Sedation for middle ear surgery: prospective clinical trial comparing propofol and midazolam

During middle-ear-surgery under local anaesthesia (MES-LA), patients report hearing noises, feeling anxious, and experiencing earache. In a prospective randomized clinical trial, we compared propofol and midazolam for sedation in 68 patients scheduled for MES-LA. The starting dose of propofol was 1 to 1.5 mg per kilogram intravenously, followed by 1 to 2 mg per kilogram per hour given by infusion. The starting dose of midazolam was 0.02 to 0.05 mg per kilogram intravenously, followed by 0.01 to 0.02 mg per kilogram intravenously. Metamizol and fentanyl were added when required. Sedation was titrated to a Ramsay score of 3 to 4 and a bispectral index value of 70 to 80. Patients were assessed for vital parameters and sedation and pain scores. In the recovery room, readiness for discharge and satisfaction of both patient and surgeon with the procedure were assessed. The group receiving propofol had a significantly lower heart rate, shorter duration of sedation, and earlier readiness for discharge (p<0.05). There were no significant differences in other parameters evaluated. Seventy-nine per cent of patients in the group receiving propofol and 91.1% receiving midazolam would choose the same method of anaesthesia and sedation for any further MES-LA. Our results suggest that, compared to midazolam, propofol is more suitable for sedation in patients undergoing MES-LA. However, appropriate patient selection, adequate preparation, and careful monitoring are mandatory.     

地佐辛与芬太尼分别联合咪达唑仑用于无痛结肠镜镇痛的效果比较

目的探讨阿片类镇痛药物地佐辛联合咪达唑仑用于无痛结肠镜静脉麻醉的镇痛效果与安全性。方法选取接受无痛结肠镜检查的成年患者120例,按随机数字表随机分为地佐辛组与芬太尼组,每组60例。2组均先给予咪达唑仑0.03 mg/kg缓慢静脉推注,然后地佐辛组缓慢推注地佐辛5.0～7.5 mg,芬太尼组缓慢推注芬太尼0.05～0.1 mg,在患者麻醉至Ramsay镇静分级4级后行结肠镜检查。在术后不同时间点（术后第10、20、30分钟）进行镇痛视觉模拟评分（VAS）,监测记录检查时间、患者心率、平均动脉压、血氧饱和度的变化及不良反应发生率。结果2组患者均安静顺利完成检查,术中各项生命体征稳定,未出现呼吸抑制、呼吸停止及心搏骤停等不良反应。患者术后无明显不良记忆,地佐辛组和芬太尼组术后各时间点（术后第10 、20、30 min分钟）VAS评分比较差异均无统计学意义［1.2±0.6 比1.3±0.5,t=-0.667;1.1±0.3比1.0±0.7,t=0.685,1.0±0.2比1.0±0.3;t=-0.377］（均P〉 0.05）。但地佐辛组头晕、恶心呕吐、皮肤瘙痒等不良反应发生率（11.7%,7/60）明显低于芬太尼组的26.7%（18/60）（P〈0.05）,芬太尼组患者发生呛咳1例。结论咪达唑仑联合地佐辛用于无痛结肠镜静脉麻醉,镇痛效果确切,不良反应发生率低,是一种安全、有效的麻醉方法。     

Amisulpride versus quetiapine for the treatment of delirium: a randomized, open prospective study

The present study aimed to: (i) provide preliminary data on the effectiveness and tolerability of atypical antipsychotics, amisulpride (AMSP) and quetiapine (QTP) for patients with delirium and (ii) investigate whether the two drugs affect sleep differently and further relation with the recovery time of delirium. Forty patients with delirium were randomly assigned to either AMSP or QTP groups, with a flexible dosing schedule. The Delirium Rating Scale-revised-98 (DRS-R-98) and clinical global impression-severity (CGI-S), total sleep time and quality of sleep were assessed daily. Sixteen subjects in the AMSP group and 15 subjects in the QTP group completed the study. The mean daily dose was 156.4 mg/day and 113 mg/day in the AMSP and QTP groups, respectively. There was no significant difference in the baseline DRS-R-98 and CGI scores. After treatment, DRS-R-98 scores were significantly decreased from the baseline in both treatment groups (P<0.001) without group difference. The mean duration of stabilization were 6.3+/-4.4 days for the AMSP group and 7.4+/-4.1 days for the QTP group without group differences. There was no group difference in the mean quality of sleep score and the mean total sleep time. The duration of stabilization was inversely correlated with the mean sleep quality score and the mean total sleep time (P<0.001). Both atypical antipsychotics were generally well tolerated. The present study shows that both amisulpride and quetiapine may be useful drugs for the treatment of delirium on the basis of effectiveness and relative lack of adverse events. Further systematic controlled studies are required.     

