Postoperative ComplicationPhase 1/2NCT02535039
Methylprednisolone Combined Electric-acupuncture on Cognitive Function
A Phase 1/2 study testing Methylprednisolone and Physiological saline in people with Postoperative Complication and Cognitive Retention Disorder, run by Shengjing Hospital at 1 site in China.
Trial summary
Postoperative cognitive dysfunction (POCD) refers to the patients in the central nervous system complications after general anesthesia and clinical manifestations of mental disorder, anxiety, personality changes, impaired memory, personality, social skills and cognitive function after surgery for this decline is… Read more about this study
- Who is it for?
- Ages 65 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Postoperative Complication, Cognitive Retention Disorder
- What is being tested?
- Methylprednisolone and Physiological saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteChina
- Study dates
- Oct 2015to Dec 2016
- Phase
- Phase 1/2
- 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 to 75 years
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- Aged from 65 to 75
- The American Society of anesthesiologists (American Society of Anesthesiology, ASA) class Ⅱ ~ III
- With a primary culture of above (including elementary school)
- There is no history of drug allergy.
Who cannot join
- Central nervous system and history of mental illness
- Taking sedatives or antidepressants history
- Insulin dependent diabetes
- Coronary heart disease
- Cerebral infarction
- Preoperative MOCA score less than 26 points
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Shengjing hospital of China medical university
Shenyang, Liaoning, 110000
Yanchao Yang, Master, 18940252916, yyc25714104@163.com
Junchao Zhu, Doctor, 18940257257, zhujunchao1@hotmail.com
About this study
Official title: Methylprednisolone Combined Electric-acupuncture Treatment Effects on Cognitive Function After Surgery for Elderly Patients With General Anesthesia
Postoperative cognitive dysfunction (POCD) refers to the patients in the central nervous system complications after general anesthesia and clinical manifestations of mental disorder, anxiety, personality changes, impaired memory, personality, social skills and cognitive function after surgery for this decline is called postoperative cognitive dysfunction.Due to the lack of effective clinical treatments, how to prevent and solve the postoperative cognitive dysfunction has become a difficulty and a focus of research in the field of anesthesia.Methylprednisolone is a new type of cortical hormone, because of its strong anti-inflammatory effect, less adverse reactions, is widely used in clinical anesthesia.Electric acupuncture as a kind of traditional treatments, after years of clinical application and achieved good curative effect in practice.In this paper by comparing brain oxygen saturation, blood biochemical indexes, Montreal cognitive assessment scale (MOCA) on cognitive function in patients with grade indexes, such as observation of methylprednisolone combined electric acupuncture treatment of elderly patients with general anesthesia early after the operation, the influence of cognitive function.
Through comparing the operation of cerebral oxygen saturation, blood biochemical indexes, Montreal cognitive assessment scale (MOCA) on cognitive function in patients with grade indexes, such as observation of methylprednisolone combined electric acupuncture treatment of elderly patients with general anesthesia early after the operation, the influence of cognitive function.
Read the detailed description
Choose descending colon cancer radical general anesthesia, 80 cases of patients, ASA Ⅱ ~ level III, aged 65 ~ 75, were randomly divided into two groups: anesthesia method selects the tracheal intubation general anesthesia.All Diprifusor propofol used in patients with TCI system, with the initial plasma concentration of 2.0 ug/ml start TCI, and intravenous sufentanil injection 0.15 ug/kg, propofol 1 ug/ml every 1 minute.After the BIS value < 75, start the fentanyl TCI system, maintaining the plasma concentrations of 4 ng/ml, vein to the interaction between rocuronium 0.8 mg/kg, insert the endotracheal intubation after mechanical ventilation.Adjust the propofol infusion control electrical double-frequency index between 45 to 55.The experimental group to give intravenous methylprednisolone 1 mg/kg/sack.And 1 mg/kg * d continuous application to the third day after surgery.
1 day before the surgery, postoperative 1 day, 2 days, 3 days, 7 days the MOCA scale to assess cognitive function after surgery for the patient.(T0) prior to the induction and bi (T1), 24 h after surgery (T2) and 48 h after surgery (T3) extraction in patients with venous blood, adopts the method of enzyme-linked immunosorbent (ELISA) determination of serum IL - 1 beta, IL - 6, Aβ1-42, p- Tau concentration.In rSO2 intraoperative continuous monitoring, and calculate the average rSO2, intraoperative rSO2 down the biggest percentage compared with basic value rSO2 % of Max.And record the occurrence of adverse reactions to special circumstances.
