Ureteral Stent OcclusionPhase 4NCT01310582
Recovery Following Desflurane Versus Sevoflurane for Outpatient Urologic Surgery in Elderly Females
A Phase 4 study testing Desflurane and Sevoflurane in people with Ureteral Stent Occlusion and Exposure Laser, run by Hahnemann University Hospital at 1 site in United States.
Trial summary
Numerous studies demonstrate that patients have improved immediate recovery characteristics following desflurane anesthesia compared to other volatile agents, including sevoflurane. Read more about this study
- Who is it for?
- Ages 60 to 85 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Ureteral Stent Occlusion, Exposure Laser, Ureterostomy; Functional Disturbance
- What is being tested?
- Desflurane and Sevoflurane
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 57 participants
- Where
- 1 siteUnited States
- Study dates
- May 2011to Aug 2013
- 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 60 to 85 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- > 65 years old, female subjects
- Scheduled for brief urologic surgery (Cyctoscopy, Ureteral stent, Laserlithotripsy, Ureteroscopy, Vaginal sling, Bladder injury repair, Rectocele repair and Stone extraction)
- Ability to read, write and speak English language
- Driving at least one year
Who cannot join
- Preexisting neurological impairment in thinking process
- Renal insufficiency or failure
- Lack of command of English language
- Inability to drive
- Motion Sickness
Trial locations and contacts
1 site in 1 country.
United States1 site
Hahnemann University Hospital
Philadelphia, Pennsylvania, 19102
About this study
Official title: Recovery Following Desflurane vs Sevoflurane for Outpatient Urologic Surgery in Elderly Females
Numerous studies demonstrate that patients have improved immediate recovery characteristics following desflurane anesthesia compared to other volatile agents, including sevoflurane. There is limited evidence in the literature to suggest that patients undergoing sevoflurane, compared to desflurane anesthesia, may suffer from limitation in function and cognitive ability for an undetermined, but prolonged period of time following surgery. These differences are not explained pharmacokinetically and may be a result of a direct neurotoxic effect of sevoflurane. An unresolved question is the time required for the ability to return to complex tasks, such as driving, following anesthesia. Commonly, patients are advised not to drive or make important decisions for 24 hours following anesthesia, but this is not well-studied and proscribed on an empiric, rather than scientific, basis with very limited data available.This study will better define recovery characteristics and characterize the severity and duration of cognitive impairment following sevoflurane or desflurane anesthesia after brief outpatient urologic surgery in elderly females using tests of cognitive ability coupled with performance on a driving simulator and cognitive task tests to objectively measure not only testing performance, but also cognitive effort in performing these tests.
Read the detailed description
Following IRB-approved consent, 60 patients were be randomized (63 patients to be enrolled accounting for a <5% screen failure and <5% dropped patient rates) to receive either a desflurane or sevoflurane-based anesthetic for pelvic floor repair. The selection of the anesthetic gas (sevoflurane or desflurane) was determined by computer generated randomization. Only the Anesthesiologist or the CRNA knows which gas has been administered to the subject. All the investigators and the co-investigator who collected the research data were blinded to the gas selection.
Potential subjects were identified during the clinic visit in the Urology Department in Hahnemann University Hospital.
On the morning of the surgery, the study investigator who is a medical doctor asked the subjects to perform a baseline cognitive task tests to determine the baseline thinking process. The detailed description of the cognitive task is as following;
- Mini-Mental Status Exam (MMSE): (10-15 minutes) This is a 30-item measure of global cognition (Folstein, Folstein \& McHugh, 1975) that tests orientation to time and place, object naming, repetition, attention, recall, and following complex commands.
- Trail Making Test Part A and Part B: Part A (3 minutes) of this measure (Army Individual Test Battery, 1944; Reitan \& Wolfson, 1985) is a test of visual attention where the subjects must draw lines on a page connecting 25 consecutive number as quickly as possible. Part B (5 minutes) requires the subject to alternately sequence numbers and letters randomly distributed on a page into their ascending and alphabetical order as quickly as possible.
