Topical use of adrenaline in different concentrations for endoscopic sinus surgery

Completed

Conditions: asal polyposis
Ear, Nose and Throat
Nasal polyposis

Registration Number: ISRCTN25350905

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

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: All

Target Recruitment: 150

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

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

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The following data were collected during surgery (No assessment was done post-operatively): <br>1. Variation of blood pressure during surgery (measured by non-invasive blood pressure measures every 3 minutes)<br>2. Variation of heart frequency during surgery (measured continuously by 12 lead ECG)<br>3. Development of heart arrythmias during surgery (measured continuously by 12 lead ECG)<br>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)<br>5. Variation of plasma levels of adrenaline measured by three blood samples obtained during each surgery<br>6. Operative time

Secondary Outcome Measures