Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Measured Hypocretin Levels and Recovery After Hip Surgery

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.
 
ClinicalTrials.gov Identifier: NCT01009710
Recruitment Status : Unknown
Verified January 2017 by Anthony Doufas, Stanford University.
Recruitment status was:  Active, not recruiting
First Posted : November 9, 2009
Last Update Posted : January 18, 2017
Sponsor:
Information provided by (Responsible Party):
Anthony Doufas, Stanford University

Tracking Information
First Submitted Date November 5, 2009
First Posted Date November 9, 2009
Last Update Posted Date January 18, 2017
Study Start Date July 2009
Actual Primary Completion Date December 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: June 24, 2013)
Anesthetic Recovery Times [ Time Frame: 0-72 hours after surgery ]
recovery from anesthesia will be measured by short-term outcomes like time to tracheal extubation and response to verbal commands, as well as by psycho-vigilance testing up to 72 hours postoperatively
Original Primary Outcome Measures
 (submitted: November 6, 2009)
  • Anesthetic Recovery Times
  • Psychomotor Vigilance
  • Patient Activity and Functional Status of the Hip after surgery [ Time Frame: 6 months ]
  • Intraoperative Drug Administration [ Time Frame: 72 hours after surgery ]
Change History
Current Secondary Outcome Measures
 (submitted: June 24, 2013)
  • sensitivity to sevoflurane during inhalation induction to anesthesia, determined by bispectral index of the EEG [ Time Frame: during anesthetic induction ]
    pharmacodynamic analysis of bispectral index of the EEG response to sevoflurane
  • pain and sleepiness [ Time Frame: from 0-72 hours after surgery ]
    assessment of pain and sleepiness using the numerical rating scale (0-10) during the 72 hours postoperatively
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Measured Hypocretin Levels and Recovery After Hip Surgery
Official Title Preoperative Cerebrospinal Fluid (CSF) Levels of Hypocretin and Recovery After Hip Surgery With Combined Spinal and General Anesthesia
Brief Summary A specific group of neurons in the brain produces hypocretin, a peptide which has been established as an important regulator of sleep and wakefulness. Activation of these neurons (increased hypocretin) stabilizes wakefulness; impairing or blocking these neurons (decreased hypocretin) promotes sleep. Evidence suggests that these neurons may be involved in the hypnotic properties of several anesthetics, and play a role in the induction and emergence from anesthesia. In humans there is a considerable inter-individual variability in hypocretin levels. This study aims to investigate how hypocretin levels affect the anesthetic care and recovery of patients undergoing elective hip surgery.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Probability Sample
Study Population Patients scheduled for elective total hip arthroplasty through the Stanford Orthopedic Clinic.
Condition Osteoarthritis, Hip
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Unknown status
Estimated Enrollment
 (submitted: November 6, 2009)
50
Original Estimated Enrollment Same as current
Estimated Study Completion Date December 2018
Actual Primary Completion Date December 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:- Adult (18 years of age or older)

  • Male or female
  • Scheduled for elective total hip arthroplasty at the Stanford Orthopedic Clinic.
  • Comprehend spoken and written English Exclusion Criteria:- ASA physical status > III (patients with severe systemic disease)
  • Diagnosed psychiatric disease (except mild depression)
  • Any diagnoses CNS disease or dementia
  • History of stroke
  • History of untreated thyroid disease
  • Difficulty in airway management (ventilation and/or intubation)
  • Body Mass Index (BMI) > 35 kg/m2
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT01009710
Other Study ID Numbers SU-07162009-3301
16339
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Anthony Doufas, Stanford University
Study Sponsor Stanford University
Collaborators Not Provided
Investigators
Principal Investigator: Anthony Doufas Stanford University
PRS Account Stanford University
Verification Date January 2017