AnesthesiaPhase 4NCT01092923
Physiological Effects of Nitrous Oxide on Anaesthesia
A Phase 4 study testing sevoflurane on air/O2 and sevoflurane in N2O/O2 in people with Anesthesia, run by Austin Health at 1 site in Australia.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Anesthesia
- What is being tested?
- sevoflurane on air/O2 and sevoflurane in N2O/O2
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteAustralia
- Study dates
- Oct 2009to Oct 2010
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adult patients undergoing elective general or orthopaedic surgery under relaxant general anaesthesia anticipated to take >1 hour
Who cannot join
- Age under 18 years
- Morbid obesity BMI > 35
- Severe or moderately severe lung disease (FEV1 < 1.0L, FEV1/FVC < 50%)
- Past history of severe post-operative nausea and vomiting
- Pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Nitrous Oxide and Inhalational Agent Pharmacokinetics During Anaesthetic Induction and Emergence
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.
Read the detailed description
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.
We 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.
We 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.
Consenting adult participants will be recruited who are undergoing general anaesthesia for elective surgery anticipated to take a minimum of 1 hour and where an arterial line is considered appropriate for monitoring of blood pressure.
As, in normal practice, the decision whether to include of nitrous oxide in the anaesthetic mixture is largely discretionary on the part of the anaesthetist, and therefore allocation to either arm of the protocol is consistent with routine practice, it is intended that the patients will be approached for consent on admission to hospital for their surgery. Standard patient monitoring will be used including BIS and a 2 mL sample of blood will be taken to assess blood gas content lung function and optimise lung ventilation.
Following induction of anaesthesia, participants will receive an inhaled gas mixture containing standard concentrations of sevoflurane. They will be randomised to a treatment group where a standard concentration of nitrous oxide is included in this mixture, or a control group where nitrous oxide is not included. Monitoring and recording of exhaled gas concentrations will be made by continuous sampling of gas from the breathing circuit and computer storage. We 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.
- Conditions
- Anesthesia
- Being tested
- sevoflurane on air/O2, sevoflurane in N2O/O2
- Keywords
- Nitrous Oxide, washin, washout, second gas effect, sevoflurane, induction, emergence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sevoflurane on air/O2Drug
sevoflurane on air/O2
sevoflurane in N2O/O2Drug
sevoflurane in N2O/O2
| Study group | Role | What they receive |
|---|---|---|
| Air/Oxygen | Experimental | Sevoflurane with Air/Oxygen Mix Receives: Drug: sevoflurane on air/O2 |
| sevoflurane in N2O/O2 | Experimental | Not described Receives: Drug: sevoflurane in N2O/O2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pa t/Pa0 Sevo (Arterial Partial Pressure of Sevoflurane), t=Time(Minutes)
Rate of fall in the arterial partial pressure of sevoflurane relative to baseline at 2 minutes (Pa 2/Pa0 Sevo), 5 minutes (Pa 5/Pa0 Sevo, and 30 minutes (Pa 30/Pa0 Sevo)
Measured: Baseline, 2 minutes, 5 minutes, and 30 minutes after emergence
PA t/PA0 Sevo (End Tidal Partial Pressure of Sevoflurane), t=Time (Minutes)
Rate of fall in the end-tidal partial pressure of sevoflurane relative to baseline at 2 minutes (PA2/PA0 sevo) and 5 minutes (PA5/PA0 sevo)
Measured: Baseline, 2 minutes, and 5 minutes after emergence
Secondary outcomes (1)
Time to Eye Opening
The time to eye opening to command after cessation of inhalational anaesthetic administration
Measured: 20 Minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2010 (estimated)
- Study startOct 2009
- Primary completionJul 2010
- Study completionOct 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for AnesthesiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Austin Health
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Dr Philip Peyton, Austin Health
- Investigators
- Phil Peyton, MBBS, Principal investigator, Austin Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01092923
- Sponsor's protocol ID
- 03749
- Status last verified
- Sep 2012
- First submitted
- 10 Mar 2010
- Last updated
- 12 Oct 2012
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 12 Oct 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nitrous Oxide and Inhalational Agent Pharmacokinetics During Anaesthetic Induction and Emergence
- ClinicalTrials.gov ID
- NCT01092923
- Acronym / sponsor ID
- 03749
- Conditions
- Anesthesia
- Keywords
- Nitrous Oxide, washin, washout, second gas effect, sevoflurane, induction, emergence
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Austin HealthOther government
- Study start
- Oct 2009
- Primary completion
- Jul 2010 (actual)
- Study completion
- Oct 2010 (actual)
- First posted
- 25 Mar 2010 (estimated)
- Results
- Posted 12 Oct 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
We 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.