Sequential therapy versus standard triple-drug therapy for Helicobacter pylori eradication: a prospective randomized study

Purpose

Eradication rates following standard triple therapy for Helicobacter pylori infection are declining. Recent studies, conducted in a number of countries, have shown that sequential therapy for H. pylori infection yields high cure rates.

Aim

To compare the efficacy and tolerability of a sequential regimen as a first-line treatment of H. pylori infection with a standard triple treatment regime in Morocco.

Methods

A total of 281 naive H. pylori-infected patients, confirmed by histological examination, were assigned randomly to one of two treatment groups: standard triple therapy [omeprazole (20 mg bid) + amoxicillin (1 g bid) + clarithromycin (500 mg bid) for 7 days] or sequential therapy [omeprazole (20 mg bid) + amoxicillin (1 g bid) for 5 days, followed by omeprazole (20 mg bid) + tinidazole (500 mg bid) + clarithromycin (500 mg bid) for an additional 5 days]. H. pylori eradication was checked 4–6 weeks after treatment initiation by using a ¹³C-urea breath test. Compliance and adverse events were assessed.

Results

The two groups did not differ significantly in gender, age, previous disease history, endoscopic and histological features and smoking. The intention-to-treat and per-protocol eradication rates were 65.9 and 71 % in the standard triple therapy group, and 82.8 and 89.9 % in the sequential therapy group, respectively. The eradication rate was significantly higher in the sequential therapy group than in the standard triple therapy group (p?<?0.001), There was no statistically significant difference in compliance (97.5  vs. 96.3 %) and incidence of side-effects (27.5 vs. 27.9 %) between the two groups.

Conclusions

Based on our results, we conclude that for eradication of H. pylori infection, the 10-day sequential therapy is more effective than the standard triple therapy and is equally tolerated. These results confirm those of other studies in other countries.     

Sedation for gastroscopy: a comparative study of midazolam and Diazemuls in patients with and without cirrhosis.

A double-blind controlled study comparing the effects of intravenous Diazemuls (0.15 mg kg-1) with midazolam (0.07 mg kg-1) in patients with normal liver function and with cirrhosis and portal hypertension is described. The clinical effect of the two drugs was assessed by serial tests of psychomotor function before and at varying intervals after administration. Using this dosage regime, midazolam caused significantly greater impairment in psychomotor function in both cirrhotic and non cirrhotic subjects, and the time taken for recovery of normal function was also significantly prolonged. Patients with cirrhosis showed a significantly prolonged recovery time following administration of either benzodiazepine compared with the controls. Administration of midazolam in a lower dose might reduce the degree of sedation and shorten the recovery time, but this could also lead to a loss of some of the amnesic effect. Caution is recommended in the administration of benzodiazepines to patients with cirrhosis.     

咪达唑仑复合丙泊酚用于十二指肠镜逆行胰胆管造影静脉全麻的临床效果

目的:观察咪达唑仑复合丙泊酚用于十二指肠镜逆行胰胆管造影(ERCP)静脉全麻的安全性及有效性。方法:选择行ERCP患者80例,年龄55~75岁,ASAⅠ~Ⅱ级,随机分成丙泊酚组(P组)和咪达唑仑复合丙泊酚组(M组),每组40例。两组术前均静脉给予东莨菪碱10 mg,地佐辛5 mg。P组麻醉诱导为单纯静脉泵入丙泊酚(诱导速度为15 mg·kg~(-1)·h~(-1))至呼之不应、无睫毛反应后,改为维持速度(4.5 mg·kg~(-1)·h~(-1));M组在麻醉诱导前小壶给予咪达唑仑0.04 mg/kg,随后静脉泵泵入丙泊酚(诱导速度为15 mg·kg~(-1)·h~(-1))至呼之不应、无睫毛反应后,改为维持速度(4.5 mg·kg~(-1)·h~(-1)),分别记录两组丙泊酚诱导量,丙泊酚维持量,手术时间,苏醒时间及术中、术后不良反应(呃逆、呛咳、恶心、呕吐)。结果:M组丙泊酚诱导量及丙泊酚维持量低于P组。M组术中呛咳发生率明显低于P组。结论:咪达唑仑复合丙泊酚用于ERCP静脉全麻安全有效,且能产生协同作用,降低丙泊酚用量,更加安全。     

