Recovery Time From Isoflurane Anesthesia in Obese PatientsNCT00752492
Acceleration of Recovery From General Anesthesia - Efficacy of Isocapnic Hyperpnoea in Obese Patients Undergoing Isoflurane Anesthesia
A study testing Isocapnic Hyperpnoea in people with Recovery Time From Isoflurane Anesthesia in Obese Patients, run by University Health Network, Toronto at 1 site in Canada.
Trial summary
Faster recovery from anesthesia is important for obese patients because they are at high risk of respiratory complications following tracheal extubation. Isoflurane has several properties that make it a preferable agent for anesthesia in obese patients. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Recovery Time From Isoflurane Anesthesia in Obese Patients
- What is being tested?
- Isocapnic Hyperpnoea
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteCanada
- Study dates
- Sep 2008to Apr 2011
- Phase
- Interventional
- 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
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Elective gynecological or urological procedure,
- BMI > 35 kg/m²,
- ASA I-III,
- Signed informed consent.
Who cannot join
- Lack of informed consent,
- ASA IV-V,
- Contra-indications to isoflurane anesthesia or other anesthetics included in the protocol,
- History of cardiac or respiratory disease,
- Alcohol or drug abuse,
- Psychiatric illness and/or medications.
Trial locations and contacts
1 site in 1 country.
About this study
Faster recovery from anesthesia is important for obese patients because they are at high risk of respiratory complications following tracheal extubation. Isoflurane has several properties that make it a preferable agent for anesthesia in obese patients. Its main limitation is a longer recovery time due to slower elimination in comparison to other agents. Elimination of isoflurane from the lungs can be accelerated by increasing in patient's minute ventilation, which decreases the level of CO2 in blood (hypocapnia).Isocapnic Hyperpnoea (IH) is a method allowing increased ventilation and therefore enhancement of the elimination of inhalation agents while maintaining a normal blood CO2 level. The investigators will compare recovery time from isoflurane anesthesia in obese patients during standard anesthesia management protocol (control) to a group treated with IH.
- Being tested
- Isocapnic Hyperpnoea
- Keywords
- Isocapnic hyperpnoea, obesity, isoflurane, Recovery of obese patient from isoflurane anesthesia
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Isocapnic HyperpnoeaOther
IH is a method of increasing alveolar ventilation (Va) while preventing the unwanted hypocapnia by addition of CO2 to the inhaled mixture.
| Study group | Role | What they receive |
|---|---|---|
| Study intervention | Active comparator | Patient will be disconnected from the anesthetic circuit and connected to the resuscitation bag attached to the IH system. Ventilation will be assisted to maintain tidal volume of 8-10 mL/kg and respiratory rate of 20-25 breaths per minute to achieve minute ventilation of 15-20 L/min. Isocapnia manifold will maintain end-tidal PCO2 in range of 40-50 mm Hg. Receives: Other: Isocapnic Hyperpnoea |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time from the end of anesthesia (turning isoflurane vaporizer off) to the readiness for Post Anesthesia Care Unit (PACU) discharge.
Measured: Intraoperatively and Post Anesthetic Care Unit
Secondary outcomes (3)
Times from end of anesthesia to BIS exceeds 75, b) eye-opening to verbal command, c) extubation, d) readiness for leaving
Measured: Intraoperatively and Post Anesthetic Care Unit
Sedation/Pain scores in the PACU.
Measured: Intraoperatively and Post Anesthetic Care Unit
Change in exhaled isoflurane concentrations in the 1st hour postoperatively.
