Sleep apnea multi-level surgery trial: long-term observational outcomes.

STUDY OBJECTIVES: The sleep apnea multi-level surgery (SAMS) randomized clinical trial showed surgery improved outcomes at 6 months compared to ongoing medical management in patients with moderate or severe obstructive sleep apnea (OSA) who failed continuous positive airway pressure therapy. This study reports the long-term outcomes of the multi-level surgery as a case series. METHODS: Surgical participants were reassessed >2 years postoperatively with the same outcomes reported in the main SAMS trial. Primary outcomes were apnea-hypopnea index (AHI) and Epworth sleepiness scale (ESS), with secondary outcomes including other polysomnography measures, symptoms, quality of life, and adverse events. Long-term effectiveness (baseline to long-term follow-up [LTFU]) and interval changes (6 month to LTFU) were assessed using mixed effects regression models. Control participants were also reassessed for rate of subsequent surgery and outcomes. RESULTS: 36/48 (75%) of surgical participants were reevaluated (mean (standard deviation)) 3.5 (1.0) years following surgery, with 29 undergoing polysomnography. AHI was 41/h (23) at preoperative baseline and 21/h (18) at follow-up, representing persistent improvement of -24/h (95% CI -32, -17; p < 0.001). ESS was 12.3 (3.5) at baseline and 5.5 (3.9) at follow-up, representing persistent improvement of -6.8 (95% CI -8.3, -5.4; p < 0.001). Secondary outcomes were improved long term, and adverse events were minor. Interval change analysis suggests stability of outcomes. 36/43 (84%) of the control participants were reevaluated, with 25 (69%) reporting subsequent surgery, with symptom and quality of life improvements. CONCLUSION: Multi-level upper airway surgery improves OSA burden with long-term maintenance of treatment effect in adults with moderate or severe OSA in whom conventional therapy failed. CLINICAL TRIAL: Multi-level airway surgery in patients with moderate-severe obstructive sleep apnea (OSA) who have failed medical management to assess change in OSA events and daytime sleepiness; https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=366019&isReview=true; ACTRN12614000338662.

Volumetric magnetic resonance imaging analysis of multilevel upper airway surgery effects on pharyngeal structure.

STUDY OBJECTIVES: The Sleep Apnea Multilevel Surgery (SAMS) trial found that modified uvulopalatopharyngoplasty with tonsillectomy (if tonsils present) combined with radiofrequency tongue ablation reduced obstructive sleep apnea (OSA) severity and daytime sleepiness in moderate-severe OSA. This study aimed to investigate mechanisms of effect on apnea-hypopnea index (AHI) reduction by assessing changes in upper airway volumes (airway space, soft palate, tongue, and intra-tongue fat). METHODS: This is a case series analysis of 43 participants of 51 randomized to the surgical arm of the SAMS trial who underwent repeat magnetic resonance imaging (MRI). Upper airway volume, length, and cross-sectional area, soft palate and tongue volumes, and tongue fat were measured. Relationships between changes in anatomical structures and AHI were assessed. RESULTS: The participant sample was predominantly male (79%); mean ± SD age 42.7 ± 13.3 years, body mass index 30.8 ± 4.1 kg/m2, and AHI 47.0 ± 22.3 events/hour. There were no, or minor, overall volumetric changes in the airway, soft palate, total tongue, or tongue fat volume. Post-surgery there was an increase in the minimum cross-sectional area by 0.1 cm2 (95% confidence interval 0.04-0.2 cm2) in the pharyngeal airway, but not statistically significant on corrected analysis. There was no association between anatomical changes and AHI improvement. CONCLUSIONS: This contemporary multilevel upper airway surgery has been shown to be an effective OSA treatment. The current anatomical investigation suggests there are not significant post-operative volumetric changes associated with OSA improvement 6-month post-surgery. This suggests that effect on OSA improvement is achieved without notable deformation of airway volume. Reduced need for neuromuscular compensation during wake following anatomical improvement via surgery could explain the lack of measurable volume change. Further research to understand the mechanisms of action of multilevel surgery is required. CLINICAL TRIAL: This manuscript presents a planned image analysis of participants randomized to the surgical arm or the clinical trial multilevel airway surgery in patients with moderate-severe obstructive sleep apnea (OSA) who have failed medical management to assess change in OSA events and daytime sleepiness. https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=266019&isReview=true%20Australian%20New%20Zealand%20Clinical%20Trials%20Registry%20ACTRN12514000338662, prospectively registered on March 31, 2014.

Effect of Multilevel Upper Airway Surgery vs Medical Management on the Apnea-Hypopnea Index and Patient-Reported Daytime Sleepiness Among Patients With Moderate or Severe Obstructive Sleep Apnea: The SAMS Randomized Clinical Trial.

Importance: Many adults with obstructive sleep apnea (OSA) use device treatments inadequately and remain untreated. Objective: To determine whether combined palatal and tongue surgery to enlarge or stabilize the upper airway is an effective treatment for patients with OSA when conventional device treatment failed. Design, Setting, and Participants: Multicenter, parallel-group, open-label randomized clinical trial of upper airway surgery vs ongoing medical management. Adults with symptomatic moderate or severe OSA in whom conventional treatments had failed were enrolled between November 2014 and October 2017, with follow-up until August 2018. Interventions: Multilevel surgery (modified uvulopalatopharyngoplasty and minimally invasive tongue volume reduction; n = 51) or ongoing medical management (eg, advice on sleep positioning, weight loss; n = 51). Main Outcomes and Measures: Primary outcome measures were the apnea-hypopnea index (AHI; ie, the number of apnea and hypopnea events/h; 15-30 indicates moderate and >30 indicates severe OSA) and the Epworth Sleepiness Scale (ESS; range, 0-24; >10 indicates pathological sleepiness). Baseline-adjusted differences between groups at 6 months were assessed. Minimal clinically important differences are 15 events per hour for AHI and 2 units for ESS. Results: Among 102 participants who were randomized (mean [SD] age, 44.6 [12.8] years; 18 [18%] women), 91 (89%) completed the trial. The mean AHI was 47.9 at baseline and 20.8 at 6 months for the surgery group and 45.3 at baseline and 34.5 at 6 months for the medical management group (mean baseline-adjusted between-group difference at 6 mo, -17.6 events/h [95% CI, -26.8 to -8.4]; P < .001). The mean ESS was 12.4 at baseline and 5.3 at 6 months in the surgery group and 11.1 at baseline and 10.5 at 6 months in the medical management group (mean baseline-adjusted between-group difference at 6 mo, -6.7 [95% CI, -8.2 to -5.2]; P < .001). Two participants (4%) in the surgery group had serious adverse events (1 had a myocardial infarction on postoperative day 5 and 1 was hospitalized for observation following hematemesis of old blood). Conclusions and Relevance: In this preliminary study of adults with moderate or severe OSA in whom conventional therapy had failed, combined palatal and tongue surgery, compared with medical management, reduced the number of apnea and hypopnea events and patient-reported sleepiness at 6 months. Further research is needed to confirm these findings in additional populations and to understand clinical utility, long-term efficacy, and safety of multilevel upper airway surgery for treatment of patients with OSA. Trial Registration: Australian New Zealand Clinical Trials Registry: ACTRN12614000338662.

Partial Adenoidectomy in Patients With Palatal Abnormalities.

