner than the standard group (group B: hazard ratio 1.21, 95% CI 0.75–1.94, p = 0.429; group C: hazard ratio 1.03, 95% CI 0.64–1.65, p = 0.91). CONCLUSIONS EVD tunnel lengths of 5 cm and longer did not show a difference in the infection rate in pediatric patients. Indeed, tunneling lengths of 5 cm and greater seem to be equally effective in preventing EVD infection. Clinical trial registration no.: IRCT20160430027680N2 (IRCT.ir)

scholarly journals The role of bovine colostrum on recovery time and length of hospital stay of acute diarrhea in infants and children: a double-blind randomized controlled trial

2016 ◽  
Vol 46 (3) ◽  
pp. 127
Author(s):  
IGN Suwarba ◽  
Sudaryat S ◽  
Hendra S ◽  
IKG Suandi ◽  
Raka Widiana
Keyword(s):  
Hospital Stay ◽  
Acute Diarrhea ◽  
Recovery Time ◽  
Controlled Trial ◽  
Length Of Hospital Stay ◽  
Bovine Colostrum ◽  
Mean Difference ◽  
Infants And Children ◽  
Double Blind ◽  
Defecation Frequency

Background WHO standard treatment for acute diarrhea remainsunsatisfying to the parents of acute diarrhea patients, particularlythe need of medical treatment. Bovine colostrum contains immuneand growth factors that is thought able to neutralize some agentscausing acute diarrhea in infants and children.Objective To evaluate the efficacy of bovine colostrum as adju-vant therapy on recovery time and length of hospital stay for acutediarrhea in infants and children.Methods A double-blind randomized controlled trial was conductedon infants and children with acute diarrhea admitted to SanglahHospital. Treatment group received standard therapy with bovinecolostrums and control group received standard therapy plus pla-cebo. The primary outcomes were achievement of recovery timeand length of hospital stay. Recovery time was determined by thenumber of days needed to achieve defecation frequency <3 times/day and needed to achieve normal stool consistency.Results Seventy infants and children were enrolled. The treatmentgroup significantly achieved recovery time earlier than the control groupin regard to the time of achieving defecation frequency to <3 times/day [2.31 (0.76) vs 3.34 (1.45); mean difference of -1.03; P= 0.001; CI95% -1.58;-0.48] and normal stool consistency [2.40 (0.77) vs 3.43(1.48); mean difference of -1.03; P = 0.001; CI 95% -1.59;-0.46]. Lengthof hospital stay was shorter in the treatment group than the controlgroup [2.89 (0.78) vs 3.94 (1.53); mean difference of -1.05; P= 0.001;CI 95% (-1.3;-0.7)]. No significant difference was found in mean ofbody weight recovery in two groups [0.47 (0.16) vs 0.49 (0.20); meandifference of -0.03; P=0.556; CI 95%: -0.11;0.06]. Age, nutritionalstatus, breastfeeding, and diarrhea before admission did not influ-ence the study outcome.Conclusion Bovine colostrums as an adjuvant in standard therapyfor acute diarrhea in infants and children is effective in regard toachieve earlier recovery time and shorter length of hospital stay

scholarly journals Comparison of Recovery Time of Propofol and Midazolam with Propofol Alone for Sedation in Endoscopic Retrograde Cholangiopancreatography

2021 ◽  
Vol 15 (5) ◽  
pp. 1024-1027
Author(s):  
Asma Samreen ◽  
Aamir Waseem ◽  
Muhammad Azam ◽  
Itrat Hussain Kazmi ◽  
Aamir Bashir ◽  
...  
Keyword(s):  
Endoscopic Retrograde Cholangiopancreatography ◽  
Recovery Time ◽  
Controlled Trial ◽  
P Value ◽  
Time Data ◽  
Endoscopic Retrograde ◽  
Intravenous Anesthetic ◽  
Significant Difference ◽  
Group A ◽  
Group B

Background: Procedural sedation is required for multiple short duration procedures outside of the operating rooms especially in radiology and endoscopy suites. Intravenous anesthetic agent with rapid recovery profile is desirable in such circumstances. This study aims to compare two regimens of intravenous anesthetic agents. Aim: To compare the mean recovery time of propofol and midazolam with propofol alone for sedation in endoscopic retrograde cholangiopancreatography. Study Design: Randomized controlled trial. Settings: Department of Anesthesia, Shalamar Hospital, Lahore. Study Duration: June 2017 to December 2017. Methods: A total of 70 adult patients aged 20-60 years undergoing ERCP under sedation were included. Patients were given a combination of propofol and midazolam in group A while propofol alone was given in group B. After procedure, pts were transferred to recovery room and were followed for assessment of recovery time. Data were analyzed in SPSS vr 21, Independent t-test was applied & p-value ≤0.05 was considered statistically significant. Results: Significant difference was found in mean recovery time amongst both the groups. Mean recovery time in Group A (propofol and midazolam) was 19.29±4.50 minutes while in Group B (propofol alone) was 26.66±3.70 minutes showing statistically significant result with p-value = 0.0001. Conclusion: We conclude that mean recovery time with propofol plus midazolam is shorter as compared to propofol alone for sedation in ERCP. Keywords: Propofol, midazolam, sedation outside operation theatre.

