Prospective, randomized, controlled clinical trial of a novel matrix hemostatic sealant in children undergoing adenoidectomy.

PROBLEM ADDRESSED: Floseal is a novel matrix hemostatic sealant composed of collagen-derived particles and topical bovine-derived thrombin. It is applied as a high-viscosity gel for hemostasis and has been clinically proven to control bleeding. This study is a prospective, randomized, controlled clinical trial of Floseal sealant compared to traditional suction cautery hemostasis in children undergoing adenoidectomy. METHODS AND MEASURES: Seventy patients (mean age 7.0 yrs, 45.7% male) with obstructive sleep apnea underwent traditional cold steel adenoidectomy with an adenoid curette and were then randomized to receive the hemostatic sealant (Floseal) or cautery to obtain hemostasis. Patients were crossed over to the other hemostatic technique if hemostasis was not achieved after more than 100 mL of blood loss or 15 minutes elapsed time. Objective data collected included time to hemostasis and blood loss during hemostasis. Visual analog scales (VAS) were used to record subjective data by the operating surgeon including bleeding following adenoid pack removal (0 = none, 3 = brisk) and ease of operation (1 = extremely easy, 6 = extremely difficult). Parents recorded diet on a journal and were contacted by phone at postoperative day 7 and questioned with regard to return to regular diet and use of narcotics. RESULTS: Compared to patients in the cautery group (n = 35), Floseal patients (n = 35) had significantly shorter times to hemostasis (0.6 +/- 1.3 minutes vs 9.5 +/- 5.4 minutes [mean +/- SD], P < 0.001), less blood loss (2.5 +/- 9.2 mL vs 29.4 +/- 27.1 mL, P < 0.001), less subjective bleeding (0.0 +/- 0.6 vs 2.0 +/- 0.7, [median 4-point VAS +/- SD], P < 0.001), and subjectively easier operations (2.6 +/- 1.0 vs 5.2 +/- 1.0 [mean 6-point VAS +/- SD], P < 0.001). Furthermore, Floseal patients returned to regular diet earlier (2.7 +/- 0.7 vs 4.1 +/- 0.5 days [mean +/- SD], P < 0.001) and had less use of narcotics at 7 days postoperatively (40% vs 69%, P < 0.05). Lastly, three patients in the cautery group were crossed over to the Floseal group, but no Floseal subjects were crossed over to the cautery group. The retail cost of Floseal is US 85 dollars. Operating room costs are estimated at US 12 dollars/minute. Reducing the operative length by 8.9 minutes on average produces a cost savings of US 106.80 dollars per operation. There were no complications in either experimental group including postoperative hemorrhage, hospitalization, blood transfusion, or aspiration. CONCLUSIONS: Floseal matrix hemostatic sealant is a safe, efficacious, easy, and cost-effective technique for obtaining hemostasis in children undergoing adenoidectomy. Limitations of the study include the fact that it is nonblinded, which does allow for some bias in the subjective data recorded. However, utilizing 4 different operating surgeons, 3 of whom were not affiliated with the study, minimized this. CLINICAL SIGNIFICANCE OF STUDY: This study demonstrates the safety and efficacy of a novel hemostatic sealant in children undergoing adenoidectomy. Floseal matrix hemostatic sealant can be used as a first-line hemostatic agent, and it is a good tool in the armamentarium of otolaryngologists who encounter significant bleeding following adenoidectomy.     

Comparative study of the efficacy of the common topical hemostatic agents with fibrin sealant in a rabbit aortic anastomosis model

