Lumbar SpondylosisNCT00788008
Cognitive Effects of Inhalational Versus Intravenous General Anesthesia in the Elderly
A study testing inhalation anesthesia with isoflurane vs. TIVA with propofol in people with Lumbar Spondylosis and Cervical Spondylosis, run by Duke University at 2 sites in United States.
Trial summary
The purpose of this research is to determine if post-operative cognition will be better if the general anesthesia for surgery is done with an inhaled (gas through a breathing tube) or intravenous (medicine injected in the IV) general anesthetic technique. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Lumbar Spondylosis, Cervical Spondylosis, Hip Osteoarthritis
- What is being tested?
- inhalation anesthesia with isoflurane vs. TIVA with propofol
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 2 sitesUnited States
- Study dates
- Nov 2008to Dec 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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- patients (aged 65 years or older) scheduled for elective spine or major joint replacement (total hip or total knee arthroplasty) at Duke University Medical Center or the Durham VA Medical Center
Who cannot join
- not fluent in English and able to comprehend the English language
- have severe visual or auditory handicaps
- Carry a diagnosis of dementia or score < 18 on the Mini-Mental State Examination (MMSE) as calculated from the Modified Mini-Mental State (3MS) (see D4 below)
- have allergies to eggs, propofol, isoflurane, fentanyl, remifentanil, or pregabalin
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Duke University Medical Center
Durham, North Carolina, 27710
VAMC
Durham, North Carolina, 27710
About this study
Official title: Does Inhalational Anesthesia Accelerate Postoperative Cognitive Decline?
The purpose of this research is to determine if post-operative cognition will be better if the general anesthesia for surgery is done with an inhaled (gas through a breathing tube) or intravenous (medicine injected in the IV) general anesthetic technique.
Read the detailed description
A prospective randomized pre-test post-test design will be used. After obtaining informed consent, patients will be randomized to either: 1) Inhalational anesthesia with isoflurane or 2) Total intravenous anesthesia(TIVA) with propofol. Randomization will be stratified by surgical type so that this variable is equally distributed between the treatment groups. All patients will be maintained at a standard depth of anesthesia (40-60) using a Bispectral Index (BIS®) monitor. Normocarbia will be maintained in the operating room using capnography monitoring. Normothermia will be maintained throughout the procedure.
The anesthesia team providing care for these patients will be able to choose the premedication and muscle relaxant for the anesthetic technique. Patient controlled anesthesia or regional anesthetic techniques may be used for post-operative analgesia at the discretion of the anesthesia team providing care for these patients. Anesthesia will be induced with intravenous propofol and fentanyl in all patients, unless contraindicated. Patients will be mechanically ventilated with air/oxygen. Temperature will be maintained > 35º C and ventilation will be adjusted to maintain end-tidal carbon dioxide (CO2) at 35 ± 5 mmHg. Mean arterial pressure will be maintained ≥ 75% of baseline or ≥ 60 mmHg, whichever is greater, in both groups. After induction of anesthesia, the maintenance anesthesia will consist of either:
- Inhalational anesthesia group - isoflurane will be used for maintenance of anesthesia. Intravenous fentanyl and/or remifentanil will be used for supplementary analgesia. These agents will be administered to maintain a normal depth of anesthesia using the BIS® monitor and traditional signs of anesthetic depth.
- TIVA group - propofol and opioid infusions (fentanyl or remifentanil) will be used for the maintenance of anesthesia. The infusions will be adjusted to maintain a normal depth of anesthesia using the BIS® monitor along with traditional signs of anesthetic depth.
All subjects will undergo pre-operative neurocognitive testing within two weeks of their surgery, and at 3 months post-surgery. The persistence versus resolution of cognitive deficits over time will be determined with a 1 year post-surgical follow-up assessment. Pre- to post-test change scores will be compared across groups on primary and secondary outcome variables (see below) while controlling for relevant demographic variables (age, education, sex).
- Being tested
- inhalation anesthesia with isoflurane vs. TIVA with propofol
- Keywords
- spinal, joint
- Medical subject headings
- Spondylosis, Osteoarthritis, Hip, Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
inhalation anesthesia with isoflurane vs. TIVA with propofolDrug
Also called Diprivan
variable depending upon patient
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Inhalational anesthesia with isoflurane Receives: Drug: inhalation anesthesia with isoflurane vs. TIVA with propofol |
| 2 | Active comparator | total intravenous anesthesia with propofol Receives: Drug: inhalation anesthesia with isoflurane vs. TIVA with propofol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Neurocognitive Performance (Z-score)
Mean change on composite scores (z-score) for memory and executive function measures.
Memory measures: Hopkins Verbal Learning Test-Revised and the Brief Visuospatial Memory Test-Revised.
Executive function measures: the Trail Making Test (Army, 1944), Digit-symbol substitution and Symbol Search subtests of the Processing Speed Index of the Wechsler Adult Intelligence Scale-III (WAIS-III; Wechsler, 1997) and the Controlled Oral Word Association subtest of the Multilingual Aphasia Examination.
The outcomes were constructed as summed z-score composites. They are scaled as standard deviations. Thus, a score of 0 was central on each composite, and 95% of the scores would fall within -2.0 and +2.0. While there is no minimum or maximum value is rare for any score (<1%) to fall outside the -3.0 to +3.0 range.
Higher scores (and thus positive change value) indicate an improvement of function.
