Overview

This trial is active, not recruiting.

Condition osteoarthritis, hip
Sponsor Stanford University
Start date July 2009
End date December 2013
Trial size 50 participants
Trial identifier NCT01009710, 16339, SU-07162009-3301

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model case-only
Time perspective prospective

Primary Outcomes

Measure
Anesthetic Recovery Times
time frame: 0-72 hours after surgery

Secondary Outcomes

Measure
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

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title Preoperative Cerebrospinal Fluid (CSF) Levels of Hypocretin and Recovery After Hip Surgery With Combined Spinal and General Anesthesia
Principal investigator Anthony Doufas
Trial information was received from ClinicalTrials.gov and was last updated in June 2013.
Information provided to ClinicalTrials.gov by Stanford University.