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Effect of medication use after video-assisted nose surgery: experimental clinical study

Effects of use of Intranasal Blue®M Solution in Post-Operative Endonasal Endoscopic Surgery: Randomized Clinical Trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
REBEC
Registry ID
RBR-72mvv89
Enrollment
Unknown
Registered
2025-01-16
Start date
2020-10-01
Completion date
Unknown
Last updated
2025-10-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic pansinusitis

Interventions

The selection included patients with indication for sinonasal surgeries, with opening and enlargement of the ostia of the paranasal sinuses that presented chronic inflammation, septoplasty if necessar
C01.748.749.827
D01.339.431

Sponsors

Hospital Paranaense de Otorrinolaringologia
Lead Sponsor
Hospital Paranaense de Otorrinolaringologia
Collaborator

Eligibility

Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: Patients with chronic rhinosinusitis unresponsive to clinical drug treatment; patients with indication for endoscopic sinus surgery; older than 18 years

Exclusion criteria

Exclusion criteria: Patients who have a history of prior sinonasal surgery; patients with a history of smoking; patients with a history of systemic diseases that compromise the airway or irregularities in mucociliary transport, such as asthma or cystic fibrosis; patients with upper airway infection during the three weeks prior to surgery

Design outcomes

Primary

MeasureTime frame
Expected outcome: Observe a reduction in symptoms for both groups, with control of the underlying disease. However, due to the antiseptic effects of Bluem, it is expected that group 1 will present fewer symptoms, especially in the first few weeks.;Outcome found: Bluem, like the saline solution, did not present any reports of serious or intolerable side effects. Comparisons between groups did not demonstrate statistically significant differences, and both groups showed improvements in symptoms. In intragroup assessments for the SNOT-22 questionnaire and VAS scale, a reduction in symptoms was observed for both groups, and in group 1 this significant reduction already appeared 15 days after surgery. However, this reduction was not sustained at the 60-day PO follow-up. In group 2, the significant reduction appeared at the 30- and 60-day PO follow-ups.

Secondary

MeasureTime frame
No secondary outcomes are expected.

Countries

Brazil

Contacts

Public ContactGuilherme Netto

Hospital Paranaense de Otorrinolaringologia

guilhermenetto@yahoo.com.br+55 (41)98839-5327

Outcome results

None listed

Source: REBEC (via WHO ICTRP)