OBJECTIVE: The purpose of this study was to compare the hemostatic efficacy of the common surgical hemostatic agents with fibrin sealant (FS) and to assess their functional strength to secure hemostasis in lieu of placing additional sutures. METHODS: End-to-end anastomosis of transected abdominal aorta was performed in moderately anticoagulated rabbits using 4 or 6 interrupted sutures. The suture line was covered either with gauze alone ("untreated") or with gauze plus Gelfoam, Avitene, Surgicel, FloSeal, or FS, following which blood flow was restored. Blood loss was absorbed by gauze and measured. The surviving rabbits were recovered and the repaired vessel was examined histologically 4 weeks after operation. The investigators were blinded to the treatment groups. Aortic anastomoses using 8 or 12 sutures (untreated) were also performed. RESULTS: Untreated 4-suture anastomosis of aorta resulted in a profuse hemorrhage with an average 108.0 +/- 19.2 (mean +/- SD) ml blood loss and 100% mortality (n = 4). FS application sealed the anastomoses, prevented blood loss (P < 0.01 vs untreated) and exsanguination of the rabbits (n = 4). Other hemostatic agents reduced the bleeding to varying degrees compared to the untreated animals (Gelfoam 66.4 +/- 17.6, Avitene 80.6 +/- 34, Surgicel 66.7 +/- 16.7, FloSeal 44.2 +/- 8.5 ml blood loss, n = 4/group), but the changes were not statistically significant. One to three rabbits in each group survived the operation. Six-suture aortic anastomoses, untreated, resulted in 67.7 +/- 21.8 ml blood loss and 100% survival (n = 6). Application of FS produced immediate and sustained hemostasis in all the animals (P < 0.01 vs untreated). Other hemostatic agents also reduced the bleeding (Gelfoam 42.5 +/- 10, Avitene 50.9 +/- 12.4, Surgicel 32.1 +/- 14, FloSeal 33.9 +/- 5.4 ml blood loss, n = 6/group), but the changes were not statistically significant. The 8- and 12-suture aorta repairs resulted in a moderate blood loss (43.9 +/- 19 and 21.3 +/- 14.9 ml, respectively), followed by a stable hemostasis that precluded the need to use any hemostatic agent. The aortic cross-clamping time of the 12-suture and time to hemostasis for both the 8- and the 12-suture techniques were significantly longer than those of the 4-suture plus FS application (P < 0.01, P < 0.01 and P < 0.05, respectively). CONCLUSION: In a moderate coagulopathy, FS was proven to be the most efficacious hemostatic agent, producing immediate and sustained hemostasis at the arterial anastomotic site. This high efficacy is in part attributed to the strong tissue adhesive property of this agent. FS application may potentially ease the anastomosis and shorten the duration of timely critical vascular procedures.     

Coblation adenotonsillectomy: an improvement over electrocautery technique?

OBJECTIVES: To compare postoperative complication rates of coblation and electrocautery adenotonsillectomies. STUDY DESIGN: Retrospective chart review. RESULTS: From January 2000 to June 2004, 1997 pediatric patients underwent adenotonsillectomy. 745 coblation, and 1252 electrocautery tonsillectomies were performed. Primary bleed, secondary bleed, and dehydration were seen in 3, 35, and 23 coblation, and 9, 41, and 64 electrocautery tonsillectomies, respectively. Data analysis revealed no significant difference in primary and secondary hemorrhage rate, but a higher dehydration rate in the electrocautery group (P=0.0423). A total of 602 coblation, 763 curette/cautery, and 632 electrocautery adenoidectomies were performed. Neck pain was seen in 0, 17, and 3 patients, respectively. Data analysis showed a higher incidence of neck pain with the curette/cautery technique compared with coblator and cautery techniques (P=0.0006 and P=0.0119, respectively). CONCLUSIONS: Coblation tonsillectomy had similar rates of primary and secondary hemorrhage when compared with electrocautery tonsillectomy but a lower incidence of postoperative dehydration. Coblation adenoidectomy caused less postoperative neck pain than curette/cautery adenoidectomy without significant advantage over cautery adenoidectomy. EBM rating: B-3b.     

A randomized, prospective, parallel group study comparing the Harmonic Scalpel to electrocautery in thyroidectomy

