Condition category
Ear, Nose and Throat
Date applied
18/12/2007
Date assigned
07/01/2008
Last edited
10/03/2008
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Krishnamurti Sarmento Junior

ORCID ID

Contact details

Praia de Botafogo
422 / 1106
Botafogo
Rio de Janeiro
+55 22250 040
Brazil
krishnamurti.sarmento@gmail.com

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Acronym

Study hypothesis

Vasoconstrictors such as cocaine or epinephrine (adrenaline) are routinely applied during functional endoscopic sinus surgery. The goal is to control bleeding because, when surgery is endoscopic, even minor bleeding can be troublesome if it blocks the small end of the endoscope. Nevertheless vasoconstrictors might cause an increase in blood pressure and heart arrhythmias. The ideal adrenaline concentration should be the one to provide optimal operative field with no cardiovascular side effects. Despite its routine use, that concentration is yet to be determined. Concentrations of adrenaline varying from 1:1000 to 1:200,000 have been used both topically and sub-mucosally. Many studies have used both adrenaline and cocaine, which makes it difficult to establish the individual role of each substance on the outcome. We have decided to work with adrenaline solutions applied only topically.

We study the effects of topical use of adrenaline solution on the nasal mucosa in three different concentrations on systemic absorption of the drug, blood pressure, heart rhythm, operative bleeding and operative time during endoscopic sinus surgery for nasal polyposis.

Ethics approval

Approved by the ethic committee of Federal University of Rio de Janeiro (UFRJ) on 24 November 2004 (ref: 207/04 CEP)

Study design

Randomised double-blind single-centre controlled trial.

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Not Specified

Patient information sheet

Condition

Nasal polyposis

Intervention

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 mucosa.

Concentrations:
1. Adrenaline 1:2000 with lidocaine 1% (4 ml)
2. Adrenaline 1:10,000 with lidocaine 1% (4 ml)
3. Adrenaline 1:50,000 with lidocaine 1% (4 ml)

The control group consisted of patients submitted to tonsillectomies using the same anesthetic protocol as the study groups but without the use of adrenaline solution during surgery.

Intervention type

Drug

Phase

Not Specified

Drug names

adrenaline

Primary outcome measures

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 outcome measures

No secondary outcome measures

Overall trial start date

01/03/2005

Overall trial end date

28/02/2007

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

150

Participant 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

Recruitment start date

01/03/2005

Recruitment end date

28/02/2007

Locations

Countries of recruitment

Brazil

Trial participating centre

Praia de Botafogo, 422 / 1106
Rio de Janeiro
+55 22250 040
Brazil

Sponsor information

Organisation

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

Sponsor details

Av. Pedro Calmon
nº 550
Prédio da Reitoria
2º andar
Cidade Universitária
Rio de Janeiro
CEP 21941-901
Brazil

Sponsor type

University/education

Website

Funders

Funder type

University/education

Funder name

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

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes