Comparison of Topical Vasoconstriction in Endoscopic Sinus Surgery

NCT ID: NCT01706952

Last Updated: 2017-05-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 45 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-12-31
• Study Completion Date: 2013-12-31

Brief 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.

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.

Conditions

Chronic Sinusitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: SINGLE

Study Groups

Cocaine

Cocaine 4%. 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.

This intervention will be done before the beginning of the surgery, and will be left in the nose for 10 minutes, this will be done just once. After the 10 minutes, the neuropatties will be taken out of the nose.

Group Type: EXPERIMENTAL

Cocaine

Intervention Type: DRUG

Pledgets soaked in 4% cocaine hydrochloride solution were placed intranasally (one side).

Adrenaline

Intervention Type: DRUG

Pledgets soaked in 1/1000 adrenaline solution were placed intranasally (one side).

Adrenaline

Adrenaline 1/1.000 Three cotton neuropatties will be soaked with Adrenaline 1/1,000. 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.

This will be done before the beginning of the surgery, and will be left in the nose for 10 minutes, this will be done just once. After the 10 minutes, the neuropatties will be taken out of the nose.

Group Type: ACTIVE_COMPARATOR

Cocaine

Intervention Type: DRUG

Pledgets soaked in 4% cocaine hydrochloride solution were placed intranasally (one side).

Adrenaline

Intervention Type: DRUG

Pledgets soaked in 1/1000 adrenaline solution were placed intranasally (one side).

Interventions

Cocaine

Pledgets soaked in 4% cocaine hydrochloride solution were placed intranasally (one side).

Intervention Type: DRUG

Adrenaline

Pledgets soaked in 1/1000 adrenaline solution were placed intranasally (one side).

Intervention Type: DRUG

Other Intervention Names

Brand Name: Cocaine Hydrochloride Sterile Topical Solution; Generic Name: Cocaine Hydrochloride Sterile Topical Solution; Active Ingredients: Cocaine hydrochloride; Concentration: 4%; Code: 1200; Format: 5 x 5 mL; DIN: 01962388; UPC: 057513012006; Preservative: Yes; Special feature: Latex Free Stopper; Epinephrine

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Marc Tewfik

OTHER

Sponsor Role: lead

Responsible Party

Marc Tewfik

Principal Investigator

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Marc A Tewfik, MD

Role: PRINCIPAL_INVESTIGATOR

McGill University Health Centre/Research Institute of the McGill University Health Centre

Constanza J Valdes, MD

Role: STUDY_CHAIR

McGill University Health Centre/Research Institute of the McGill University Health Centre

Mark Samaha, MD

Role: STUDY_CHAIR

McGill University Health Centre/Research Institute of the McGill University Health Centre

Locations

Department of Otolaryngology-Head and Neck Surgery. McGill University Health Center

Montreal, Quebec, Canada

Countries

Canada

References

Valdes CJ, Bogado M, Rammal A, Samaha M, Tewfik MA. Topical cocaine vs adrenaline in endoscopic sinus surgery: a blinded randomized controlled study. Int Forum Allergy Rhinol. 2014 Aug;4(8):646-50. doi: 10.1002/alr.21325. Epub 2014 Mar 26.

Reference Type: RESULT

PMID: 24678064 (View on PubMed)

Other Identifiers

12-251-SDR

Identifier Type: -

Identifier Source: org_study_id