AnesthesiaNCT01478906
Difference of Plasma Orexin A Levels Between Elderly and Young Patients at Emergence
An observational study of Anesthesia, run by Xijing Hospital at 1 site in China.
Trial summary
The current study is designed to investigate the difference of plasma orexin A levels between elderly and young patients at emergence from sevoflurane-fentanyl anesthesia who will undergo elective lumbar surgery. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Anesthesia
- How many people
- 40 participants
- Where
- 1 siteChina
- Study dates
- Jul 2011to Sep 2012
- 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 18 to 80 years old ,undergo Lumbar Surgery
Who may be able to join
- Participant is Adult (≥18 years old )
- Participants with a Body Mass Index (BMI) 20-25 kg/m2 at the prestudy (screening) visit.
- Participants with ASA physical status Ⅰor Ⅱ
- Participants with Heart function rating Ⅰor Ⅱ
- Glucose of patients is lower than 8 mmol/L
- patients will undergo elective lumbar surgery
Who cannot join
- Participant is a pregnant woman or a nursing mother.
- Participants have a history of narcotics allergic reactions
- indices of liver or kidney function is twice higher than normal
- Participants have a history or diagnosis of depression
- Participants have a history of Brain Trauma
- Participants have a history of narcotics addiction or drug addiction
- Participants have a history or diagnosis of adrenal gland diseases
- Participants or his family have an International Classification of Sleep Disorders diagnosis of OSA
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Anesthesiology department of Xijing Hospital
Xi'an, Shaanxi, 710032
Zhihua Wang, postgraduate, 86-2984775343, xiangrikui038@sohu.com
Hailong Dong, MD,PhD
About this study
Official title: To Investigate Difference of Plasma Orexin A Levels Between Elderly and Youth Patients at Emergence From Sevoflurane-fentanyl Anesthesia Undergoing Elective Lumbar Surgery
The current study is designed to investigate the difference of plasma orexin A levels between elderly and young patients at emergence from sevoflurane-fentanyl anesthesia who will undergo elective lumbar surgery.
Read the detailed description
BACKGROUND:A specific group of neurons in the brain produces hypocretin, also called orexin, a peptide which has been established as an important regulator of anesthesia and emergence in the latest few years. In the animal experiment,we found that the level of orexin A in aged rats was higher when compared with that of the young ones. Whereas the numbers of both the orexin receptor 1 and 2 in aged rats decreased. We wonder if there is a similar phenomenon in human beings which might account for the difference between the intervals of elderly and young patients recovering from anesthesia. This study aims to investigate difference of plasma orexin A levels between elderly patients and young at emergence from sevoflurane-fentanyl anesthesia.
DESIGNING:Forty patients with ASA physical status I or II scheduled for elective lumbar surgery under general anesthesia (lasting for 2h to 4h)were enrolled. Anesthesia was induced with propofol 1-1.5mg/kg and fentanyl 2-3μg/kg. Following muscle relaxation with iv rocuronium bromide 1mg/kg endotracheal intubation was performed. Anesthesia was maintained with sevoflurane(inhalational concentration: 0.8-1.5 MAC) fentanyl (total 6μg/kg) and target controlled infusion remifentanil (targeted concentration:2-7ng/ml ) along with an oxygen/air mixture (FiO2 = 0.5). Muscle relaxation was maintained with intermittent rocuronium. Inhalational concentration of sevoflurane and injected target concentration were titrated to maintain the bispectral index (BIS) between 45 and 65 during anesthesia. The end-tidal carbon dioxide level was maintained between 30 and 40mmHg by controlled mechanical ventilation. When the surgery was complicated we adjust the concentration sevoflurane to 0.8MAC of the patient and targeted concentration of remifentanil to 2ng/ml and then stop all anesthetics . Record time from stopping anesthetics to emergence. Arterial blood (2ml) was collected at the following time, such as before and 1h after induction of anesthesia, at emergence (1min after tracheal extubation) and half an hour after tracheal extubation. This was centrifuged at 3000 rpm for 15min at -4 ◦C in order to separate plasma then stored at -80 ◦C until assay for orexin A concentrations.
EXPECTED RESULTS:The plasma orexin A of group elderly will be higher with the emergence time longer than youth patients.