Measured: Intraoperatively and Post Anesthetic Care Unit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2008 (estimated)
- Study startSep 2008
- Primary completionJun 2010
- Study completionApr 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Recovery Time From Isoflurane Anesthesia in Obese PatientsStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 44 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Health Network, Toronto
- Sponsor type
- University, hospital or other
- Collaborators
- The Physicians' Services Incorporated Foundation
- Investigators
- Rita Katznelson, MD, Principal investigator, Toronto General Hospital, University Health Network
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00752492
- Sponsor's protocol ID
- UHNREB08-0019B
- Status last verified
- Apr 2011
- First submitted
- 22 Jul 2008
- Last updated
- 20 Apr 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acceleration of Recovery From General Anesthesia - Efficacy of Isocapnic Hyperpnoea in Obese Patients Undergoing Isoflurane Anesthesia
- ClinicalTrials.gov ID
- NCT00752492
- Acronym / sponsor ID
- UHNREB08-0019B
- Keywords
- Isocapnic hyperpnoea, obesity, isoflurane, Recovery of obese patient from isoflurane anesthesia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (estimated)
- Lead sponsor
- University Health Network, TorontoUniversity, hospital or other
- Collaborators
- The Physicians' Services Incorporated Foundation
- Study start
- Sep 2008
- Primary completion
- Jun 2010 (actual)
- Study completion
- Apr 2011 (actual)
- First posted
- 15 Sep 2008 (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.
Faster recovery from anesthesia is important for obese patients because they are at high risk of respiratory complications following tracheal extubation. Isoflurane has several properties that make it a preferable agent for anesthesia in obese patients. Its main limitation is a longer recovery time due to slower elimination in comparison to other agents. Elimination of isoflurane from the lungs can be accelerated by increasing in patient's minute ventilation, which decreases the level of CO2 in blood (hypocapnia).Isocapnic Hyperpnoea (IH) is a method allowing increased ventilation and therefore enhancement of the elimination of inhalation agents while maintaining a normal blood CO2 level. The investigators will compare recovery time from isoflurane anesthesia in obese patients during standard anesthesia management protocol (control) to a group treated with IH.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (participant)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study intervention | Active comparator | Other: Isocapnic HyperpnoeaPatient will be disconnected from the anesthetic circuit and connected to the resuscitation bag attached to the IH system. Ventilation will be assisted to maintain tidal volume of 8-10 mL/kg and respiratory rate of 20-25 breaths per minute to achieve minute ventilation of 15-20 L/min. Isocapnia manifold will maintain end-tidal PCO2 in range of 40-50 mm Hg. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Elective gynecological or urological procedure,
- BMI > 35 kg/m²,
- ASA I-III,
- Signed informed consent.
Key exclusion criteria (6 listed)
- Lack of informed consent,
- ASA IV-V,
- Contra-indications to isoflurane anesthesia or other anesthetics included in the protocol,
- History of cardiac or respiratory disease,
- Alcohol or drug abuse,
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 HyperpnoeaIH is a method of increasing alveolar ventilation (Va) while preventing the unwanted hypocapnia by addition of CO2 to the inhaled mixture. | Other | Study intervention |
Primary outcome
Time from the end of anesthesia (turning isoflurane vaporizer off) to the readiness for Post Anesthesia Care Unit (PACU) discharge.
Time frame: Intraoperatively and Post Anesthetic Care Unit
3 secondary outcomes
Times from end of anesthesia to BIS exceeds 75, b) eye-opening to verbal command, c) extubation, d) readiness for leaving
Time frame: Intraoperatively and Post Anesthetic Care Unit
Sedation/Pain scores in the PACU.
Time frame: Intraoperatively and Post Anesthetic Care Unit
Change in exhaled isoflurane concentrations in the 1st hour postoperatively.
Time frame: Intraoperatively and Post Anesthetic Care Unit
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 20 Apr 2011.
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 study testing Isocapnic Hyperpnoea in people with Recovery Time From Isoflurane Anesthesia in Obese Patients, 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 6 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 20 Apr 2011. 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.
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 from the end of anesthesia (turning isoflurane vaporizer off) to the readiness for Post Anesthesia Care Unit (PACU) discharge. (time frame: Intraoperatively and Post Anesthetic Care Unit). 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 20 Apr 2011.