Measured Hypocretin Levels and Recovery After Hip Surgery

• Conditions: Osteoarthritis, Hip

• Registration Number: NCT01009710
• Lead Sponsor: 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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2009-07
• Study First Submitted: 2009-11-05
• Study First Submitted QC: 2009-11-06
• Study First Posted: 2009-11-09
• Primary Completion: 2013-12
• Status Verified: 2017-01
• Last Update Submitted: 2017-01-14
• Last Update Posted: 2017-01-18
• Study Completion: 2018-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 50

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

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Anesthetic Recovery Times	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

Name	Time	Method
sensitivity to sevoflurane during inhalation induction to anesthesia, determined by bispectral index of the EEG	during anesthetic induction	pharmacodynamic analysis of bispectral index of the EEG response to sevoflurane
pain and sleepiness	from 0-72 hours after surgery	assessment of pain and sleepiness using the numerical rating scale (0-10) during the 72 hours postoperatively

Trial Locations

Locations (1)

Stanford University School of Medicine; 🇺🇸 Stanford, California, United States