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Background Chronic rhinosinusitis (CRS) is a common source of ill health; 11% of UK adults reported CRS symptoms in a worldwide population study. Guidelines are conflicting regarding whether antibiotics should be included in primary medical management, reflecting the lack of evidence in systematic reviews. Insufficient evidence to inform the role of surgery contributes to a fivefold variation in UK intervention rates. The objective of this trial is to establish the comparative effectiveness of endoscopic sinus surgery (ESS) or a prolonged course of antibiotics (clarithromycin) in adult patients with CRS in terms of symptomatic improvement and costs to the National Health Service compared with standard medical care (intranasal medication) at 6 months. Methods/design A three-arm parallel-group trial will be conducted with patients who remain symptomatic after receiving appropriate medical therapy (either in primary or secondary care). They will be randomised to receive: (1) intranasal medication plus ESS, (2) intranasal medication plus clarithromycin (250 mg) or (3) intranasal medication plus a placebo. Intranasal medication (current standard medical care) is defined as a spray or drops of intranasal corticosteroids and saline irrigations. The primary outcome measure is the SNOT-22 questionnaire, which assesses disease-specific health-related quality of life. The study sample size is 600. Principal analyses will be according to the randomised groups irrespective of compliance. The trial will be conducted in at least 16 secondary or tertiary care centres with an internal pilot at six sites for 6 months. Discussion The potential cardiovascular side effects of macrolide antibiotics have been recently highlighted. The effectiveness of antibiotics will be established through this trial, which may help to reduce unnecessary usage and potential morbidity. If ESS is shown to be clinically effective and cost-effective, the trial may encourage earlier intervention. In contrast, if it is shown to be ineffective, then there should be a significant reduction in surgery rates. The trial results will feed into the other components of the MACRO research programme to establish best practice for the management of adults with CRS and design the ideal patient pathway across primary and secondary care. Trial registration ISRCTN36962030 . Registered on 17 October 2018.

Purpose Nasal packing is frequently used after septoplasty and some complications caused by nasal packing are unavoidable. A nasal septal retainer has recently been developed. We evaluated the safety and clinical efficacy of the retainer in septoplasty, and the subjective symptoms of patients with the retainer were compared with Merocel nasal packing. Methods A prospective, randomized, controlled study was performed in patients who had undergone septoplasty. In total, 39 patients were randomized to receive Merocel ( n  = 17) or the retainer ( n  = 22) after septoplasty. The deviation of nasal septum and nasal mucosa was evaluated by endoscopy. The clinical efficacy and subjective symptoms were compared using the visual analog scale. Results During the packing/retaining period, the mean scores of headache, nasal obstruction, epiphora, and facial pressure in the retainer group were significantly lower than in the Merocel group ( P  < 0.05); the mean scores of nasal pain, nasal itching, rhinorrhea, dysphagia, and sleep disturbance in the retainer group were lower than in the Merocel group, but the difference did not reach statistical significance. On the removal of Merocel/retainer, nasal pain was significantly lower in patients with the retainer ( P  < 0.05). In the retainer group, the incidence of grade 1 bleeding was 45.5%, and grade 0 bleeding was 54.5%. In the Merocel group, the incidence of grade 2 bleeding was 23.5%, grade 1 was 47.1%, and grade 0 was 29.4%. Conclusions The nasal septal retainer is suitable for use after septoplasty with more beneficial effects than nasal packing.

Background Post-anesthetic emergence agitation is common after general anesthesia and may cause adverse consequences, such as injury as well as respiratory and circulatory complications. Emergence agitation after general anesthesia occurs more frequently in nasal surgery than in other surgical procedures. This study aimed to assess the occurrence of emergence agitation in patients undergoing nasal surgery who were extubated under deep anesthesia or when fully awake. Methods A total of 202 patients (18–60 years, American Society of Anesthesiologists classification: I–II) undergoing nasal surgery under general anesthesia were randomized 1:1 into two groups: a deep extubation group (group D) and an awake extubation group (group A). The primary outcome was the incidence of emergence agitation. The secondary outcomes included number of emergence agitations, sedation score, vital signs, and incidence of adverse events. Results The incidence of emergence agitation was lower in group D than in group A (34.7% vs. 72.8%; p  < 0.001). Compared to group A, patients in group D had lower Richmond Agitation-Sedation Scale scores, higher Ramsay sedation scores, fewer agitation episodes, and lower mean arterial pressure when extubated and 30 min after surgery, whereas these indicators did not differ 90 min after surgery. There was no difference in the incidence of adverse events between the two groups. Conclusions Extubation under deep anesthesia can significantly reduce emergence agitation after nasal surgery under general anesthesia without increasing the incidence of adverse events. Trial registration Registered in Clinicaltrials.gov (NCT04844333) on 14/04/2021.