Etoricoxib versus naproxen in patients with rheumatoid arthritis: a prospective,randomized, comparator-controlled 121-week trial

ABSTRACT

Background: Etoricoxib is a cyclooxygenase-2 (COX?2) selective inhibitor effective in the treatment of rheumatoid arthritis. An initial 12-week treatment study found that etoricoxib (90?mg once daily) was more effective than naproxen (500?mg twice daily) or placebo in treating rheumatoid arthritis. The present two-part extension of that study was performed to monitor tolerability and examine long-term efficacy of etoricoxib 90?mg or 120?mg compared with naproxen.

Methods: Patients completing the initial 12-week study and those discontinuing due to lack of efficacy, were eligible for the Extension Study Part I (12–52 weeks) and assigned (2?:?1?:?2 ratio) to receive etoricoxib (90?mg or 120?mg daily) or naproxen (500?mg twice daily); these patients remained on the same therapy for Extension Study Part II (52–121 weeks). Primary outcome measures included investigator and patient assessment of disease activity, and tender and swollen joint counts.

Results: Of 816 patients enrolled in the initial 12-week trial, 717 continued into the Extension Study Part I; 505 patients completed and 390 entered the Extension Study Part II, with 283 patients completing 121 weeks. Patients receiving etoricoxib (90?mg) or naproxen throughout the study experienced sustained efficacy in all outcomes, as did patients transitioning to etoricoxib (120?mg) following the initial 12-week trial. Patients transitioning from placebo to etoricoxib (90?mg) experienced rapid, sustained improvements in all outcome measures.

Conclusion: In conclusion, etoricoxib provided sustained efficacy throughout the 121-week study, with efficacy comparable to naproxen.     

Antibiotic prophylaxis for percutaneous endoscopic gastrostomy for non-malignant conditions: a double-blind prospective randomized controlled trial

BACKGROUND: The use of antibiotic prophylaxis prior to percutaneous endoscopic gastrostomy insertion has been encouraged following development of guidelines by a number of professional societies within the past few years. However, not all evidence supports routine prophylaxis, particularly in patients with 'benign' disease indications for percutaneous endoscopic gastrostomy insertion. AIM: To identify whether prophylactic antibiotic usage is beneficial in patients undergoing percutaneous endoscopic gastrostomy insertion without malignant disease. METHODS: Adult patients without malignant disease who were referred for percutaneous endoscopic gastrostomy insertion at our unit were assessed for participation in this prospective, double-blind, randomized controlled study. Patients were randomized to receive either placebo or 2.2 g co-amoxiclav (or 2 g cefotaxime if penicillin-allergic) at time of percutaneous endoscopic gastrostomy insertion. Clinical endpoints studies were percutaneous endoscopic gastrostomy site or systemic infection and death within 7 days of percutaneous endoscopic gastrostomy insertion. Results : Ninety-nine patients completed the study (51 antibiotics, 48 placebo). Outcomes in the antibiotic and placebo groups respectively were: percutaneous endoscopic gastrostomy site infection, 11% vs. 47% (P < 0.01); systemic infection, 16% vs. 38% (P < 0.05); and death, 8% vs. 15% (P = 0.5). CONCLUSIONS: Antibiotic prophylaxis prior to percutaneous endoscopic gastrostomy insertion reduces both percutaneous endoscopic gastrostomy site and systemic infections in patients without malignant disease.     

Cefotetan versus piperacillin in the prophylaxis of abdominal and vaginal hysterectomy: a prospective randomized study

A prospective randomized study was carried out on a total of 686 patients who underwent vaginal or abdominal hysterectomy. Of these, 338 were given prophylactic cefotetan (2 g) and 348 piperacillin (2 g). Both drugs were administered as i.v. bolus 30 min before operation. Findings confirm the higher risk of infection with abdominal hysterectomy and the advantages of the long half-life cephalosporin, cefotetan.     

