Does cocaine routinely used in sinus surgery get absorbed into the body and have an effect on your sleep during anaesthetic?

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)

Status

Recruiting

Phases

Phase 4

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12617000303347

Enrollment

Registered

2017-02-27

Start date

2017-01-04

Completion date

Unknown

Last updated

2017-03-13

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

Conditions

None listed

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.

Interventions

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

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Treatment

Masking

Blinded (masking used) (Subject, Outcomes Assessor)

Eligibility

Sex/Gender

All

Age

18 Years to 80 Years

Healthy volunteers

Inclusion criteria

patients aged between 18 to 80 years (inclusive) undergoing bilateral endoscopic sinus surgery (ESS)

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

Outcome results