Cognitive Ability, GeneralPhase 4NCT02123355
The Effect of Dexmedetomidine to Cognition of Geriatrics in Prolonged Surgery
A Phase 4 study testing Induction of anesthesia, Intubation and Sevoflurane, remifentanil ,vecuronium in people with Cognitive Ability, General and Brain Injury, run by Shaanxi Provincial People's Hospital.
Trial summary
The incidence of postoperative cognitive dysfunction (POCD) is high and POCD affect the life quality and the prognosis of patients. Geriatrics is the independent risk factor of POCD, and POCD is also correlated with many other factors such as type of surgery, the duration of anesthesia and the anesthesia drugs used et… Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Cognitive Ability, General, Brain Injury
- What is being tested?
- Induction of anesthesia, Intubation and Sevoflurane, remifentanil ,vecuronium
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- No sites listed yet
- Study dates
- Aug 2014to Aug 2014
- Phase
- Phase 4
- 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
Who may be able to join
- Written informed consent
- Scheduled for elective abdominal surgery
- Age≥65 yrs
- Weight is within the range of ±20% of standard weight [standard weight=Height(cm)-80)×70﹪ for male and(Height(cm)-70)×60﹪] for female
- American society of anesthesia classification I~III
- Expected time of surgery is more than 4 hours -
Who cannot join
- Systolic blood pressure≥180 mm Hg or <90 mm Hg，diastolic blood pressure≥110 mm Hg or < 60 mm Hg；
- Serious cardiac,liver,kidney,lung, endocrine disease or sepsis.
- Allergy to trial drug or other contraindication；
- Difficult airway occurred before,or difficult airway possibly occurred and difficult to extubation
- History of mental illness and cerebral vascular disease
- History of unstable angina or myocardial infarction
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- Education level<7 yrs
- Factors existed that affect cognition assessment such as language, visual sense,auditory sense disorders.
- Abuse of narcotic analgesia or suspected;
- Neuromuscular diseases;
- Mentally unstable or has a mental illness;
- Pregnant or breast-feeding women;
- Attended other trial past 30 days; -
About this study
Official title: The Effect of Dexmedetomidine to Cognition of Geriatrics in Prolonged Surgery,A Randomized Controlled Study
The incidence of postoperative cognitive dysfunction (POCD) is high and POCD affect the life quality and the prognosis of patients. Geriatrics is the independent risk factor of POCD, and POCD is also correlated with many other factors such as type of surgery, the duration of anesthesia and the anesthesia drugs used et al. So, the prevention and treatment of POCD in geriatrics is important.
Dexmedetomidine is found to have the effect of neuro-protection, but it is controversy whether Dexmedetomidine has the effect of neuro-protection in geriatrics, especially the prolonged surgery.
The purpose of this study is to explore the effect of Dexmedetomidine to the cognitive function at prolonged surgery in geriatrics in geriatrics.
- Conditions
- Cognitive Ability, General, Brain Injury
- Being tested
- Induction of anesthesia, Intubation, Sevoflurane, remifentanil ,vecuronium, Dexmedetomidine, Placebo
- Medical subject headings
- Brain Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Induction of anesthesiaDrug
Midazolam 0.05 mg/kg、Propofol 1.0 mg/kg、Sufentanyl 3μg/kg、Victracurium 0.1 mg/kg sequential intravenous injection
IntubationProcedure or surgery
After muscle relaxed and loss of eyelash reflex of the patients, intubation is done,then mechanical ventilation is performed, and maintain the PETCO2于35~40 mmHg，pulse oxygen saturation is more than 95%.
Sevoflurane, remifentanil ,vecuroniumDrug
Sevoflurane（1%-2%）is inspirated, and remifentanil 0.1-0.5μg/kg//min is continuously pumped,vecuronium 0.03 mg/kg is injected intermittently.
DexmedetomidineDrug
Dexmedetomidine is given at 0.5μg/kg/h by continuous infusion and is stopped to given 30 minutes before the surgery is over.
PlaceboDrug
Normal saline is given at 0.5μg/kg/h by continuous infusion and is stopped to given 30 minutes before the surgery is over.
| Study group | Role | What they receive |
|---|---|---|
| Dexmedetomidine | Experimental | Dexmedetomidine is given at 0.5μg/kg/h by continuous infusion and is stopped to given 30 minutes before the surgery is over. Receives: Drug: Induction of anesthesia; Procedure: Intubation; Drug: Sevoflurane, remifentanil ,vecuronium; Drug: Dexmedetomidine |
| Normal saline | Sham comparator | Normal saline is given at 0.5μg/kg/h by continuous infusion and is stopped to given 30 minutes before the surgery is over. Receives: Drug: Induction of anesthesia; Procedure: Intubation; Drug: Sevoflurane, remifentanil ,vecuronium; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in cognitive function at 7 days
- Modified Newman scale to assess the cognitive function, including five tests.
