Topical use of adrenaline in different concentrations for endoscopic sinus surgery

ISRCTN	ISRCTN25350905
DOI	https://doi.org/10.1186/ISRCTN25350905
Protocol serial number	N/A
Sponsor	Federal University of Rio de Janeiro (UFRJ) (Brazil)
Funder	Federal University of Rio de Janeiro (UFRJ) (Brazil)

Submission date: 18/12/2007
Registration date: 07/01/2008
Last edited: 10/03/2008

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Ear, Nose and Throat

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Krishnamurti Sarmento Junior
Scientific

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

Email	krishnamurti.sarmento@gmail.com

Study information

Primary study design	Interventional
Study design	Randomised double-blind single-centre controlled trial.
Secondary study design	Randomised controlled trial
Scientific title
Study objectives	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(s)	Approved by the ethic committee of Federal University of Rio de Janeiro (UFRJ) on 24 November 2004 (ref: 207/04 CEP)
Health condition(s) or problem(s) studied	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 / device / biological / vaccine name(s)	adrenaline
Primary outcome measure(s)	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
Key secondary outcome measure(s)	No secondary outcome measures
Completion date	28/02/2007

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	All
Target sample size at registration	150
Key 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
Key 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
Date of first enrolment	01/03/2005
Date of final enrolment	28/02/2007

Locations

Countries of recruitment

Brazil

Study participating centre

Praia de Botafogo, 422 / 1106

Rio de Janeiro
+55 22250 040
Brazil

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan