NCT01478906

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jul 2011

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2011

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

November 21, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 23, 2011

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2012

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2012

Completed
Last Updated

May 15, 2012

Status Verified

May 1, 2012

Enrollment Period

11 months

First QC Date

November 21, 2011

Last Update Submit

May 13, 2012

Conditions

Anesthesia

Study Arms (1)

elderly ,adult

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

18 to 80 years old ,undergo Lumbar Surgery

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Anesthesiology department of Xijing Hospital

Xi'an, Shaanxi, 710032, China

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

plasma

Study Officials

  • Hailong Dong, MD,PhD

    Xijing Hospital

    STUDY DIRECTOR

Central Study Contacts

Hailong Dong, MD,PhD

CONTACT

86-2984775337hldong6@hotmail.com

Study Design

Study Type
observational
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 21, 2011

First Posted

November 23, 2011

Study Start

July 1, 2011

Primary Completion

June 1, 2012

Study Completion

September 1, 2012

Last Updated

May 15, 2012

Record last verified: 2012-05

Locations

CN(1)