- Digit Symbol Coding: (2 minutes) This subtest of the WAIS-III (Wechsler, 1997) consists of nine digit-symbol pairs followed by a list of digits. Under each digit the subject must write down the corresponding symbol as quickly as possible.
- Hopkins Verbal Learning Test-Revised (HVLT-R): (8 minutes) Memory for verbal information will be assessed with this list learning task assessing immediate and delayed recall.
- Stroop Color and Word Test: (5 minutes) This test (Stroop, 1935; Golden, 2002) measures cognitive control by asking subjects to suppress a habitual response in favor of an alternate response. Participants are shown a word and asked to name the color in which the word is written Total time expected for cognitive task tests is 28-33 min. If the patients' were able to drive and have been driving for at least one year, they were required to perform driving simulation. After performing the baseline cognitive task tests, baseline driving simulation (15 minutes) on the driving simulator.
After the baseline Cognitive Task Test and Virtual Driving Training session, the subjects underwent their planned surgery. The selection of the anesthetic gas was determined by a computer generated randomization list. The anesthesiologist or the CRNA in charge of the subject administered anesthesia. The investigators and the subjects were blinded to the anesthetic gas given. At the conclusion of the surgery, the anesthetic gas was shut down and the co-investigator was called into the OR to document the time the subjects take to open their eyes after the cessation of the gas.
At 30 minutes after discontinuation of the anesthetic gas, the subjects were asked to repeat the same sets of cognitive task tests (28-33 min).
And, at 2 hours after the surgery, the subjects repeated the cognitive tasks test (28-33 min) and the driving simulation (20 min) for patients who were able to drive.
On the next day of the surgery, the co-investigator had a telephone conversation with the subjects who were discharged home after the surgery. Modified Telephone Interview for Cognitive Status (TICS-M) was used to collect data (10 minutes). This is a 13-item telephone interview (Welsh, Breitner, \& Magruder-Habib, 1993) for late-life cognitive assessment that includes tests of orientation, attention, working memory, praxis, sentence repetition, naming to verbal description, recent memory, word opposites, and an additional immediate and delayed recall of a 10-word list. The subjects' participation in the study ended after this follow-up telephone call.
The participants were followed for the duration up to 28 hours. The follow-up and participation in this study ended after 24-28 hours.
From date of randomization until the date of first documented progression, end of participation or date of death from any cause, whichever came first, assessed up to 30 days.
- Conditions
- Ureteral Stent Occlusion, Exposure Laser, Ureterostomy; Functional Disturbance, Vaginal Diseases, Injury of Bladder, Excessive Repair
- Being tested
- Desflurane, Sevoflurane
- Keywords
- Sevoflurane, Desflurane
- Medical subject headings
- Vaginal Diseases, Calculi
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DesfluraneDrug
SevofluraneDrug
| Study group | Role | What they receive |
|---|---|---|
| Desflurane | Active comparator | During the surgery the subjects were given Desflurane, general anesthesia, that will keep the patient asleep during the surgery. The dosage form was inhalation gas, dosage equivalent to 1 MAC, frequency was once and the duration was throughout the surgery (30-45 minutes). Receives: Drug: Desflurane |
| Sevoflurane | Active comparator | During the surgery the subjects were given Sevoflurane, general anesthesia, that will keep the patient asleep during the surgery. The dosage form was inhalation gas, dosage equivalent to 1 MAC, frequency was once and the duration was throughout the surgery (30-45 minutes). Receives: Drug: Sevoflurane |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to Opening of Eyes
Measured: At 30-45 minutes, following discontinuation of volatile anesthetic at the end of surgery
Secondary outcomes (1)
Time to Discharge From PACU
Measured: At 30-45 minutes, following discontinuation of volatile anesthetic at the end of surgery and transfer to PACU
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2011 (estimated)
- Study startMay 2011
- Primary completionAug 2013
- Study completionAug 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 Ureteral Stent OcclusionStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 57 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hahnemann University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Baxter Healthcare Corporation
