Postoperative ComplicationsNCT02766062
Effects of Propofol and Sevoflurane on Early POCD in Elderly Patients With Metabolic Syndrome
A study testing metabolic syndrome in people with Postoperative Complications, run by General Hospital of Ningxia Medical University.
Trial summary
The purpose of this study is to investigate propofol versus sevoflurane anesthesia on the effects of early postoperative cognitive function in elderly patients with metabolic syndrome. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Postoperative Complications
- What is being tested?
- metabolic syndrome
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 94 participants
- Where
- No sites listed yet
- Study dates
- Sep 2015to May 2016
- 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 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- aged ≥60 years;
- ASAⅡor Ⅲ
- noncardiac surgery and nonneural surgery
Who cannot join
- Mini Mental State Examination [MMSE] score too low
- chronic alcoho and drug abuse
- disturbed renal and liver function
- history of a cerebrovascular accident
- permanent ventricular pacing
- preoperative cognitive deficits
- lack of cooperation
About this study
Official title: Effects of Propofol and Sevoflurane on Early Postoperative Cognitive Dysfunction in Elderly Patients With Metabolic Syndrome
The purpose of this study is to investigate propofol versus sevoflurane anesthesia on the effects of early postoperative cognitive function in elderly patients with metabolic syndrome.
Read the detailed description
By now, a series risk factors of cardiovascular diseases, which are also related to the development of postoperative cognitive dysfunction (POCD), are becoming more common.The investigators don't know whether propofol based anesthesia has a more severe impact on early postoperative cognitive function than sevoflurane in elderly patients with metabolic syndrome. In this study, the investigators want to investigate propofol versus sevoflurane anesthesia on the effects of early postoperative cognitive function in elderly patients with metabolic syndrome.
- Conditions
- Postoperative Complications
- Being tested
- metabolic syndrome
- Keywords
- Postoperative cognitive dysfunction, metabolic syndrome, propofol, sevoflurane
- Medical subject headings
- Postoperative Complications, Postoperative Cognitive Complications, Metabolic Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
metabolic syndromeOther
metabolic syndrome
| Study group | Role | What they receive |
|---|---|---|
| propofol group | Active comparator | Patients with metabolic syndrome were randomly assigned to receive propofol anesthesia Receives: Other: metabolic syndrome |
| sevoflurane group | Active comparator | Patients with metabolic syndrome were randomly assigned to receive sevoflurane anesthesia Receives: Other: metabolic syndrome |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with Postoperative cognitive dysfunction (POCD) as assessed by Mini-Mental State Examination (MMSE) score in propofol group and sevoflurane group
Measured: up to 7days postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2016 (estimated)
- Study startSep 2015
- Primary completionApr 2016
- Study completionMay 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative ComplicationsStudies 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 94 participants (actual)
Sponsor and investigators
- Lead sponsor
- General Hospital of Ningxia Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02766062
- Sponsor's protocol ID
- NZ1651
- Status last verified
- Jan 2016
- First submitted
- 1 May 2016
- Last updated
- 30 Jun 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No: safety
Study at a glance
From the registry record, last updated by the sponsor on 30 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Propofol and Sevoflurane on Early Postoperative Cognitive Dysfunction in Elderly Patients With Metabolic Syndrome
- ClinicalTrials.gov ID
- NCT02766062
- Acronym / sponsor ID
- NZ1651
- Conditions
- Postoperative Complications
- Keywords
- Postoperative cognitive dysfunction, metabolic syndrome, propofol, sevoflurane
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 94 participants (actual)
- Lead sponsor
- General Hospital of Ningxia Medical UniversityUniversity, hospital or other
- Study start
- Sep 2015
- Primary completion
- Apr 2016 (actual)
- Study completion
- May 2016 (actual)
- First posted
- 9 May 2016 (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 purpose of this study is to investigate propofol versus sevoflurane anesthesia on the effects of early postoperative cognitive function in elderly patients with metabolic syndrome.
Detailed description
By now, a series risk factors of cardiovascular diseases, which are also related to the development of postoperative cognitive dysfunction (POCD), are becoming more common.The investigators don't know whether propofol based anesthesia has a more severe impact on early postoperative cognitive function than sevoflurane in elderly patients with metabolic syndrome. In this study, the investigators want to investigate propofol versus sevoflurane anesthesia on the effects of early postoperative cognitive function in elderly patients with metabolic syndrome.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| propofol group | Active comparator | Other: metabolic syndromePatients with metabolic syndrome were randomly assigned to receive propofol anesthesia |
| sevoflurane group | Active comparator | Other: metabolic syndromePatients with metabolic syndrome were randomly assigned to receive sevoflurane anesthesia |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- aged ≥60 years;
- ASAⅡor Ⅲ
- noncardiac surgery and nonneural surgery
Key exclusion criteria (7 listed)
- Mini Mental State Examination [MMSE] score too low
- chronic alcoho and drug abuse
- disturbed renal and liver function
- history of a cerebrovascular accident
- permanent ventricular pacing
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 |
|---|---|---|
| metabolic syndromemetabolic syndrome | Other | propofol group, sevoflurane group |
Primary outcome
Number of participants with Postoperative cognitive dysfunction (POCD) as assessed by Mini-Mental State Examination (MMSE) score in propofol group and sevoflurane group
Time frame: up to 7days postoperatively
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 30 Jun 2016.
- Individual participant dataSharing planned: No. safety
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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.
Questions about this trial
What is this clinical trial studying?
A study testing metabolic syndrome in people with Postoperative Complications, run by General Hospital of Ningxia Medical University.
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 3 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 30 Jun 2016. Status can change between updates, so confirm with the study contact before making plans.
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?
Number of participants with Postoperative cognitive dysfunction (POCD) as assessed by Mini-Mental State Examination (MMSE) score in propofol group and sevoflurane group (time frame: up to 7days postoperatively). 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 30 Jun 2016.