Study objectiveBilateral endoscopic nasal surgery is usually associated with pain and sleep disturbance. The aim of this study was to evaluate the effects of dexmedetomidine-soaked nasal packing on analgesia and improvement of sleep quality in patients undergoing this surgery.MethodEighty patients were enrolled and randomly allocated into 4 groups. At the end of surgery, dexmedetomidine-soaked nasal packings were applied to three groups with a dosage of 1 μg kg−1 (D1), 2μg kg−1 (D2), 4 μg kg−1 (D4) and normal saline-soaked nasal packing (NS) was applied to a fourth group. The primary outcome was postoperative pain scores using a visual analog scale (VAS) recorded at six time points: before the surgery (T1); 2 h (T2), 8 h (T3), 24 h (T4), 48 h (T5) after surgery; and at the moment of nasal packing removal (T6). Secondary outcomes were postoperative sleep status evaluated by the Pittsburgh sleep quality index (PSQI) and subjective sleep quality value (SSQV). Factors affecting sleep, hemodynamic changes, and adverse events were also recorded.ResultsCompared with the NS group, dexmedetomidine-soaked nasal packing significantly relieved postoperative pain and improved sleep quality. The effect was similar between D2 and D4, which was greater than in D1. However, D2 was associated with fewer adverse events.ConclusionsDexmedetomidine-soaked nasal packing not only offers effective analgesia but also improves postoperative sleep quality in patients undergoing bilateral endoscopic nasal surgery. Taking effect and adverse events into consideration, a dosage of 2μg kg−1 may be optimal.Trial registrationwww.chictr.org.cn/index.aspx (ChiCTR1900025692) Retrospectively registered 5 September 2019

Nasal lavage with mupirocin has the potential to reduce sinonasal morbidity in endoscopic endonasal approaches for skull base surgery. To evaluate the effects of nasal lavage with and without mupirocin after endoscopic endonasal skull base surgery. A pilot randomised, controlled trial was conducted on 20 adult patients who had undergone endoscopic endonasal approaches for skull base lesions. These patients were randomly assigned to cohorts using nasal lavages with mupirocin or without mupirocin. Patients were assessed in the out-patient clinic, one week and one month after surgery, using the 22-item Sino-Nasal Outcome Test questionnaire and nasal endoscopy. Patients in the mupirocin nasal lavage group had lower nasal endoscopy scores post-operatively, and a statistically significant larger difference in nasal endoscopy scores at one month compared to one week. The mupirocin nasal lavage group also showed better Sino-Nasal Outcome Test scores at one month compared to the group without mupirocin. Nasal lavage with mupirocin seems to yield better outcomes regarding patients' symptoms and endoscopic findings.

The aim of this study was to investigate the effects of four different types of nasal packs on pain, nasal fullness and postoperative bleeding following septoplasty. Prospective randomised double blind study was conducted. The study group included 119 patients who underwent endonasal septoplasty under general anaesthesia. Four types of nasal packing materials were utilized: (1) Merocel standard 8-cm nasal dressing without airway, (2) Doyle Combo splint (DCS), (3) Merocel in a glove finger and (4) Vaseline gauze. All packs were removed at the 48th hour (±3 h) after the surgery. Three different variables were investigated following the surgical procedure: (1) pain, (2) nasal fullness and (3) bleeding after removal of the nasal packing material. DCS produced the greatest pain at the first and sixth postoperative hours. At the first postoperative day, the greatest pain score was reported for Merocel in the glove finger and the least for Merocel. The pain scores during the removal of the nasal packings were highest for Merocel and lowest for Merocel in the glove finger. DCS had the lowest nasal fullness score. Bleeding ratio was highest for Merocel, followed by Vaseline gauze, DCS and Merocel in the glove finger. Many different commercially available packing materials are presently used, each with inherent advantages and disadvantages. We evaluated the pain, nasal fullness and bleeding potential of four nasal packing materials and determined that Merocel had the highest pain potential during removal and the highest rate of bleeding following removal.

Background MACRO (Defining best Management for Adults with Chronic RhinOsinusitis) is an NIHR-funded programme of work designed to establish best practice for adults with chronic rhinosinusitis (CRS). The 7-year programme comprises three consecutive workstreams, designed to explore NHS care pathways through analysis of primary and secondary data sources, and to undertake a randomised controlled trial to evaluate a longer-term course of macrolide antibiotics and endoscopic sinus surgery for patients with CRS. A number of outstanding elements still required clarification at the funding stage. This paper reports an expert panel review process designed to agree and finalise the MACRO trial design, ensuring relevance to patients and clinicians whilst maximising trial recruitment and retention. Methods An expert panel, consisting of the MACRO Programme Management Group, independent advisors, and patient contributors, was convened to review current evidence and the mixed-method data collected as part of the programme, and reach agreement on MACRO trial design. Specifically, agreement was sought for selection of macrolide antibiotic, use of orally administered steroids, inclusion of CRS phenotypes (with/without nasal polyps), and overall trial design. Results A 12-week course of clarithromycin was agreed as the main trial comparator due to its increasing use as a first- and second-line treatment for patients with CRS, and the perceived need to establish its role in CRS management. Orally administered steroids will be used as a rescue medication during the trial, rather than routinely either pre or post trial randomisation, to limit any potential effects on surgical outcomes and better reflect current UK prescribing habits. Both CRS phenotypes will be included in a single trial to ensure that the MACRO trial is both pragmatic and generalisable to primary care. A modified, three-arm trial design was agreed after intense discussions and further exploratory work. Inclusion criteria were amended to ensure that the patients recruited would be considered eligible for the treatment offered in the trial due to having already received appropriate medical therapy as deemed suitable by their ENT surgeon. A proposed 6-week run-in period prior to randomisation was removed due to the new criteria prior to randomisation. Conclusion The expert panel review process resulted in agreement on key elements and an optimal design for the MACRO trial, considered most likely to be successful in terms of both recruitment potential and ability to establish best management of patients with CRS.

