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

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.

Condition or disease
Osteoarthritis, Hip

Layout table for study information
Study Type : Observational
Estimated Enrollment : 50 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Preoperative Cerebrospinal Fluid (CSF) Levels of Hypocretin and Recovery After Hip Surgery With Combined Spinal and General Anesthesia
Study Start Date : July 2009
Actual Primary Completion Date : December 2013
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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

  2. 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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients scheduled for elective total hip arthroplasty through the Stanford Orthopedic Clinic.
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

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 ClinicalTrials.gov identifier (NCT number): NCT01009710


Locations
Layout table for location information
United States, California
Stanford University School of Medicine
Stanford, California, United States, 94305
Sponsors and Collaborators
Stanford University
Investigators
Layout table for investigator information
Principal Investigator: Anthony Doufas Stanford University
Layout table for additonal information
Responsible Party: Anthony Doufas, MD, PhD, Stanford University
ClinicalTrials.gov Identifier: NCT01009710    
Other Study ID Numbers: SU-07162009-3301
16339
First Posted: November 9, 2009    Key Record Dates
Last Update Posted: January 18, 2017
Last Verified: January 2017
Additional relevant MeSH terms:
Layout table for MeSH terms
Osteoarthritis, Hip
Osteoarthritis
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases