Skip to content

Comparison of Topical Vasoconstriction in Endoscopic Sinus Surgery

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

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01706952
Enrollment
45
Registered
2012-10-15
Start date
2012-12-31
Completion date
2013-12-31
Last updated
2017-05-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Sinusitis

Keywords

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

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.

Interventions

DRUGCocaine

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

DRUGAdrenaline

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

Sponsors

Marc Tewfik
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
SINGLE (Caregiver)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
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).Every 15 minutes until 300 minutes0 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

Secondary

MeasureTime frameDescription
Heart RateEvery 15 minutes until 300 minutesThe 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
Blood PressureEvery 15 minutes or until 300 minutesThe 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
End Tidal CO2Every 15 minutes or until 300 minutesThe 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

Countries

Canada

Participant flow

Participants by arm

ArmCount
Cocaine/Adrenaline
Three cotton neuropatties will be placed in each nostril. 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. Cocaine: Pledgets soaked in 4% cocaine hydrochloride solution were placed intranasally (one side). Adrenaline: Pledgets soaked in 1/1000 adrenaline solution were placed intranasally (one side).
37
Total37

Baseline characteristics

CharacteristicCocaine/Adrenaline
Age, Categorical
<=18 years
0 Participants
Age, Categorical
>=65 years
0 Participants
Age, Categorical
Between 18 and 65 years
37 Participants
Age, Continuous47.92 years
STANDARD_DEVIATION 16.51
Region of Enrollment
Canada
37 participants
Sex: Female, Male
Female
14 Participants
Sex: Female, Male
Male
23 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
— / —— / —
other
Total, other adverse events
0 / 370 / 37
serious
Total, serious adverse events
0 / 370 / 37

Outcome results

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. 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

Time frame: Every 15 minutes until 300 minutes

Population: EACH SIDE WAS EVALUATED SEPARATELY

ArmMeasureValue (MEAN)Dispersion
Cocaine SIDETo 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).2.17 units on a scaleStandard Deviation 0.7
Adrenaline SIDETo 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).2.04 units on a scaleStandard Deviation 0.75
Comparison: Data analysis was performed using SPSS version 13 for Windows (SPSS Inc, Chicago, IL). A power study was per formed with a power of 80% and a clinically significant difference in bleeding between the sides of 20% with a significance level of 5% (p \< 0.05).p-value: 0.05t-test, 2 sided
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. For the secondary objective of blood pressure, we calculated the mean within sides treated with cocaine vs adrenaline and assessed its difference

Time frame: Every 15 minutes or until 300 minutes

ArmMeasureValue (MEAN)Dispersion
Cocaine SIDEBlood Pressure68.02 mmHgStandard Deviation 11.94
Adrenaline SIDEBlood Pressure68.41 mmHgStandard Deviation 9.15
Secondary

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

Time frame: Every 15 minutes or until 300 minutes

ArmMeasureValue (MEAN)Dispersion
Cocaine SIDEEnd Tidal CO232.26 Percentage of carbon dioxideStandard Deviation 3.24
Adrenaline SIDEEnd Tidal CO231.69 Percentage of carbon dioxideStandard Deviation 2.83
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 For the secondary objective of Heart rate, we calculated the average within sides treated with cocaine vs adrenaline and assessed its difference

Time frame: Every 15 minutes until 300 minutes

ArmMeasureValue (MEAN)Dispersion
Cocaine SIDEHeart Rate74.68 Heart Beats per minuteStandard Deviation 13.64
Adrenaline SIDEHeart Rate73.62 Heart Beats per minuteStandard Deviation 14.23

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026