Measured: 3 months post operatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Nov 2008 (estimated)
- Study startNov 2008
- Primary completionDec 2013
- Study completionDec 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 Lumbar SpondylosisStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Collaborators
- US Department of Veterans Affairs
- Responsible party
- Sponsor
- Investigators
- Terri G Monk, MD, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00788008
- Sponsor's protocol ID
- Pro00010070
- Status last verified
- Mar 2015
- First submitted
- 6 Nov 2008
- Last updated
- 26 Mar 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Inhalational Anesthesia Accelerate Postoperative Cognitive Decline?
- ClinicalTrials.gov ID
- NCT00788008
- Acronym / sponsor ID
- Pro00010070
- Keywords
- spinal, joint
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Collaborators
- US Department of Veterans Affairs
- Study start
- Nov 2008
- Primary completion
- Dec 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 10 Nov 2008 (estimated)
- Results
- Posted 26 Mar 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this research is to determine if post-operative cognition will be better if the general anesthesia for surgery is done with an inhaled (gas through a breathing tube) or intravenous (medicine injected in the IV) general anesthetic technique.
Detailed description
A prospective randomized pre-test post-test design will be used. After obtaining informed consent, patients will be randomized to either: 1) Inhalational anesthesia with isoflurane or 2) Total intravenous anesthesia(TIVA) with propofol. Randomization will be stratified by surgical type so that this variable is equally distributed between the treatment groups. All patients will be maintained at a standard depth of anesthesia (40-60) using a Bispectral Index (BIS®) monitor. Normocarbia will be maintained in the operating room using capnography monitoring. Normothermia will be maintained throughout the procedure.
The anesthesia team providing care for these patients will be able to choose the premedication and muscle relaxant for the anesthetic technique. Patient controlled anesthesia or regional anesthetic techniques may be used for post-operative analgesia at the discretion of the anesthesia team providing care for these patients. Anesthesia will be induced with intravenous propofol and fentanyl in all patients, unless contraindicated. Patients will be mechanically ventilated with air/oxygen. Temperature will be maintained > 35º C and ventilation will be adjusted to maintain end-tidal carbon dioxide (CO2) at 35 ± 5 mmHg. Mean arterial pressure will be maintained ≥ 75% of baseline or ≥ 60 mmHg, whichever is greater, in both groups. After induction of anesthesia, the maintenance anesthesia will consist of either:
- Inhalational anesthesia group - isoflurane will be used for maintenance of anesthesia. Intravenous fentanyl and/or remifentanil will be used for supplementary analgesia. These agents will be administered to maintain a normal depth of anesthesia using the BIS® monitor and traditional signs of anesthetic depth.
- TIVA group - propofol and opioid infusions (fentanyl or remifentanil) will be used for the maintenance of anesthesia. The infusions will be adjusted to maintain a normal depth of anesthesia using the BIS® monitor along with traditional signs of anesthetic depth.
All subjects will undergo pre-operative neurocognitive testing within two weeks of their surgery, and at 3 months post-surgery. The persistence versus resolution of cognitive deficits over time will be determined with a 1 year post-surgical follow-up assessment. Pre- to post-test change scores will be compared across groups on primary and secondary outcome variables (see below) while controlling for relevant demographic variables (age, education, sex).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Drug: inhalation anesthesia with isoflurane vs. TIVA with propofolInhalational anesthesia with isoflurane |
| 2 | Active comparator | Drug: inhalation anesthesia with isoflurane vs. TIVA with propofoltotal intravenous anesthesia with propofol |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (1 listed)
- patients (aged 65 years or older) scheduled for elective spine or major joint replacement (total hip or total knee arthroplasty) at Duke University Medical Center or the Durham VA Medical Center
Key exclusion criteria (4 listed)
- not fluent in English and able to comprehend the English language
- have severe visual or auditory handicaps
- Carry a diagnosis of dementia or score < 18 on the Mini-Mental State Examination (MMSE) as calculated from the Modified Mini-Mental State (3MS) (see D4 below)
- have allergies to eggs, propofol, isoflurane, fentanyl, remifentanil, or pregabalin
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 |
|---|---|---|
| inhalation anesthesia with isoflurane vs. TIVA with propofolAlso: Diprivanvariable depending upon patient | Drug | 1, 2 |
Primary outcome
Change in Neurocognitive Performance (Z-score)
Time frame: 3 months post operatively
Mean change on composite scores (z-score) for memory and executive function measures. Memory measures: Hopkins Verbal Learning Test-Revised and the Brief Visuospatial Memory Test-Revised. Executive function measures: the Trail Making Test (Army, 1944), Digit-symbol substitution and Symbol Search subtests of the Processing Speed Index of the Wechsler Adult Intelligence Scale-III (WAIS-III; Wechsler, 1997) and the Controlled Oral Word Association subtest of the Multilingual Aphasia Examination. The outcomes were constructed as summed z-score composites. They are scaled as standard deviations. Thus, a score of 0 was central on each composite, and 95% of the scores would fall within -2.0 and +2.0. While there is no minimum or maximum value is rare for any score (<1%) to fall outside the -3.0 to +3.0 range. Higher scores (and thus positive change value) indicate an improvement of function.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Mar 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Terri G Monk, MD principal investigator
Duke University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing inhalation anesthesia with isoflurane vs. TIVA with propofol in people with Lumbar Spondylosis and Cervical Spondylosis, run by Duke University at 2 sites 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 4 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 26 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 26 Mar 2015). 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?
Change in Neurocognitive Performance (Z-score) (time frame: 3 months post operatively). 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 26 Mar 2015.