Cerebral Arterial AneurysmPhase 4NCT02691416

Role of Propofol Postconditioning on Oxidative Stress and Cognitive Function

A Phase 4 study testing propofol postconditioning and sevoflurane in people with Cerebral Arterial Aneurysm, run by The Third Central Clinical College of Tianjin Medical University.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The purpose of this study was to evaluate differences between propofol postconditioning and sevoflurane anesthesia in the intracranial aneurysm surgery about antioxidant effect. Read more about this study

Who is it for?: Any age
Conditions the study is for: Cerebral Arterial Aneurysm
What is being tested?: propofol postconditioning and sevoflurane
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 60 participants
Where: No sites listed yet
Study dates: Jul 2014to Jan 2016
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 Any age
All sexes
No healthy volunteers
Child, Adult, Older adult

Who may be able to join

Clinical diagnosis intracranial aneurysm surgery ,
American Society of Anesthesiologists (ASA)Ⅰ-Ⅱ.

Who cannot join

severe hepatic and renal dysfunction
coagulation disorder
taking antioxidant perioperative period

About this study

Official title: Role of Propofol Postconditioning on Oxidative Stress and Cognitive Function in Patients Undergoing Intracranial Aneurysm Surgery.

The purpose of this study was to evaluate differences between propofol postconditioning and sevoflurane anesthesia in the intracranial aneurysm surgery about antioxidant effect.

Read the detailed description

intracranial aneurysm surgery may lead to regional ischemic reperfusion injury. Propofol, as an antioxidative phenol, has been demonstrated that mitigate the brain I/R in rats.

As for sevoflurane, some investigation indicated that sevoflurane is able to reduce oxidative stress in cell(except neuronal cell lines ) and rodent models, but the antioxidant effect did not found in human minor incision surgeries, furthermore, oxidative stress was raised in the major surgeries including orthopedic surgeries, hysterectomy, cholecystectomy, and thoracotomy

Conditions: Cerebral Arterial Aneurysm
Being tested: propofol postconditioning, sevoflurane

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

propofol postconditioningDrug
administrated Target Controlled Infusion(TCI) of propofol (Cp 1.2ug/ml) and decreased sevoflurane with a Bispectral index (BIS) value of 40-60 to maintain anesthesia after clamp removal
sevofluraneDrug
0.5%-2% sevoflurane with BIS 40-60

Study groups in NCT02691416
Study group	Role	What they receive
propofol postconditioning	Experimental	1.2mg/L propofol Receives: Drug: propofol postconditioning; Drug: sevoflurane
sevoflurane	Experimental	0.5%-2% sevoflurane Receives: Drug: sevoflurane

What is being measured

The primary outcome is the main question the study is designed to answer.

Evidences of Clinically Definite Oxidative Stress Confirmed by ELISA Kit
Evidences of clinically definite oxidative stress :Superoxide dismutase activity, Hydroxyl radical
Measured: before induction,after clamping removal ,operation ending ,1,3,7days post surgery
Evidences of Clinically Definite Oxidative Stress Confirmed by ELISA
Evidences of clinically definite oxidative stress:8-isoprostane,as a reliable biomarkers of lipid peroxidation
Measured: before induction, after clamping removal,operation ending,1,3,7days post surgery
Evidences of Clinically Definite Oxidative Stress:Micronuclei
Evidences of clinically definite oxidative stress:micronuclei confirmed by Cytokinesis-block Micronucleus Test
Measured: before induction,clamping removal ,operation ending,1,3,7days post surgery
Evidences of Clinically Definite Oxidative Stress Confirmed by High Performance Liquid Chromatography
Evidences of clinically definite oxidative stress :α- tocopherol,γ- tocopherol which was used to assess the antioxidant defense.
Measured: before induction,after clamping removal ,operation ending ,1,3,7days post surgery
Evidences of Clinically Definite Oxidative Stress: Nuclear Buds
Evidences of clinically definite oxidative stress:nuclear buds Confirmed by Cytokinesis-block Micronucleus Test
Measured: before induction,clamping removal ,operation ending,1,3,7days post surgery
Evidences of Clinically Definite Oxidative Stress: Nucleoplasmic Bridges
Evidences of clinically definite oxidative stress: nucleoplasmic bridges confirmed by Cytokinesis-block Micronucleus Test
Measured: before induction,clamping removal ,operation ending,1,3,7days post surgery

Secondary outcomes (2)

Mini Mental State Examination (MMSE)
A questionnaires is used to assess the cognitive function of patients in clinical,the total range was 0-30,and 27-30 were considered as normal value,<27 were considered as recognitive dysfunction.
Measured: before induction,1,3,7days post surgery
Montreal Cognitive Assessment (MoCA)
A questionnaires is used to assess the cognitive function of patients in clinical,the total range was 0-30,and 27-30 were considered as normal value,<27 were considered as recognitive dysfunction.
Measured: before induction,1,3,7days post surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jul 2014Jan 2016

