Hemodynamic effects of topical lidocaine on the laryngoscope blade and trachea during endotracheal intubation: a prospective,double-blind,randomized study

Purpose

Minimizing hemodynamic changes during the peri-intubation period is a concern for anesthesiologists. We investigated the effect of lidocaine sprayed on the laryngoscope blade and trachea on hemodynamics during direct laryngoscopic intubation.

Methods

Seventy-two patients were randomly allocated to one of four groups: 10 % lidocaine was sprayed either on the laryngoscope blade (group L), on the trachea (group V), or on the laryngoscope blade and the trachea (group LV). No lidocaine was used in group C. Anesthesia was induced in all patients with remifentanil (effect site concentration: 4.0 ng/ml) and propofol (effect site concentration 4.0 μg/ml) continuous infusion using a target control infusion (TCI) device. Mean arterial pressure (MAP) and heart rate (HR) were recorded during the peri-intubation period.

Results

Changes in MAP and HR over time were markedly different among the four groups (P < 0.05). MAP at 1 min post-intubation was significantly lower in groups L, V, and LV than in group C (86.1 ± 12.7, 85.3 ± 12.6, and 83.7 ± 13.1 vs 106.3 ± 22.9 mmHg, P < 0.01). Maximum MAP values were lower in groups L and LV than in group C (P < 0.05). HRs at 1, 2, and 3 min post-intubation were lower in group LV than in group C (70.4 ± 9.0 vs 84.2 ± 15.3; 64.0 ± 8.1 vs 79.2 ± 15.4; 61.6 ± 8.3 vs 77.2 ± 14.5 beats/min, P < 0.01, respectively).

Conclusions

Lidocaine sprayed on the laryngoscope blade and/or trachea reduced the hemodynamic response to laryngoscopic intubation during the post-intubation period following anesthetic induction with remifentanil and propofol using a TCI device.     

Cefamandole in gastroduodenal surgery: a controlled, prospective, randomized, double-blind study

Acceptance of the value of antibiotic prophylaxis in gastroduodenal surgery is growing, but only one controlled, double-blind study justifying this is available. In this second, controlled, randomized, double-blind study 60 patients underwent urgent and elective gastroduodenal operations. Among 32 patients receiving cefamandole perioperatively for prophylaxis, only 1 subsequently had a wound infection, but wound infections occurred in 8 of the 28 patients who received a placebo (P less than 0.01). Infection rates were higher in contaminated wounds and in urgent operations than in clean-contaminated wounds and elective surgery. The results confirm the value of antibiotic prophylaxis in this setting.     

Laparoscopic versus open appendectomy: a prospective randomized double-blind study

SUMMARY BACKGROUND DATA: The value of laparoscopy in appendicitis is not established. Studies suffer from multiple limitations. Our aim is to compare the safety and benefits of laparoscopic versus open appendectomy in a prospective randomized double blind study. METHODS: Two hundred forty-seven patients were analyzed following either laparoscopic or open appendectomy. A standardized wound dressing was applied blinding both patients and independent data collectors. Surgical technique was standardized among 4 surgeons. The main outcome measures were postoperative complications. Secondary outcome measures included evaluation of pain and activity scores at base line preoperatively and on every postoperative day, as well as resumption of diet and length of stay. Activity scores and quality of life were assessed on short-term follow-up. RESULTS: There was no mortality. The overall complication rate was similar in both groups (18.5% versus 17% in the laparoscopic and open groups respectively), but some early complications in the laparoscopic group required a reoperation. Operating time was significantly longer in the laparoscopic group (80 minutes versus 60 minutes; P = 0.000) while there was no difference in the pain scores and medications, resumption of diet, length of stay, or activity scores. At 2 weeks, there was no difference in the activity or pain scores, but physical health and general scores on the short-form 36 (SF36) quality of life assessment forms were significantly better in the laparoscopic group. Appendectomy for acute or complicated (perforated and gangrenous) appendicitis had similar complication rates, regardless of the technique (P = 0.181). CONCLUSIONS: Unlike other minimally invasive procedures, laparoscopic appendectomy did not offer a significant advantage over open appendectomy in all studied parameters except quality of life scores at 2 weeks. It also took longer to perform. The choice of the procedure should be based on surgeon or patient preference.     

Effect of labor epidural analgesia with and without fentanyl on infant breast-feeding: a prospective, randomized, double-blind study

BACKGROUND: The influence of labor epidural fentanyl on the neonate is controversial. The purpose of this study was to determine whether epidural fentanyl has an impact on breast-feeding. METHODS: Women who previously breast-fed a child and who requested labor epidural analgesia were randomly assigned in a double-blinded manner to one of three groups: (1) no fentanyl group, (2) intermediate-dose fentanyl group (intent to administer between 1 and 150 microg epidural fentanyl), or (3) high-dose epidural fentanyl group (intent to administer > 150 microg epidural fentanyl). On postpartum day 1, the mother and a lactation consultant separately assessed whether the infant was experiencing difficulty breast-feeding, and a pediatrician assessed infant neurobehavior. All women were contacted 6 weeks postpartum to determine whether they were still breast-feeding. RESULTS: Sixty women were randomly assigned to receive no fentanyl, 59 were randomly assigned to receive an intermediate dose, and 58 were randomly assigned to receive high-dose fentanyl. On postpartum day 1, women who were randomly assigned to receive high-dose fentanyl reported difficulty breast-feeding (n = 12, 21%) more often than women who were randomly assigned to receive an intermediate fentanyl dose (n = 6, 10%), or no fentanyl (n = 6, 10%), although this did not reach statistical significance (P = 0.09). There was also no significant difference among groups in breast-feeding difficulty based on the lactation consultant's evaluation (40% difficulty in each group; P = 1.0). Neurobehavior scores were lowest in the infants of women who were randomly assigned to receive more than 150 microg fentanyl (P = 0.03). At 6 weeks postpartum, more women who were randomly assigned to high-dose epidural fentanyl were not breast-feeding (n = 10, 17%) than women who were randomly assigned to receive either an intermediate fentanyl dose (n = 3, 5%) or no fentanyl (n = 1, 2%) (P = 0.005). CONCLUSIONS: Among women who breast-fed previously, those who were randomly assigned to receive high-dose labor epidural fentanyl were more likely to have stopped breast-feeding 6 weeks postpartum than woman who were randomly assigned to receive less fentanyl or no fentanyl.     

Intravenous lidocaine suppresses fentanyl-induced coughing: a double-blind, prospective, randomized placebo-controlled study

IV lidocaine is effective in suppressing the cough reflex of tracheal intubation, extubation, bronchography, bronchoscopy, and laryngoscopy. We investigated this effect of lidocaine on fentanyl-induced cough in 502 patients of ASA physical status I and II scheduled for elective surgery. The patients were assigned to 2 equal groups to receive either lidocaine 1.5 mg/kg or placebo (0.9% saline) over 5 s 1 min before the administration of fentanyl 3 mug/kg in a randomized and double-blind fashion. Coughs were classified as coughing and graded as mild (1-2), moderate (3-4), or severe (5 or more). The results of the study suggest that IV lidocaine 1.5 mg/kg, when administered 1 min before fentanyl, is significantly effective in suppressing fentanyl-induced cough compared to placebo (0.9% saline) (218 versus 165 patients) (P < 0.002) but without affecting the severity of cough (P > 0.05).     

Opioid-related side-effects after intrathecal morphine: a prospective, randomized, double-blind dose-response study

BACKGROUND AND OBJECTIVE: The aim of this prospective, randomized, double-blind investigation was to assess the dose-effect characteristics of postoperative nausea and vomiting after intrathecal administration of small doses of morphine (from 0.015 to 0.25 mg) in opioid-na?ve, non-surgical patients. METHODS: With Ethic Committee approval and written informed consent 144 opioid-na?ve patients suffering from non-cancerous chronic back-pain, and receiving intrathecal morphine as diagnostic test for their chronic pain, were randomly allocated to receive intrathecal injection of 0.015 mg (Group I, n=25), 0.03 mg (Group II, n=30), 0.06 mg (Group III, n=31) or 0.25 mg (Group IV, n=33) morphine. The control group consisted in 25 further patients not included in the dose-effect study and receiving a placebo injection of normal saline in the interspinous ligament. A blinded observer recorded the occurrence of pruritus, nausea, vomiting, urinary retention and respiratory depression (respiratory rate<6 bpm) at 2, 4 and 24 h after injection. RESULTS: Clinically significant pain relief was observed in all patients receiving intrathecal morphine but only six patients (25%) of the control group (P=0.0005). The incidence of pruritus was lower in patients of Groups III (6%) and IV (3%) than in Groups I (12%) and II (20%) (P=0.002). The incidence of nausea and vomiting was higher at 2- and 4-h observation times, and decreased 24 h after intrathecal injection. Surprisingly, nausea was more frequent in Groups I (56%) and II (50%) than in Groups III (33%) and IV (24%) (P=0.0005). Vomiting was higher in patients receiving morphine than in control group, but without differences among the four doses. No urinary retention was observed in the control group, while 2 h after intrathecal injection urinary retention was observed in 20-40% of cases, and decreased to less than 10% 24 h after spinal injection without differences among the four doses. CONCLUSIONS: The onset and incidence of minor opioid-related side-effects after intrathecal morphine administration do not depend on its dose, occurring with even very small doses of morphine. Accordingly, they can be considered as a patient-dependent effect of the drug, suggesting the presence of a primary dose-independent excitatory component that might be related to the theory of the bimodal activation of opioid receptors. The very low incidence major respiratory depression prevents us from drawing any conclusion about the dose-effect relationship for this side-effect, and further properly powered studies should be advocated to evaluate major respiratory depression after spinal morphine.     

Additional antiproteinuric effect of ultrahigh dose candesartan: a double-blind, randomized, prospective study

Proteinuria indicates future renal and cardiovascular morbidity, and, conversely, its reduction is associated with improved outcome. In a randomized, double-blind trial with parallel group design, the antiproteinuric effect of candesartan at high doses was analyzed. Patients with normal or mildly impaired renal function, protein excretion rate of 1 to 10 g/d, and treatment with an angiotensin-converting enzyme inhibitor or angiotensin receptor blocker for 3 mo were eligible. After a 4-wk treatment with 16 mg/d candesartan, patients (n = 32) were allocated to double-blind therapy with either 32 or 64 mg/d candesartan for 12 wk (including 4 wk of uptitration), followed again by 4 wk of candesartan 16 mg/d. Proteinuria at study entry was similar in both groups (geometric mean [95% confidence interval (CI)]; 32 mg/d candesartan 2.14 g/d [95% CI, 1.45 to 3.17]; 64 mg/d candesartan 2.54 g/d [95% CI, 1.91 to 3.40]; NS). After the double-blind treatment phase, proteinuria was reduced to 1.42 g/d (0.85 to 2.37) in the 64-mg/d group (P = 0.017), without any change in the 32-mg/d group (2.02 g/d [95% CI, 1.26 to 3.26]). The change in proteinuria differed between the two groups in absolute (P = 0.025) and relative terms (-29 +/- 50 versus -0 +/- 26%; P = 0.012). After downtitration to 16 mg/d candesartan, proteinuria increased again to 2.38 g/d (1.57 to 3.62) in the 64-mg/d group (P = 0.001) but remained unchanged in the 32-mg/d group (2.04 g/d [95% CI, 1.17 to 3.57]; NS). No change in BP was noticed in response to the different doses of candesartan. These data indicate an additive antiproteinuric effect of ultrahigh dose of the angiotensin receptor blocker candesartan compared with standard dose.     

Intrasurgical use of steroids on carpal tunnel syndrome: a randomized,prospective, double-blind controlled study

We studied steroid irrigation of the median nerve during surgical decompression in carpal tunnel syndrome through a prospective randomized controlled study. After sample size calculation, 20 patients were randomized into two groups: one group had a release of the transverse carpal ligament alone, and the other one had a release associated with steroid irrigation of the median nerve. The patients were evaluated preoperatively and postoperatively at 15 days and 2 months through a widely used and validated patient-oriented measure (the Carpal tunnel questionnaire) and through neurophysiological evaluation. The follow-up assessment showed significant differences in the postoperative evolution between the two groups with regard to symptoms: symptoms were less in the steroid-treated group both at 15 days (p>0.035; z=−2.9) and at two months (p<0.005; z=−2.8). This suggests that steroid irrigation of the median nerve offers benefit compared with the transverse carpal ligament release alone. This study provides clear evidence of the use-fulness of the procedure in the post-operative evolution of symptoms.     

Local anesthesia for extracorporeal shock wave lithotripsy: a double-blind, prospective, randomized study

OBJECTIVE: The efficacy of local anesthesia in decreasing intravenous analgesic requirements during extracorporeal shock wave lithotripsy with a second-generation lithotriptor was studied. METHODS: Subcutaneous infiltration was performed before the procedure. Sixty-nine patients (ASA I-II) were randomly allocated into four groups. Lidocaine 1% plus epinephrine (5 microg/ml) were infiltrated subcutaneously in a group of patients with ureteral stones (group UL), and a group with renal stones (group RL). The same amount of saline was administered to a group of patients with ureteral stones (group UC), and a group with renal stones (group RC). RESULTS: Patients with ureteral stones needed higher doses of intravenous analgesic. Neither patients with renal stones nor patients with ureteral stones administered local anesthetic required less intravenous analgesic than patients given placebo. CONCLUSION: Local anesthesia did not decrease the requirement of intravenous doses of analgesics in patients treated with a second-generation lithotriptor (Dornier MPL 9000).     

Tranexamic acid administration after cardiac surgery: a prospective, randomized, double-blind, placebo-controlled study

BACKGROUND: Many different doses and administration schemes have been proposed for the use of the antifibrinolytic drug tranexamic acid during cardiac surgery. This study evaluated the effects of the treatment using tranexamic acid during the intraoperative period only and compared the results with the effects of the treatment continued into the postoperative period. METHODS: Patients undergoing elective cardiac surgery with use of cardiopulmonary bypass (N = 510) were treated intraoperatively with tranexamic acid and then were randomized in a double-blind fashion to one of three postoperative treatment groups: group A: 169 patients, infusion of saline for 12 h; group B: 171 patients, infusion of tranexamic acid, 1 mg x kg(-1) x h(-1) for 12 h; group C: 170 patients, infusion of tranexamic acid, 2 mg x kg(-1) x h(-1) for 12 h. Bleeding was considered to be a primary outcome variable. Hematologic data, allogeneic transfusions, thrombotic complications, intubation time, and intensive care unit and hospital stay duration also were evaluated. RESULTS: No differences were found among groups regarding postoperative bleeding and outcomes; however, the group treated with 1 mg x kg(-1) x h(-1) tranexamic acid required more units of packed red blood cells because of a significantly lower basal value of hematocrit, as shown by multivariate analysis. CONCLUSIONS: Prolongation of treatment with tranexamic acid after cardiac surgery is not advantageous with respect to intraoperative administration alone in reducing bleeding and number of allogeneic transfusions. Although the prevalence of postoperative complications was similar among groups, there is an increased risk of procoagulant response because of antifibrinolytic treatment. Therefore, the use of tranexamic acid during the postoperative period should be limited to patients with excessive bleeding as a result of primary fibrinolysis.     

控制气管导管套囊压力对全麻手术患者气管插管相关性并发症的影响:前瞻性、多中心、随机、双盲研究

目的 探讨控制气管导管套囊压力对全麻手术患者气管插管相关性并发症的影响.方法 本研究为前瞻性、多中心、随机、双盲研究.择期拟行全麻手术患者509例,ASA分级Ⅰ或Ⅱ级,年龄11～89岁,体重35～92kg,性别不限,随机分为2组:对照组(C组)和套囊压力测定组(CPM组),记录手术时间和带管时间.各组随机选取20例带管时间120～180 min的患者,于拔除气管导管时行纤维支气管镜检查.拔除气管导管后24 h内随访咳嗽及痰中带血等气管插管相关性并发症的发生情况.结果 两组患者年龄、性别构成比、手术时间及带管时间差异无统计学意义(P＞0.05).与C组比较,CPM组患者咽喉痛及痰中带血的发生率降低(P＜0.05);随带管时间延长,C组咽喉痛及痰中带血的发生率均升高,CPM组仅咽喉痛的发生率升高(P＜0.01).纤维支气管镜检查可见气管粘膜不同程度损伤,C组较CPM组严重.结论 控制气管导管套囊压力有助于减少全麻手术患者术后气管插管相关性并发症的发生.     

Clonidine premedication effects on inhaled induction with sevoflurane in adults: a prospective, double-blind, randomized study

BACKGROUND: The purpose of this study was to evaluate whether oral clonidine premedication becomes an alternative to N2O in terms of shortening the induction time and attenuation of the adrenergic response to tracheal intubation during inhalation induction with sevoflurane, and to evaluate the quality of anesthetic induction according to the patient's satisfaction. METHODS: We studied 84 female patients who were randomly allocated into four study groups: Groups I and II received a placebo orally, and Groups III and IV received clonidine at 150 and 300 microg, respectively, 90 min before induction of anaesthesia. Patients were anesthetized using a triple-deep-breath technique with 5% sevoflurane in Groups I, III and IV, and with 60% N2O-5% sevoflurane in group II. RESULTS: Induction time was significantly longer (P < 0.05) in Group I. Increases in mean blood pressure and heart rate after tracheal intubation were significantly suppressed in Groups III and IV but not in Group II compared with Group I. Comfort and impression of anesthesia was better in Groups III and IV than in Groups I and II. CONCLUSION: In volatile anesthetic induction, pre-anesthetic clonidine may become an alternative to N2O and may provide more comfort than with N2O.