AnesthesiaPhase 3NCT00242671
The Efficacy of Isocapnic Hyperpnoea to Accelerate Recovery After General Anesthesia With Sevoflurane
A Phase 3 study testing Isocapnic Hyperponea in people with Anesthesia, run by University Health Network, Toronto at 1 site in Canada.
Trial summary
The twilight phase between being asleep and awake during recovery from anesthesia is a precarious time fraught with risks to the post-operative patient. Hyperventilation accelerates the elimination of inhaled anesthetics but reduces their CO2 blood concentrations which delays their resumption of spontaneous breathing. Read more about this study
- Who is it for?
- Ages 18 to 80 years, women only
- Conditions the study is for
- Anesthesia
- What is being tested?
- Isocapnic Hyperponea
- Type of treatment
- Surgery or procedure
- How many people
- Not given
- Where
- 1 siteCanada
- Study dates
- Oct 2005to Dec 2008
- Phase
- Phase 3
- Are there results?
- None posted in the registry
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 to 80 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Elective gynecological procedure
- ASA I-III
- Age 18-80 years
- Signed informed consent
Who cannot join
- ASA IV
- Patients with contra-indications to Sevoflurane anesthesia or other anesthetics included in the protocol
- Active smoking, asthma or other history of hyper-reactive airway disease
- History of chronic obstructive lung disease limiting exercise
- History of angina, previous myocardial infarction, valvular heart disease, or heart surgery
- Presence of heart murmurs or neck bruits
Show all 13Show fewer
- ECT abnormalities including atrial fibrillation, prolonged P-R interval, prolonged Q-T interval, presence of Q waves in inferior, anterior or lateral leads, criteria for left ventricular hypertrophy, T-wave abnormalities,
- History of difficult airway access
- Pulmonary hypertension and/or right ventricle dysfunction
- History of bulous emphysema, and/or spontaneous pneumothorax
- History of alcohol or drugs abuse
- Known history of psychiatric illness and/or medications
- Patients that required postoperative mechanical ventilation for any reason
Trial locations and contacts
1 site in 1 country.
Canada1 site
Toronto General Hospital, University Health Network
Toronto, Ontario, M5G 2C4
About this study
Official title: The Efficacy of Isocapnic Hyperpnoea to Accelerate Recovery After General Anesthesia With Sevoflurane.
The twilight phase between being asleep and awake during recovery from anesthesia is a precarious time fraught with risks to the post-operative patient. Hyperventilation accelerates the elimination of inhaled anesthetics but reduces their CO2 blood concentrations which delays their resumption of spontaneous breathing. We previously showed that our method of hyperventilation without affecting the CO2 concentration--which we call IH--accelerates the rate of emergence from anesthesia with isoflurane. In this study we will study the effect of IH on the rate of emergence from Sevoflurane anesthesia.
- Conditions
- Anesthesia
- Being tested
- Isocapnic Hyperponea
- Keywords
- general anesthesia, hyperventilation, carbon dioxide, isocapnic hyperponea
- Medical subject headings
- Hyperventilation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Isocapnic HyperponeaProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to recovery from anesthesia as indicated by time to extubation and rate of change of BIS score
Secondary outcomes (1)
Quality of recovery in the recovery room as indicated by the level of consciousness, incidence of nausea, vomiting, shivering and other phenomena occuring during recovery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2005 (estimated)
- Study startOct 2005
- Primary completionAug 2008
- Study completionDec 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnesthesiaStudies of the same condition, open and under way.
- More trials run by University Health Network, TorontoThe sponsor's other registered studies.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
Sponsor and investigators
- Lead sponsor
- University Health Network, Toronto
- Sponsor type
- University, hospital or other
- Investigators
- Rita Katznelson, MD, Principal investigator, Toronto General Hospital, University Health Network
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00242671
- Sponsor's protocol ID
- UHN REB 05-0299-AE
- Status last verified
- Sep 2006
- First submitted
- 18 Oct 2005
- Last updated
- 5 Aug 2010
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy of Isocapnic Hyperpnoea to Accelerate Recovery After General Anesthesia With Sevoflurane.
- ClinicalTrials.gov ID
- NCT00242671
- Acronym / sponsor ID
- UHN REB 05-0299-AE
- Conditions
- Anesthesia
- Keywords
- general anesthesia, hyperventilation, carbon dioxide, isocapnic hyperponea
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- University Health Network, TorontoUniversity, hospital or other
- Study start
- Oct 2005
- Primary completion
- Aug 2008 (actual)
- Study completion
- Dec 2008 (actual)
- First posted
- 20 Oct 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The twilight phase between being asleep and awake during recovery from anesthesia is a precarious time fraught with risks to the post-operative patient. Hyperventilation accelerates the elimination of inhaled anesthetics but reduces their CO2 blood concentrations which delays their resumption of spontaneous breathing. We previously showed that our method of hyperventilation without affecting the CO2 concentration--which we call IH--accelerates the rate of emergence from anesthesia with isoflurane. In this study we will study the effect of IH on the rate of emergence from Sevoflurane anesthesia.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Elective gynecological procedure
- ASA I-III
- Age 18-80 years
- Signed informed consent
Key exclusion criteria (13 listed)
- ASA IV
- Patients with contra-indications to Sevoflurane anesthesia or other anesthetics included in the protocol
- Active smoking, asthma or other history of hyper-reactive airway disease
- History of chronic obstructive lung disease limiting exercise
- History of angina, previous myocardial infarction, valvular heart disease, or heart surgery
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 |
|---|---|---|
| Isocapnic Hyperponea | Procedure or surgery | – |
Primary outcome
Time to recovery from anesthesia as indicated by time to extubation and rate of change of BIS score
1 secondary outcome
Quality of recovery in the recovery room as indicated by the level of consciousness, incidence of nausea, vomiting, shivering and other phenomena occuring during recovery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2010.
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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.
Rita Katznelson, MD principal investigator
Toronto General Hospital, University Health Network
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Isocapnic Hyperponea in people with Anesthesia, run by University Health Network, Toronto at 1 site in Canada.
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 4 inclusion and 13 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 5 Aug 2010. 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 Canada. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Time to recovery from anesthesia as indicated by time to extubation and rate of change of BIS score. 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 5 Aug 2010.