Duration of HospitalizationNCT01379664
Volatile Anesthetic Choice and Duration of Hospitalization: A Quality Improvement and Cost-control Project
A study testing Isoflurane and Sevoflurane in people with Duration of Hospitalization, run by The Cleveland Clinic at 1 site in United States.
Trial summary
Preliminary retrospective data suggest that the relatively soluble but inexpensive volatile anesthesia isoflurane prolongs the duration of hospitalization compared to the less soluble but more expensive anesthetic sevoflurane. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Duration of Hospitalization
- What is being tested?
- Isoflurane and Sevoflurane
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,584 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2011to Apr 2013
- Phase
- Interventional
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Must have surgery in G operating room suite
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Preliminary retrospective data suggest that the relatively soluble but inexpensive volatile anesthesia isoflurane prolongs the duration of hospitalization compared to the less soluble but more expensive anesthetic sevoflurane. Even a small reduction in the duration of hospitalization would easily compensate for the modest additional cost of sevoflurane. The investigators therefore propose to test the primary hypothesis that duration of hospitalization is longer with isoflurane than sevoflurane.
The investigators will also test the secondary hypotheses that: 1) pain scores are greater in patients recovering from isoflurane than sevoflurane anesthesia; and, 2) opioid consumption is greater after isoflurane than sevoflurane anesthesia. All statistical analyses will be adjusted for age, gender, race, baseline risk, 9 and procedure.
- Conditions
- Duration of Hospitalization
- Being tested
- Isoflurane, Sevoflurane
- Keywords
- Sevoflurane, Isoflurane, volatile anesthetic, duration of hospitalization
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IsofluraneDrug
Isoflurane is administered to patient during surgery as it would normally be administered by the attending anesthesiologist
SevofluraneDrug
Sevoflurane is administered to patient during surgery as it would normally be administered by the attending anesthesiologist
| Study group | Role | What they receive |
|---|---|---|
| Isoflurane | Experimental | Isoflurane is to be administered to patients in this arm during surgery Receives: Drug: Isoflurane |
| Sevoflurane | Experimental | Sevoflurane is to be administered to patients in this arm during surgery Receives: Drug: Sevoflurane |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hospital Length of Stay
Measured: participants will be followed for the duration of hospital stay, an expected average of 3 days
Secondary outcomes (2)
Time-weighted Average Verbal Rating Pain Score
Time-weighted average VRS (Verbal Rating Scale) pain score over the first 72 h after surgery as recorded by nurses at approximately 4-h intervals. The VRS pain score is from 0 (no pain) to 10 (worst imaginable pain).
Measured: up to 72 hours after surgery
Total Intraoperative Opioid Consumption
Total amount of opioid in IV morphine equivalents used during surgeyr
Measured: intraoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2011 (estimated)
- Study startJul 2011
- Primary completionApr 2013
- Study completionApr 2013
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 Duration of HospitalizationStudies of the same condition, open and under way.
- More trials run by The Cleveland ClinicThe 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
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,584 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Cleveland Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, d sessler, The Cleveland Clinic
- Investigators
- Daniel I Sessler, MD, Principal investigator, The Cleveland Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01379664
- Sponsor's protocol ID
- 11-440
- Status last verified
- Feb 2017
- First submitted
- 17 Jun 2011
- Last updated
- 10 Apr 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Volatile Anesthetic Choice and Duration of Hospitalization: A Quality Improvement and Cost-control Project
- ClinicalTrials.gov ID
- NCT01379664
- Acronym / sponsor ID
- 11-440
- Conditions
- Duration of Hospitalization
- Keywords
- Sevoflurane, Isoflurane, volatile anesthetic, duration of hospitalization
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,584 participants (actual)
- Lead sponsor
- The Cleveland ClinicUniversity, hospital or other
- Study start
- Jul 2011
- Primary completion
- Apr 2013 (actual)
- Study completion
- Apr 2013 (actual)
- First posted
- 23 Jun 2011 (estimated)
- Results
- Posted 10 Apr 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Preliminary retrospective data suggest that the relatively soluble but inexpensive volatile anesthesia isoflurane prolongs the duration of hospitalization compared to the less soluble but more expensive anesthetic sevoflurane. Even a small reduction in the duration of hospitalization would easily compensate for the modest additional cost of sevoflurane. The investigators therefore propose to test the primary hypothesis that duration of hospitalization is longer with isoflurane than sevoflurane.
The investigators will also test the secondary hypotheses that: 1) pain scores are greater in patients recovering from isoflurane than sevoflurane anesthesia; and, 2) opioid consumption is greater after isoflurane than sevoflurane anesthesia. All statistical analyses will be adjusted for age, gender, race, baseline risk, 9 and procedure.
Study design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Isoflurane | Experimental | Drug: IsofluraneIsoflurane is to be administered to patients in this arm during surgery |
| Sevoflurane | Experimental | Drug: SevofluraneSevoflurane is to be administered to patients in this arm during surgery |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Must have surgery in G operating room suite
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| IsofluraneIsoflurane is administered to patient during surgery as it would normally be administered by the attending anesthesiologist | Drug | Isoflurane |
| SevofluraneSevoflurane is administered to patient during surgery as it would normally be administered by the attending anesthesiologist | Drug | Sevoflurane |
Primary outcome
Hospital Length of Stay
Time frame: participants will be followed for the duration of hospital stay, an expected average of 3 days
2 secondary outcomes
Time-weighted Average Verbal Rating Pain Score
Time frame: up to 72 hours after surgery
Total Intraoperative Opioid Consumption
Time frame: intraoperative
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Apr 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
Daniel I Sessler, MD principal investigator
The Cleveland Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Isoflurane and Sevoflurane in people with Duration of Hospitalization, run by The Cleveland Clinic at 1 site in United States.
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 0 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 10 Apr 2017. 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 United States. 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?
Yes. Results are posted in the registry (first posted 10 Apr 2017). 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?
Hospital Length of Stay (time frame: participants will be followed for the duration of hospital stay, an expected average of 3 days). 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 10 Apr 2017.