Comparison of Topical Vasoconstriction in Endoscopic Sinus Surgery

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

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.

Study Overview

• Status: Completed
• Conditions: Chronic Sinusitis
• Intervention / Treatment: Drug: Cocaine; Drug: Adrenaline

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.

• Study Type: Interventional
• Enrollment (Actual): 45
• Phase: Phase 4

Contacts and Locations

Study Locations

• Canada
  • Quebec
    • Montreal, Quebec, Canada, H3A 1A1
      • Department of Otolaryngology-Head and Neck Surgery. McGill University Health Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Drug: Cocaine; Pledgets soaked in 4% cocaine hydrochloride solution were placed intranasally (one side).; Other 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; Drug: Adrenaline; Pledgets soaked in 1/1000 adrenaline solution were placed intranasally (one side).; Other Names: Epinephrine
Active Comparator: 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.	Drug: Cocaine; Pledgets soaked in 4% cocaine hydrochloride solution were placed intranasally (one side).; Other 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; Drug: Adrenaline; Pledgets soaked in 1/1000 adrenaline solution were placed intranasally (one side).; Other Names: Epinephrine

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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. For the primary objective of surgical field grade, we calculated the mean within sides treated with cocaine vs adrenaline and assessed its difference	Every 15 minutes until 300 minutes

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 For the secondary objective of Heart rate, we calculated the average within sides treated with cocaine vs adrenaline and assessed its difference	Every 15 minutes until 300 minutes
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. For the secondary objective of blood pressure, we calculated the mean within sides treated with cocaine vs adrenaline and assessed its difference	Every 15 minutes or until 300 minutes
End Tidal CO2	The concentration of carbon dioxide (CO2) in the respiratory gases will be recorded every 15 minutes or until 300 minutes. For the secondary objective of concentration of carbon dioxide, we calculated the mean within sides treated with cocaine vs adrenaline and assessed its difference	Every 15 minutes or until 300 minutes

Collaborators and Investigators

• Sponsor: Marc Tewfik
• Investigators: Principal Investigator: Marc A Tewfik, MD, McGill University Health Centre/Research Institute of the McGill University Health Centre; Study Chair: Constanza J Valdes, MD, McGill University Health Centre/Research Institute of the McGill University Health Centre; Study Chair: Mark Samaha, MD, McGill University Health Centre/Research Institute of the McGill University Health Centre

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: December 1, 2012
• Primary Completion (Actual): December 1, 2013
• Study Completion (Actual): December 1, 2013

Study Registration Dates

• First Submitted: October 3, 2012
• First Submitted That Met QC Criteria: October 12, 2012
• First Posted (Estimate): October 15, 2012

Study Record Updates

• Last Update Posted (Actual): May 3, 2017
• Last Update Submitted That Met QC Criteria: March 22, 2017
• Last Verified: March 1, 2017

More Information

Terms related to this study

• Keywords: Bleeding; Cocaine; Adrenaline; Endoscopic sinus surgery; Topical Vasocontriction
• Additional Relevant MeSH Terms: Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Otorhinolaryngologic Diseases; Paranasal Sinus Diseases; Nose Diseases; Sinusitis; Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Autonomic Agents; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Adrenergic alpha-Agonists; Adrenergic Agonists; Neurotransmitter Uptake Inhibitors; Membrane Transport Modulators; Dopamine Agents; Anesthetics, Local; Bronchodilator Agents; Anti-Asthmatic Agents; Respiratory System Agents; Dopamine Uptake Inhibitors; Adrenergic beta-Agonists; Sympathomimetics; Vasoconstrictor Agents; Mydriatics; Pharmaceutical Solutions; Epinephrine; Racepinephrine; Epinephryl borate; Cocaine
• Other Study ID Numbers: 12-251-SDR