We 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.
Consenting adult participants will be recruited who are undergoing general anaesthesia for elective surgery anticipated to take a minimum of 1 hour and where an arterial line is considered appropriate for monitoring of blood pressure.
As, in normal practice, the decision whether to include of nitrous oxide in the anaesthetic mixture is largely discretionary on the part of the anaesthetist, and therefore allocation to either arm of the protocol is consistent with routine practice, it is intended that the patients will be approached for consent on admission to hospital for their surgery. Standard patient monitoring will be used including BIS and a 2 mL sample of blood will be taken to assess blood gas content lung function and optimise lung ventilation.
Following induction of anaesthesia, participants will receive an inhaled gas mixture containing standard concentrations of sevoflurane. They will be randomised to a treatment group where a standard concentration of nitrous oxide is included in this mixture, or a control group where nitrous oxide is not included. Monitoring and recording of exhaled gas concentrations will be made by continuous sampling of gas from the breathing circuit and computer storage. We 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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Air/Oxygen | Experimental | Drug: sevoflurane on air/O2Sevoflurane with Air/Oxygen Mix |
| sevoflurane in N2O/O2 | Experimental | Drug: sevoflurane in N2O/O2 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Adult patients undergoing elective general or orthopaedic surgery under relaxant general anaesthesia anticipated to take >1 hour
Key exclusion criteria (5 listed)
- Age under 18 years
- Morbid obesity BMI > 35
- Severe or moderately severe lung disease (FEV1 < 1.0L, FEV1/FVC < 50%)
- Past history of severe post-operative nausea and vomiting
- Pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| sevoflurane on air/O2sevoflurane on air/O2 | Drug | Air/Oxygen |
| sevoflurane in N2O/O2sevoflurane in N2O/O2 | Drug | sevoflurane in N2O/O2 |
Primary outcome
Pa t/Pa0 Sevo (Arterial Partial Pressure of Sevoflurane), t=Time(Minutes)
Time frame: Baseline, 2 minutes, 5 minutes, and 30 minutes after emergence
Rate of fall in the arterial partial pressure of sevoflurane relative to baseline at 2 minutes (Pa 2/Pa0 Sevo), 5 minutes (Pa 5/Pa0 Sevo, and 30 minutes (Pa 30/Pa0 Sevo)
PA t/PA0 Sevo (End Tidal Partial Pressure of Sevoflurane), t=Time (Minutes)
Time frame: Baseline, 2 minutes, and 5 minutes after emergence
Rate of fall in the end-tidal partial pressure of sevoflurane relative to baseline at 2 minutes (PA2/PA0 sevo) and 5 minutes (PA5/PA0 sevo)
1 secondary outcome
Time to Eye Opening
Time frame: 20 Minutes
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Oct 2012.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Anesthesia
Recruiting
Comparison of Spinal Anesthesia With Intrathecal Morphine Versus PENG Block With or Without Dexamethasone in Hip Arthroplasty
Arthropathy of Hip, Hip Osteoarthritis
RecruitingObservational study
Norepinephrine in the Management of General Anesthesia-Induced Arterial Hypotension in Chronic Heart Failure Patients
Hypotension
Not yet recruiting
Magnesium Sulphate as an Adjuvant in Combined Costoclavicular Block and Suprascapular Block Versus Interscalene Block for Ambulatory Shoulder Arthroscopy
Postoperative Pain, Shoulder Arthroscopy
RecruitingObservational study
COMparative Performance of General Purpose Models
Neurosurgical Patients
Active, not recruitingObservational study
The Effect of Magnesium on Post-spinal Headaches
Post-spinal Headache
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Phil Peyton, MBBS principal investigator
Austin Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing sevoflurane on air/O2 and sevoflurane in N2O/O2 in people with Anesthesia, run by Austin Health at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Oct 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 12 Oct 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pa t/Pa0 Sevo (Arterial Partial Pressure of Sevoflurane), t=Time(Minutes) (time frame: Baseline, 2 minutes, 5 minutes, and 30 minutes after emergence). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Oct 2012.