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Quantifying Nitrous Oxide Effect on Depth of Anaesthesia Using Theoretically Based Time Series Modelling

M

Melbourne Health

Status and phase

Completed
Phase 4

Conditions

Depth of Anaesthesia

Treatments

Drug: Nitrous oxide

Study type

Interventional

Funder types

Other

Identifiers

NCT00226837
2004.109

Details and patient eligibility

About

Our hypothesis is that a new method of depth of anaesthesia monitoring, using theoretically based time series modelling will result in improved ability to determine nitrous oxide anaesthetic effect

Full description

We randomised patients to 0% 33% or 66% nitrous oxide during sevoflurane induction and measured anesthetic endpoints.

Enrollment

60 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Aged 18 years or older
  • Presenting for surgery under general anaesthesia

Exclusion criteria

  • Poor English language comprehension
  • Risk of reflux
  • Epilepsy or other EEG abnormality

Trial design

Primary purpose

Diagnostic

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

60 participants in 3 patient groups, including a placebo group

1
Placebo Comparator group
Description:
0% nitrous oxide
Treatment:
Drug: Nitrous oxide
2
Active Comparator group
Description:
33% nitrous oxide
Treatment:
Drug: Nitrous oxide
3
Active Comparator group
Description:
66% nitrous oxide
Treatment:
Drug: Nitrous oxide

Trial contacts and locations

2

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Data sourced from clinicaltrials.gov

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