- Responsible party
- Principal investigator, Michael Green, DO, Hahnemann University Hospital
- Investigators
- George Mychaskiw, DO, Principal investigator, Professor and Chair, Department of Anesthesiology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01310582
- Sponsor's protocol ID
- 19326
- Status last verified
- Nov 2013
- First submitted
- 7 Mar 2011
- Last updated
- 24 Dec 2013
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Recovery Following Desflurane vs Sevoflurane for Outpatient Urologic Surgery in Elderly Females
- ClinicalTrials.gov ID
- NCT01310582
- Acronym / sponsor ID
- 19326
- Conditions
- Ureteral Stent Occlusion, Exposure Laser, Ureterostomy; Functional Disturbance, Vaginal Diseases, Injury of Bladder, Excessive Repair
- Keywords
- Sevoflurane, Desflurane
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 57 participants (actual)
- Lead sponsor
- Hahnemann University HospitalUniversity, hospital or other
- Collaborators
- Baxter Healthcare Corporation
- Study start
- May 2011
- Primary completion
- Aug 2013 (actual)
- Study completion
- Aug 2013 (actual)
- First posted
- 8 Mar 2011 (estimated)
- Results
- Posted 24 Dec 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Numerous studies demonstrate that patients have improved immediate recovery characteristics following desflurane anesthesia compared to other volatile agents, including sevoflurane. There is limited evidence in the literature to suggest that patients undergoing sevoflurane, compared to desflurane anesthesia, may suffer from limitation in function and cognitive ability for an undetermined, but prolonged period of time following surgery. These differences are not explained pharmacokinetically and may be a result of a direct neurotoxic effect of sevoflurane. An unresolved question is the time required for the ability to return to complex tasks, such as driving, following anesthesia. Commonly, patients are advised not to drive or make important decisions for 24 hours following anesthesia, but this is not well-studied and proscribed on an empiric, rather than scientific, basis with very limited data available.This study will better define recovery characteristics and characterize the severity and duration of cognitive impairment following sevoflurane or desflurane anesthesia after brief outpatient urologic surgery in elderly females using tests of cognitive ability coupled with performance on a driving simulator and cognitive task tests to objectively measure not only testing performance, but also cognitive effort in performing these tests.
Detailed description
Following IRB-approved consent, 60 patients were be randomized (63 patients to be enrolled accounting for a <5% screen failure and <5% dropped patient rates) to receive either a desflurane or sevoflurane-based anesthetic for pelvic floor repair. The selection of the anesthetic gas (sevoflurane or desflurane) was determined by computer generated randomization. Only the Anesthesiologist or the CRNA knows which gas has been administered to the subject. All the investigators and the co-investigator who collected the research data were blinded to the gas selection.
Potential subjects were identified during the clinic visit in the Urology Department in Hahnemann University Hospital.
On the morning of the surgery, the study investigator who is a medical doctor asked the subjects to perform a baseline cognitive task tests to determine the baseline thinking process. The detailed description of the cognitive task is as following;
- Mini-Mental Status Exam (MMSE): (10-15 minutes) This is a 30-item measure of global cognition (Folstein, Folstein \& McHugh, 1975) that tests orientation to time and place, object naming, repetition, attention, recall, and following complex commands.
- Trail Making Test Part A and Part B: Part A (3 minutes) of this measure (Army Individual Test Battery, 1944; Reitan \& Wolfson, 1985) is a test of visual attention where the subjects must draw lines on a page connecting 25 consecutive number as quickly as possible. Part B (5 minutes) requires the subject to alternately sequence numbers and letters randomly distributed on a page into their ascending and alphabetical order as quickly as possible.
- Digit Symbol Coding: (2 minutes) This subtest of the WAIS-III (Wechsler, 1997) consists of nine digit-symbol pairs followed by a list of digits. Under each digit the subject must write down the corresponding symbol as quickly as possible.
- Hopkins Verbal Learning Test-Revised (HVLT-R): (8 minutes) Memory for verbal information will be assessed with this list learning task assessing immediate and delayed recall.