BACKGROUND: Exhaustive hemostasis is essential to successful thyroidectomy. Electrocoagulation to control bleeding has the potential risk of injuring the surrounding structures from lateral dispersion of heat. The Harmonic Scalpel (HS) cuts and coagulates simultaneously using mechanical vibration rather than high temperatures. Because its use in thyroidectomies has been limited, we sought to compare procedure parameters and complications of thyroidectomies performed using the HS with those using electrocoagulation. METHODS: Sixty patients were randomized into 2 surgical groups, HS and the standard technique using electrocautery and ligatures as the primary hemostatic method. A sample t test or Wilcoxon rank sum test was used to compare the following parameters: operative time, number of ligatures, blood loss, pain intensity, need for extra dose(s) of analgesic, incidence of recurrent laryngeal nerve palsy, and hypoparathyroidism. RESULTS: Both groups of 30 patients were comparable in age, gender, and nature of disease. In 38 patients (63%), surgery was performed for benign disease, and in 22 (37%), for differentiated carcinoma. Operative time (arithmetic mean +/- SD) was 25 minutes less in the HS group (96 +/- 23 vs 121 +/- 34, P = .005). Median number of ligatures in the HS group was 1 (range, 0-7) versus 17 (range, 6-28) ( P < .001). Mean blood loss, estimated by gauze weight, was less with HS (35 +/- 27 mL vs 54 +/- 51 mL, P = .06). Drainage during the first 24 postoperative hours and pain intensity during the first postoperative week were similar in both groups. There were no episodes of persistent nerve palsy or hypoparathyroidism in either group. CONCLUSION: The use of HS in thyroidectomies requires less operative time than does electrocoagulation.     

Prognostic significance of preoperative plasma D-dimer level in patients with surgically resected clinical stage I non-small cell lung cancer: a retrospective cohort study

Flowable haemostatic agents have been shown to be superior to non-flowable agents in terms of haemostatic control and need for transfusion products in patients undergoing cardiac surgery. We investigated the economic impact of the use of a flowable haemostatic agent (Floseal) compared with non-flowable oxidised regenerated cellulose (ORC) agent in primary elective cardiac surgery from the perspective of the UK National Health Service (NHS). A cost-consequence framework based upon clinical data from a prospective trial and an observational trial and NHS-specific actual reference costs (2016) was developed to compare the economic impact of Floseal with that of ORC. The individual domains of care investigated comprised complications (major and minor) avoided, operating room time savings, surgical revisions for bleeding avoided and transfusions avoided. The cost impact of Floseal versus ORC on ICU days and extended bed days avoided was modelled separately. Compared with ORC, the use of Floseal would be associated with overall net savings to the NHS of £178,283 per 100 cardiac surgery patients who experience intraoperative bleeding requiring haemostatic therapy. Cost savings were apparent in all individual domains of care (complications avoided: £83,536; operating room time saved: £63,969; surgical revisions avoided: £34,038; and blood transfusions avoided: £22,317). Cost savings per 100 patients with Floseal over ORC in terms of ICU days avoided (n = 30) and extended bed days avoided (n = 51.7) were £57,960 and £21,965, respectively. A sensitivity analysis indicated that these findings remained robust when the model parameters representing the clinical benefit of Floseal over ORC were reduced by up to 20%. Despite higher initial acquisition costs, the use of flowable haemostatic agents achieves substantial cost savings over non-flowable agents in cardiac surgery. These cost savings commence during the operating theatre and appear to continue to be realised throughout the postoperative period.     

Comparison of posttonsillectomy pain using the ultrasonic scalpel, coblator, and electrocautery.

OBJECTIVE: To compare postoperative tonsillectomy pain between 3 commonly used surgical devices: the Harmonic Ultrasonic Scalpel (Ethicon Endo-Surgery, Cincinnati, OH), the Coblator (ArthroCare Corp, Sunnyvale, CA), and electrocautery. STUDY DESIGN AND SETTING: A prospective, randomized trial. One hundred thirty-four patients were randomly assigned to receive a tonsillectomy with 1 of 3 surgical devices. All patients were asked to fill out a postoperative diary. RESULTS: Statistically significant differences in pain scores were revealed between the Coblator and electrocautery (P = 0.02) and between the Coblator and the Ultrasonic Scalpel (P = 0.003), with the Coblator having lower pain scores. Electrocautery and the Ultrasonic Scalpel did not differ significantly from each other. The Coblation method showed a strong trend toward quicker return to normal diet. CONCLUSION: Patients undergoing tonsillectomy with the Coblator device reported less pain over a 10-day period than patients undergoing tonsillectomy with electrocautery or the Ultrasonic Scalpel. Pain after tonsillectomy remains a major issue for our patients. The choice of surgical instrument appears to be one way to reduce this pain. EBM rating: A-1b.     

Comparative study of the hemostatic efficacy of a new human fibrin sealant: is an antifibrinolytic agent necessary?