First posted25 Feb 2016 (estimated)
Study startJul 2014
Primary completionDec 2015
Study completionJan 2016

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 Cerebral Arterial AneurysmStudies 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: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Outcomes assessor
Enrolment: 60 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02691416
Sponsor's protocol ID: ThirdCCCTianjin
Status last verified: Feb 2016
First submitted: 3 Feb 2016
Last updated: 11 Jul 2017
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

RecruitingObservational study
Determining the Clinical Impact and Prevalence of Hemorrhagic Subtypes in Perimesencephalic Subarachnoid Hemorrhage
Subarachnoid Hemorrhage, Spontaneous, Subarachnoid Hemorrhage, Aneurysmal
RecruitingObservational study
A Study of Choydar Flow-Directed Mesh Stent in the Treatment of Unruptured Intracranial Aneurysms
Intracranial Aneurysm
Not yet recruiting
Effect of Bilateral Greater Occipital Nerve Block on Headache After Intracranial Aneurysm Coiling
Intracranial Aneurysm, Postoperative Pain
RecruitingObservational study
Evaluation of Intestinal Microbiota Implication in Ruptured Intracranial Aneurysm
Intracranial Sacciform Aneurysm
Active, not recruitingPhase 2
Effect of Sirolimus on Molecular Alterations in Cerebral Aneurysms
Cerebral Aneurysm

All Cerebral Arterial Aneurysm trials

Study at a glance

From the registry record, last updated by the sponsor on 11 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Role of Propofol Postconditioning on Oxidative Stress and Cognitive Function in Patients Undergoing Intracranial Aneurysm Surgery.
ClinicalTrials.gov ID: NCT02691416
Acronym / sponsor ID: ThirdCCCTianjin
Conditions: Cerebral Arterial Aneurysm
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 60 participants (actual)
Lead sponsor: The Third Central Clinical College of Tianjin Medical UniversityUniversity, hospital or other
Study start: Jul 2014
Primary completion: Dec 2015 (actual)
Study completion: Jan 2016 (actual)
First posted: 25 Feb 2016 (estimated)
Results: Posted 2 Sep 2016

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 was to evaluate differences between propofol postconditioning and sevoflurane anesthesia in the intracranial aneurysm surgery about antioxidant effect.

Detailed description

intracranial aneurysm surgery may lead to regional ischemic reperfusion injury. Propofol, as an antioxidative phenol, has been demonstrated that mitigate the brain I/R in rats.

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
propofol postconditioning	Experimental	Drug: propofol postconditioning, Drug: sevoflurane1.2mg/L propofol
sevoflurane	Experimental	Drug: sevoflurane0.5%-2% sevoflurane

Who may qualify

Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult

Key inclusion criteria (2 listed)

Clinical diagnosis intracranial aneurysm surgery ,
American Society of Anesthesiologists (ASA)Ⅰ-Ⅱ.

Key exclusion criteria (3 listed)

severe hepatic and renal dysfunction
coagulation disorder
taking antioxidant perioperative period

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
propofol postconditioningadministrated Target Controlled Infusion(TCI) of propofol (Cp 1.2ug/ml) and decreased sevoflurane with a Bispectral index (BIS) value of 40-60 to maintain anesthesia after clamp removal	Drug	propofol postconditioning
sevoflurane0.5%-2% sevoflurane with BIS 40-60	Drug	propofol postconditioning, sevoflurane

Primary outcome

Evidences of Clinically Definite Oxidative Stress Confirmed by ELISA Kit
Time frame: before induction,after clamping removal ,operation ending ,1,3,7days post surgery
Evidences of clinically definite oxidative stress :Superoxide dismutase activity, Hydroxyl radical
Evidences of Clinically Definite Oxidative Stress Confirmed by ELISA
Time frame: before induction, after clamping removal,operation ending,1,3,7days post surgery
Evidences of clinically definite oxidative stress:8-isoprostane,as a reliable biomarkers of lipid peroxidation
Evidences of Clinically Definite Oxidative Stress:Micronuclei
Time frame: before induction,clamping removal ,operation ending,1,3,7days post surgery
Evidences of clinically definite oxidative stress:micronuclei confirmed by Cytokinesis-block Micronucleus Test
Evidences of Clinically Definite Oxidative Stress Confirmed by High Performance Liquid Chromatography
Time frame: before induction,after clamping removal ,operation ending ,1,3,7days post surgery
Evidences of clinically definite oxidative stress :α- tocopherol,γ- tocopherol which was used to assess the antioxidant defense.
Evidences of Clinically Definite Oxidative Stress: Nuclear Buds
Time frame: before induction,clamping removal ,operation ending,1,3,7days post surgery
Evidences of clinically definite oxidative stress:nuclear buds Confirmed by Cytokinesis-block Micronucleus Test
Evidences of Clinically Definite Oxidative Stress: Nucleoplasmic Bridges
Time frame: before induction,clamping removal ,operation ending,1,3,7days post surgery
Evidences of clinically definite oxidative stress: nucleoplasmic bridges confirmed by Cytokinesis-block Micronucleus Test

