Comparison of Topical Vasoconstriction in Endoscopic Sinus Surgery

This study is currently recruiting participants.
Verified October 2013 by McGill University Health Center
Sponsor:
Information provided by (Responsible Party):
Marc Tewfik, McGill University Health Center
ClinicalTrials.gov Identifier:
NCT01706952
First received: October 3, 2012
Last updated: October 23, 2013
Last verified: October 2013
  Purpose

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.


Condition Intervention Phase
Chronic Sinusitis
Drug: Cocaine
Drug: Adrenaline
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Caregiver)
Official Title: Comparison of Topical Vasoconstriction in Endoscopic Sinus Surgery: Cocaine Versus Adrenaline

Resource links provided by NLM:


Further study details as provided by McGill University Health Center:

Primary Outcome Measures:
  • 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). [ Time Frame: Every 15 minutes until 300 minutes ] [ Designated as safety issue: No ]

    0 No bleeding.

    1. Slight bleeding - no suctioning of blood required.
    2. Slight bleeding - occasional suctioning required. Surgical field not threatened.
    3. Slight bleeding - frequent suctioning required. Bleeding threatens surgical field a few seconds after suction is removed.
    4. Moderate bleeding - frequent suctioning required. Bleeding threatens surgical field directly after suction is removed.
    5. Severe bleeding - constant suctioning required. Bleeding appears faster than can be removed by suction. Surgical field severely threatened and surgery not possible.


Secondary Outcome Measures:
  • Heart rate [ Time Frame: Every 15 minutes until 300 minutes ] [ Designated as safety issue: No ]

    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


  • Blood pressure [ Time Frame: Every 15 minutes or until 300 minutes ] [ Designated as safety issue: No ]
    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.

  • End tidal CO2 [ Time Frame: Every 15 minutes or until 300 minutes ] [ Designated as safety issue: No ]
    The concentration of carbon dioxide (CO2) in the respiratory gases will be recorded every 15 minutes or until 300 minutes.


Estimated Enrollment: 45
Study Start Date: December 2012
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
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
Other Name: 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
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
Other Name: Epinephrine

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01706952

Contacts
Contact: Marc A Tewfik, MD +15149341934 ext 34971 marc.tewfik@mcgill.ca
Contact: Constanza J Valdes, MD +15144332602 cjvaldes@gmail.com

Locations
Canada, Quebec
Department of Otolaryngology-Head and Neck Surgery. McGill University Health Center Recruiting
Montreal, Quebec, Canada, H3A 1A1
Contact: Marc A Tewfik, MD    +1-514-934-1934 ext 34971    marc.tewfik@mcgill.ca   
Contact: Constanza J Valdes, MD    +15144332602    cjvaldes@gmail.com   
Principal Investigator: Marc A Tewfik, MD         
Sub-Investigator: Constanza J Valdes, MD         
Sub-Investigator: Mark Samaha, MD         
Sponsors and Collaborators
Marc Tewfik
Investigators
Principal Investigator: Marc A Tewfik, MD McGill University Health Center
Study Chair: Constanza J Valdes, MD McGill University Health Center
Study Chair: Mark Samaha, MD McGill University Health Center
  More Information

No publications provided

Responsible Party: Marc Tewfik, Principal Investigator, McGill University Health Center
ClinicalTrials.gov Identifier: NCT01706952     History of Changes
Other Study ID Numbers: 12-251-SDR
Study First Received: October 3, 2012
Last Updated: October 23, 2013
Health Authority: Canada: Ethics Review Committee

Keywords provided by McGill University Health Center:
Endoscopic sinus surgery
Bleeding
Topical Vasocontriction
Cocaine
Adrenaline

Additional relevant MeSH terms:
Sinusitis
Chronic Disease
Paranasal Sinus Diseases
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases
Disease Attributes
Pathologic Processes
Epinephrine
Epinephryl borate
Cocaine
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Anti-Asthmatic Agents
Respiratory System Agents
Therapeutic Uses
Mydriatics
Adrenergic alpha-Agonists
Sympathomimetics
Vasoconstrictor Agents
Cardiovascular Agents

ClinicalTrials.gov processed this record on April 17, 2014