1. Postoperative Cognitive DysfunctionNCT01199913
POCD in Elderly Patients Following Desflurane or Sevoflurane General Anesthesia
An observational study of 1. Postoperative Cognitive Dysfunction, run by Loma Linda University at 1 site in United States.
Trial summary
The use of desflurane in elderly subjects (>65 years old) undergoing general anesthesia with endotracheal intubation will result in decreased POCD compared to sevoflurane if the patient's MAP is within 20% of the patient's baseline and the cerebral suppression state index stays within the moderately anesthetized range… Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- 1. Postoperative Cognitive Dysfunction
- What is being tested?
- The intervention will be Mini-Mental Status Examination (MMSE)
- How many people
- 110 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2010to Aug 2014
- Phase
- Observational
- 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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Study population: Adult patients, male and female, 65 years or older scheduled for elective surgery requiring general anesthesia.
Who may be able to join
- Adult patients (>65 years old)
- Scheduled for elective surgery requiring general anesthesia at LLUMC HSH
- Airway management expected to include endotracheal intubation
- Expected surgical duration 120 to 240 minutes
Who cannot join
- Pre-existing significant psychiatric disease or mental status changes
- Clinically significant cardiovascular, respiratory, hepatic, renal,neurological, psychiatric, or metabolic disease
- Patient's weighing >50% ideal body weight
- Men: Ideal Body Weight (in kilograms) = 50 + 2.3 kg per inch over 5 feet
- Women: Ideal Body Weight (in kilograms) = 45.5 + 2.3kg per inch over 5 feet
- Patients who have undergone a general anesthetic within the past 7 days
- Patient refusal
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Incidence of Postoperative Cognitive Dysfunction in Elderly Patients Following Desflurane or Sevoflurane General Anesthesia: A Randomized, Controlled Trial
The use of desflurane in elderly subjects (>65 years old) undergoing general anesthesia with endotracheal intubation will result in decreased POCD compared to sevoflurane if the patient's MAP is within 20% of the patient's baseline and the cerebral suppression state index stays within the moderately anesthetized range during general anesthesia.
- Conditions
- 1. Postoperative Cognitive Dysfunction
- Being tested
- The intervention will be Mini-Mental Status Examination (MMSE)
- Keywords
- problems with thinking after surgery;
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The intervention will be Mini-Mental Status Examination (MMSE)Other
A questionnaire given to the study patient before and after the anesthetic at 1, 6 and 24 hours.
| Study group | Role | What they receive |
|---|---|---|
| desflurane and sevoflurane | Subjects will be randomized to either desflurane or sevoflurane. They will be given the Mini Mental State exam at 1, 6 and 24 hours after the end of anesthesia. Receives: Other: The intervention will be Mini-Mental Status Examination (MMSE) |
What is being measured
The primary outcome is the main question the study is designed to answer.
POCD in Elderly Patients Following Desflurane or Sevoflurane General Anesthesia
The primary outcome measure will be changes in cognitive function after anesthesia as measured by MMSE.
Measured: Both groups will complete the MMSE at 1, 6, and 24 hours after the end of anesthesia or to disharge up to 7 days.
Secondary outcomes (1)
Secondary outcome measures will include: 1) time to extubation, anesthetic complications (e.g. coughing during extubation), 2) time to readiness for discharge from PACU, 3) length of hospital stay, and 4) any postoperative complications.
Measured: 24 hours to 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2010 (estimated)
- Study startAug 2010
- Primary completionAug 2014
- Study completionAug 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for 1. Postoperative Cognitive DysfunctionStudies of the same condition, open and under way.
- More trials run by Loma Linda 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 110 participants (actual)
Sponsor and investigators
- Lead sponsor
- Loma Linda University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Richard Applegate, Loma Linda University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01199913
- Sponsor's protocol ID
- 5100193
- Status last verified
- Sep 2014
- First submitted
- 9 Sep 2010
- Last updated
- 9 Sep 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Meineke M, Applegate RL 2nd, Rasmussen T, Anderson D, Azer S, Mehdizadeh A, Kim A, Allard M. Cognitive dysfunction following desflurane versus sevoflurane general anesthesia in elderly patients: a randomized controlled trial. Med Gas Res. 2014 Mar 25;4(1):6. doi: 10.1186/2045-9912-4-6.