A Randomized Double Blind Controlled Trial of An Oral Anti-Foam and Mucolytic Pre-Medication in Upper Gastrointestinal (GI) Endoscopy

2005 ◽  
Vol 61 (5) ◽  
pp. AB81
Author(s):  
Aravamuthan Sreedharan ◽  
Gerri Beech ◽  
Clare Donnellan ◽  
Cathryn Flynn ◽  
Bjorn Rembacken
Keyword(s):  
Controlled Trial ◽  
Double Blind ◽  
Gi Endoscopy ◽  
Upper Gastrointestinal

scholarly journals Effects of 12-Week Supplementation of a Polyherbal Formulation in Old Adults with Prehypertension/Hypertension: A Randomized, Double-Blind, Placebo-Controlled Trial

2019 ◽  
Vol 2019 ◽  
pp. 1-15 ◽  
Author(s):  
Tian Shen ◽  
Guoqiang Xing ◽  
Jingfen Zhu ◽  
Yong Cai ◽  
Shuxian Zhang ◽  
...  
Keyword(s):  
Blood Pressure ◽  
Heart Rate ◽  
Placebo Group ◽  
Controlled Trial ◽  
Adult Population ◽  
Chest Tightness ◽  
Double Blind ◽  
Old Adults ◽  
Severity Scores ◽  
Rapid Heart Rate

Background. Uncontrolled blood pressure is the leading cause of mortality and disability due to associated cerebral and cardiovascular diseases and kidney failure. More than one-third of the old adult population have hypertension or prehypertension and many of their blood pressure are poorly controlled. Objective. We hypothesized that plant extracts-based antioxidants may benefit those with prehypertension/hypertension. Method. One hundred age- and gender-matched healthy older adults were randomly assigned to receive HyperBalance capsules (n=50) or placebo (n=50) at Tang-Qiao Community Health Service Center, Shanghai. Blood pressure and severity scores of hypertension treatment-related symptoms (dizziness, headache, ringing/buzzing in ears, rapid heart rate, and chest tightness) were evaluated before and after the 12-week intervention. Results. Ninety-eight people completed the study, with 2 dropouts in the placebo group before the end of the study. Forty-one subjects (82%) of the HyperBalance group and 40 subjects (83.3%) of the placebo group had prehypertension (systolic blood pressures (SBP) between 130-139 and diastolic blood pressure (DBP) between 85-89mmHg), and 9 subjects (18%) in the HyperBalance group and 8 subjects (16.7%) in the placebo group had hypertension (≥140/90mmHg) before the intervention. HyperBalance significantly (P<0.01) reduced SBP from 136.18±4.38 to 124.14±3.96 mmHg and reduced DBP from 82.45±2.91 to 80.24±2.41mmHg, respectively, and reversed all 9 hypertension people to normotension or prehypertension state, whereas the placebo moderately reduced SBP from 135.79±4.22 to 132.35±4.656mmHg and reduced DBP from 82.90±3.07 to 82.27±3.01mmHg. All symptom severity scores became significantly lower in the HyperBalance group than in the placebo group after HyperBalance intervention: dizziness (0.82±0.44; vs 2.02±0.64, P<0.01); headache (0.46±0.50; vs 1.81±0.61, P<0.01); ringing/buzzing in ears (0.44±0.50; vs 1.04±0.29, P<0.01); and rapid heart rate and chest tightness (0.30±0.46; vs 0.92±0.28, P<0.01). Conclusion. Polyherbal supplementation such as HyperBalance could benefit old adults with prehypertension/hypertension and improve treatment-related symptoms. Further studies are needed to validate the current findings.

scholarly journals A Double-Blind Randomized Prospective Study Comparing Ondansetron with Droperidol in the Prevention of Emesis following Strabismus Surgery