- Being tested
- Methylprednisolone, Physiological saline
- Keywords
- Elderly, cognitive retention disorder, methylprednisolone
- Medical subject headings
- Postoperative Complications, Memory Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Also called meprednisone
Anaesthesia in giving 1 mg/kg intravenous methylprednisolone, methylprednisolone (1 mg/kg * d for application to the third day after surgery
Physiological salineOther
Also called Placebo
The same volume of physiological saline will be given in Placebo group
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Before anesthesia induction, with electroacupuncture can cave, inside the closed cavity, foot three mile point, cupping model for continuous wave type, current pulse frequency of 2 hz, adjust the intensity of the electric acupuncture, with patients complained of needle feeling, can accept no pain and discomfort.Intraoperative sustained electroacupuncture.The same volume of physiological saline will be given. Receives: Other: Physiological saline |
| Methylprednisolne | Experimental | in the anaesthesia to 1 mg/kg intravenous methylprednisolone, methylprednisolone continuous use 1 mg/kg * d until the third day after surgery.Before anesthesia induction, with electroacupuncture can cave, inside the closed cavity, foot three mile point, cupping model for continuous wave type, current pulse frequency of 2 hz, adjust the intensity of the electric acupuncture, with patients complained of needle feeling, can accept no pain and discomfort.Intraoperative sustained electroacupuncture. Receives: Drug: Methylprednisolone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cognitive function evaluation as measured by Montreal cognitive assessment scale score
Measured: Cognitive function evaluation 1 day after the surgey
Secondary outcomes (1)
Plasma concentration of IL - 6
Measured: Plasma concentration of IL - 6 1 day after the surgey
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2015 (estimated)
- Study startOct 2015
- Primary completionDec 2016 (estimated)
- Study completionDec 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative ComplicationStudies 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 1/2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shengjing Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yanchao Yang, Shengjing Hospital
- Investigators
- Junchao Zhu, doctor, Study director, professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02535039
- Sponsor's protocol ID
- Shengjing hospital
- Status last verified
- Dec 2016
- First submitted
- 29 May 2015
- Last updated
- 20 Dec 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Methylprednisolone Combined Electric-acupuncture Treatment Effects on Cognitive Function After Surgery for Elderly Patients With General Anesthesia
- ClinicalTrials.gov ID
- NCT02535039
- Acronym / sponsor ID
- Shengjing hospital
- Keywords
- Elderly, cognitive retention disorder, methylprednisolone
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Shengjing HospitalUniversity, hospital or other
- Study start
- Oct 2015
- Primary completion
- Dec 2016 (estimated)
- Study completion
- Dec 2016 (estimated)
- First posted
- 28 Aug 2015 (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.
Postoperative cognitive dysfunction (POCD) refers to the patients in the central nervous system complications after general anesthesia and clinical manifestations of mental disorder, anxiety, personality changes, impaired memory, personality, social skills and cognitive function after surgery for this decline is called postoperative cognitive dysfunction.Due to the lack of effective clinical treatments, how to prevent and solve the postoperative cognitive dysfunction has become a difficulty and a focus of research in the field of anesthesia.Methylprednisolone is a new type of cortical hormone, because of its strong anti-inflammatory effect, less adverse reactions, is widely used in clinical anesthesia.Electric acupuncture as a kind of traditional treatments, after years of clinical application and achieved good curative effect in practice.In this paper by comparing brain oxygen saturation, blood biochemical indexes, Montreal cognitive assessment scale (MOCA) on cognitive function in patients with grade indexes, such as observation of methylprednisolone combined electric acupuncture treatment of elderly patients with general anesthesia early after the operation, the influence of cognitive function.
Through comparing the operation of cerebral oxygen saturation, blood biochemical indexes, Montreal cognitive assessment scale (MOCA) on cognitive function in patients with grade indexes, such as observation of methylprednisolone combined electric acupuncture treatment of elderly patients with general anesthesia early after the operation, the influence of cognitive function.
