Comparison of Topical Vasoconstriction in Endoscopic Sinus Surgery
Information source: McGill University Health Center
ClinicalTrials.gov processed this data on August 20, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Chronic Sinusitis
Intervention: Cocaine (Drug); Adrenaline (Drug)
Phase: Phase 4
Status: Recruiting
Sponsored by: Marc Tewfik Official(s) and/or principal investigator(s): Marc A Tewfik, MD, Principal Investigator, Affiliation: McGill University Health Center Constanza J Valdes, MD, Study Chair, Affiliation: McGill University Health Center Mark Samaha, MD, Study Chair, Affiliation: McGill University Health Center
Overall contact: Marc A Tewfik, MD, Phone: +15149341934, Ext: 34971, Email: marc.tewfik@mcgill.ca
Summary
The purpose of our study is to assess the effect of topical vasoconstriction (cocaine 4%
versus adrenaline 1/1000) on the surgical field during endoscopic sinus surgery.
Clinical Details
Official title: Comparison of Topical Vasoconstriction in Endoscopic Sinus Surgery: Cocaine Versus Adrenaline
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Caregiver)
Primary outcome: to estimate the change in bleeding category (surgical field improvement) as measured on a six-point scale, measured from 0 (best case) to 5 (worst case).
Secondary outcome: Heart rateBlood pressure End tidal CO2
Detailed description:
Chronic Rhinosinusitis (CRS) is one of the most common chronic illnesses in North America,
with an incidence of approximately 13 per cent in the US.
Endoscopic sinus surgery (ESS) has become standard treatment for patients with chronic
rhinosinusitis (CRS) unresponsive to maximum medical treatment. The success of surgery
depends on several factors, an adequate surgical field is among the most important factors
in preventing complications in ESS.
Topical vasoconstrictors, such as adrenaline and cocaine has been widely used. To date no
studies exist comparing the use of topical cocaine with adrenaline in ESS.
The purpose of this study is to assess the effect of topical cocaine 4% versus adrenaline on
intra-operative bleeding during ESS and to describe the phisiologic changes with the use of
topical vasocontrictors. A secondary objective is to describe the phisiologic changes with
the use of topical vasocontrictors
Study Design:
A prospective randomized single-blind controlled trial will be conducted. The surgeon
performing the ESS and evaluating the bleeding will not be present at the time of injection,
and so will remain blinded.
All patients over the age of 18 years undergoing bilateral ESS for chronic sinusitis at
McGill University Health Center will be invited to participate. The study will be conducted
from November 2012 until the number required of patients is enrolled.
Topical vasoconstriction technique After oral intubation, vital signs and all anaesthetic
parameters will be kept as constant as possible for the duration of the surgery. Three
cotton neuropatties will be soaked with 4% cocaine. One neuropattie will be placed in the
sphenoethmoidal recess, one in the middle meatus, and one in the anterior end of the middle
turbinates on the side that the randomization has determined. In the other side, three
cotton neuropaties will be soaked with adrenaline 1: 1000 and placed in the same positions
than the others. Then the patient will be draped and both sides will be injected with
xylocaine 2% and adrenaline 1: 100. 000. After this we will wait for 10 minutes and the
surgery will be initiated.
At the commencement of surgery and at regular 15-minute intervals, the operating surgeon
will estimate the intensity of bleeding in the operative field. The extent of nasal bleeding
will be evaluated according to the validated scale used by Boezaart. At each assessment,
other parameters including mean arterial blood pressure (MAP), heart rate, and end tidal CO2
will be recorded into a chart by the co-investigator.
The total blood loss will be collected and recorded separately for each side. Separate
suction tubes and canisters will be used for each side. The total blood loss will be
measured by subtracting the amount of saline solution used to rinse the surgical field from
the amount of blood and fluids suctioned from the surgical field. Although this method of
estimating the intra operative blood loss is not flawless as some blood and fluids usually
fall posteriorly into the nasopharynx and are later suctioned by the anesthesiologist prior
to extubation, this amount is deemed to be negligible.
Proposed data analysis: The data will be collected by the co-investigator. Patient names and
other specific identifiers will not be included. Data will be entered into an Excel
spreadsheet and statistical analysis will be applied with SPSS vs. 13.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Patients older than 18 years undergoing bilateral ESS for chronic sinusitis.
Exclusion Criteria:
- Patients with heart disease
- History of bleeding diathesis
- Patients with untreated or poorly controlled high blood pressure
- Aspirin, anticoagulant or natural herbal medication usage in the last 4 weeks
- Hypersensitivity to adrenaline or cocaine
- Significant asymmetry between the right and left side disease extent as determine by
findings on their pre-operative CT scan and nasal endoscopy.
Locations and Contacts
Marc A Tewfik, MD, Phone: +15149341934, Ext: 34971, Email: marc.tewfik@mcgill.ca
Department of Otolaryngology-Head and Neck Surgery. McGill University Health Center, Montreal, Quebec H3A 1A1, Canada; Recruiting Marc A Tewfik, MD, Phone: +1-514-934-1934, Ext: 34971, Email: marc.tewfik@mcgill.ca Constanza J Valdes, MD, Phone: +15144332602, Email: cjvaldes@gmail.com Marc A Tewfik, MD, Principal Investigator Constanza J Valdes, MD, Sub-Investigator Mark Samaha, MD, Sub-Investigator
Additional Information
Starting date: December 2012
Last updated: October 23, 2013
|