BACKGROUND: Velopharyngeal insufficiency is a feared complication of adenoidectomies in patients with palatal abnormalities. Thus, the benefits of adenoidectomy in this population are less understood. The techniques of partial adenoidectomy aim to preserve velopharyngeal closure while sufficiently debulking the nasal airway to ameliorate obstruction and snoring. METHODOLOGY: Systematic review of online databases using a combination of search terms including "cleft palate," "submucosal cleft palate," "short palate," "adenoidectomy," "partial adenoidectomy," "subtotal adenoidectomy," and "powered adenoidectomy." Two independent reviewers assessed the eligibility of each study based on predefined inclusion criteria. RESULTS: From 323 studies identified, 8 were included. All were retrospective case series, except 1 prospective study. Study period ranged from 1.1 to 14 years (median 7.5 years). There were 172 patients with a cleft palate (n = 80), submucous cleft palate (n = 67) or another defined palatal abnormality [short soft palate (n = 14), bifid uvula (n = 4), questionable palatal mobility (n = 4) or incomplete CP (n = 3)] identified. Mean age was 5.5 years and just over half were male (58%). Nearly all patients showed improvement in nasal airway obstruction and snoring. The pooled risk for velopharyngeal insufficiency across all studies was 2 out of 122, which approximates to 1.6% of patients. There were very few complications. CONCLUSION: This is the first systematic review of partial adenoidectomy in patients with palatal abnormalities. Sub-total adenoidectomy in patients with submucosal cleft palate or repaired cleft palate appears to be a safe and efficacious procedure. There is; however, a need for prospective data collection using a standardized technique in large patient series required to properly assess outcomes.

Human papillomavirus, smoking status and outcomes in tonsillar squamous cell carcinoma.

It is now clear that the two separate entitles of tonsillar cancer, HPV induced and non-HPV induced (smoking induced), have significantly different presenting stage and outcomes. A significant proportion of patients with human papillomavirus positive tonsillar cancer have had exposure to smoking. We examined the combined effect of human papillomavirus and smoking on the outcomes and determined whether smoking can modify the beneficial effect of human papillomavirus. A total of 403 patients from nine centers were followed up for recurrence or death for a median of 38 months. Determinants of the rate of loco-regional recurrence, death from tonsillar cancer and overall survival were modeled using Cox regression. Smoking status was a significant predictor of overall survival (p = 0.04). There were nonstatistically significant trends favoring never smokers for loco-regional recurrence and disease specific survival. In addition, there was no statistically significant interactions between smoking and human papillomavirus (p-values for the interaction were 0.26 for loco-regional recurrence, 0.97 for disease specific survival and 0.73 for overall survival). The effect of smoking on loco-regional recurrence and disease specific survival outcomes was not statistically significant, nor was there significant evidence that the effect of smoking status on these outcomes was modified by HPV status. Irrespective of HPV status, however, smokers did have poorer overall survival than never-smokers, presumably due to effects of smoking that are unrelated to the primary cancer.

Quality of life valuations of HPV-associated cancer health states by the general population.

OBJECTIVES: To obtain health-related quality of life valuations (ie, utilities) for human papillomavirus (HPV)-related cancer health states of vulval, vaginal, penile, anal and oropharyngeal cancers for use in modelling cost-effectiveness of prophylactic HPV vaccination. METHODS: Written case descriptions of each HPV-associated cancer describing the 'average' patient surviving after the initial cancer diagnosis and treatment were developed in consultation with oncology clinicians. A general overview, standard gamble questionnaire for each health state and a quiz was conducted in 120 participants recruited from the general population. RESULTS: In the included population sample (n=99), the average age was 43 years (range = 18-70 years) with 54% men, 44% never married/43% married, 76% education beyond year 12 and 39% employed full-time. The utility values for the five health states were 0.57 (95% CI 0.52 to 0.62) for anal cancer, 0.58 (0.53 to 0.63) for oropharyngeal cancer, 0.59 (0.54 to 0.64) for vaginal cancer, 0.65 (0.60 to 0.70) for vulval cancer and 0.79 (0.74 to 0.84) for penile cancer. Participants demonstrated a very good understanding of the symptoms, diagnosis and treatment of these cancers with a mean score of 9 (SD=1.1) on a 10-item quiz. CONCLUSIONS: This study provides utility estimates for the specific HPV-related cancers of vulval, vaginal, penile, anal and oropharyngeal cancers valued by a general population sample using standard gamble. The results demonstrate considerable quality of life impact associated with surviving these cancers that will be important to incorporate into modelling cost-effectiveness of prophylactic HPV vaccination in different populations.

Gastroesophageal reflux disease and chronic sinusitis: in search of an esophageal-nasal reflex.

BACKGROUND: This study was performed to explore whether or not a neural reflex linking the esophagus and the nasal airway exists, as a pathogenic mechanism accounting for the association between gastroesophageal reflux (GER) disease and chronic rhinosinusitis (CRS). A prospective trial of healthy human volunteers was performed. METHODS: Ten healthy volunteers without GER or sinonasal disease were investigated using an acid infusion challenge test. Normal saline and hydrochloric acid were infused into the lower esophagus through an esophageal manometry catheter. Nasal responses in symptom score, nasal inspiratory peak flow, and mucus production were analyzed after the esophageal challenge. RESULTS: A tendency for an increase in nasal mucus production was observed after esophageal stimulation with both normal saline and HCl. This returned to baseline level 45 minutes after the acid infusion. A similar trend was also observed with the measurements of nasal symptom scores and, to a lesser extent, nasal inspiratory peak flow. CONCLUSION: These results support the possibility that a neural reflex exists between the esophagus and the paranasal sinuses via the vagus nerve. If indeed present, the reflex-mediated rhinitis derived from this neuropathic inflammation may contribute to the development of CRS in patients with GER. Further study is required to define the relationship between GER and CRS.

Long term survival following the detection of circulating tumour cells in head and neck squamous cell carcinoma.

BACKGROUND: Techniques for detecting circulating tumor cells in the peripheral blood of patients with head and neck cancers may identify individuals likely to benefit from early systemic treatment. METHODS: Reconstruction experiments were used to optimise immunomagnetic enrichment and RT-PCR detection of circulating tumor cells using four markers (ELF3, CK19, EGFR and EphB4). This method was then tested in a pilot study using samples from 16 patients with advanced head and neck carcinomas. RESULTS: Seven patients were positive for circulating tumour cells both prior to and after surgery, 4 patients were positive prior to but not after surgery, 3 patients were positive after but not prior to surgery and 2 patients were negative. Two patients tested positive for circulating cells but there was no other evidence of tumor spread. Given this patient cohort had mostly advanced disease, as expected the detection of circulating tumour cells was not associated with significant differences in overall or disease free survival. CONCLUSION: For the first time, we show that almost all patients with advanced head and neck cancers have circulating cells at the time of surgery. The clinical application of techniques for detection of spreading disease, such as the immunomagnetic enrichment RT-PCR analysis used in this study, should be explored further.

Radiofrequency coblation for the resection of head and neck malignancies.

OBJECTIVE: To review the safety and efficacy of the use of radiofrequency coblation for endoscopic resection of upper aerodigestive tract malignancies and to compare length of procedures using coblation with CO(2) laser surgery. STUDY DESIGN AND SETTING: A retrospective case-note review of 40 adult patients with endoscopically treated mucosal squamous cell carcinoma of the head and neck, 20 having undergone resection using radiofrequency coblation and being case-matched to 20 treated with CO(2) laser. RESULTS: Coblation proved to be an effective method for resection of selected head and neck malignancies. It allows for much faster resection times than the CO(2) laser (P = 0.017) especially in the oropharynx (P = 0.007), but the large probes currently available can cause problems in assessment of adequate resection margins. CONCLUSIONS: Although current probe design limits the potential for resection of some tumors, radiofrequency coblation appears to be an attractive evolving technique for the endoscopic resection of selected upper aerodigestive tract malignancies.

Dissection of the submuscular recess (sublevel IIb) in squamous cell cancer of the upper aerodigestive tract: prospective study and systematic review of the literature.

