CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 20 enrolled
Drug / intervention
sevoflurane on air/O2 +1 moredrug
Likely dose
Not stated in record
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Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01092923
NCT01092923Phase 4Completed

Nitrous Oxide and Inhalational Agent Pharmacokinetics During Anaesthetic Induction and Emergence

Austin Health·interventional·Posted Mar 25, 2010·Updated Oct 12, 2012

In Brief

A Phase 4 clinical trial evaluating sevoflurane on air/O2 and sevoflurane in N2O/O2 for Anesthesia. Completed, enrolled 20 participants across 1 site.

Detailed Summary

Nitrous oxide is the oldest anaesthetic agent still in routine use today. Despite huge changes in the pharmacology of volatile anaesthetic agents and intravenous anaesthetics, the unique properties of nitrous oxide have maintained its place in modern practice, where it is used in combination with other, more powerful inhaled agents, such as sevoflurane. It has useful analgesic properties, unlike the other agents used today, and its inclusion reduces the concentration of other agents required to maintain an adequate depth of anaesthesia for surgery. In particular, its low solubility in body tissues gives it a unique pharmacokinetic profile, with rapid washin and washout from the body. It has been shown to have a similar effect on the speed of uptake of accompanying agents like sevoflurane (the "second gas effect"), which have much slower pharmacokinetics. A recent study by us suggested that this promotes faster and smoother onset of anaesthesia, as measured using the standard monitor of depth of anaesthesia (the BIS monitor). This finding requires confirmation prospectively in a larger group of patients. The investigators further hypothesise that a similar effect also exists on washout of sevoflurane at the end of the procedure, promoting quicker recovery (emergence) from anaesthesia. This has never been previously demonstrated. This information will help better define the place of nitrous oxide in achieving optimal outcomes in modern anaesthetic practice. The investigators propose to conduct a simple study to measure the effects of nitrous oxide washin and washout on exhaled concentrations of accompanying sevoflurane during both induction of anaesthesia and emergence, and identify any accompanying effect on the rate of change in depth of anaesthesia using BIS. The investigators hypothesise that the rate of fall of exhaled sevoflurane concentration at the end of anaesthesia will be more rapid in the group of patients breathing a gas mixture containing nitrous oxide, and that the rate of fall of BIS on induction and the rate of rise of BIS on emergence will be faster in the nitrous oxide group.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAnesthesia
CountriesAustralia
Collaborators--

Timeline

Phase 4CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedMar 25, 2010
Enrollment StartOct 1, 2009
Primary CompletionJul 1, 2010
Study CompletionOct 1, 2010
TodayJul 2, 2026
Enrollment to primary: 9 monthsPosted 16.3 years ago

Interventions

sevoflurane on air/O2drug

sevoflurane on air/O2

sevoflurane in N2O/O2drug

sevoflurane in N2O/O2