PubMed 24666542
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Incidence of Postoperative Cognitive Dysfunction in Elderly Patients Following Desflurane or Sevoflurane General Anesthesia: A Randomized, Controlled Trial
- ClinicalTrials.gov ID
- NCT01199913
- Acronym / sponsor ID
- 5100193
- Conditions
- 1. Postoperative Cognitive Dysfunction
- Keywords
- problems with thinking after surgery;
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 110 participants (actual)
- Lead sponsor
- Loma Linda UniversityUniversity, hospital or other
- Study start
- Aug 2010
- Primary completion
- Aug 2014 (actual)
- Study completion
- Aug 2014 (actual)
- First posted
- 13 Sep 2010 (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 use of desflurane in elderly subjects (>65 years old) undergoing general anesthesia with endotracheal intubation will result in decreased POCD compared to sevoflurane if the patient's MAP is within 20% of the patient's baseline and the cerebral suppression state index stays within the moderately anesthetized range during general anesthesia.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| desflurane and sevoflurane | – | Other: The intervention will be Mini-Mental Status Examination (MMSE)Subjects will be randomized to either desflurane or sevoflurane. They will be given the Mini Mental State exam at 1, 6 and 24 hours after the end of anesthesia. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- Adult patients, male and female, 65 years or older scheduled for elective surgery requiring general anesthesia.
Key inclusion criteria (4 listed)
- Adult patients (>65 years old)
- Scheduled for elective surgery requiring general anesthesia at LLUMC HSH
- Airway management expected to include endotracheal intubation
- Expected surgical duration 120 to 240 minutes
Key exclusion criteria (7 listed)
- Pre-existing significant psychiatric disease or mental status changes
- Clinically significant cardiovascular, respiratory, hepatic, renal,neurological, psychiatric, or metabolic disease
- Patient's weighing >50% ideal body weight
- Patients who have undergone a general anesthetic within the past 7 days
- Patient refusal
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 |
|---|---|---|
| The intervention will be Mini-Mental Status Examination (MMSE)A questionnaire given to the study patient before and after the anesthetic at 1, 6 and 24 hours. | Other | desflurane and sevoflurane |
Primary outcome
POCD in Elderly Patients Following Desflurane or Sevoflurane General Anesthesia
Time frame: Both groups will complete the MMSE at 1, 6, and 24 hours after the end of anesthesia or to disharge up to 7 days.
The primary outcome measure will be changes in cognitive function after anesthesia as measured by MMSE.
1 secondary outcome
Secondary outcome measures will include: 1) time to extubation, anesthetic complications (e.g. coughing during extubation), 2) time to readiness for discharge from PACU, 3) length of hospital stay, and 4) any postoperative complications.
Time frame: 24 hours to 7 days
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 9 Sep 2014.
- Derived from this study: PubMed 24666542Meineke M, Applegate RL 2nd, Rasmussen T, Anderson D, Azer S, Mehdizadeh A, Kim A, Allard M. Cognitive dysfunction following desflurane versus sevoflurane general anesthesia in elderly patients: a randomized controlled trial. Med Gas Res. 2014 Mar 25;4(1):6. doi: 10.1186/2045-9912-4-6.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of 1. Postoperative Cognitive Dysfunction, run by Loma Linda University 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 7 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 9 Sep 2014. 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?
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?
POCD in Elderly Patients Following Desflurane or Sevoflurane General Anesthesia (time frame: Both groups will complete the MMSE at 1, 6, and 24 hours after the end of anesthesia or to disharge up to 7 days.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01199913, which also lists 1 linked publication.
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 9 Sep 2014.