Comparison of Topical Vasoconstriction in Endoscopic Sinus Surgery

NCT01706952 | Completed Phase 4 Results

• 1 other identifier: 12-251-SDR
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Sinusitis

Keywords

Endoscopic sinus surgery; Bleeding; Topical Vasocontriction; Cocaine; Adrenaline

Outcome Measures

Primary Outcomes (1)

• 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. 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. 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 Outcomes (3)

• Heart Rate

  Every 15 minutes until 300 minutes

• Blood Pressure

  Every 15 minutes or until 300 minutes

• End Tidal CO2

  Every 15 minutes or until 300 minutes

Study Arms (2)

Cocaine

EXPERIMENTAL

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; Drug: Adrenaline

Adrenaline

ACTIVE COMPARATOR

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; Drug: Adrenaline

Interventions

Cocaine DRUG

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

Also known as: 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

Adrenaline; Cocaine

Adrenaline DRUG

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

Also known as: Epinephrine

Adrenaline; Cocaine

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \- Patients older than 18 years undergoing bilateral ESS for chronic sinusitis.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Marc Tewfik: lead

Study Sites (1)

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

Montreal, Quebec, H3A 1A1, Canada

Location

Related Publications (1)

• 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.

  PMID: 24678064 RESULT

MeSH Terms

Conditions

Hemorrhage

Interventions

Cocaine; Epinephrine

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Tropanes; Azabicyclo Compounds; Aza Compounds; Organic Chemicals; Alkaloids; Heterocyclic Compounds; Bridged Bicyclo Compounds, Heterocyclic; Heterocyclic Compounds, Bridged-Ring; Ethanolamines; Amino Alcohols; Alcohols; Amines; Biogenic Monoamines; Biogenic Amines; Catecholamines; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons

Results Point of Contact

• Title: Marc A. Tewfik
• Organization: McGill University Health Centre

marc.tewfik@mcgill.ca

+15147976673

Study Officials

• Marc A Tewfik, MD

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

  PRINCIPAL INVESTIGATOR

• 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

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 3, 2012
• First Posted: October 15, 2012
• Study Start: December 1, 2012
• Primary Completion: December 1, 2013
• Study Completion: December 1, 2013
• Last Updated: May 3, 2017
• Results First Posted: May 3, 2017

Record last verified: 2017-03

Locations

CA (1)