Trial Outcomes & Findings for Comparison of Topical Vasoconstriction in Endoscopic Sinus Surgery (NCT NCT01706952)

Results Overview

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

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

45 participants

Primary outcome timeframe

Every 15 minutes until 300 minutes

Results posted on

2017-05-03

Participant Flow

Participant milestones

Participant milestones
Measure	Cocaine/Adrenaline 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). Three cotton neuropatties will be placed in each side of the 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.
Overall Study STARTED	45
Overall Study COMPLETED	37
Overall Study NOT COMPLETED	8

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Comparison of Topical Vasoconstriction in Endoscopic Sinus Surgery

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Cocaine/Adrenaline n=37 Participants 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).
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	37 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age, Continuous	47.92 years STANDARD_DEVIATION 16.51 • n=5 Participants
Sex: Female, Male Female	14 Participants n=5 Participants
Sex: Female, Male Male	23 Participants n=5 Participants
Region of Enrollment Canada	37 participants n=5 Participants

PRIMARY outcome

Timeframe: Every 15 minutes until 300 minutes

Population: EACH SIDE WAS EVALUATED SEPARATELY

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

Outcome measures

Outcome measures
Measure	Cocaine SIDE n=37 Participants 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. 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).	Adrenaline SIDE n=37 Participants 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. 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).
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).	2.17 units on a scale Standard Deviation 0.70	2.04 units on a scale Standard Deviation 0.75

SECONDARY outcome

Timeframe: Every 15 minutes until 300 minutes

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

Outcome measures

Outcome measures
Measure	Cocaine SIDE n=37 Participants 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. 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).	Adrenaline SIDE n=37 Participants 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. 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).
Heart Rate	74.68 Heart Beats per minute Standard Deviation 13.64	73.62 Heart Beats per minute Standard Deviation 14.23

SECONDARY outcome

Timeframe: Every 15 minutes or until 300 minutes

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

Outcome measures

Outcome measures
Measure	Cocaine SIDE n=37 Participants 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. 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).	Adrenaline SIDE n=37 Participants 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. 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).
Blood Pressure	68.02 mmHg Standard Deviation 11.94	68.41 mmHg Standard Deviation 9.15

SECONDARY outcome

Timeframe: Every 15 minutes or until 300 minutes

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

Outcome measures

Outcome measures
Measure	Cocaine SIDE n=37 Participants 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. 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).	Adrenaline SIDE n=37 Participants 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. 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).
End Tidal CO2	32.26 Percentage of carbon dioxide Standard Deviation 3.24	31.69 Percentage of carbon dioxide Standard Deviation 2.83

Adverse Events

Cocaine

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Adrenaline

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Marc A. Tewfik

McGill University Health Centre

Phone: +15147976673

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place