Osteoarthritis, HipNCT01009710
Measured Hypocretin Levels and Recovery After Hip Surgery
An observational study of Osteoarthritis, Hip, run by Stanford University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Osteoarthritis, Hip
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2009to Dec 2018
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients scheduled for elective total hip arthroplasty through the Stanford Orthopedic Clinic.
Who may be able to join
- 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
Show all 9Show fewer
- History of untreated thyroid disease
- Difficulty in airway management (ventilation and/or intubation)
- Body Mass Index (BMI) > 35 kg/m2
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
Stanford University School of Medicine
Stanford, California, 94305
About this study
Official title: Preoperative Cerebrospinal Fluid (CSF) Levels of Hypocretin and Recovery After Hip Surgery With Combined Spinal and General Anesthesia
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.
- Conditions
- Osteoarthritis, Hip
- Medical subject headings
- Osteoarthritis, Hip
What is being measured
The primary outcome is the main question the study is designed to answer.
Anesthetic Recovery Times
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
Measured: 0-72 hours after surgery
Secondary outcomes (2)
sensitivity to sevoflurane during inhalation induction to anesthesia, determined by bispectral index of the EEG
pharmacodynamic analysis of bispectral index of the EEG response to sevoflurane
Measured: during anesthetic induction
pain and sleepiness
assessment of pain and sleepiness using the numerical rating scale (0-10) during the 72 hours postoperatively
Measured: from 0-72 hours after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2009 (estimated)
- Study startJul 2009
- Primary completionDec 2013
- Study completionDec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteoarthritis, HipStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe sponsor's other registered studies.
- 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
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Anthony Doufas, Stanford University
- Investigators
- Anthony Doufas, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01009710
- Sponsor's protocol ID
- SU-07162009-3301
- Other IDs
- 16339
- Status last verified
- Jan 2017
- First submitted
- 5 Nov 2009
- Last updated
- 18 Jan 2017
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preoperative Cerebrospinal Fluid (CSF) Levels of Hypocretin and Recovery After Hip Surgery With Combined Spinal and General Anesthesia
- ClinicalTrials.gov ID
- NCT01009710
- Acronym / sponsor ID
- SU-07162009-3301
- Conditions
- Osteoarthritis, Hip
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Study start
- Jul 2009
- Primary completion
- Dec 2013 (actual)
- Study completion
- Dec 2018 (estimated)
- First posted
- 9 Nov 2009 (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.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients scheduled for elective total hip arthroplasty through the Stanford Orthopedic Clinic.
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (0 listed)
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
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
2 secondary outcomes
sensitivity to sevoflurane during inhalation induction to anesthesia, determined by bispectral index of the EEG
Time frame: during anesthetic induction
pain and sleepiness
Time frame: from 0-72 hours after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jan 2017.
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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.
Anthony Doufas principal investigator
Stanford University
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 Osteoarthritis, Hip, run by Stanford University at 1 site in United States.
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 9 inclusion and 0 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 18 Jan 2017. 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 United States. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Anesthetic Recovery Times (time frame: 0-72 hours after surgery). It is what the study was designed to measure, not a finding.
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 18 Jan 2017.