Background Postoperative pain is common after nasal endoscopic surgery. It interferes with the quality of sleep and delays postoperative recovery. Acupuncture is an effective tool for pain management. However, electroacupuncture specifically for the relief of postoperative pain after nasal endoscopic surgery has not yet been studied in a randomized controlled trial. Methods/design This randomized sham-controlled patient- and assessor-blind pilot trial has been designed to evaluate the efficacy and safety of electroacupuncture in managing postoperative pain following nasal endoscopic surgery to treat sinusitis due to nasal polyps. Altogether, 30 participants will be randomly allocated to an electroacupuncture or non-invasive sham control in a 1:1 ratio. Treatment will occur within 2 h before the operation, immediately after the operation upon arrival in the recovery ward, and once daily for 3 days. The primary outcome is the pain numerical rating scale, which will be analyzed using the area under the curve. The secondary outcome measures include heart rate and blood pressure after the operation, sleep quality during the hospital stay (actigraph), quality of recovery, and the 36-item short form health survey. This trial will use an intention-to-treat analysis. Discussion This pilot randomized controlled trial will explore the feasibility of the further clinical application of electroacupuncture for the management of postoperative pain. It will inform the design of a further full-scale trial. Trial registration Chinese Clinical Trial Registry, ChiCTR1900024183 . Registered on 29 June 2019.

The objective of the study is to conduct a prospective randomized blind clinical study comparing the efficacy and safety of use of acellular dermal (alloderm) grafts versus silastic sheets submucosal implants for management of empty nose syndrome (ENS). A total of 24 patients with a clinical diagnosis of ENS were randomly distributed in two equal groups: silastic implant group and alloderm implant group according to the type of implant used to rebuild the nose. This implant was inserted in submucoperichondrial and/or submucoperiosteal pockets fashioned along the septum, nasal floor, and lateral nasal wall. Subjective evaluation was done by reviewing the Sino-Nasal Outcome Test (SNOT-25), while objective evaluation was done by anterior rhinoscopy and nasal endoscopy. Both groups experienced a significant improvement after surgery (the mean SNOT-25 score before implantation was 61.4 compared to 33.6 after implantation in silastic implant group, while in alloderm implant group, it was 63.7 before surgery compared to 34.2 after implantation). There was no statistical evidence for a significant difference between the two groups. Objective evaluation showed rapid healing with no signs of implant infection, rejection, or allergic reaction in both groups. Both graft materials are well suited to this procedure with no statistical evidence for a significant difference between them. The silastic implant is inert and yet incorporated into the surrounding tissue because of the fashioned macropores. It is available and inexpensive. Acellular dermis graft is reliable, predictable, and readily shaped. Patients of both groups showed marked subjective and objective improvements. The surgical procedure is safe and relatively simple to perform.

Remimazolam is an ultrashort-acting benzodiazepine that is increasingly used for its efficacy in anesthesia induction and maintenance. However, limited research has explored its impact on intraoperative hypothermia compared to that of traditional inhalation anesthetics. This study aimed to compare the incidence of hypothermia during endoscopic nasal surgery when using remimazolam for maintenance anesthesia versus using inhalation anesthetics. This prospective study included 70 patients who underwent endoscopic nasal surgery under general anesthesia. The patients were randomly assigned to one of two groups: the inhalation anesthetic (IA) group (n=35), in which desflurane and nitrous oxide were administered, and the remimazolam (R) group (n=35), in which remimazolam and remifentanil were administered for anesthesia maintenance. The primary outcome was the incidence of intraoperative hypothermia, defined as an esophageal temperature below 36 °C during anesthesia. The incidence of intraoperative hypothermia was significantly higher in the R group than in the IA group (P = 0.014). Furthermore, the temperature at the end of the surgery was significantly lower in the R group than in the IA group (P = 0.006). Additionally, the use of warming devices after surgery was more frequent in the R group than in the IA group (P = 0.047). These findings suggest that the use of remimazolam for maintenance anesthesia during endoscopic nasal surgery increases the risk of intraoperative hypothermia compared to the use of inhalation anesthetics. This highlights the importance of temperature monitoring in patients receiving remimazolam to minimize the adverse outcomes associated with hypothermia during surgery.