Measured Hypocretin Levels and Recovery After Hip Surgery

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.

Study Overview

• Status: Unknown
• Conditions: Osteoarthritis, Hip

• Study Type: Observational
• Enrollment (Anticipated): 50

Contacts and Locations

Study Locations

• United States
  • California
    • Stanford, California, United States, 94305
      • Stanford University School of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Patients scheduled for elective total hip arthroplasty through the Stanford Orthopedic Clinic.

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	0-72 hours after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	during anesthetic induction
pain and sleepiness	assessment of pain and sleepiness using the numerical rating scale (0-10) during the 72 hours postoperatively	from 0-72 hours after surgery

Collaborators and Investigators

• Sponsor: Stanford University

Study record dates

Study Major Dates

• Study Start: July 1, 2009
• Primary Completion (Actual): December 1, 2013
• Study Completion (Anticipated): December 1, 2018

Study Registration Dates

• First Submitted: November 5, 2009
• First Submitted That Met QC Criteria: November 6, 2009
• First Posted (Estimate): November 9, 2009

Study Record Updates

• Last Update Posted (Estimate): January 18, 2017
• Last Update Submitted That Met QC Criteria: January 14, 2017
• Last Verified: January 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis; Osteoarthritis, Hip
• Other Study ID Numbers: SU-07162009-3301; 16339