- Stroop Color and Word Test: (5 minutes) This test (Stroop, 1935; Golden, 2002) measures cognitive control by asking subjects to suppress a habitual response in favor of an alternate response. Participants are shown a word and asked to name the color in which the word is written Total time expected for cognitive task tests is 28-33 min. If the patients' were able to drive and have been driving for at least one year, they were required to perform driving simulation. After performing the baseline cognitive task tests, baseline driving simulation (15 minutes) on the driving simulator.
After the baseline Cognitive Task Test and Virtual Driving Training session, the subjects underwent their planned surgery. The selection of the anesthetic gas was determined by a computer generated randomization list. The anesthesiologist or the CRNA in charge of the subject administered anesthesia. The investigators and the subjects were blinded to the anesthetic gas given. At the conclusion of the surgery, the anesthetic gas was shut down and the co-investigator was called into the OR to document the time the subjects take to open their eyes after the cessation of the gas.
At 30 minutes after discontinuation of the anesthetic gas, the subjects were asked to repeat the same sets of cognitive task tests (28-33 min).
And, at 2 hours after the surgery, the subjects repeated the cognitive tasks test (28-33 min) and the driving simulation (20 min) for patients who were able to drive.
On the next day of the surgery, the co-investigator had a telephone conversation with the subjects who were discharged home after the surgery. Modified Telephone Interview for Cognitive Status (TICS-M) was used to collect data (10 minutes). This is a 13-item telephone interview (Welsh, Breitner, \& Magruder-Habib, 1993) for late-life cognitive assessment that includes tests of orientation, attention, working memory, praxis, sentence repetition, naming to verbal description, recent memory, word opposites, and an additional immediate and delayed recall of a 10-word list. The subjects' participation in the study ended after this follow-up telephone call.
The participants were followed for the duration up to 28 hours. The follow-up and participation in this study ended after 24-28 hours.
From date of randomization until the date of first documented progression, end of participation or date of death from any cause, whichever came first, assessed up to 30 days.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Desflurane | Active comparator | Drug: DesfluraneDuring the surgery the subjects were given Desflurane, general anesthesia, that will keep the patient asleep during the surgery. The dosage form was inhalation gas, dosage equivalent to 1 MAC, frequency was once and the duration was throughout the surgery (30-45 minutes). |
| Sevoflurane | Active comparator | Drug: SevofluraneDuring the surgery the subjects were given Sevoflurane, general anesthesia, that will keep the patient asleep during the surgery. The dosage form was inhalation gas, dosage equivalent to 1 MAC, frequency was once and the duration was throughout the surgery (30-45 minutes). |
Who may qualify
- Ages
- 60 to 85 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- > 65 years old, female subjects
- Scheduled for brief urologic surgery (Cyctoscopy, Ureteral stent, Laserlithotripsy, Ureteroscopy, Vaginal sling, Bladder injury repair, Rectocele repair and Stone extraction)
- Ability to read, write and speak English language
- Driving at least one year
Key exclusion criteria (5 listed)
- Preexisting neurological impairment in thinking process
- Renal insufficiency or failure
- Lack of command of English language
- Inability to drive
- Motion Sickness
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 |
|---|---|---|
| Desflurane | Drug | Desflurane |
| Sevoflurane | Drug | Sevoflurane |
Primary outcome
Time to Opening of Eyes
Time frame: At 30-45 minutes, following discontinuation of volatile anesthetic at the end of surgery
1 secondary outcome
Time to Discharge From PACU
Time frame: At 30-45 minutes, following discontinuation of volatile anesthetic at the end of surgery and transfer to PACU
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Dec 2013.
- 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.
George Mychaskiw, DO principal investigator
Professor and Chair, Department of Anesthesiology
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 Desflurane and Sevoflurane in people with Ureteral Stent Occlusion and Exposure Laser, run by Hahnemann University Hospital 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 4 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 24 Dec 2013. 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.
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 24 Dec 2013). 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?
Time to Opening of Eyes (time frame: At 30-45 minutes, following discontinuation of volatile anesthetic at the end of surgery). 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 24 Dec 2013.