None listed
Conditions
Brief summary
Local anaesthetic injections to the nose may be painful and patients often require intravenous sedation. At the same time, local anaesthetics injections to the nose may lead to sneezing especially when performed in a sedated state. Sneezing during these injections however poses potential patient safety concern, potential infectious spread via aerosol generation and an occupational health hazard. We hypothesise that administering intravenous fentanyl (a strong opioid) as part of intravenous sedation may lessen the incidence of sneezing in these circumstances. The primary aim of the study therefore is to determine whether administration of intravenous fentanyl as part of propofol-based intravenous sedation given prior to nasal injection of local anaesthetics will reduce the rate of sneezing compared to propofol-only intravenous sedation in adults undergoing plastic surgery to the nose.
Interventions
1. FENTANYL INTRAVENOUS 0.5microg/kg (ideal body weight) once + [Propofol, intravenous, delivered once, in an infusion using target controlled infusion via Marsh model set initially at 3micrograms per mL] + (Intervention group 1)
AND
2. FENTANYL INTRAVENOUS 1.5microg/kg (ideal body weight) once + [Propofol, intravenous, delivered once, in an infusion using target controlled infusion via Marsh model set initially at 3micrograms per mL] + (Intervention group 2)
In both groups, the total dose o
1. FENTANYL INTRAVENOUS 0.5microg/kg (ideal body weight) once + [Propofol, intravenous, delivered once, in an infusion using target controlled infusion via Marsh model set initially at 3micrograms per mL] + (Intervention group 1) AND 2. FENTANYL INTRAVENOUS 1.5microg/kg (ideal body weight) once + [Propofol, intravenous, delivered once, in an infusion using target controlled infusion via Marsh model set initially at 3micrograms per mL] + (Intervention group 2) In both groups, the total dose of propofol delivered to the participant will be based on reaching the predefined depth of sedation level using the Modified Ramsay Sedation Scale of 6 to 8. Bispectral Index Monitoring is also attached as another marker to monitor the level of sedation. The depth of sedation therefore is controlled. Adherence to this intervention is ensured by patient medical records, and recordings made by an independent observer/research assistant present during the case.
Sponsors
Department of Anaesthesia, Portland District Health
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Prevention
Masking
Blinded (masking used) (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Participants admitted to the study will be adult surgical patients aged 18 and over who require nasal injections of local anaesthetics under intravenous sedation for plastic surgical procedures on the nose
Exclusion criteria
Participants will be excluded from the study if they have known allergy to propofol or fentanyl or their refusal to participate.
Outcome results
None listed