Difference of Plasma Orexin A Levels Between Elderly and Young Patients at Emergence

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01478906
Recruitment Status : Unknown
Verified May 2012 by Xijing Hospital.
Recruitment status was:  Recruiting
First Posted : November 23, 2011
Last Update Posted : May 15, 2012
Information provided by (Responsible Party):
Xijing Hospital

Brief 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.

Condition or disease

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 Type : Observational
Estimated Enrollment : 40 participants
Time Perspective: Prospective
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
Study Start Date : July 2011
Estimated Primary Completion Date : June 2012
Estimated Study Completion Date : September 2012

elderly ,adult

Biospecimen Retention:   Samples Without DNA

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
18 to 80 years old ,undergo Lumbar Surgery

Inclusion Criteria:

  1. Participant is Adult (≥18 years old )
  2. Participants with a Body Mass Index (BMI) 20-25 kg/m2 at the prestudy (screening) visit.
  3. Participants with ASA physical status Ⅰor Ⅱ
  4. Participants with Heart function rating Ⅰor Ⅱ
  5. Glucose of patients is lower than 8 mmol/L
  6. patients will undergo elective lumbar surgery

Exclusion Criteria:

  1. Participant is a pregnant woman or a nursing mother.
  2. Participants have a history of narcotics allergic reactions
  3. indices of liver or kidney function is twice higher than normal
  4. Participants have a history or diagnosis of depression
  5. Participants have a history of Brain Trauma
  6. Participants have a history of narcotics addiction or drug addiction
  7. Participants have a history or diagnosis of adrenal gland diseases
  8. Participants or his family have an International Classification of Sleep Disorders diagnosis of OSA

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01478906

Contact: Hailong Dong, MD,PhD 86-2984775337

China, Shaanxi
Anesthesiology department of Xijing Hospital Recruiting
Xi'an, Shaanxi, China, 710032
Contact: Zhihua Wang, postgraduate    86-2984775343   
Principal Investigator: Hailong Dong, MD,PhD         
Sponsors and Collaborators
Xijing Hospital
Study Director: Hailong Dong, MD,PhD Xijing Hospital

Responsible Party: Xijing Hospital Identifier: NCT01478906     History of Changes
Other Study ID Numbers: mzk2010orexin
First Posted: November 23, 2011    Key Record Dates
Last Update Posted: May 15, 2012
Last Verified: May 2012