- Conditions
- Anesthesia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| elderly ,adult | Not described |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Nov 2011 (estimated)
- Study startJul 2011
- Primary completionJun 2012 (estimated)
- Study completionSep 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnesthesiaStudies 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
- Observational
- Time perspective
- Prospective
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xijing Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hailong Dong, MD,PhD, Study director, Xijing Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01478906
- Sponsor's protocol ID
- mzk2010orexin
- Status last verified
- May 2012
- First submitted
- 21 Nov 2011
- Last updated
- 15 May 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- To Investigate Difference of Plasma Orexin A Levels Between Elderly and Youth Patients at Emergence From Sevoflurane-fentanyl Anesthesia Undergoing Elective Lumbar Surgery
- ClinicalTrials.gov ID
- NCT01478906
- Acronym / sponsor ID
- mzk2010orexin
- Conditions
- Anesthesia
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Xijing HospitalUniversity, hospital or other
- Study start
- Jul 2011
- Primary completion
- Jun 2012 (estimated)
- Study completion
- Sep 2012 (estimated)
- First posted
- 23 Nov 2011 (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 current study is designed to investigate the difference of plasma orexin A levels between elderly and young patients at emergence from sevoflurane-fentanyl anesthesia who will undergo elective lumbar surgery.
Detailed description
BACKGROUND:A specific group of neurons in the brain produces hypocretin, also called orexin, a peptide which has been established as an important regulator of anesthesia and emergence in the latest few years. In the animal experiment,we found that the level of orexin A in aged rats was higher when compared with that of the young ones. Whereas the numbers of both the orexin receptor 1 and 2 in aged rats decreased. We wonder if there is a similar phenomenon in human beings which might account for the difference between the intervals of elderly and young patients recovering from anesthesia. This study aims to investigate difference of plasma orexin A levels between elderly patients and young at emergence from sevoflurane-fentanyl anesthesia.
DESIGNING:Forty patients with ASA physical status I or II scheduled for elective lumbar surgery under general anesthesia (lasting for 2h to 4h)were enrolled. Anesthesia was induced with propofol 1-1.5mg/kg and fentanyl 2-3μg/kg. Following muscle relaxation with iv rocuronium bromide 1mg/kg endotracheal intubation was performed. Anesthesia was maintained with sevoflurane(inhalational concentration: 0.8-1.5 MAC) fentanyl (total 6μg/kg) and target controlled infusion remifentanil (targeted concentration:2-7ng/ml ) along with an oxygen/air mixture (FiO2 = 0.5). Muscle relaxation was maintained with intermittent rocuronium. Inhalational concentration of sevoflurane and injected target concentration were titrated to maintain the bispectral index (BIS) between 45 and 65 during anesthesia. The end-tidal carbon dioxide level was maintained between 30 and 40mmHg by controlled mechanical ventilation. When the surgery was complicated we adjust the concentration sevoflurane to 0.8MAC of the patient and targeted concentration of remifentanil to 2ng/ml and then stop all anesthetics . Record time from stopping anesthetics to emergence. Arterial blood (2ml) was collected at the following time, such as before and 1h after induction of anesthesia, at emergence (1min after tracheal extubation) and half an hour after tracheal extubation. This was centrifuged at 3000 rpm for 15min at -4 ◦C in order to separate plasma then stored at -80 ◦C until assay for orexin A concentrations.
EXPECTED RESULTS:The plasma orexin A of group elderly will be higher with the emergence time longer than youth patients.
Study design
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| elderly ,adult | – | – |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 18 to 80 years old ,undergo Lumbar Surgery
Key inclusion criteria (6 listed)
- Participant is Adult (≥18 years old )
- Participants with a Body Mass Index (BMI) 20-25 kg/m2 at the prestudy (screening) visit.
- Participants with ASA physical status Ⅰor Ⅱ
- Participants with Heart function rating Ⅰor Ⅱ
- Glucose of patients is lower than 8 mmol/L
Key exclusion criteria (8 listed)
- Participant is a pregnant woman or a nursing mother.
- Participants have a history of narcotics allergic reactions
- indices of liver or kidney function is twice higher than normal
- Participants have a history or diagnosis of depression
- Participants have a history of Brain Trauma
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2012.
Related trials for Anesthesia
Recruiting
NOL Guided Analgesia During Elective Laparoscopic Surgery Under General Anesthesia
Intraoperative Analgesia
RecruitingObservational study
Prevalence of Pain During Cesarean Section
Cesarean Birth
RecruitingObservational study
Pulse Wave Transit Time After Infraclavicular Block
Infraclavicular Brachial Plexus Block
RecruitingPhase 4
Propofol-Ketamine Versus Sevoflurane for Laryngeal Mask Anesthesia in Pediatric Cardiac Catheterization
Propofol, Ketamine
Recruiting
Lateral QL Block vs Intrathecal Morphine for Cesarean Section
Anesthesia, Postoperative Pain
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.
Hailong Dong, MD,PhD study director
Xijing Hospital
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 Anesthesia, run by Xijing 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 6 inclusion and 8 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 15 May 2012. 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. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hailong Dong, MD,PhD (86-2984775337, hldong6@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
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 15 May 2012.