- The quiet environment, enough daylight, no disturb is needed when the modified Newman scale is done. All the five tests are finished within 30 min.
- all the score of each test of all the patients assessed before the surgery is calculated, then get the standard variation, the score of each subject of each test is compared with the standard deviation, if one or more stand deviation decrease, then the cognitive function is considered as deterioration .
- When 2 or more of the tests is considered as deterioration, then the patients is diagnosed as Post Operation Cognitive Dysfunction (POCD).
Measured: Baseline, the 7th day after the surgery
Secondary outcomes (10)
Brain injury assessment
- 2 ml blood sample is collected at 8 time points including before surgery,the right moment,2 hr and 4 hr after the induction, the right moment,12,24 and 48 hours after the surgery.
- The serum level of C-reaction protein(CRP),tumor necrosis factor(TNF-α)、interleukin-6（IL-6）,interleukin-10（IL-10) is tested using immunohistochemical double antibody sandwich enzyme-linked immunosorbent assay (ELISA)
Measured: From entering the operating room to 48 hours after the surgery
Inflammatory responsive assessment
- 2 ml blood sample is collected at 8 time points including before surgery,the right moment,2 hr and 4 hr after the induction, the right moment,12,24 and 48 hours after the surgery.
- The concentration of protein S100B（S100B）and neuron specific enolase (NSE）in serum is tested using immunohistochemical double antibody sandwich enzyme-linked immunosorbent assay (ELISA).
Measured: From entering the operating room to 48 hours after the surgery
Heart rate
Heart rate are monitored every 15 min from the induction of anesthesia to the right moment of extubation.
Measured: From the induction of anesthesia to the right moment of extubation, up to 1 day.
Depth of anesthesia
Bispectral index(BIS) monitor are performed every 15 min from the induction of anesthesia to the right moment of extubation.
Measured: From the induction of anesthesia to the right moment of extubation, up to 1 day.
Recovery of anesthesia
Time of anesthetic ceased,time of call to open eyes,time to extubation, time to leave the PACU are recorded.
Measured: From the induction of anesthesia to the right moment of extubation, up to 1 day.
Central venous pressure(CVP)
Central venous pressure(CVP) are monitored every 15 min from the induction of anesthesia to the right moment of extubation.
Measured: From the induction of anesthesia to the right moment of extubation, up to 1 day.
Blood pressure
systolic blood pressure, Diastolic blood pressure are monitored every 15 min from the induction of anesthesia to the right moment of extubation.
Measured: From the induction of anesthesia to the right moment of extubation, up to 1 day.
Respiration rate
Respiration rate are monitored every 15 min from the induction of anesthesia to the right moment of extubation.
Measured: From the induction of anesthesia to the right moment of extubation, up to 1 day.
Pulse blood oxygen saturation
Pulse blood oxygen saturation are monitored every 15 min from the induction of anesthesia to the right moment of extubation.
Measured: From the induction of anesthesia to the right moment of extubation, up to 1 day.
Number of Participants with Serious and Non-Serious Adverse Events
Measured: Up 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 posted25 Apr 2014 (estimated)
- Study startAug 2014
- Primary completionAug 2014 (estimated)
- Study completionAug 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cognitive Ability, GeneralStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shaanxi Provincial People's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Chinese Medical Association
- Responsible party
- Principal investigator, Yang Li, Shaanxi Provincial People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02123355
- Sponsor's protocol ID
- SPPHA01
- Status last verified
- Apr 2014
- First submitted
- 20 Apr 2014
- Last updated
- 25 Apr 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Dexmedetomidine to Cognition of Geriatrics in Prolonged Surgery,A Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT02123355
- Acronym / sponsor ID
- SPPHA01
- Conditions
- Cognitive Ability, General, Brain Injury
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Shaanxi Provincial People's HospitalUniversity, hospital or other
- Collaborators
- Chinese Medical Association
- Study start
- Aug 2014
- Primary completion
- Aug 2014 (estimated)
- Study completion
- Aug 2014 (estimated)
- First posted
- 25 Apr 2014 (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 incidence of postoperative cognitive dysfunction (POCD) is high and POCD affect the life quality and the prognosis of patients. Geriatrics is the independent risk factor of POCD, and POCD is also correlated with many other factors such as type of surgery, the duration of anesthesia and the anesthesia drugs used et al. So, the prevention and treatment of POCD in geriatrics is important.
Dexmedetomidine is found to have the effect of neuro-protection, but it is controversy whether Dexmedetomidine has the effect of neuro-protection in geriatrics, especially the prolonged surgery.