BACKGROUND: Selective neck dissection is commonly used to clear occult neck metastases in the N0 neck. The aim of this study was to identify the incidence of occult metastases in lymph nodes of sublevel IIb (submuscular recess; SMR) in upper aerodigestive tract squamous cell carcinoma in the setting of clinically and radiologically staged N0 necks and to perform a systematic review of the literature on the incidence of metastases in this setting. METHODS: We conducted a prospective study of 50 neck dissections and systematic review of the literature. RESULTS: (A) Prospective study: Tissue dissected out from the SMR was sent separately for histopathologic analysis. Between 0 and 7 nodes were harvested from sublevel IIb. One patient had a metastatic node in sublevel IIb with extracapsular spread in the ipsilateral neck. No other positive nodes were detected. Sixteen necks showed occult metastases at other levels. (B) Systematic review: The review identified 14 articles with 903 necks suitable for inclusion. The overall incidence of metastatic disease at this sublevel in the context of an N0 neck from any site is 2.0% (18 of 903). The incidence of occult metastatic disease in sublevel IIb for oral cavity, oropharyngeal, and laryngeal cancer is 3.9% (11 of 279), 5.2% (5 of 96), and 0.4% (1 of 230) patients, respectively. Contralateral positive nodes (0.9%) and isolated metastases (0.3%) at this sublevel were rare. CONCLUSION: Nodal metastases are uncommon in the SMR even in the presence of positive nodes in adjacent sublevel IIa. There appears to be no advantage in performing contralateral SMR dissection in N0 necks and in laryngeal primaries.

Retrospective study of survival and treatment pattern in a cohort of patients with oral and oropharyngeal tongue cancers from 1987 to 2004.

This is a retrospective study of patients with oral and oropharyngeal tongue cancers who presented to the Royal Adelaide Hospital (RAH) from 1987 to 2004. The aims of this study were to determine sociodemographic and tumour characteristics, treatment patterns and five-year disease-specific survival of the disease. All cases of tongue cancers, including untreated and palliative cases, were identified through the Royal Adelaide Hospital Cancer Registry and were included in statistical analysis. A total of 212 cases of tongue cancer were identified. Patients less than 45 years of age accounted for 15% of cases and had a tendency to present with advanced stage disease. Squamous cell carcinoma was the most common histological type. Almost 30% of recorded cases were oropharyngeal or base of tongue cancers. Nearly half of the patients had advanced stage (III and IV) disease at presentation, which was significantly associated with rural area of residence, base of tongue sub-site and early diagnostic period. Treatment involved a multidisciplinary approach and majority of patients were treated with a curative intent. Palliative treatment was more likely to be given to patient with oropharyngeal tongue cancers or advance stage disease. There was no significant improvement of five-year disease-specific survival over the 18-year period. Poorer survival was significantly associated with age 45 years or older, oropharyngeal tongue cancers and advanced stage disease. Tongue cancer is an important health issue associated with poor survival. Early detection and diagnosis is important in order to improve survival rate for this malignancy.

Sino-orbital fistula: a complication of exenteration.

PURPOSE: To report the incidence, characteristics, and management of sino-orbital fistulas, a complication of orbital exenteration. DESIGN: Retrospective interventional case series. PARTICIPANTS: One hundred ten patients who underwent orbital exenteration at 2 orbital units. METHODS: Retrospective chart review of all cases of orbital exenteration between 1993 and 2005 at one orbital unit and between 1999 and 2005 at a second orbital unit. MAIN OUTCOME MEASURES: Incidence of sino-orbital fistulas. RESULTS: Seventy-three and 37 orbital exenterations were performed at the first and second orbital units, respectively. Five patients developed sino-orbital fistulas, 1 of whom developed 2 fistulas at separate sites. In the first unit, 4 fistulas developed in 3 of 73 (4.1%) patients who underwent orbital exenteration. In the second unit, 2 fistulas developed in 2 of 37 (5.4%) exenterated orbits. The majority (5/6) of fistulas occurred medially to the ethmoid sinus, whereas 1 occurred superiorly to the frontal sinus. Risk factors that may have contributed to fistula formation include radiotherapy (3/6), sinus disease (3/6), intraoperative penetration into a sinus (3/6), and immunocompromise (1/6). Management was tailored to the individual case and ranged from conservative socket hygiene to surgical repair with grafts or flaps. Four of the 6 fistulas recurred after repair. Three of these subsequently were closed successfully. Only 1 fistula persisted until the patient died from malignant disease. CONCLUSIONS: Sino-orbital fistulas are uncommon but not rare complications of orbital exenteration that may be predicted by several risk factors. Bothersome symptoms may necessitate treatment, which can range from conservative management to surgical repair with various grafts or flaps. Despite repair, fistulas may be difficult to eradicate.

Prevalence of pus in radiologically diseased sinuses in patients undergoing surgery for chronic rhinosinusitis.

OBJECTIVE: To establish the prevalence of pus in radiologically diseased sinuses in patients undergoing sinus surgery and to correlate this with the bacterial load in the sinuses. STUDY DESIGN AND SETTING: A prospective study performed on adult patients with the diagnosis of chronic sinusitis undergoing endoscopic sinus surgery at an Adelaide group of academic hospitals. In 45 consecutive and unselected patients, a radiologically diseased sinus was surgically opened, and a specially designed suction aspirator was placed into the sinus under endoscopic control. These aspirates were Gram stained and cultured to quantify the polymorphonuclear neutrophil count, bacterial flora, and bacterial colony count. The CT scans of all patients were graded by using the Lund-Mackay scoring system. RESULTS: A variety of bacteria, most commonly staphylococci, were cultured from a radiologically diseased sinus in 88% of patients. There was no correlation between the bacterial colony count and presence of pus, and only 11% of patients had microscopic evidence of inflammation in sinus aspirates. There was no correlation between the Lund-Mackay CT score and the presence of pus in the sinus. CONCLUSIONS: The majority of patients undergoing surgery for chronic sinusitis did not have a purulent exudate, and there was no correlation with the bacterial load. The usefulness of antibiotics in the treatment of chronic rhinosinusitis, in the absence of macroscopic pus, is questionable.

Sentinel node biopsy in squamous cell cancer of the oral cavity and oral pharynx: a diagnostic meta-analysis.

BACKGROUND: The sentinel node biopsy concept has been gaining support in the head and neck cancer literature during only the last few years, and several pilot studies have been published. This procedure aims to avoid unnecessary treatment to the clinically negative neck by identifying the patients with occult neck disease. METHODS: We performed a systematic review and a diagnostic meta-analysis of all published literature regarding sentinel node biopsies in head and neck cancer until December 2003 using established guidelines. Using the pooled sensitivity rates obtained from the meta-analysis and treatment outcomes from published literature, we created a decision analysis model to identify the treatment arm with better payoffs. RESULTS: A total of 301 patients with oral cavity primary tumors and 46 patients with oropharyngeal primary tumors from 19 articles were included for the meta-analysis. The pooled sensitivity result using the random effects model was 0.926 (95% confidence interval, 0.852-0.964). The cumulative payoff for the sentinel node biopsy arm was lower than that for the elective node dissection arm by about 1%. The payoffs were assigned for the recurrence and mortality rates only and did not take into account the morbidity caused by the procedures. CONCLUSIONS: The sentinel node biopsy procedure has shown high sensitivity rates in pilot studies for oral and oropharyngeal squamous cell cancer across the globe and is reliable and reproducible. This study provides a firm evidence base for forthcoming trials on the role of sentinel node biopsy in head and neck cancer.

An evaluation of effect of pterygopalatine fossa injection with local anesthetic and adrenalin in the control of nasal bleeding during endoscopic sinus surgery.