Intravenous midazolam as a sedative for colonoscopy: a randomized, double-blind clinical trial

Methods : Forty patients, aged between 36 and 60 years, scheduled to undergo colonoscopic removal of colorectal polyps were randomly assigned to receive 0.9% saline solution ( n =20) or 0.05 mg/kg body weight of midazolam ( n =20) intravenously.
Results : Midazolam significantly ( P <0.001) increased the tolerance of patients to colonoscopy. It had no significant effect on pulse or systolic blood pressure during endoscopy. Arterial oxygen saturation decreased significantly ( P <0.01) during endoscopy in patients pre-treated with midazolam, but it did not decrease by more than 5%.
Conclusions : Intravenous midazolam is useful as a sedative for colonoscopy, but we recommend continuous oxygen saturation monitoring during endoscopy.     

Polyhexamethylene biguanide for treatment of external genital warts: a prospective, double-blind, randomized study

Genital human papillomavirus infection is one of the most common sexually transmitted diseases. Polyhexamethylene biguanide is a new agent, that has been demonstrated to have potent in vivo antiviral effects in animal and in human models. The present prospective, double-blind, randomized, placebo (vehicle-controlled) trial evaluated the efficacy and safety of daily patient-applied polyhexamethylene biguanide for up to 16-weeks for the treatment of external genital warts. Wart recurrence was investigated during a 12-week treatment-free follow-up period. In the intent-to-treat analysis, baseline warts cleared from 49 of 94 (52%) patients treated with polyhexamethylene biguanide cream versus and 3 of 95 (4%) placebo patients; the differences between the groups treated with placebo and polyhexamethylene biguanide were significant (P < 0.0001). For subjects who completed the follow-up period, recurrence rates after a complete response were 19% (9 of 48 patients) in the polyhexamethylene biguanide cream group, 17% cream group, and 0% (0 of 3) in the placebo group. There were no systemic reactions, although local skin reactions (generally of mild or moderate severity) were common in the polyhexamethylene biguanide cream group. Local reactions caused two patients to discontinue treatment. The most frequently reported local skin reactions were erythema, excoriation or flaking, and erosion. Patient-applied polyhexamethylene biguanide cream is effective for the treatment of external genital warts and has a favorable safety profile.     

Validity and reliability of the Observer's Assessment of Alertness/Sedation Scale: study with intravenous midazolam

The Observer's Assessment of Alertness/Sedation (OAA/S) Scale was developed to measure the level of alertness in subjects who are sedated. This scale was tested in 18 subjects in a three-period crossover study to assess its reliability and its criterion, behavioral, and construct validity. After receiving either placebo or a titrated dose of midazolam to produce light or heavy sedation, each subject was administered two sedation scales (OAA/S Scale and a Visual Analogue Scale) and two performances tests (Digit Symbol Substitution Test and Serial Sevens Subtraction). Two raters individually evaluated the subject's level of alertness on each of the two sedation scales. The results obtained on the OAA/S Scale were reliable and valid as measured by high correlations between the two raters and high correlations between the OAA/S Scale and two of the three standard tests used in this study. The OAA/S Scale was sensitive to the level of midazolam administered; all pairwise comparisons were significant (p less than 0.05) for all three treatment levels at both test periods.     

Ceftriaxone versus clavulanate-potentiated amoxycillin for prophylaxis against post-operative sepsis in biliary surgery: a prospective randomized study in 200 patients

A prospective study was carried out in 200 consecutive patients undergoing biliary surgery to compare the prophylactic effectiveness of ceftriaxone and clavulanate-potentiated (CP-) amoxycillin. Patients were assigned in a randomized fashion to two groups and received ceftriaxone (2 g intravenously pre-operatively), or CP-amoxycillin (1200 mg, to be repeated for 2 more doses in the case of patients undergoing procedures other than elective cholecystectomy). Post-operative wound infection occurred in 4% of patients in each group. Administration of ceftriaxone was associated with a lower incidence of post-operative pyrexia and chest infection as well as with a shorter hospital stay.     

Second-degree burns: a comparative, multicenter, randomized trial of hyaluronic acid plus silver sulfadiazine vs. silver sulfadiazine alone

AIMS: This multicenter, multinational, randomized, double-blind, controlled, parallel-group study, was designed to assess the efficacy and safety of a fixed combination topical medicinal product, containing 0.2% hyaluronic acid and 1% silver sulfadiazine (HA-SSD) (Connettivina Plus cream) versus 1% silver sulfadiazine cream alone (SSD), in the treatment of second-degree burns. METHODS: 111 adult patients (age 18-75 years) of both sexes, with IIa-degree (superficial) and IIb-degree (deep dermal) burns, were randomized to receive HA-SSD or SSD. Treatments (approximately 5 g/100 cm2) were applied once a day until the wounds healed, but for no longer than 4 weeks. Burns had to have occurred within 48 hours from the start of treatment, be caused by thermal injury, and be confined to the trunk and/or upper and lower extremities. RESULTS: Results showed that both the fixed combination HA-SSD, and SSD alone, were effective and well tolerated topical agents for the treatment of second-degree burns. All burns were healed except in one patient treated with SSD. It was also observed that the fixed combination HA-SSD caused a significantly more rapid re-epithelialization of burns, i.e. a shorter time to healing, than SSD alone. The difference recorded--4.5 days--was statistically significant (p = 0.0073). CONCLUSION: The observed shorter time to healing caused by the fixed combination is clinically relevant and further demonstrates the wound healing activity of HA.     

冷冻联合 A型肉毒毒素与单独 A型肉毒毒素治疗瘢痕疙瘩的疗效比较:前瞻性随机对照研究

目的比较冷冻联合 A型肉毒毒素与单独 A型肉毒毒素治疗瘢痕疙瘩的疗效。方法选择 2017年 4月至 2020年 4月期间中国人民解放军联勤保障部队第九八一医院收治的瘢痕疙瘩病人 98例为该研究对象,按照随机数字表法将其分成两组,对照组 49例给予 A型肉毒毒素治疗,研究组 49例在对照组基础上联合冷冻进行治疗。比较两组疗效、瘢痕厚度、瘢痕面积、痒程度、不良反应发生率、复发情况。结果研究组总有效率 93.88%(46/49)高于对照组 71.43%(35/49)(P<0.05)。治疗后,痛组瘢痕厚度、瘢痕面积、痛痒程度均低于治疗前(P<0.05)且治疗后研究组瘢痕厚度、瘢痕面积、痛痒程度低于对照组(P<0.05)。两研究组不良反应总发生率 12.24%(6/49)与对照组 10.20%(,5/49)相较,差异无统计学意义( P>0.05)。在完整治疗后为期 6个月随访,对照组复发 12例,研究组复发 8例,研究组复发率 16.33%与对照组 24.49%相较,差异无统计学意义( P>0.05)。结论冷冻联合 A型肉毒毒素治疗瘢痕疙瘩疗效肯定,能改善瘢痕厚度、瘢痕面积、痛痒程度,并且不会明显增加不良反应发生率、复发率。     

Nabumetone in elderly patients with osteoarthritis: economic benefits versus ibuprofen alone or ibuprofen plus misoprostol

Nonsteroidal anti-inflammatory drugs (NSAIDs) vary in their potential to produce gastropathy. We compared the 3-month direct medical costs, including those associated with treating NSAID-induced adverse events, of nabumetone, ibuprofen, or ibuprofen plus misoprostol in 171 elderly patients with osteoarthritis. Total direct medical costs per patient treated were $US183 for nabumetone, $US252 for ibuprofen, and $US270 for ibuprofen plus misoprostol. Differences resulted from higher costs associated with treatment of drug-related adverse events with ibuprofen, and higher drug acquisition prices with the combination regimen. Sensitivity analyses demonstrated that direct costs with nabumetone approached those for the other 2 regimens if the price of nabumetone increased by 60%, the probability of lesion formation with nabumetone increased 4-fold, the probability of a lesion greater than 0.5cm being symptomatic and needing treatment was 31%, or the price of misoprostol decreased by 50%. Although this study found more lesions because of mandated endoscopies than might be recognised or treated in clinical practice, the results suggest an economic benefit of nabumetone.