Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12617000303347
Ethics application status
Approved
Date submitted
17/02/2017
Date registered
27/02/2017
Date last updated
27/02/2017
Type of registration
Retrospectively registered

Titles & IDs
Public title
Does cocaine routinely used in sinus surgery get absorbed into the body and have an effect on your sleep during anaesthetic?
Scientific title
The systemic absorption of cocaine and the effect on depth of anaesthesia using intranasal atomised modified Moffat’s solution prior to endoscopic sinus surgery (ESS)
Secondary ID [1] 291231 0
none
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
sinusitis 302124 0
sinus surgery 302126 0
Condition category
Condition code
Surgery 301739 301739 0 0
Other surgery
Anaesthesiology 301762 301762 0 0
Other anaesthesiology

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Patients will be rendomised pre sinus surgery to receive either a single spray of modified Moffat’s (adrenaline + cocaine) or dilute adrenaline as nasal preparation (active control).

Modified moffats solution contains 100mg cocaine, 1mg adrenaline and normal saline made to a 10ml solution. This is administered 5ml either side into the nose pre-surgry

Adrenaline contains 10 ml 1:10,000 (1mg) sprayed 5ml either side into the nose pre-surgery

Surgery will be carried out as normal
Intervention code [1] 297212 0
Treatment: Drugs
Comparator / control treatment
Active control group will be patients receiving adrenaline containining 10 ml 1:10,000 (1mg) sprayed 5ml either side into the nose pre-surgery
Control group
Active

Outcomes
Primary outcome [1] 301138 0
To determine the amount and duration of systemic cocaine absorption administered by intranasal atomised modified Moffat’s solution during ESS (composite primary outcome)

Blood samples will be taken to assess cocaine plasma levels
Timepoint [1] 301138 0
Blood samples will be taken at: baseline (pre administration of Moffats solution), 10mins, 20mins, 30mins, 60mins, 120mins, 6hrs, 12hrs
Secondary outcome [1] 331815 0
To determine whether this systemically absorbed cocaine has an effect on depth of anaesthesia during ESS by comparing this with patients receiving only a dilute adrenaline spray.

This will be assessed using a a BIS Registered Trademark sensor to determine depth of anaesthesia. BIS Registered Trademark sensors monitor a patient's electroencephalogram (EEG) and using a proprietary algorithm give a number to represent the depth of anaesthesia. The BIS Registered Trademark monitor used for this study will be a bilateral sensor that will provide a spectral array of EEG.
Timepoint [1] 331815 0
The BIS Registered Trademark monitoring will be carried out during induction and entire anaesthetic given for the operation.

Eligibility
Key inclusion criteria
patients aged between 18 to 80 years (inclusive) undergoing bilateral endoscopic sinus surgery (ESS)
Minimum age
18 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Refusal or inability to provide consent
2. Use of cocaine within 2 weeks of surgery
3. Modified Moffat’s solution contraindicated due to safety
4. Sensitivity to cocaine
5. Significant IHD/history of arrhythmias
6. Pregnant/breastfeeding
7. Limited mucosal application of modified Moffat’s or dilute adrenaline solution
8. Grade 3 polyps in 1 or more nasal cavities
9. Obstructing intranasal mass
10. Severe septal deformity

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
yes. Central computer
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
random number generator
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
Intervention assignment
Parallel
Other design features
nil
Phase
Phase 4
Type of endpoint/s
Efficacy
Statistical methods / analysis
Using previous studies a number of required patient was determined to identify trends. Groups will be compared but no formal statistical analysis will be completed

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
4/01/2017
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
30
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 7504 0
Casey Hospital - Berwick
Recruitment postcode(s) [1] 15330 0
3806 - Berwick

Funding & Sponsors
Funding source category [1] 295656 0
Government body
Name [1] 295656 0
Forensic Science South Australia laboratory
Country [1] 295656 0
Australia
Primary sponsor type
Individual
Name
Dean Page
Address
Monash Health
246 Clayton Road, Clayton
Victoria 3168
Country
Australia
Secondary sponsor category [1] 294501 0
None
Name [1] 294501 0
-
Address [1] 294501 0
-
Country [1] 294501 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 296973 0
Monash Health HREC
Ethics committee address [1] 296973 0
246 Clayton Road, Clayton
Victoria 3168
Ethics committee country [1] 296973 0
Australia
Date submitted for ethics approval [1] 296973 0
21/07/2016
Approval date [1] 296973 0
10/08/2016
Ethics approval number [1] 296973 0
LNR/16/MonH/343

Summary
Brief summary
Endoscopic sinus surgery (ESS) requires pre-surgery medication applied into the nose to minimise bleeding. At Monash Health we either use a solution called modified Moffat’s solution which contains cocaine, adrenaline and saline, or just adrenaline with saline. Although acting inside the nose a small percentage of both adrenaline and cocaine may be absorbed into the blood. The absorption may depend on the concentration, method of application and time in contact with the lining of the nose. Overall there exists limited research looking at cocaine absorption in the context of sinus surgery. Specifically, no studies have looked at modified Moffat’s solution sprayed into the nose. It is important that we determine how much and for how long cocaine is absorbed so we can advise patients appropriately after the operation.

Additionally, it is thought that cocaine may affect a brain chemical called dopamine, and this may in turn affect how much anaesthetic is required to keep you asleep. The study will aim to look at how deeply patients sleep after being administered either the Modified Moffat’s spray or the adrenaline spray.

Overall we will aim to enroll a total of 30 patients. Half (15) will receive the modified Moffat’s solution prior to surgery and the other half (15) will receive the dilute adrenaline prior to surgery.

Blood samples taken during and after surgery will measure cocaine blood levels.
Trial website
nil
Trial related presentations / publications
nil
Public notes

Contacts
Principal investigator
Name 72590 0
Dr Dean Page
Address 72590 0
ENT Unit, Monash Health
Moorrabbin Cancer Centre
Centre rd East Bentleigh, Victoria
3165
Country 72590 0
Australia
Phone 72590 0
+61 3 99288799
Fax 72590 0
Email 72590 0
[email protected]
Contact person for public queries
Name 72591 0
Dr Joanne Rimmer
Address 72591 0
ENT Unit, Monash Health
Moorrabbin Cancer Centre
Centre rd East Bentleigh, Victoria
3165
Country 72591 0
Australia
Phone 72591 0
+61 3 99288799
Fax 72591 0
Email 72591 0
[email protected]
Contact person for scientific queries
Name 72592 0
Dr Joanne Rimmer
Address 72592 0
ENT Unit, Monash Health
Moorabbin Cancer Centre
Centre rd East Bentleigh, Victoria
3165
Country 72592 0
Australia
Phone 72592 0
+61 3 99288799
Fax 72592 0
Email 72592 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.