Detailed description
Choose descending colon cancer radical general anesthesia, 80 cases of patients, ASA Ⅱ ~ level III, aged 65 ~ 75, were randomly divided into two groups: anesthesia method selects the tracheal intubation general anesthesia.All Diprifusor propofol used in patients with TCI system, with the initial plasma concentration of 2.0 ug/ml start TCI, and intravenous sufentanil injection 0.15 ug/kg, propofol 1 ug/ml every 1 minute.After the BIS value < 75, start the fentanyl TCI system, maintaining the plasma concentrations of 4 ng/ml, vein to the interaction between rocuronium 0.8 mg/kg, insert the endotracheal intubation after mechanical ventilation.Adjust the propofol infusion control electrical double-frequency index between 45 to 55.The experimental group to give intravenous methylprednisolone 1 mg/kg/sack.And 1 mg/kg * d continuous application to the third day after surgery.
1 day before the surgery, postoperative 1 day, 2 days, 3 days, 7 days the MOCA scale to assess cognitive function after surgery for the patient.(T0) prior to the induction and bi (T1), 24 h after surgery (T2) and 48 h after surgery (T3) extraction in patients with venous blood, adopts the method of enzyme-linked immunosorbent (ELISA) determination of serum IL - 1 beta, IL - 6, Aβ1-42, p- Tau concentration.In rSO2 intraoperative continuous monitoring, and calculate the average rSO2, intraoperative rSO2 down the biggest percentage compared with basic value rSO2 % of Max.And record the occurrence of adverse reactions to special circumstances.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Other: Physiological salineBefore anesthesia induction, with electroacupuncture can cave, inside the closed cavity, foot three mile point, cupping model for continuous wave type, current pulse frequency of 2 hz, adjust the intensity of the electric acupuncture, with patients complained of needle feeling, can accept no pain and discomfort.Intraoperative sustained electroacupuncture.The same volume of physiological saline will be given. |
| Methylprednisolne | Experimental | Drug: Methylprednisolonein the anaesthesia to 1 mg/kg intravenous methylprednisolone, methylprednisolone continuous use 1 mg/kg * d until the third day after surgery.Before anesthesia induction, with electroacupuncture can cave, inside the closed cavity, foot three mile point, cupping model for continuous wave type, current pulse frequency of 2 hz, adjust the intensity of the electric acupuncture, with patients complained of needle feeling, can accept no pain and discomfort.Intraoperative sustained electroacupuncture. |
Who may qualify
- Ages
- 65 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (4 listed)
- Aged from 65 to 75
- The American Society of anesthesiologists (American Society of Anesthesiology, ASA) class Ⅱ ~ III
- With a primary culture of above (including elementary school)
- There is no history of drug allergy.
Key exclusion criteria (6 listed)
- Central nervous system and history of mental illness
- Taking sedatives or antidepressants history
- Insulin dependent diabetes
- Coronary heart disease
- Cerebral infarction
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 |
|---|---|---|
| MethylprednisoloneAlso: meprednisoneAnaesthesia in giving 1 mg/kg intravenous methylprednisolone, methylprednisolone (1 mg/kg * d for application to the third day after surgery | Drug | Methylprednisolne |
| Physiological salineAlso: PlaceboThe same volume of physiological saline will be given in Placebo group | Other | Placebo |
Primary outcome
Cognitive function evaluation as measured by Montreal cognitive assessment scale score
Time frame: Cognitive function evaluation 1 day after the surgey
1 secondary outcome
Plasma concentration of IL - 6
Time frame: Plasma concentration of IL - 6 1 day after the surgey
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Dec 2016.
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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.
Junchao Zhu, doctor study director
professor
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Methylprednisolone and Physiological saline in people with Postoperative Complication and Cognitive Retention Disorder, run by Shengjing Hospital at 1 site in China.
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 6 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: status not confirmed, as of the sponsor's last update on 20 Dec 2016. 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 China. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yanchao Yang, master (18940252916, yyc25714104@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cognitive function evaluation as measured by Montreal cognitive assessment scale score (time frame: Cognitive function evaluation 1 day after the surgey). 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 20 Dec 2016.