The purpose of this study is to explore the effect of Dexmedetomidine to the cognitive function at prolonged surgery in geriatrics in geriatrics.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dexmedetomidine | Experimental | Drug: Induction of anesthesia, Procedure: Intubation, Drug: Sevoflurane, remifentanil ,vecuronium, Drug: DexmedetomidineDexmedetomidine is given at 0.5μg/kg/h by continuous infusion and is stopped to given 30 minutes before the surgery is over. |
| Normal saline | Sham comparator | Drug: Induction of anesthesia, Procedure: Intubation, Drug: Sevoflurane, remifentanil ,vecuronium, Drug: PlaceboNormal saline is given at 0.5μg/kg/h by continuous infusion and is stopped to given 30 minutes before the surgery is over. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (6 listed)
- Written informed consent
- Scheduled for elective abdominal surgery
- Age≥65 yrs
- Weight is within the range of ±20% of standard weight [standard weight=Height(cm)-80)×70﹪ for male and(Height(cm)-70)×60﹪] for female
- American society of anesthesia classification I~III
Key exclusion criteria (13 listed)
- Systolic blood pressure≥180 mm Hg or <90 mm Hg，diastolic blood pressure≥110 mm Hg or < 60 mm Hg；
- Serious cardiac,liver,kidney,lung, endocrine disease or sepsis.
- Allergy to trial drug or other contraindication；
- Difficult airway occurred before,or difficult airway possibly occurred and difficult to extubation
- History of mental illness and cerebral vascular disease
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 |
|---|---|---|
| Induction of anesthesiaMidazolam 0.05 mg/kg、Propofol 1.0 mg/kg、Sufentanyl 3μg/kg、Victracurium 0.1 mg/kg sequential intravenous injection | Drug | Dexmedetomidine, Normal saline |
| IntubationAfter muscle relaxed and loss of eyelash reflex of the patients, intubation is done,then mechanical ventilation is performed, and maintain the PETCO2于35~40 mmHg，pulse oxygen saturation is more than 95%. | Procedure or surgery | Dexmedetomidine, Normal saline |
| Sevoflurane, remifentanil ,vecuroniumSevoflurane（1%-2%）is inspirated, and remifentanil 0.1-0.5μg/kg//min is continuously pumped,vecuronium 0.03 mg/kg is injected intermittently. | Drug | Dexmedetomidine, Normal saline |
| DexmedetomidineDexmedetomidine is given at 0.5μg/kg/h by continuous infusion and is stopped to given 30 minutes before the surgery is over. | Drug | Dexmedetomidine |
| PlaceboNormal saline is given at 0.5μg/kg/h by continuous infusion and is stopped to given 30 minutes before the surgery is over. | Drug | Normal saline |
Primary outcome
Change from baseline in cognitive function at 7 days
Time frame: Baseline, the 7th day after the surgery
1. Modified Newman scale to assess the cognitive function, including five tests. 2. The quiet environment, enough daylight, no disturb is needed when the modified Newman scale is done. All the five tests are finished within 30 min. 3. all the score of each test of all the patients assessed before the surgery is calculated, then get the standard variation, the score of each subject of each test is compared with the standard deviation, if one or more stand deviation decrease, then the cognitive function is considered as deterioration . 4. When 2 or more of the tests is considered as deterioration, then the patients is diagnosed as Post Operation Cognitive Dysfunction (POCD).
10 secondary outcomes
Brain injury assessment
Time frame: From entering the operating room to 48 hours after the surgery
Inflammatory responsive assessment
Time frame: From entering the operating room to 48 hours after the surgery
Heart rate
Time frame: From the induction of anesthesia to the right moment of extubation, up to 1 day.
Depth of anesthesia
Time frame: From the induction of anesthesia to the right moment of extubation, up to 1 day.
Recovery of anesthesia
Time frame: From the induction of anesthesia to the right moment of extubation, up to 1 day.
Central venous pressure(CVP)
Time frame: From the induction of anesthesia to the right moment of extubation, up to 1 day.
Blood pressure
Time frame: From the induction of anesthesia to the right moment of extubation, up to 1 day.
Respiration rate
Time frame: From the induction of anesthesia to the right moment of extubation, up to 1 day.
Pulse blood oxygen saturation
Time frame: From the induction of anesthesia to the right moment of extubation, up to 1 day.
Number of Participants with Serious and Non-Serious Adverse Events
Time frame: Up to 7 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Apr 2014.
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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 Phase 4 study testing Induction of anesthesia, Intubation and Sevoflurane, remifentanil ,vecuronium in people with Cognitive Ability, General and Brain Injury, run by Shaanxi Provincial People's Hospital.
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 6 inclusion and 13 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 25 Apr 2014. 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. 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 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?
Results are not available in the source record.
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?
Change from baseline in cognitive function at 7 days (time frame: Baseline, the 7th day after the 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 25 Apr 2014.