Comparison of Topical Vasoconstriction in Endoscopic Sinus Surgery

Chronic Sinusitis Clinical Trial

Official title:

Comparison of Topical Vasoconstriction in Endoscopic Sinus Surgery: Cocaine Versus Adrenaline

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01706952
• Other study ID #: 12-251-SDR
• Status: Recruiting
• Phase: Phase 4
• First received: October 3, 2012
• Last updated: October 23, 2013
• Start date: December 2012
• Est. completion date: December 2013

Study information

• Verified date: October 2013
• Source: McGill University Health Center
• Contact: Marc A Tewfik, MD
• Phone: +15149341934
• Email: marc.tewfik[@]mcgill.ca
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 45
• Est. completion date: December 2013
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Caregiver)

Related Conditions & MeSH terms

• Chronic Sinusitis

Intervention

Drug:
• Cocaine

• Adrenaline

Locations

Country	Name	City	State
Canada	Department of Otolaryngology-Head and Neck Surgery. McGill University Health Center	Montreal	Quebec

Sponsors (1)

Lead Sponsor	Collaborator
Marc Tewfik

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	0 No bleeding.; Slight bleeding - no suctioning of blood required.; Slight bleeding - occasional suctioning required. Surgical field not threatened.; Slight bleeding - frequent suctioning required. Bleeding threatens surgical field a few seconds after suction is removed.; Moderate bleeding - frequent suctioning required. Bleeding threatens surgical field directly after suction is removed.; Severe bleeding - constant suctioning required. Bleeding appears faster than can be removed by suction. Surgical field severely threatened and surgery not possible.	Every 15 minutes until 300 minutes	No
Secondary	Heart rate	The heart rate (heart beats for minutes) will be recorded every 15 minutes, until the surgery is over or until 300 minutes.; The Co-investigator will record this data in a special data sheeet	Every 15 minutes until 300 minutes	No
Secondary	Blood pressure	The mean blood pressure, defined as the average arterial pressure during a single cardiac cycle, will be recorded every 15 minutes, until the surgery is over or until 300 minutes.	Every 15 minutes or until 300 minutes	No
Secondary	End tidal CO2	The concentration of carbon dioxide (CO2) in the respiratory gases will be recorded every 15 minutes or until 300 minutes.	Every 15 minutes or until 300 minutes	No