BACKGROUND: Sustained hemostasis by fibrin sealant (FS) is critically important when it is used in trauma surgery. To purportedly delay fibrin degradation and prevent premature hemostatic failure, some FS products added an antifibrinolytic agent (e.g., bovine aprotinin). The purpose of this study was to compare the overall hemostatic efficacy of a new inhibitor-free FS obtained from the American Red Cross (ARC-FS) to a clinically available aprotinin-containing FS preparation (Tisseel). The need for addition of an antifibrinolytic agent was assessed under normal and high-fibrinolytic conditions. METHODS: The abdominal aortas of anesthetized rabbits were transected and anastomosed, end-to end, using only four interrupted sutures. The suture line was covered with approximately 2 mL of either type of FS and blood flow was restored. Blood loss was absorbed by gauze and measured. All rabbits were recovered and underwent histologic examination 4 weeks after operation. The efficacy of FS was also tested under a high-fibrinolytic state by treating the rabbits with human recombinant tissue plasminogen activator (0.15 mg/kg, 3-hour infusion). The investigators were blinded to the treatment groups. RESULTS: The majority (11 of 12) of deaths occurred because of bleeding at the suture line within 7 days of surgery. Sustained hemostasis by FS (>1 week) was required for normal tissue healing and long-term survival of animals. Application of ARC-FS to the suture line produced immediate hemostasis in 43% of animals (three of seven), with mean blood loss of 4.8 +/- 1.8 mL, and 86% long-term survival. Tisseel application produced immediate hemostasis in 13% of animals (one of eight), with mean blood loss of 26.9 +/- 7.0 mL (p < 0.05 vs. ARC-FS) and survival rate of 37% (three of eight). Under high-fibrinolytic conditions, ARC-FS produced immediate and complete hemostasis in seven of eight animals (88%), whereas the Tisseel demonstrated complete hemostasis in one of seven (p < 0.01). The ARC-FS rabbits had a blood loss of 1.9 +/- 1.9 mL and survival rate of 75% (six of eight), whereas the Tisseel animals had a mean blood loss of 30 +/- 6.0 mL and survival rate of 43% (three of seven) (p < 0.01). No detrimental effect on healing was noted with either product. CONCLUSION: ARC-FS provides effective and secure hemostasis against high-pressure arterial bleeding under both normal and high-fibrinolytic conditions. Addition of an antifibrinolytic agent such as aprotinin is not required to sustain the hemostatic function of this fibrin sealant.     

Comparison of morphine sulphate and codeine phosphate in children undergoing adenotonsillectomy

We undertook a double-blind study to evaluate equianalgesic doses of intramuscular morphine sulphate (0.15 mg.kg-1) and codeine phosphate (1.5 mg.kg-1) in 40 healthy children undergoing adenotonsillectomy. There were no significant differences in pain scores, analgesic requirements or sedation scores between the two groups over the following 24 h. More children vomited in the morphine group (60%) than the codeine group (30%) between one and six h after the procedure (P < 0.05). Codeine phosphate is associated with less postoperative vomiting than morphine sulphate while providing comparable postoperative analgesia for adenotonsillectomy.     

Extracardiac conduit versus lateral tunnel cavopulmonary connections at a single institution: impact on outcomes.

OBJECTIVE: To compare outcomes of extracardiac conduit and lateral tunnel Fontan connections in a single institution over a concurrent time period. METHODS: Between January 1994 and September 1998, 60 extracardiac conduit and 47 lateral tunnel total cavopulmonary connections were performed. Age, sex, and weight did not differ between the 2 groups. Compared with the lateral tunnel group (LT group), patients undergoing the extracardiac conduit procedure (EC group) had a trend to a higher incidence of morphologically right ventricle (EC group 48% vs LT group 32%; P <.09), a higher incidence of isomerism/heterotaxy syndrome (EC 22% vs LT 0%; P <.001), worse atrioventricular valve regurgitation (EC 11% moderate-plus vs LT 0%; P <.06), and lower McGoon indices (EC 1.8 +/- 0.5 vs LT 2.1 +/- 0.5; P <.03). Preoperative arrhythmias, transpulmonary gradients, room air oxygen saturations, ejection fractions, ventricular end-diastolic pressure, and pulmonary artery distortion did not differ between groups. Cardiopulmonary bypass times and fenestration usage were similar in both groups. RESULTS: Overall operative mortality was 5.6% and did not differ between groups. The LT group had a significantly higher incidence of postoperative sinoatrial node dysfunction (45% vs EC group 15%; P <.007), supraventricular tachycardia (33% vs EC group 8%; P <.0009), and need for temporary postoperative pacing (32% vs 12%; P <.01). Median duration of intensive care unit stay (EC 2 days, range 1-10 days, vs LT 2.8 days, range 1-103 days; P <.07) and ventilatory support (EC 1 day, range 0.25-10 days, vs LT 1 day, range 0.25-99 days; P <.03) were all longer in the LT group. Median chest tube drainage (EC 8 days, LT 9 days) was similar in both groups. Follow-up averaged 2.5 +/- 1.4 years in the EC group and 2.8 +/- 1.9 years in the LT group. There were 2 late deaths. Overall survival is 94% at 1 month, 92% at 1 year, and 92% at 5 years. Late ejection fraction or atrioventricular valve function did not differ between groups. Intermediate follow-up Holter analysis showed a higher incidence of atrial arrhythmias in the LT group (23% vs 7%; P <.02). Multivariable analysis showed that (1) prolonged cardiopulmonary bypass time was the only independent predictor for perioperative mortality, prolonged ventilation and intensive care unit length of stay, and increased time to final removal of chest tube drains and (2) lateral tunnel Fontan connection is an independent predictor of early postoperative and intermediate atrial arrhythmias. CONCLUSIONS: Although patients in the EC group were at higher preoperative risk, their outcomes were comparable with those of the LT group. Use of the extracardiac conduit technique for the modified Fontan operation reduces the risk of early and midterm atrial arrhythmia.     

A Prospective,Randomized, Phase III Study to Evaluate the Efficacy and Safety of Fibrin Sealant Grifols as an Adjunct to Hemostasis as Compared to Cellulose Sheets in Hepatic Surgery Resections

Background

Local hemostatic agents have a role in limiting bleeding complications associated with liver resection.

Methods

In this randomized, phase III study, we compared the efficacy and safety of Fibrin Sealant Grifols (FS Grifols) with oxidized cellulose sheets (Surgicel®) as adjuncts to hemostasis during hepatic resections. The primary efficacy endpoint was the proportion of patients achieving hemostasis at target bleeding sites (TBS) within 4 min (T₄) of treatment application. Secondary efficacy variables were time to hemostasis (TTH) at a later time point if re-bleeding occurs and cumulative proportion of patients achieving hemostasis by time points T₂, T₃, T₅, T₇, and T₁₀.

Results

The rate of hemostasis by T₄ was 92.8% in the FS Grifols group (n?=?163) and 80.5% in the Surgicel® group (n?=?162) (p?=?0.01). The mean TTH was significantly shorter (p?<?0.001) in the FS Grifols group (2.8?±?0.14 vs. 3.8?±?0.24 min). The rate of hemostasis by T₂, T₅, and T₇ was higher and statistically superior in the FS Grifols group compared to Surgicel®. No substantial differences in adverse events (AE) were noted between treatment groups. The most common AEs were procedural pain (36.2 vs. 37.7%), nausea (20.9 vs. 23.5%), and hypotension (14.1 vs 6.2%).

Conclusions

FS Grifols was safe and well tolerated as a local hemostatic agent during liver resection surgeries. Overall, data demonstrate that the hemostatic efficacy of FS Grifols is superior to Surgicel® and support the use of FS Grifols as an effective local hemostatic agent in these surgical procedures.

     

Dexamethasone reduces postoperative vomiting and pain after pediatric tonsillectomy

PURPOSE: Previous studies on dexamethasone's antiemetic and analgesic potential in children undergoing tonsillectomy have produced conflicting results. The aim of this study was to evaluate the effects of a single dose of dexamethasone on the incidence and severity of postoperative vomiting and pain in children undergoing electrocautery tonsillectomy under standardized general anesthesia. METHODS: In a double-blinded study, 120 patients were randomly allocated to receive either dexamethasone 0.5 mg.kg(-1) (maximum dose 8 mg) iv or an equivalent volume of saline preoperatively. The incidence of early and late vomiting, need for rescue antiemetics, time to first oral intake, time to first demand of analgesia and analgesic consumption were compared in both groups. Pain scores used included Children's Hospital Eastern Ontario Pain Scale, "faces", and a 0-10 visual analogue pain scale. RESULTS: Compared with placebo, dexamethasone significantly decreased the incidence of early and late vomiting (P < 0.05, P < 0.001 respectively). Fewer patients in the dexamethasone group needed antiemetic rescue (P < 0.01). The time to first oral intake was shorter, and the time to first dose of analgesic was longer in the dexamethasone group (P < 0.01). Pain scores 30 min after extubation were lower (P < 0.05) in the dexamethasone group. At 12 and 24 hr postoperative swallowing was still significantly less painful in the dexamethasone group than in the control group (P < 0.01). CONCLUSION: Preoperative dexamethasone 0.5 mg.kg(-1) iv reduced both postoperative vomiting and pain in children after electrocautery tonsillectomy.     

Harmonic scalpel tonsillectomy in children: a randomized prospective study.

OBJECTIVE: In this randomized prospective study, we evaluated postoperative morbidity after use of the Harmonic Scalpel (HS), an ultrasonic dissector coagulator (Ethicon Endo-Surgery Inc, Cincinnati, OH), or conventional electrocautery (EC) during tonsillectomy. STUDY DESIGN AND SETTINGS: Pediatric subjects at 2 sites were randomized and underwent tonsillectomy. Intraoperative blood loss and operation duration were recorded. Postoperative parameters and complications were recorded. RESULTS: One hundred seventeen subjects completed the study. For the HS group, mean operative time was significantly longer (P < 0.001), but intraoperative blood loss was equivalent (P = 1.000). HS subjects slept soundly on postoperative days 1, 2, 3, and 14 (P = 0.041, 0.013, 0.022, and 0.038, respectively, compared with EC group). Mean postoperative pain scores trended lower for HS subjects on postoperative days 2, 3, and 4. CONCLUSION: The use of the HS in pediatric tonsillectomy showed no increase in intraoperative or postoperative blood loss compared with the use of EC, and HS provided possible clinical advantages over EC in patient comfort. SIGNIFICANCE: Tonsillectomy subjects in the HS group showed a statistically significant ability to sleep soundly, suggesting that the subjects experienced less pain. These data correlate with the observed decrease in pain scores.     

A multicentre collaborative study on the use of cold scalpel and electrocautery for midline abdominal incision

BACKGROUND: Although studies in animals demonstrated a better wound healing after abdominal incision with cold scalpel than with electrocautery, clinical experiences did not confirm these findings. The purpose of this study was to compare early and late wound complications between diathermy and scalpel in gynecologic oncologic patients undergoing midline abdominal incision. METHODS: Patients undergoing midline abdominal incision for uterine malignancies were divided into two groups according to the method used to perform the abdominal midline incision: cold scalpel and diathermy in coagulation mode. Early and late complications were compared. Logistic regressions were used for statistical analysis. RESULTS: Nine hundred sixty-four patients were included, of whom 531 were in the scalpel group and 433 in the electrocautery group. Both groups were similar with respect to demographic, operative, and postoperative characteristics. Univariate analysis revealed a higher incidence of severe wound complications in the scalpel group than in the electrocautery group (8 of 531 versus 1 of 433, P <0.05). After adjustment for confounding variables (eg, age, body mass index) no differences were found between groups. CONCLUSIONS: Scalpel and diathermy are similar in terms of early and late wound complications when used to perform midline abdominal incisions. Therefore the choice of which method to use remains only a matter of surgeon preference.     

Electrocautery versus cold knife technique adenotonsillectomy: a cost analysis.

OBJECTIVE: Much has been written about the merits of various techniques of adenotonsillectomy. Proponents of each technique tout many virtues over one another. However, cost remains one variable that has not been thoroughly addressed. In this study, we compared the surgery time, anesthesia time, bleeding, and cost between 2 well-established techniques. Electrocautery tonsillectomy/adenoid ablation was compared against traditional cold knife dissection with adenoid curette. STUDY DESIGN AND SETTING: A retrospective chart review of 275 patients in a large tertiary teaching hospital. RESULTS: The electrocautery group had overall savings of 8, 8, and 9 minutes in surgery, anesthesia, and operating room times, respectively. In terms of cost, the variable cost of the electrocautery group was 19% less than the cold knife dissection group. CONCLUSION/SIGNIFICANCE: This study demonstrated that cautery ablation of adenoids, when employed as part of adenotonsillectomy, enables the surgical team to save significant amount of time, and substantial cost for patients. EBM rating: B-3.     

Emergence delirium and postoperative pain in children undergoing adenotonsillectomy: a comparison of propofol vs sevoflurane anesthesia

Background: Emergence delirium (ED) is a frequent postoperative complication in young children undergoing ENT procedures and it may be exacerbated by sevoflurane anesthesia whereas propofol maintenance has been suggested to decrease the incidence of ED. The aim of this randomized, prospective, double‐blind study was to evaluate the effect of sevoflurane vs propofol anesthesia on the quality of recovery after adenotonsillectomy. Methods: Forty‐two patients were randomized to maintenance with either propofol or sevoflurane for adenotonsillectomy. At the conclusion of surgery, patients were extubated awake. ED and pain were assessed using the Pediatric Anesthesia Emergence Delirium (PAED) and the Children’s Hospital of Eastern Ontario Scale (CHEOPS), respectively. Higher PAED scores (0–20) indicate greater severity of ED. Nursing and parental satisfaction, hospital length of stay, postoperative nausea and vomiting (PONV), anesthetic complications, and subsequent emergency room admissions were also assessed. Results: Median PAED score was 14 in the propofol group and 17 in the sevoflurane group (NS). Propofol was associated with less pain medication required during recovery and a lower incidence of PONV (5.3% vs 36.8%, P < 0.05). Nursing and parental satisfaction as well as time spent in recovery room was similar for the two groups. Conclusion: Propofol anesthesia does not influence agitation after adenotonsillectomy, as measured by the PAED score. A PAED score of ≥10 was not useful in identifying patients with ED. However, propofol maintenance is associated with less need for pain medication in the recovery room and a lower incidence of PONV compared to sevoflurane anesthesia.     

Control of bone bleeding at the sternum and iliac crest donor sites using a collagen-based composite combined with autologous plasma: results of a randomized controlled trial

In a randomized controlled trial, hemostatic effectiveness of a collagen-based composite (experimental group) was compared with standard hemostatic methods (ie, electrocautery and collagen sponge) (control group) at two bone sites. Hemostatic success, time to "controlled bleeding," and time to "complete hemostasis" were determined at the sternal edge following median sternotomy (n=64) and at the iliac crest following bone graft harvest (n=19). Almost twice the percentage of sternal edge patients (83% versus 44%, P=.002) and nearly three times the percentage of iliac crest patients (83% versus 29%, P<.05) achieved complete hemostasis in the experimental group compared to controls. Time to controlled bleeding and complete hemostasis for all bone sites also favored the experimental group over the control group at highly significant levels (P<.0001 for most comparisons). There were no adverse events related to experimental treatment use. The results support the use of this investigational hemostatic agent to control cancellous bone bleeding.     

Assessment of topical hemostats in a renal hemorrhage model in heparinized rats

Various topical hemostatic agents or devices have been employed to address the challenges associated with hemorrhage from parenchymal organs during surgery or trauma. Their relative efficacy, however, has not been assessed in a single animal model. The objective of this study was to develop a small animal renal hemorrhage model for comparing hemostatic efficacy of various topical agents, and then to compare fibrin sealant (FS) to an existing standard of care for topical hemostasis. A left heminephrectomy was performed in anesthetized adult male Sprague-Dawley rats. Animals were anticoagulated with 2000 IU/kg heparin IV and various topical hemostatic agents were applied to the injury. Treatment groups included FS applied as a spray; FS applied through a cannula; gelatin sponge (GS) soaked in 1000 IU/mL thrombin solution; GS soaked in 300 IU/mL thrombin; dry GS; and fibrinogen without thrombin applied as a spray. The main endpoints of the study were incidence of hemostasis, blood loss, acute survival trends, and maintenance of mean arterial pressure (MAP). Three treatment groups, the two FS groups and the GS soaked in 1000 IU/mL thrombin, afforded significant hemostasis compared to the controls (P < 0.01). Both FS groups had significantly less blood loss, longer survival times, and maintained higher MAPs than the GS-treated groups. Quantitative dose effects and functional deficiencies in topical hemostatic products could be assessed using this animal model. The study demonstrated that liquid FS was significantly more efficacious than a GS soaked in thrombin for abating hemorrhage from a renal excision in a heparinized rat.     