2 secondary outcomes

Mini Mental State Examination (MMSE)
Time frame: before induction,1,3,7days post surgery
Montreal Cognitive Assessment (MoCA)
Time frame: before induction,1,3,7days post surgery

Results and safety

Results posted to the registry on 2 Sep 2016, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Propofol Postconditioning	30	30
Sevoflurane	30	30

Primary outcome: Evidences of Clinically Definite Oxidative Stress Confirmed by ELISA Kit

Time frame: before induction,after clamping removal ,operation ending ,1,3,7days post surgery. Mean (Standard Deviation). Unit: U/ml

Measure	Propofol Postconditioning n = 30	Sevoflurane n = 30
Superoxide dismutase activity of before induction	72.87 (23.15)	74.02 (21.27)
Superoxide dismutase activity of clamping removal	67.10 (16.52)	65.91 (16.07)
Superoxide dismutase activity of operation ending	66.74 (16.50)	51.58 (14.92)
Superoxide dismutase activity of 1days postsurgery	66.80 (16.56)	52.82 (14.93)
Superoxide dismutase activity of 3days postsurgery	69.27 (16.66)	57.35 (17.36)
Superoxide dismutase activity of 7days postsurgery	69.02 (16.95)	59.33 (17.30)
Hydroxyl radical of before induction	5.30 (6.46)	6.60 (6.49)
Hydroxyl radical of clamping removal	15.80 (4.42)	16.22 (5.23)

Primary outcome: Evidences of Clinically Definite Oxidative Stress Confirmed by ELISA

Time frame: before induction, after clamping removal,operation ending,1,3,7days post surgery. Mean (Standard Deviation). Unit: pg/ml

Measure	Propofol Postconditioning n = 30	Sevoflurane n = 30
8-isoprostane of before induction	1.15 (0.14)	1.18 (0.14)
8-isoprostane of clamping removal	1.19 (0.15)	1.22 (0.14)
8-isoprostane of operation ending	1.54 (0.16)	1.70 (0.18)
8-isoprostane of 1days post surgery	1.51 (0.16)	1.64 (0.21)
8-isoprostane of 3days post surgery	1.48 (0.17)	1.60 (0.18)
8-isoprostane of 7days post surgery	1.38 (0.18)	1.49 (0.19)

Primary outcome: Evidences of Clinically Definite Oxidative Stress:Micronuclei

Time frame: before induction,clamping removal ,operation ending,1,3,7days post surgery. Mean (Standard Deviation). Unit: number of micronuclei/1000 BN cells

Measure	Propofol Postconditioning n = 30	Sevoflurane n = 30
micronuclei of before induction	185.83 (21.69)	186.40 (19.87)
micronuclei of clamping removal	194.57 (25.27)	195.73 (24.21)
micronuclei of operation ending	230.77 (25.00)	375.87 (30.90)
micronuclei of 1days post surgery	278.73 (30.86)	402.27 (27.60)
micronuclei of 3days post surgery	248.43 (30.88)	338.00 (30.85)
micronuclei of 7days post surgery	201.33 (28.98)	243.63 (29.59)

Primary outcome: Evidences of Clinically Definite Oxidative Stress Confirmed by High Performance Liquid Chromatography

Time frame: before induction,after clamping removal ,operation ending ,1,3,7days post surgery. Mean (Standard Deviation). Unit: ug/ml

Measure	Propofol Postconditioning n = 30	Sevoflurane n = 30
α- tocopherol of before induction	12.67 (1.96)	12.22 (1.83)
α- tocopherol of clamping removal	6.13 (1.81)	6.12 (1.68)
α- tocopherol of opertaion ending	6.71 (1.79)	5.91 (1.68)
α- tocopherol of 1days post surgery	8.97 (1.87)	8.23 (1.51)
α- tocopherol of 3days post surgery	10.02 (2.06)	9.31 (1.56)
α- tocopherol of 7days post surgery	11.54 (1.84)	10.98 (1.80)
γ- tocopherol of before induction	0.52 (0.08)	0.53 (0.08)
γ- tocopherol of clamping removal	0.59 (0.09)	0.57 (0.09)

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: 7days. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Propofol Postconditioning	0 of 30 (0%)	0 of 30 (0%)	Not reported
Sevoflurane	0 of 30 (0%)	0 of 30 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 11 Jul 2017.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

Related trials for Cerebral Arterial Aneurysm

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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.

Haiyun Wang study director

The Third Central Clinical College of Tianjin Medical University

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing propofol postconditioning and sevoflurane in people with Cerebral Arterial Aneurysm, run by The Third Central Clinical College of Tianjin 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 2 inclusion and 3 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 11 Jul 2017. 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.

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 2 Sep 2016). 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?

Evidences of Clinically Definite Oxidative Stress Confirmed by ELISA Kit (time frame: before induction,after clamping removal ,operation ending ,1,3,7days post surgery). The study lists 6 primary outcomes in all. 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 NCT02691416.

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 11 Jul 2017.