1995 ◽  
Vol 23 (4) ◽  
pp. 438-443 ◽  
Author(s):  
A. Davis ◽  
S. Krige ◽  
D. Moyes
Keyword(s):  
Recovery Time ◽  
Strabismus Surgery ◽  
Double Blind Study ◽  
Double Blind ◽  
Oral Fluids ◽  
Group A ◽  
The Mean ◽  
Group B ◽  
To Receive ◽  
Mean Time

A prospective double-blind study was conducted to compare the anti-emetic efficacy of ondansetron and droperidol in preventing postoperative emesis following strabismus surgery. A sample size of 213 patients was divided into three equal groups to receive ondansetron 150 μg/kg (Group A), ondansetron 75 μg/kg (Group B), or droperidol 75 fig/kg (Group C). All patients received a standardized anaesthetic technique. All episodes of emesis, recovery time, and time to tolerating oral fluids were recorded. The incidence of emesis during 24 hours was Groups A and B 19.7%, and Group C 28.2%. The lower incidence of emesis recorded by the ondansetron groups compared with the droperidol group was not statistically significant. Ondansetron at 75 μg/kg was as effective as 150 μg/kg in reducing emesis when compared with droperidol. Mean time to discharge from the recovery room was 75.3 minutes (Group A), 44.4 minutes (Group B), and 41.0 minutes (Group C). The mean time to tolerating oral fluids was 356.5 minutes (Group A), 402.8 minutes (Group B), and 378.1 minutes (Group C). There was no statistical difference in discharge times from recovery or time to tolerating oral fluids in any of the three groups.

A Double-Blind Controlled Trial of Betamethasone Dipropionate 0·05% (Diproderm®) in Comparison with Fluocinolone Acetonide 0·025% (Synalar®) in Psoriasis and other Steroid-Responsive Dermatoses

1979 ◽  
Vol 7 (5) ◽  
pp. 411-414 ◽  
Author(s):  
Hans-Wilhelm Afzelius ◽  
K U Jacobsen
Keyword(s):  
Topical Corticosteroid ◽  
Controlled Trial ◽  
Randomized Study ◽  
Fluocinolone Acetonide ◽  
Betamethasone Dipropionate ◽  
Trial Period ◽  
Double Blind

In a double-blind randomized study, sixty-two patients suffering from psoriasis or eczema were treated, twice daily for three weeks, either with 0.05% betamethasone 17, 21-dipropionate cream or with 0.025% fluocinolone acetonide cream. The results showed that both topical corticosteroid preparations were effective, well tolerated and cosmetically acceptable. Fifty-seven per cent of the patients treated with betamethasone dipropionate were rated as being ‘much better’ in the overall assessment of response at the end of the trial period compared to only 25% of those in the fluocinolone acetonide group.

scholarly journals Effect of a Fermented Milk CombiningLactobacillus AcidophilusCL1285 andLactobacillus Caseiin the Prevention of Antibiotic-Associated Diarrhea: A Randomized, Double-Blind, Placebo-Controlled Trial

2007 ◽  
Vol 21 (11) ◽  
pp. 732-736 ◽  
Author(s):  
Mélanie Beausoleil ◽  
Nadia Fortier ◽  
Stéphanie Guénette ◽  
Amélie L’Ecuyer ◽  
Michel Savoie ◽  
...  
Keyword(s):  
Placebo Group ◽  
Controlled Trial ◽  
Randomized Study ◽  
Fermented Milk ◽  
Daily Basis ◽  
Hospitalized Patients ◽  
Double Blind ◽  
Antibiotic Associated Diarrhea ◽  
Potential Measure ◽  
To Receive

BACKGROUND: Antibiotic-associated diarrhea is an important problem in hospitalized patients. The use of probiotics is gaining interest in the scientific community as a potential measure to prevent this complication. The main objective of the present study was to assess the efficacy and safety of a fermented milk combiningLactobacillus acidophilusandLactobacillus caseithat is widely available in Canada, in the prevention of antibiotic-associated diarrhea.METHODS: In this double-blind, randomized study, hospitalized patients were randomly assigned to receive either a lactobacilli-fermented milk or a placebo on a daily basis.RESULTS: Among 89 randomized patients, antibiotic-associated diarrhea occurred in seven of 44 patients (15.9%) in the lactobacilli group and in 16 of 45 patients (35.6%) in the placebo group (OR 0.34, 95% CI 0.125 to 0.944; P=0.05). The median hospitalization duration was eight days in the lactobacilli group, compared with 10 days in the placebo group (P=0.09). Overall, the lactobacilli-fermented milk was well tolerated.CONCLUSION: The daily administration of a lactobacilli-fermented milk was safe and effective in the prevention of antibiotic-associated diarrhea in hospitalized patients.

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