BACKGROUND: The aim of this study was to determine the effect of pterygopalatine fossa infiltration with lidocaine and adrenalin on bleeding in the surgical field during endoscopic sinus surgery. METHODS: A prospective blind randomized controlled trial was performed. Fifty-five patients were randomized to receive a unilateral transoral infiltration of the pterygopalatine fossa with 2 mL of 2% lidocaine and 1:80,000 adrenalin. The operating surgeon was blinded as to which side had been infiltrated at the start of surgery. The surgical field was graded on a previously validated surgical field grading scale every 15 minutes with the side being operated on alternated every 30 minutes. The pulse, mean arterial blood pressure, and end-tidal CO2 concentration were monitored with each surgical field observation. RESULTS: At each individual time point from 30 minutes to 3.5 hours there was a significant difference in surgical grade between injected and noninjected sides in favor of the injected side (p = 0.01). The difference between surgical grades averaged across all time points was slight but significant. The injected side had an overall mean of 2.59 (SE, 0.22) compared with 2.99 (SE, 0.23) for the noninjected side. Heart rate also was found to correlate independently to surgical grade. CONCLUSION: Injection of the pterygopalatine fossa resulted in an improved surgical field during endoscopic sinus surgery.

Effect of using multiple culture media for the diagnosis of noninvasive fungal sinusitis.

BACKGROUND: This study was designed to assess the relative efficiency of three different culture media for isolating fungi in patients suspected of having noninvasive fungal sinusitis. METHODS: A prospective study was performed of 209 operative samples of sinus "fungal-like" mucin from 134 patients on 171 occasions and processed for microscopy and fungal culture in Sabouraud's dextrose agar, potato dextrose agar, and broth media. RESULTS: Ninety-three (69%) of 134 patients had evidence of fungal infection. Two-thirds of patients had negative microscopy samples yet 56% of these went on to positive cultures. Forty-five percent cultured Aspergillus genus. Discrepancy between the fungi cultured in different media and on different occasions was common. With a single culture medium up to 19% of patients and 15% of samples would have been falsely labeled fungal negative. CONCLUSION: Increasing the number and type of fungal culture media used increases the number and range of fungal isolates from mucin in patients with the features of fungal sinusitis. Negative specimen microscopy is unreliable. All specimens should be cultured in multiple media and on multiple occasions when fungal sinusitis is suspected.

The effect of beta-blocker premedication on the surgical field during endoscopic sinus surgery.

OBJECTIVES/HYPOTHESIS: A number of previous studies have tried to assess the effects of hypotension on the surgical field during endoscopic sinus surgery. These studies have been limited by inadequate sample sizes, lack of a control group, and limited data collection. The aim of the present study was to determine whether the routine use of beta-blockers as a pre-medication could improve the operative field in endoscopic sinus surgery. STUDY DESIGN: A prospective, randomized, double-blinded, placebo-controlled trial. METHODS: Eighty patients undergoing endoscopic sinus surgery who fit the inclusion and exclusion criteria were randomly assigned to receive either a beta-blocker, Metoprolol (group 1), or a placebo tablet (group 2) 30 minutes before surgery. A standard anesthetic protocol was followed. At the commencement of surgery and at regular 15-minute intervals the surgical field, blood loss, heart rate, blood pressure, and isoflurane concentration were assessed. RESULTS: There was a significant difference in overall mean heart rate between the placebo and beta-blocker groups (P <.0001). In the entire group, surgical grade correlated with heart rate (r = 0.36, P <.05) but not with mean arterial blood pressure. Mean surgical grade was similar between the placebo and beta-blocker groups, but early in the study a significantly better surgical field was recorded in the beta-blocker group (P <.001). Surgical grade was significantly better in those with a mean heart rate of less than 60 beats per minute (P <.02). CONCLUSION: Although "optimum" conditions were present in the patients receiving beta-blocker, the authors thought that the grading system was not discriminating enough to demonstrate a significant difference between the groups. The crucial finding in the study was the correlation between heart rate and surgical grade in the entire group. During endoscopic sinus surgery surgery, anesthetic manipulations should be directed at maintaining a low heart rate.