Not Yet RecruitingPhase 4ACTRN12621000850875

Sneezing under intravenous sedation during nasal local anaesthetic injection for plastic surgery procedures

The effect of fentanyl co-administration on sneezing during nasal local anaesthetic injection for adults undergoing plastic surgery under propofol-based intravenous sedation: Randomised-Controlled Blinded Trial


Sponsor

Department of Anaesthesia, Portland District Health

Enrollment

60 participants

Start Date

Jul 1, 2026

Study Type

Interventional

Conditions

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.


Eligibility

Sex: Both males and femalesMin Age: 18 Yearss

Inclusion Criteria1

  • 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 Criteria1

  • Participants will be excluded from the study if they have known allergy to propofol or fentanyl or their refusal to participate.

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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 pe

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.


Locations(1)

Portland District Health - Portland

VIC, Australia

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ACTRN12621000850875