Combined epidural-spinal opioid-free anaesthesia and analgesia for hysterectomy

Postoperative nausea and vomiting (PONV) are major problems after gynaecological surgery. We studied 40 patients undergoing total abdominal hysterectomy, allocated randomly to receive opioid-free epidural-spinal anaesthesia or general anaesthesia with continuous epidural bupivacaine 15 mg h-1 or continuous bupivacaine 10 mg h-1 with epidural morphine 0.2 mg h-1, respectively, for postoperative analgesia. Nausea, vomiting, pain and bowel function were scored on 4- point scales for 3 days. Patients undergoing general anaesthesia had significantly higher nausea and vomiting scores (P < 0.01) but significantly lower pain scores during rest (P < 0.05) and mobilization (P < 0.01). More patients undergoing general anaesthesia received antiemetics (13 vs five; P < 0.05), but fewer received supplementary opioids on the ward (eight vs 16; P < 0.05). We conclude that opioid- free epidural-spinal anaesthesia for hysterectomy caused less PONV, but with less effective analgesia compared with general anaesthesia with postoperative continuous epidural morphine and bupivacaine.      

Use of hemostatic sealant in tubeless percutaneous nephrolithotomy: Experience of a single institution from Taiwan

ObjectiveTubeless percutaneous nephrolithotomy (PCNL) offers several advantages over standard PCNL, including a shorter hospital stay, less analgesic requirement, and less postoperative pain. Using a fibrin sealant to seal the nephrostomy tract had become a widely accepted technique at the conclusion of tubeless PCNL. Our objective is to evaluate the efficacy and safety of tubeless PCNL using hemostatic matrix.Materials and methodsThis is a retrospective review of PCNL database at our hospital between June 2014 and March 2016. During this period, a total of 139 PCNLs were performed, including 41 with tubeless technique with adjunct of hemostatic matrix (Floseal; Baxter, Deerfield, IL, USA) at the conclusion of the PCNL procedure. The standard PCNL group and the tubeless PCNL group were compared in terms of demographic characteristics, perioperative data, stone characteristics, and complication rate.ResultsOf all 123 patients included in this study, 41 underwent tubeless PCNL. Demographic data of the two groups were comparable except for a higher proportion of male patients in the tubeless PCNL group (73.2% vs. 53.7%). Stone characteristics were also comparable in the two groups. Perioperative variables, including operative time, drop of serum hemoglobin level, and perioperative complication rate, revealed no statistical difference between the two groups. Tubeless PCNL was associated with less postoperative pain, less analgesic requirement, and a shorter hospital stay (p < 0.01).ConclusionTubeless PCNL with adjunct use of a hemostatic sealant can be considered as a safe treatment option for renal calculi with favorable outcome, without an increase in complications. Compared with standard PCNL, tubeless PCNL with hemostatic sealant use is associated with less pain, use of fewer narcotic agents, and a shorter hospital stay.     

Monopolar electrocautery, an alternative novel method of hemostasis during radical cystectomy: Preliminary report

Objective  During radical cystectomy, local hemostasis is a critical factor for surgical success. It can be accomplished with a variety of techniques including mechanical compression, ligatures, cauterization and laser. The aim of this work was to evaluate monopolar electrocautery alone for achieving hemostasis during radical cystectomy. Patients and Methods  In this prospective study 30 patients were scheduled for radical cystectomy over a period of 2 years at Al-Azhar University Hospitals using monopolar electrocautery as the only hemostatie tool. The parameters studied were: operative time, estimated blood loss and incidence of complications. The data were analyzed clinically and statistically. Results  Monopolar electrocautery as the only hemostatic tool during radical cystectomy resulted in a short operative time (35±5 minutes). The mean estimated blood loss was 150±50 ml. Intraoperative bleeding was encountered in 2 patients only and they received blood transfusion. The overall post-operative early (within the first month) complication rate was low (13.3%) and all complications were managed conservatively. Conclusion  Monopolar electrocauterization is a safe method for achieving hemostasis during radical cystectomy, with a significantly short operative time, low cost, low blood loss, a low cystectomy-related complication rate and a short hospital stay.