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Topical use of adrenaline in different concentrations for endoscopic sinus surgery

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN25350905
Enrollment
150
Registered
2008-01-07
Start date
2005-03-01
Completion date
Unknown
Last updated
2015-01-13

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

Conditions

Nasal polyposis Ear, Nose and Throat Nasal polyposis

Interventions

Patients were submitted to endoscopic sinus surgery under general anesthesia for treatment of nasal polyposis using different concentrations of adrenaline solution applied topically to the nasal mucos

Sponsors

Federal University of Rio de Janeiro (UFRJ) (Brazil)
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Be over 18 years old 2. Need elective endoscopic sinus surgery under general anesthesia for the treatment of nasal polyposis 3. Understand and give written consent to participate in the trial 4. To be classified as grade I or II according to the American Society of Anesthesiology classification of pre-operative assessment

Exclusion criteria

Exclusion criteria: 1. Patients legally incompetent or unable, for any reason, to read and sign a written consent form 2. Patients who withdraw their consent in any time during the course of the trial, even if they have signed the consent form 3. Patients with systemic hypertension, coronary diseases, heart arrythmia, coagulation disorders, collagen disorders, renal or liver insufficiency in any degree, previously diagnosed or detected during pre-operative assessment 4. Pregnant women 5. Patients who do not follow the trial protocol for any reason, unless it is related to the use of the adrenaline solution 6. Patients in use of a number of medications that might interfere with blood pressure or coagulaion, such as anti-inflammatory drugs, oral hypoglicemics, beta agonists, etc

Design outcomes

Primary

MeasureTime frame
The following data were collected during surgery (No assessment was done post-operatively): 1. Variation of blood pressure during surgery (measured by non-invasive blood pressure measures every 3 minutes) 2. Variation of heart frequency during surgery (measured continuously by 12 lead ECG) 3. Development of heart arrythmias during surgery (measured continuously by 12 lead ECG) 4. Operative bleeding (measured both objectively by the amount of blood aspirated during the procedure and subjectively by visual-analogue scale from 01 = no bleeding to 10 = very high bleeding) 5. Variation of plasma levels of adrenaline measured by three blood samples obtained during each surgery 6. Operative time

Secondary

MeasureTime frame
No secondary outcome measures

Countries

Brazil

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026